NOVARTIS PHARMACEUTICALS CORPORATION v. GRIFFIN (2026)

ORDER

This case concerns Act 630, a statute enacted in the 2025 Regular Session of the State of Arkansas's 95th General Assembly.¹ Among other things, Act 630 curtails pharmaceutical manufacturers' ability to maintain drug distribution networks that do not include pharmacies with physical locations in Arkansas.² Plaintiff Novartis Pharmaceuticals Corporation—a major pharmaceutical manufacturer that limits distribution of a subset of its drugs—filed a Complaint in June of 2025 challenging Act 630.³ In this Complaint, Novartis sued the Arkansas Attorney General, the President of the Arkansas Board of Pharmacy, the Vice President/Secretary of the Arkansas Board of Pharmacy, and other members of the Arkansas Board of Pharmacy.⁴ Each defendant is sued in his or her official capacity.⁵

Novartis claims that Act 630 violates the Dormant Commerce Clause doctrine and is preempted by federal law.⁶ Accordingly, Novartis wants this Court to—ultimately—invalidate Act 630.⁷ While its claims are being adjudicated, however, Novartis wants this Court to issue a preliminary injunction to pause enforcement of Act 630.⁸ It is this preliminary injunction request that is the subject of today's Order.⁹ And, for the reasons stated below, the Court GRANTS Novartis's request.¹⁰

I. FACTUAL BACKGROUND

Some background on drug distribution in the United States is necessary to understand the legal issues in this case. Each day, people across the country obtain prescription drugs. From one perspective, this process is (typically) pretty simple. A doctor sends a prescription for a particular drug to a pharmacy; the pharmacy fills that prescription; the patient drives to the pharmacy; and within a short time, the patient picks up the drug. But underlying this relatively simple process is a complex chain that gets the drug to the pharmacy in the first place.¹¹ This process of getting a drug from a manufacturer into the hands of a patient involves a web of different industry players, distribution channels, and regulations—all designed to ensure patients can access prescription drugs safely and efficiently.¹² The drug distribution process lies at the heart of the issues in this case.

A. THE DRUG DISTRIBUTION PROCESS

Manufacturers, like Novartis, research, develop, and produce drugs to treat a variety of health conditions.¹³ There are several ways that those drugs end up in a patient's hands.¹⁴ Some drugs may be dispensed to patients at a local pharmacy (like Smith Family Pharmacy in Conway) or a national chain pharmacy (like CVS or Walgreens).¹⁵ Other drugs are dispensed to patients at their doctor's office or a hospital.¹⁶ And others may only be available through specialty pharmacies or health centers that have special expertise in handling and administering those drugs.¹⁷

With respect to the drug distribution process, places like retail pharmacies, hospitals, and specialty pharmacies are known as dispensers—because they actually dispense drugs to patients.¹⁸ Manufacturers rarely sell drugs directly to these dispensers.¹⁹ Instead, manufacturers sell their drugs to intermediary wholesale distributors who, in turn, resell them to dispensers.²⁰ And because manufacturers contract with such distributors for the sale of drugs on a nationwide basis,²¹ the contracts are, generally speaking, “not ․ particular to any state.”²²

The contracts between manufacturers and wholesale distributors are centered around the type of drug being distributed.²³ Negotiating these contracts starts with the manufacturer identifying a distribution strategy.²⁴ According to Novartis, the broader goal of the strategy is to maximize patient access while still ensuring that the drugs at issue are administered safely, effectively, legally, and in a way that best meets the needs of that drug's patients.²⁵ But the specific strategies used to accomplish that broader goal inevitably vary from drug to drug.²⁶

To select an appropriate distribution strategy for a drug, manufacturers like Novartis must consider the characteristics of the drug and the patients receiving the drug.²⁷ Generally, there are two forms of drug distribution strategies for manufacturers to select from: wide distribution and limited distribution.²⁸ Wide distribution usually entails broad distribution of a certain drug without many restrictions.²⁹ That form of distribution is ideal for drugs with broad patient populations and those that are easily stored, easily administered, and pose limited safety risks.³⁰ Industry players may use the term “open distribution network” when describing the resulting unrestricted access that manufacturers provide through wide distribution.³¹ To form a completely open distribution network, a manufacturer could sell its drug through one or more nationwide full-line wholesale distributors—the type of distributors who focus on wide distribution and primarily sell to retail pharmacies.³² And the manufacturer can (and often does) allow those distributors to sell the drug to whomever they want down the distribution chain.³³

Alternatively, a manufacturer may determine that a drug is more suited for limited distribution.³⁴ Manufacturers often choose to limit distribution for orphan drugs (drugs with small patient populations) and for specialty drugs (drugs that treat complex medical conditions, require extra handling because of their formulation, or carry increased risk of adverse effects).³⁵ Limited distribution of these drugs ensures that the entities who dispense them can (1) meet more intensive requirements for storage and handling, and (2) provide the necessary heightened care for patients that come along with these drugs.³⁶ Whereas a wide distribution strategy creates an open distribution network, limited distribution creates what can be called a “limited distribution network.”³⁷

To be frank about it, “limited distribution” and “limited distribution networks” are somewhat elusive terms.³⁸ Technically, anything less than a fully open distribution network could be classified as limited distribution.³⁹ And manufacturers can limit distribution of their drugs in several ways and to various degrees, with or without intending to do so.⁴⁰ First, a manufacturer may restrict the type of dispenser that is permitted to buy a drug from a distributor.⁴¹ In this way, a manufacturer could completely bar pharmacies from receiving a specific drug or limit distribution of a drug to only one type of dispenser like hospitals.⁴² Or, instead of barring an entire class of dispensers, manufacturers may set specific criteria for selecting within a class of dispensers.⁴³ Both of these dispenser-based restrictions are typically written into the terms of contracts between manufacturers and distributors.⁴⁴

Second, a manufacturer's choice of distributor may itself limit distribution directly or indirectly.⁴⁵ As for direct (i.e., intended) limitations, if a manufacturer chooses to distribute a drug through a specialty distributor—a distributor who focuses on distributing specialty drugs and supplies a smaller network of dispensers than a full-line distributor does—many retail pharmacies will not have access to the drug.⁴⁶ That's because retail pharmacies do not typically deal directly with specialty distributors.⁴⁷ More indirectly, a manufacturer's selection of a distributor may inadvertently create a limited distribution situation.⁴⁸ Think about a manufacturer that contracts with a distributor that imposes its own volume or credit requirements on the dispensers to which it is willing to sell.⁴⁹ Those requirements—which have nothing to do with the distributor's contract with the manufacturer—may screen out certain dispensers and therefore result in limited distribution.⁵⁰

Third, a manufacturer may bypass distributors altogether and sell a drug directly to a select specialty pharmacy (or other particular dispensers that focus on specialty drugs).⁵¹ Specialty pharmacies are not like your local pharmacy. These pharmacies “focus on high-cost, high touch [drugs] for patients with complex disease[s]” and offer “a high level of patient monitoring and more clinical support than a traditional pharmacy” provides.⁵² These pharmacies typically rely extensively on mail delivery to send their drugs to patients—rather than having physical locations where drugs can be picked up—because keeping inventory of these drugs in myriad locations with only a few patients in the vicinity (or no patients in the area at all) is inefficient.⁵³ If a manufacturer chooses to sell directly and exclusively to one of these specialty pharmacies—or, let's say, to a nationwide network of oncology clinics—the drug will not be accessible to more traditional dispensers like local pharmacies and hospitals.⁵⁴

According to Novartis, limited distribution networks serve many purposes.⁵⁵ For one thing, a manufacturer may choose limited distribution to improve patient outcomes for a certain drug.⁵⁶ To illustrate this concept, Novartis points to its limited distribution scheme for its leukemia drug SCEMBLIX.⁵⁷ Novartis says that that the effectiveness of SCEMBLIX, like all orally-administered cancer treatments, depends on patients taking the drug consistently and as prescribed.⁵⁸ Novartis also says that drugs like SCEMBLIX, which are taken in an outpatient setting, pose a serious risk that patients will not correctly follow Novartis's prescribed regimen or will abandon treatment altogether.⁵⁹ Novartis, therefore, will limit distribution of these drugs to pharmacies that specialize in dispensing such oral oncolytics, have experience managing such barriers to effective treatment, and have the resources to provide additional services that limit the corresponding risks.⁶⁰ These pharmacies, in turn, provide Novartis with data that identify barriers to treatment and help Novartis improve the way it delivers drugs like SCEMBLIX.⁶¹

Overall, limiting drugs to certain pharmacies is a way for Novartis to promote consistency, get more accurate and frequent data, and improve the effectiveness of its drugs.⁶² This is particularly true of specialty pharmacies and providers who have enhanced data capabilities and can “offer manufacturers more and better quality safety and patient experience data.”⁶³ And, as an added benefit, consolidating distribution to certain pharmacies or providers builds those providers' expertise in dispensing that particular drug, which in turn leads to better patient outcomes.⁶⁴

In a similar vein, Novartis explains that some drugs have particular handling and storage requirements to be effective.⁶⁵ Accordingly, manufacturers limit their distribution to dispensers that are capable of meeting those handling and storage requirements.⁶⁶ Consider Novartis's drug KISQALI. According to Novartis, KISQALI treats metastatic breast cancer and is an example of a high-cost drug that has special handling and storage requirements.⁶⁷ Because it is an expensive drug, retail pharmacies are not incentivized to store KISQALI.⁶⁸ Instead, pharmacies often use a mail carrier or courier delivery system to get drugs to a patient (sometimes overnight if necessary).⁶⁹ Pharmacies that are experienced in drugs like KISQALI also attempt to avoid patients having to get their drugs urgently by monitoring prescriptions, allowing patients to refill drugs before their last prescription runs out, and reaching out to physicians and patients when prescriptions are running low.⁷⁰

Other drugs are so patient-specific that they cannot be widely distributed.⁷¹ As an example, Novartis highlights its drug KYMRIAH, which it says is used to treat rare cancers.⁷² According to Novartis, KYMRIAH must be produced on a patient-by-patient basis because it is created using a patient's own white blood cells.⁷³ This drug is shipped directly to oncology providers—think cancer treatment centers whose medical staff treat cancer patients—who directly administer the drug (by way of an intravenous infusion) to a patient.⁷⁴ Therefore, wide distribution of this product to pharmacies is not possible.⁷⁵

B. FEDERAL REGULATION OF DRUG DISTRIBUTION

Sometimes, limited distribution is less a strategy than it is a way to comply with federal law.⁷⁶ National drug distribution is a heavily regulated industry.⁷⁷ Indeed, every drug that is marketed in interstate commerce must be approved by the Food and Drug Administration as “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof ․”⁷⁸ That is, the FDA can only approve a drug as safe if its “probable therapeutic benefits ․ outweigh its risk of harm.”⁷⁹

Some drugs easily meet the standard. Some drugs have no hope of meeting the standard. And some drugs can meet the standard only with a little help.⁸⁰ As to this third bucket of drugs, Congress has given the FDA the power to require the manufacturer to propose, and then to carry out, “a risk evaluation and mitigation strategy” (or REMS for short) that will make the drug safe enough for FDA approval.⁸¹ If the FDA approves a drug for which it has required REMS, the manufacturer must comply with that REMS.⁸²

The REMS required by the FDA can, depending on the drug, be pretty onerous. For example, Congress authorizes the FDA to require, in certain circumstances, that REMS “include such elements as are necessary to assure safe use of the drug ․ because of [the drug's] inherent toxicity or potential harmfulness ․”⁸³ Such elements—known as Elements to Assure Safe Use (or ETASUs for short)—may be required if the FDA determines that (1) “the drug ․ has been shown to be effective, but is associated with a serious adverse drug experience,” (2) the drug “can be approved only if ․ such elements are required as part of such strategy to mitigate a specific serious risk listed in the labeling of the drug[,]” and (3) other more general REMS elements “are not sufficient to mitigate such serious risk.”⁸⁴ ETASUs for a particular drug could be, among other things, (1) that those who dispense the drug in question are specially certified, (2) that the drug can only be dispensed in certain medical settings (like hospitals), and (3) that the drug be dispensed to patients with certain confirmatory documents like lab results.⁸⁵

The biggest takeaway here is that sometimes the approved REMS (and embedded ETASUs) explicitly compel a manufacturer to limit distribution of a drug to a certain type of dispenser.⁸⁶ But even when the need to limit distribution is not explicit, the applicable REMS/ETASUs can make it infeasible for a manufacturer to offer fully open distribution of a drug. This is especially true because manufacturers must, under the law, continually assess any approved REMS.⁸⁷ Pursuant to their continual duty, manufacturers are required to submit periodic assessments (as specified in a drug's REMS) so that the FDA can determine whether the REMS needs to be modified.⁸⁸ Mandatory assessments may come with mandatory additional data reporting requirements.⁸⁹ Manufacturers are responsible for collecting and reporting this data.⁹⁰

Accordingly, if there are data reporting requirements, a manufacturer must ensure that dispensers that receive these drugs are capable of gathering the appropriate data necessary for the manufacturer to comply with its periodic assessment responsibilities.⁹¹ That's because, regardless of who in the distribution chain failed to obtain the correct data, the manufacturer is the one ultimately on the hook for not complying with a REMS.⁹² A manufacturer who has not complied with a REMS for a particular drug, including periodic assessments, cannot market a drug while it is out of compliance.⁹³ Doing so could result in serious civil monetary penalties of up to $250,000 per violation and up to $1,000,000 for a single proceeding encompassing these violations.⁹⁴

According to Novartis, the drug FABHALTA is an example of a drug that necessitates limited distribution to comply with federal law.⁹⁵ Novartis says that FABHALTA provides therapeutic benefits in treating rare blood and kidney disorders, but its use also gives rise to a risk of serious infection.⁹⁶ Thus, for FABHALTA to gain approval from the FDA—and then maintain that approval—Novartis had to (and has to) market the drug under a REMS that contains several ETASUs.⁹⁷ These ETASUs are geared toward reducing FABHALTA's risk of infection.⁹⁸ They require limited distribution because only dispensers who are certified to meet FABHALTA's REMS requirements can dispense the drug.⁹⁹ Specifically, the ETASUs require that “[h]ealth care providers who prescribe FABHALTA are specially certified under 505-1(f)(3)(A)” and that “[p]harmacies that dispense FABHALTA are specially certified under 505-1-(f)(3)(B).”¹⁰⁰

Even putting aside the special certification issues, the significant data collection and reporting requirements associated with FABHALA's REMS will inevitably make a limited distribution scheme the right (or really the only) choice for Novartis.¹⁰¹ Novartis explains that, to make its collection and reporting efforts feasible, dispensers certified to dispense FABHALTA will have to install data feeds that include IT infrastructure with testing and validation capabilities.¹⁰² These data feeds are important to provide Novartis with daily information on REMS compliance and other patient-specific data,¹⁰³ much of which corresponds with specific metrics that Novartis must later report to the FDA as part of its compliance with FABHALTA's REMS obligations.¹⁰⁴ Certified dispensers must also agree to regular audits.¹⁰⁵ Given all this, it is not surprising that Novartis says its process for vetting and qualifying pharmacies is both time-consuming (taking weeks or months) and labor intensive (requiring work with pharmacies and external vendors).¹⁰⁶

But this front-end work is only the beginning for dispensers of specialty drugs like FABHALTA. These drugs also come with specific dispensing requirements—stated in the REMS—with which dispensers must comply.¹⁰⁷ In the case of FABHALTA's REMS, dispensing pharmacies must verify that the drug was prescribed by a certified prescriber and collect the patient's vaccination history.¹⁰⁸ If the patient has not received the required vaccinations (i.e., the meningococcal and pneumococcal vaccines) but needs FABHALTA urgently, the pharmacy must, prior to dispending the first dose of FABHALTA, ensure that the patient has verified that he or she has taken a specific antibiotic regimen.¹⁰⁹ Additionally, in situations where the vaccine prerequisites were not successfully verified before the first dose of FABHALTA was dispensed, the pharmacy must assess the patient's vaccination status (and/or antibiotic regime status) before dispensing subsequent doses.¹¹⁰

The foregoing is not an exhaustive catalogue of the express and implicit ways in which REMS and ETASUs (and thus more generally the FDA oversight process) can operate to directly or indirectly limit distribution networks. But it is sufficient for providing the necessary background to understand the legal issues addressed in today's Order. Any more would be overkill.

C. CRITICISM OF LIMITED DISTRIBUTION NETWORKS

Limited distribution networks are not universally praised. Far from it. Consider the testimony of Dr. John Kirtley, the executive director of the Arkansas Board of Pharmacy.¹¹¹ Dr. Kirtley acknowledges that limited distribution networks are helpful (and even necessary) in some instances.¹¹² But Dr. Kirtley asserts these networks can come with real costs. In his time at the Arkansas Board of Pharmacy—which spans 21 years and includes 14 years as Executive Director—he has received numerous complaints about the downstream effects of limited distribution.¹¹³

According to Dr. Kirtley, Arkansas dispensers (e.g., pharmacies, hospitals, and medical centers) are being cut off from direct access to medications for patients who are physically present in their facilities.¹¹⁴ Patients have complained about lack of access to medications.¹¹⁵ Dr. Kirtley estimates that the Board receives roughly two to three complaints per year from patients about lack of access to specific limited distribution drugs.¹¹⁶ And it's not just patient complaints. Dr. Kirtley notes that the Board has fielded various complaints in the last couple of years (even after Act 630 was passed) from (primarily) three major providers: Highlands Oncology, CARTI Cancer Center, and University of Arkansas Medical Sciences or UAMS.¹¹⁷ Those facilities have expressed frustration that they have been unable to access certain drugs.¹¹⁸

For example, Dr. Kirtley asserts that UAMS has not been able to access certain drugs because manufacturers bar UAMS from applying for entry into their REMS system for those drugs.¹¹⁹ Adam Head, the CEO of CARTI Cancer Center in Little Rock, Arkansas, has voiced similar concerns with limited distribution networks.¹²⁰ In his Declaration, he explains that CARTI regularly encounters barriers caused by limited distribution networks that restrict access to certain drugs to a small list of pharmacies (sometimes one pharmacy) selected exclusively by the manufacturer of that drug.¹²¹ The result is that CARTI's cancer patients face significant delays, out-of-pocket costs, and may possibly not be able to obtain treatment at all.¹²² Mr. Head says that these delays affect the prognosis of CARTI's patients who have serious and time-sensitive conditions like cancer.¹²³ According to him, “[t]his [limited distribution] system prioritizes manufacturer control over patient care and imposes unjustifiable burdens on cancer patients and their families.”¹²⁴

Dr. Stephen Carroll, an Arkansas-based pharmacist and co-owner of AllCare Specialty Pharmacy in Little Rock, provides a more recent concrete example of how limited distribution has impacted Arkansas pharmacies.¹²⁵ Dr. Carroll operates a specialty pharmacy that focuses on specialty and limited distribution drugs, including many of Novartis's drugs.¹²⁶ AllCare Specialty Pharmacy does not rely on common carriers.¹²⁷ Instead, its employees deliver drugs directly to patients.¹²⁸ It also provides a variety of other similar customer services.¹²⁹

On October 31, 2025, Dr. Carroll attempted to order KISQALI, a Novartis drug used to treat metastatic breast cancer.¹³⁰ This order was nothing new. In fact, AllCare Specialty Pharmacy had been dispensing KISQALI since 2017 when KISQALI came to market.¹³¹ The pharmacy had provided the medication for about 21 patients.¹³² This time, however, Dr. Carroll was told by his wholesale account representative that KISQALI would no longer be available to AllCare Specialty Pharmacy.¹³³ (The record does not clearly indicate why KISQALI was no longer available to AllCare Specialty Pharmacy.)¹³⁴ Although Dr. Carroll's patient obtained the drug through samples kept on hand at that patient's physician's office, Dr. Carroll is “very concerned about Novartis taking away [KISQALI] from an accredited specialty pharmacy that provides same-day access to medications to patients located anywhere in Arkansas.”¹³⁵ Dr. Carroll notes that this has distressed many of his patients, who he claims “must [now] get their medication from a mail-order pharmacy rather than a qualified local specialty pharmacy who they are familiar with and who have cared for them for years.”¹³⁶

D. ACT 630 137

Enter Act 630, titled “An Act to Prohibit Pharmaceutical Manufacturers from Restricting or Limiting Prescription Medications to a Limited Distribution Network of Out-of-State Pharmacies ․”¹³⁸ Act 630 begins with a legislative findings section.¹³⁹ According to these findings, “[i]t is beneficial” to the State of Arkansas to have a pharmaceutical market that (1) “ensures that patients can access safe and effective prescription medications with same day access[,]” and (2) gives patients “freedom of choice to utilize local trusted medication experts and state-based local pharmacists who support patients with advice and guidance for safe and effective use of these medications.”¹⁴⁰

The General Assembly's legislative findings explain the problem to be addressed by the Act as follows:

It may cause harm to patients in [Arkansas] when local pharmacies, clinics, and hospitals are unable to access prescription medications from pharmaceutical manufacturers or pharmaceutical wholesalers due to out-of-state limited distribution to pharmacies utilizing: [1] Pharmacy benefits manager-affiliated mail order pharmacies; [2] Publicly traded corporation pharmacies; [3] Pharmaceutical manufacturer-affiliated mail order pharmacies; [4] Insurance company-affiliated mail order pharmacies; or [5] Pharmaceutical wholesaler-affiliated mail order pharmacies ․141

Echoing the concerns of some dispensers in Arkansas, the legislative findings adopted by the General Assembly take note that “[t]he reasons for the limited distribution networks by pharmaceutical manufacturers are not often disclosed or may not operate with optimal patient safety and same day patient access in mind ․”¹⁴² And the findings criticize the current prescription medication supply chain as “complex and lack[ing] transparency ․”¹⁴³ Ultimately, the General Assembly finds that “more transparency and oversight” with regard to “limited distribution medications would” (1) “[p]rotect patients with better and more stable prescription drug inventory for both immediate and long-term patient care needs” and (2) “[b]etter respond to future national security threats and natural disasters in [Arkansas].”¹⁴⁴

After setting out these findings, Act 630 moves on to its operative provisions. In this regard, Act 630 has two major provisions: subsections (c)(1) and (d).

i. SUBSECTION (c)(1) OF ACT 630

The Court turns first to subsection (c)(1) of Act 630. Here's how that subsection reads word for word.

(c)(1) A pharmaceutical manufacturer or a pharmaceutical manufacturer for Medicaid that expects for its prescription medications to be eligible, considered for payment, and covered in a state government and public plan sponsor for health benefit plans:

(A) Shall have an active wholesale distributor permit active and in good standing with the Arkansas State Board of Pharmacy under § 20-64-505; and

(B) Shall not restrict or limit prescription medications more than three (3) months after a launch of a new product to a limited distribution network of pharmacies without having similar access and allowing for upon request or application by a pharmacy at least:

(i) A local network of public institution academic medical center access;

(ii) Geographic diversity of access within the state;

(iii) Diverse access for local for-profit and nonprofit pharmacies in good standing with the board and that have experience or accreditation in managing expensive specialty or limited distribution medications; and

(iv) The pharmacy meeting medication specific United States Food and Drug Administration guidance or requirements for:

(a) Proper and safe storage, handling, monitoring, and drug delivery;

(b) Patient or medication data collection, monitoring, or reporting; and

(c) Patient management services.145

This portion of the Act places two restrictions on pharmaceutical manufacturers. First, under subsection (c)(1)(A), pharmaceutical manufacturers that wish to sell their drugs in Arkansas must be licensed under the same licensing scheme as wholesale distributors. Second, under subsection (c)(1)(B), certain requirements are placed on manufacturers that wish to use a limited distribution network for longer than three months after the launch of a new drug. The nature and scope of these (c)(1)(B) requirements are both hotly contested by the parties and relevant to the legal analysis of several of Novartis's claims. So the Court has spent considerable time and effort on interpretating subsection (c)(1)(B).

Before diving headlong into that statutory interpretation, however, it is important for us all to remember that Act 630 is an Arkansas statute. Accordingly, the interpretation of Act 630 should be governed by the methods of statutory interpretation used by the Arkansas Supreme Court.¹⁴⁶ After all, that court has the last word on the meaning of Arkansas statutes.¹⁴⁷

For a long time, the Arkansas Supreme Court clung to the now-fairly-discredited proposition that “[t]he basic rule of statutory construction to which all other interpretive guides must yield is to give effect to the intent of the legislature.”¹⁴⁸ Today, however, the court's pronouncements on statutory interpretation have shifted towards an approach that focuses more seriously on the text of the statute at issue. At first, the change was somewhat subtle—retaining the idea that determining the intent of the legislature was the lodestar, but adding that “[w]here the language of a statute is plain and unambiguous, this court determines legislative intent from the ordinary meaning of the language used.”¹⁴⁹ Then, in a more recent case, the Arkansas Supreme Court dropped the legislative-intent verbiage entirely, explaining that the court “construe[s] statutes just as they read, giving the words their ordinary and usually accepted meaning in common language.”¹⁵⁰ And this was no mere oversight, as the dissent—which was specifically about legislative intent—used the exact legislative-intent verbiage that the majority opinion omitted.¹⁵¹ The Arkansas Supreme Court's evolution concerning statutory interpretation is consistent with the broader movement in American law towards emphasizing the actual text enacted into law and deemphasizing the supposed intent a legislature had when enacting the text.¹⁵²

At this point, the Court believes that the Arkansas Supreme Court's approach to statutory interpretation is, in substance, the same as the federal judiciary's approach. The lodestar—that is, the thing we are trying to figure out—is what the actual words of a statute would have meant to a reasonable, informed citizen at the time of its enactment.¹⁵³ And there are only extremely limited circumstances where legislative intent is allowed to play any role in that analysis. That is, if two equally likely interpretations of a statute remain after every other tool of statutory interpretation has been exhausted, legislative intent might be a permissible way of resolving this real 50-50 ambiguity.¹⁵⁴ But legislative intent cannot be used to justify an impermissible reading of a statute, and legislative intent should not be used to elevate a less likely reading of the statutory text over a more likely reading of it.¹⁵⁵ Nor can legislative intent be used to effectively rewrite a statute in an effort to make the statute better align with the legislative intent.¹⁵⁶

There is a quirk to all this. Sometimes a legislature will expressly and clearly write its legislative intent into the actual law it enacts. When this occurs, the enacted intent section is of course considered when interpreting other sections of the statute.¹⁵⁷ That is because we do not interpret statutory language in a vacuum, but rather as whole.¹⁵⁸ Still, even in these circumstances, legislative intent must be used with caution and not for more than it is worth. It cannot be used as an expedient for or alternative to serious textual statutory interpretation.¹⁵⁹

With all of these interpretive rules in mind, the best interpretation of subsection (c)(1)(B)—meaning the one that is most loyal to the subsection's text, structure, and relation to the other portions of the Act—is as follows. Subsection (c)(1)(B) only comes into play where (1) a pharmaceutical manufacturer is using a limited distribution network for longer than three months after the launch of a new drug, and (2) a dispenser with a facility in Arkansas applies to become part of the distribution network.¹⁶⁰ If such a dispenser does apply, however, (c)(1)(B) requires that the dispenser be allowed into the distribution network in any of four very different (and independent) circumstances.¹⁶¹

First, the applicant dispenser must be allowed into the distribution network if the applicant dispenser is part of “[a] local network of public institution academic medical center[s]” and the current distribution network does not yet include a local network of public institution academic medical centers.¹⁶² Second, the applicant dispenser must be allowed into the distribution network if the applicant dispenser is from a part of the state that has no representation in the current distribution network.¹⁶³ Third, unless the limited distribution network already has a good array of such dispensers, the applicant dispenser must be allowed into the distribution network if the applicant dispenser is a local for-profit or local nonprofit pharmacy in good standing with the Board of Pharmacy and has experience or accreditation in managing expensive specialty or limited distribution medications.¹⁶⁴ Finally, the applicant dispenser must be allowed into distribution network if it can meet the applicable REMS and ETASUs on (1) “[p]roper and safe storage, handling, monitoring, and drug delivery;” (2) “[p]atient or medication data collection, monitoring, or reporting;” and (3) “[p]atient management services.”¹⁶⁵

The foregoing interpretation of subsection (c)(1)(B) is the only one that makes any sense at all of the language, syntax, and structure in (c)(1)(B). The first portion of (c)(1)(B) is telling pharmaceutical manufacturers that they can't have a limited distribution network unless they do something else.¹⁶⁶ The something else is “having similar access for” or “allowing for” other dispensers in certain situations.¹⁶⁷ The second portion of (c)(1)(B) lists out those situations in the form of a numbered list.¹⁶⁸ Finally, the “and” between the third and fourth list component makes clear that the list is conjunctive rather than disjunctive.¹⁶⁹ The pharmaceutical manufacturer must give similar access to and allow for an applying dispenser to get the drug at issue so long as (1) the dispenser comes within the ambit of any category in the conjunctive list and (2) that category has not been satisfied by the current dispensers already in the limited network.¹⁷⁰

The Court acknowledges that (c)(1)(B) is—to put it politely—a difficult statutory subsection to interpret. The foregoing interpretation is certainly strained. That is because only a strained interpretation can hope to make the words on the page grammatically, syntactically, and structurally cohesive. But whatever shortcomings the Court's interpretation has, they pale in comparison to the State's suggested interpretation.

The State suggests that (c)(1)(B) simply “requires the manufacturer doing business in Arkansas pick up the phone when a specialty pharmacy in Arkansas calls, wishing to be considered for admittance into one of [the manufacturer's] limited distribution networks.”¹⁷¹ According to the State, “the manufacturer has the discretion to deny or defer a pharmacy's application” if any “one [of the] requirement[s]” in the numbered list in (c)(1)(B) is not met.¹⁷² It is only where the manufacturer denies an application for some other reason—or operates in bad faith in denying the application for a reason on the numbered list—that the manufacturer would be violating (c)(1)(B).¹⁷³

Whatever the public policy merits of the State's creative reimagining of (c)(1)(B), the State's position basically amounts to an argument not to take the words of the Act seriously. Without explicitly saying so—because, nowadays, who would—the State wants the Court to find the gestalt, or gist, or spirit, of (c)(1)(B) and rewrite the subsection to harmonize it with and thus effectuate legislative intent.¹⁷⁴ The Court declines this radical invitation.

The State's position has no basis in the text of the statute. Consider the State's position that (c)(1)(B) requires nothing more than that a manufacturer consider a request from a pharmacy in Arkansas for admission into the distribution network and base its admittance decision on factors identified in the subsection's numbered list.¹⁷⁵ How can one possibly squeeze all of that out of the “similar access” and “allowing for” language in (c)(1)(B)? You can't. And the State doesn't even try. The Court can find no place in the State's brief where the State seriously links up the language, syntax, and grammar of the text in subsection (c)(1)(b) with the State's “consideration is enough” theory.

Consider further the State's position that the manufacturer may deny entry to an applicant dispenser if even “one requirement” in the numbered list “is not met.”¹⁷⁶ That is ridiculous on its face. The first numbered category is: “A local network of public institution academic medical center access.”¹⁷⁷ On the State's view, then, any dispenser who is not part of a local network of public institution academic medical centers could always be denied on that basis alone. That doesn't even make logical sense. And the reason it makes no sense is because the numbered list is not a list of four things an applicant must prove to get into the limited network, but rather a list of four things the manufacturer must make sure it is offering if it is to have a limited distribution network.¹⁷⁸

What about the State's position that, if a pharmaceutical manufacturer denies an applicant for a reason in the numbered list in (c)(1)(B), the manufacturer is only acting unlawfully if the denial was in bad faith?¹⁷⁹ You might imagine that comes from statutory language about good-faith denials and bad-faith denials. Or at least some language about when and how the manufacturer can deny an applicant access to a limited distribution network. But you would be wrong. No such text exists in this subsection, or anywhere else in the statute. Where did the State get the concept from? Thin air, it seems.

Why is the State using all this energy to avoid the conclusion that (c)(1)(B) sets out a conjunctive list of four things the manufacturer must make sure it is offering if it is to have a limited distribution network? One reason may be that the way the list is structured strongly suggests that Act 630 requires access to the limited distribution network even for dispensers that do not meet the applicable REMS and ETASUs on (1) “[p]roper and safe storage, handling, monitoring, and drug delivery;” (2) “[p]atient or medication data collection, monitoring, or reporting;” and (3) “[p]atient management services.”¹⁸⁰ Although the State wishes to make this requirement a floor that is required of all dispenser applicants, that is simply not the way the conjunctive numbered list reads. If this is what Act 630 was trying to do, it would have put this requirement in a separate portion of the subsection as opposed to making it one of four conjunctive categories. The State admits as much.¹⁸¹ The Court is not a legislature. It can't just start isolating and moving portions of a numbered statutory list to create a new subsection that operates on all the other portions of the numbered statutory list.

Relying on the whole-text canon—without explicitly saying so—the State seeks aid and comfort from the legislative findings section of Act 630.¹⁸² According to the State, its interpretation of Act 630 is the only way to effectuate the legislative intent that the State says can be gleaned from that section of the Act.¹⁸³ But this runs headlong into two major problems. First, as the Court has explained above, the State's desired reading of subsection (c)(1)(B) is nowhere close to a permissible reading of the subsection.¹⁸⁴ Second, to the extent some legislative intent can be gleaned out of the legislative findings, it is not close to clear that the Court's interpretation of (c)(1)(B) is inconsistent with that legislative intent.¹⁸⁵

ii. SUBSECTION (d) OF ACT 630

The second major provision is located in subsection (d). Here's the language of that provision word for word.

(d)(1)(A) A pharmaceutical manufacturer or a pharmaceutical manufacturer for Medicaid that requests for restricted networks for six (6) months or longer shall present the request to the board to explain how the restriction will support and not hinder the mission of the board to promote, preserve, and protect the public health, safety, and welfare of citizens of this state.

(B) The request under subdivision (d)(1)(A) of this section shall not be effective until the request is approved by the board.

(2)(A) When considering the request under subdivision (d)(1)(A) of this section, the board may consider the following factors for a request of a limited network:

(i) Costs;

(ii) Logistics;

(iii) Patient caseload;

(iv) The rarity of the prescription drug that is used;

(v) The rarity of the disease or condition; and

(vi) Any other factors unique or relevant to the medication and disease or condition treated.

(B) The limited network shall allow some pharmacies in this state, upon request or application, to participate and access the medications to meet the needs of patients with same day access in this state without requiring patients to use out-of-state or in-state common mail carriers for access.

(3) The board may issue a temporary waiver or temporary limited use allowance for utilization, payment, or coverage of prescription drugs from a pharmaceutical manufacturer or a pharmaceutical manufacturer for Medicaid for coverage and payment for a state government and public plan sponsor for a health benefit plan to protect public health and access.

(4) A public hearing of the board shall be called as soon as possible to discuss and approve or deny any request for a permanent limited network or restriction relating to state-based Class A pharmacies with retail permits in good standing with the board.186

This provision explains that manufacturers who wish to maintain “restricted networks for six (6) months or longer” must “present [a] request to the [Board of Pharmacy] to explain how the restriction will support and not hinder the mission of the [Board of Pharmacy] to promote, preserve, and protect the public health, safety, and welfare of citizens of [Arkansas].”¹⁸⁷ Regardless of when the request is made, a manufacturer may not use a particular limited distribution network for six months or longer until the Board of Pharmacy approves the use of such network.¹⁸⁸

Under subsection (d)(2)(A), the Board must consider a variety of factors when choosing to approve or deny any limited distribution network lasting six months or more.¹⁸⁹ But even where these factors point towards (or require) approval of a limited distribution network lasting six months or more, subsection (d)(2)(B) requires that, in order to obtain and maintain board approval, “the [requested] limited network shall allow some pharmacies in [Arkansas], upon request or application, to participate and access the medications to meet the needs of patients with same day access in [Arkansas] without requiring patients to use out-of-state or in-state common mail carriers for access.”¹⁹⁰ And “[a]ny request for a permanent limited network or restriction relating to state-based Class A pharmacies with retail permits in good standing with the board” requires a public hearing of the Borad to determine whether to approve or deny the request.¹⁹¹

The meaning of subsection (d) is generally less contested by the parties. But there is a notable exception. Consistent with its position concerning subsection (c)(1)(B), the State again contends that a manufacturer need not admit a dispenser who cannot meet the REMS and ETASUs requirements (or is otherwise unqualified to dispense specialty drugs).¹⁹² But nothing in the statutory text of subsection (d) says this. Instead, subsection (d) makes it mandatory for pharmaceutical manufacturers to “allow some pharmacies in this state, upon request or application, to participate and access the medications” at issue.¹⁹³ What happens if the only dispenser applying from Arkansas can't meet the REMS requirements? The State says the manufacturer can deny the application.¹⁹⁴ The language of the statute says otherwise. And for all of the reasons the Court just discussed with respect to section (c)(1)(B), the Court is not going to rewrite section (d)—or fudge its analysis—to reach an atextual result.¹⁹⁵

E. IMPACT ON NOVARTIS

At least with respect to section (d), Act 630 gives the Board the option to “issue a temporary waiver or temporary limited use allowance for utilization, payment, or coverage of prescription drugs from a pharmaceutical manufacturer ․”¹⁹⁶ But absent such a waiver, any manufacturer that is in any way out of compliance with Act 630—because of a violation of subsection (c)(1)(B), subsection (d), or any other part of the Act—faces two penalties: (1) loss of Arkansas Medicaid coverage for all its drugs and (2) a “fine [of] ․ ten thousand dollars ($10,000) per day of noncompliance.”¹⁹⁷ These are serious penalties, making meticulous compliance with Act 630 all the more urgent for a pharmaceutical manufacturer.

Putting aside new drugs that may come to market, Novartis estimates that twelve of its current drugs will be impacted by Act 630.¹⁹⁸ According to Novartis, one of those drugs, FABHALTA, is distributed in a limited way to comply with the drug's REMS (including any ETASUs).¹⁹⁹ Four of the twelve drugs are limited by their very nature and cannot be distributed to most retail pharmacies.²⁰⁰ The remaining seven are distributed to a select group of healthcare providers or pharmacies for various reasons—which Novartis does not specify—that purportedly align with the general reasons for limited distribution of a drug discussed in Section I.A. above.²⁰¹ To comply with Act 630, Novartis would need to renegotiate and rewrite its nationwide distribution contracts for these drugs.²⁰² It claims that this compliance could take up to six months to accomplish and consume significant unrecoverable resources.²⁰³

And, if Novartis chooses not to comply with the Act, it may face the loss of Medicaid coverage in Arkansas or face penalties of $10,000 per day of noncompliance.²⁰⁴ The loss of Medicaid coverage in Arkansas is estimated to impact all 120 of Novartis's products and come with significant financial loss.²⁰⁵ According to Novartis's 2024 numbers—which were provided to the Court back in 2025 when the Motion for a Preliminary Injunction was filed—Novartis “received approximately $28.7 million in sales to Medicaid recipients from Arkansas (net of rebates provided under the Medicaid Rebate Program).”²⁰⁶

F. PROCEDURAL HISTORY

Novartis filed its Complaint on June 24, 2025.²⁰⁷ That same day, Novartis also filed a Motion for a Preliminary Injunction, asking the Court to stop the Arkansas Board of Pharmacy (among others) from enforcing Act 630.²⁰⁸ After briefing on the issue from the parties, the Court held a hearing on January 20, 2026.²⁰⁹ The Court heard testimony from one witness, Dr. John Kirtley, and then oral arguments from the parties.²¹⁰ Novartis seeks a preliminary injunction on two grounds. First, Novartis claims that Act 630 violates the Dormant Commerce Clause doctrine.²¹¹ Second, Novartis claims that the Act is preempted by federal law.²¹² The Court need not delve into the preemption question today. That's because, as explained below, Novartis can demonstrate that Act 630 likely violates the Dormant Commerce Clause doctrine.

II. ANALYSIS

Obtaining a preliminary injunction in any case is a tall order. Indeed, such relief is extraordinary.²¹³ It demands that a plaintiff establish (1) “that [it] is likely to succeed on the merits,” (2) “that [it] is likely to suffer irreparable harm in the absence of preliminary relief,” (3) “that the balance of equities tips in [its] favor,” and (4) “that an injunction is in the public interest ․”²¹⁴ Although the third and fourth factor can get somewhat squishy, all courts agree that the likelihood of success inquiry and the irreparable harm inquiry are necessities.²¹⁵ Moreover, in a case like this one, where the Court is asked to enjoin the enforcement of a statute enacted by a democratically elected and democratically accountable branch of government, the Eighth Circuit is crystal clear that the plaintiff must show that it is “likely to prevail on the merits.”  ²¹⁶ Similarly, the Eighth Circuit is crystal clear that the plaintiff must show that irreparable harm is likely in the absence of preliminary relief.²¹⁷

A. LIKELIHOOD OF SUCCESS ON THE MERITS

The Constitution gives Congress the power “[t]o regulate Commerce ․ among the several States ․”²¹⁸ The Supreme Court has recognized that this exclusive positive grant of power to Congress also “contain[s] a further, negative command,” restricting the power of states.²¹⁹ That is, “states may not enact laws that ‘unduly restrict interstate commerce.’ ”²²⁰ This restriction, known as the Dormant Commerce Clause doctrine, “prevents the States from adopting protectionist measures and thus preserves a national market for goods and services.”²²¹ According to binding precedent, a state law violates the Constitution if the law “(1) clearly discriminates against interstate commerce in favor of in-state commerce, (2) imposes a burden on interstate commerce that outweighs any benefits received, or (3) has the practical effect of extraterritorial control on interstate commerce.”²²² In the case at bar, Act 630 overtly discriminates against interstate commerce in favor of in-state commerce.²²³

i. FACIAL DISCRIMINATION AGAINST OUT-OF-STATE PHARMACIES

Overt discrimination against interstate commerce comes in three forms: (1) facial discrimination; (2) discriminatory purpose; or (3) discriminatory effect.²²⁴ And, in the context of the Dormant Commerce Clause doctrine, the word “discrimination” “means ‘differential treatment of in-state and out-of-state economic interests that benefits the former and burdens the latter.’ ”²²⁵ Novartis asserts that Act 630 discriminates in all three forms. The Court addresses two of the three assertions.

The Court begins with facial discrimination. State laws are facially discriminatory when they expressly favor in-state residents and business over out-of-state residents and business.²²⁶ Act 630 plainly does just that. On its face, the law gives in-state pharmaceutical dispensers benefits that out-of-state dispensers do not have. The easiest way to discuss these discriminatory benefits is by dividing Act 630 into two buckets—one bucket pertaining to limited distribution networks that last for three months or longer and the other bucket dealing with limited distribution networks that last for six months or longer.

For a pharmaceutical manufacturer to maintain a limited distribution network that lasts three months or longer, the manufacturer must give “similar access” to some variety of in-state entities that include “[a] local network of public institution academic medical center[s]” and “local for-profit and nonprofit pharmacies.”²²⁷ As the Court explained earlier in this Order, this portion of the Act is only triggered when a dispenser in Arkansas applies for admittance into a limited distribution network.²²⁸ This three-month provision provides benefits to dispensers located in Arkansas that dispensers located outside of Arkansas are not given.

First, the Act requires in-state dispensers to be considered for access into limited distribution networks. Consider the differential treatment between in-state and out-of-state dispensers that are not initially a part of a particular limited distribution network.²²⁹ Act 630 gives in-state dispensers a way to avoid exclusions from a limited distribution network by requiring manufacturers to consider their application for entry into a limited distribution network.²³⁰ Out-of-state dispensers who are initially not part of the limited distribution network have no such statutorily-required opportunities for application or consideration.

Second, Act 630 requires pharmaceutical manufacturers to give a variety of in-state dispensers actual access to new drugs. It does so by mandating that manufacturers open their limited distribution networks to certain applying dispensers with physical locations in Arkansas.²³¹ And, just as excluded out-of-state dispensers are not given statutory rights to be considered for entry into limited distribution networks, they are also not given the statutorily-required access that some in-state entities will get. Furthermore, out-of-state dispensers that initially enjoyed exclusive access to the drug will lose this exclusivity because of the newly granted access to in-state dispensers.²³²

The six-month restriction in Act 630 comes with its own flavor of facial discrimination. For a pharmaceutical manufacturer to maintain a limited distribution network for six months or more, Act 630 expressly requires that “[t]he limited network shall allow some pharmacies in [Arkansas], upon request or application, to participate and access the medications to meet the needs of patients with same day access in [Arkansas] without requiring patients to use out-of-state or in-state common mail carriers for access.”²³³ Accordingly, absent a discretionary waiver, this type of limited distribution network is unlawful unless the manufacturer allows some access to applying pharmacies with physical locations in Arkansas.²³⁴ The long and short of it is that Arkansas pharmacies are given special access to limited distribution networks to which businesses with only an out-of-state physical presence do not have access.²³⁵

The State Defendants insist that this law is not facially discriminatory because “Act 630's purpose and text apply equally to all pharmaceutical manufacturers—in-state and out-of-state.”²³⁶ But the differential treatment the Court is concerned with is not the differential treatment between in-state and out-of-state pharmaceutical manufacturers. Rather, it is the differential treatment between pharmacies (or other dispensers) inside and outside of Arkansas.

It may be that the State “misspoke” and actually meant that “Act 630's purpose and text apply equally to all [pharmacies]—in-state and out-of-state.” This would be more consistent with the State's contention that, under Act 630, “there is nothing prohibiting non-locally-owned pharmacies that have a physical presence in Arkansas from applying to be a part of a limited distribution network ․”²³⁷ Indeed, the State notes that there are no residency requirements on pharmacy ownership or exclusions preventing manufacturers from doing business with out-of-state entities.²³⁸ The State's point seems to be that the Act is not concerned with whether the pharmacy or other dispenser is an in-state or out-of-state business, but rather with whether the pharmacy or other dispenser has a physical presence in Arkansas. The State maintains that “Act 630 prohibits manufacturers who do business in Arkansas from arbitrarily excluding qualified specialty pharmacies that can provide patients with in-person assistance and/or same-day access to a particular ‘specialty’ drug because of their locale.”²³⁹

The Eighth Circuit has been clear that similar laws which provide benefits and burdens based on physical presence in a state are facially discriminatory in violation of the Dormant Commerce Clause doctrine.²⁴⁰ In Jones v. Gale, the Eighth Circuit was presented with a Nebraska constitutional provision which restricted farming and ranching real-estate ownership by corporations and other partnerships.²⁴¹ But the provision contained an exception for “a corporation ․ in which the majority of the voting stock is held by members of a family ․ at least one of whom is a person residing on or actively engaged in the day to day labor and management of the farm or ranch.”²⁴² The state constitutional provision was deemed facially invalid because, “on its face,” the law “favor[ed] Nebraska residents, and people who are in such close proximity to Nebraska farms and ranches that a daily commute is physically and economically feasible for them.”²⁴³

So too here. Act 630 gives preferential treatment based on physical location (i.e., setting up shop in Arkansas is favored over operating from out-of-state). The Court acknowledges that Act 630 does not discriminate based on where a pharmacy (or other dispenser) is incorporated or has most of its stores. But that isn't dispositive. Just because Act 630 does not facially discriminate in one way doesn't mean it isn't facially discriminatory in other ways. Act 630 expressly provides benefits to pharmacies that have a physical presence in Arkansas over pharmacies that do not. Thus, physical presence in the state is the distinguishing factor that gives in-state pharmacies benefits that out-of-state pharmacies do not share.²⁴⁴ Such geographic distinctions violate the Dormant Commerce Clause doctrine because they favor in-state entities to the detriment of out-of-state entities.²⁴⁵

In a last-ditch effort during oral argument to show that Act 630 does not facially discriminate, the State proffered Paul's Industrial Garage v. Goodhue County.²⁴⁶ The State focuses on the Eighth Circuit's statement that “the dormant Commerce Clause doesn't prohibit differential treatment of companies that perform different services, because ‘any notion of discrimination assumes a comparison of substantially similar entities.’ ”²⁴⁷ In dicta, the Eighth Circuit then observed that “[s]tate and local governments are therefore free to treat vacation homes differently from primary residences,” “humane societies differently from for-profit breeders,” “and brick and mortar liquor stores differently from their online counterparts ․”²⁴⁸ At face value, these observations appear to immunize Act 630's distinction between (1) pharmacies with a physical presence in Arkansas that can provide in-person service and (2) out-of-state pharmacies with mail-order or courier-delivery service. But appearances can be deceiving.

The crux of the Eighth Circuit's point in Paul's Industrial Garage was that, “in the absence of actual or prospective competition between the supposedly favored and disfavored entities in a single market[,] there can be no local preference ․”²⁴⁹ In the case at bar, however, out-of-state pharmacies that send drugs to patients through mail-delivery are direct competitors to pharmacies with physical locations in Arkansas. Each of these two types of pharmacies would be offering the same services (supplying specialty prescription drugs) to the same patient population if accepted into a manufacturer's limited distribution network. Therefore, notwithstanding the dicta in Paul's Industrial Garage, the Dormant Commerce Clause doctrine is violated in our case by the differential treatment (based on in-state and out-of-state presence) between competitors. Act 630 unconstitutionally favors the pharmacies with physical locations in Arkansas over competitor pharmacies with facilities out-of-state.

ii. DISCRIMINATORY EFFECT

Now let's consider the discriminatory effect that Act 630 creates.²⁵⁰ Inserting a dispenser with a physical presence in Arkansas into the distribution network likely means that out-of-state dispensers in the chain will either receive less business or be crowded out altogether.²⁵¹ For example, if one or more pharmacies in Arkansas were to apply to be in the distribution network for FABHALTA, Act 630 would require at least one such pharmacy (and likely more) to be admitted into the network.²⁵² Given that there are currently eight patients in Arkansas taking FABHALTA and no current in-state dispensers, it is likely that out-of-state dispensers will lose some (if not all) of those patients.²⁵³ The effect of Act 630 (especially for specialty drugs that have few patients) is thus likely to be a shift in sales out of the hands of out-of-state pharmacies and into the hands of pharmacies with physical locations in Arkansas. The law thus “favors in-state economic interests over out-of-state interests[,]” giving pharmacies with in-state presence distinct advantages and access to an otherwise inaccessible out-of-state market for particular drugs.²⁵⁴

Here again, the State Defendants push back on this proposition by explaining that the law does not favor in-state corporations over out-of-state corporations. Rather, in their view, it applies equally to all pharmacies that are physically present in Arkansas.²⁵⁵ Further, the State is adamant that Act 630 does not require manufacturers to put pharmacies with a physical presence in Arkansas above the out-of-state pharmacies with which it already has a relationship.²⁵⁶ It just requires that pharmacies with a physical presence can get a fair chance to compete in the market if they are qualified.²⁵⁷

The State's interpretation misses the mark. As explained above, the proper comparison is not between dispensers that are incorporated in Arkansas and those who are not.²⁵⁸ Rather, the negative effect of Act 630 applies against out-of-state dispensers who are not physically located in Arkansas and already enjoy exclusivity because they are part of the limited distribution network for a certain drug. By adding in-state pharmacies to a limited network, Act 630 will likely have the effect of either (1) reducing the drug transactions that already-admitted pharmacies currently have from their exclusive agreement with Novartis or (2) crowding these out-of-state pharmacies out altogether.²⁵⁹ In the latter situation, if a drug has a very limited patient population and Novartis is forced to do business with an Arkansas-based pharmacy, it may entirely shift its distribution model to that Arkansas-based network of pharmacies or have to change its distributor altogether if the distributor does not do business with Arkansas-based pharmacies.²⁶⁰ Accordingly, the effect of Act 630 is likely discriminatory because it will likely give a competitive advantage to in-state pharmacies and thus disadvantage out-of-state pharmacies.

iii. RIGOROUS SCRUTINY

Just because Act 630 discriminates against interstate commerce in favor in-state commerce does not mean that Act 630 is invalid. Act 630 will be upheld as constitutional if those defending it “can demonstrate, under rigorous scrutiny, that they have no other means to advance a legitimate local interest.”²⁶¹ At this stage in the case, however, Defendants have not shown it's likely they will be able to meet this test. Thus, for now, it is more likely than not that Act 630 will not survive rigorous scrutiny.

To start, the purported local benefits of accessibility, safety, and freedom of choice that the State Defendants offer go no further than generalizations.²⁶² The Court has not been provided with evidence of any specific patients who were denied prompt access to a life-saving treatment because a drug had to come from out-of-state. And the State provides no example of a patient who was harmed after taking their specialty medication incorrectly because they received it from a mail-order pharmacy rather than a local pharmacy. There have been, for sure, generalized complaints about patient anxiety, delays, and frustrated providers.²⁶³ But none of these complaints amount to a concrete or widespread issue that is currently affecting the health and safety of Arkansans.²⁶⁴ Rather, many of the complaints in the record thus far amount to frustration from a few providers who are being cut out of the financial benefits of dispensing certain drugs or not being given access at all.²⁶⁵ In short, the Court is not entirely convinced that the purported local interests are anything but de minimis at this juncture.

Even assuming the proffered local benefits—accessibility, safety, and freedom of choice—are legitimate and actually advanced by Act 630,²⁶⁶ these benefits can be achieved by other readily-available, nondiscriminatory, and otherwise lawful alternatives.²⁶⁷ For one example, consider the State's desire for same-day access to drugs by Arkansas patients. The General Assembly could have passed a law that required just that. The General Assembly could have mandated that manufacturers provide same-day access to certain critical drugs for Arkansas patients. Or the General Assembly could have authorized the purchase and storage (by the State) of critical medications to ensure their availability for Arkansans in emergency situations. For a second example, consider the State's desire for Arkansans to be able to obtain drugs in-person (and thus receive in-person service from a pharmacist). The General Assembly could have passed a law requiring manufacturers to provide an option for face-to-face communication for its Arkansas patients, such as through Zoom or through a local representative.

These are just some of the plethora of more tailored alternatives that the State could have pursued to achieve the purported local benefits of Act 630.²⁶⁸ Given these and other alternatives that could have achieved the same purported local benefits, the State has not demonstrated that Act 630 is likely to pass rigorous scrutiny. Therefore, Novartis has shown (as a preliminary matter) that it is likely to prevail on the merits of its claim that Act 630 violates the Dormant Commerce Clause doctrine.²⁶⁹

B. OTHER DATAPHASE FACTORS

Having determined that Novartis is likely to succeed on the merits of its claim that Act 630 violates the Dormant Commerce Clause doctrine, the Court is left with two more factors to consider: (1) whether absent an injunction Novartis will suffer irreparable harm and (2) the merged balance of equities/public interest factor.

i. IRREPERABLE HARM

A preliminary injunction cannot issue unless it is more likely than not that the party seeking the injunction will suffer irreparable harm in its absence.²⁷⁰ Irreparable harm is a ten-cent phrase for a five-cent idea. It simply means harm that can't be compensated later.²⁷¹ And Novartis has shown that, in the absence of preliminary relief—i.e., enjoining Act 630 while the instant litigation is conducted—Novartis is likely to real harm for which it cannot later be compensated.

For one thing, Novartis would have to take steps now to ensure compliance with Act 630 on the Act's enforcement date (September 1, 2026). According to the record evidence, if Novartis wants to be in compliance with Act 630 from the outset—which it would need to be in order to avoid the significant consequences set out in subsections (e) and (f)—Novartis needs to immediately take actions that would cost money it will never be able to recoup. At a minimum, Novartis will need to renegotiate distribution contracts with wholesale distributors.²⁷² And the record evidence is uncontested that these renegotiations would cost Novartis real money.²⁷³ As Justice Scalia said in Thunder Basin Coal Co. v. Reich, “complying with a regulation later held invalid almost always produces the irreparable harm of nonrecoverable compliance costs.”²⁷⁴

But there's more. Because there is no way this litigation will be concluded by the enforcement date of Act 630, the Court also finds it appropriate to consider now any irreparable harm that will come from the Act once it is enforced. First, Novartis will be forced to comply—upon pain of severe financial penalties—with an unconstitutional statute. Precedent recognizes this as a form of irreparable harm.²⁷⁵ Second, it is likely that Novartis will be required to include in its limited network Arkansas-based pharmacies that neither have experience with specialty drugs nor meet the relevant REMS and ETASUs. (The Court has explained why this is true in its statutory interpretation section above.).²⁷⁶ This places Novartis's FDA approvals at risk.²⁷⁷ And it places patient goodwill at risk by increasing the likelihood of effectiveness or side-effect problems with Novartis's drugs.²⁷⁸ Both risks, if they came to fruition, would cause a loss of real and unrecoverable money to Novartis.

ii. BALANCE OF THE EQUITIES/PUBLIC INTEREST

There is no question that the State and public have an interest in the enforcement of a democratically enacted law.²⁷⁹ But that interest, while still quite significant, is not at full force where (as here) the Court has concluded that the state statute at issue is likely unconstitutional.²⁸⁰ In the context of this case, the Court concludes that the interest in the enforcement of a (likely unconstitutional) democratically enacted law is fairly well-countered by Novartis's interest in avoiding the harms discussed in the last section of this Order. In any event, there are also other equities and interests to be considered in the analysis.

First, as the Court explained earlier in this Order, the record does not show that there is some access-to-drugs crisis in Arkansas that is motivating this law. The record complaints from patients and pharmacies in Arkansas are small in number, weak in severity, and lacking in specificity.²⁸¹ At a grand scale, there is nothing to suggest the current drug distribution system is failing Arkansans. For certain, the State believes Act 630 would make the drug distribution system better for Arkansans. But that's a far cry from suggesting the current system is now causing harm to patients or will cause harm to patients during the pendency of the preliminary injunction.²⁸²

On the other hand, if Act 630 becomes effective, there is a significant chance that Novartis will have to allow into its distribution networks Arkansas pharmacies that are not equipped or prepared to (1) properly handle and dispense specialty drugs or (2) meet Novartis's and the FDA's needs with respect to reporting requirements.²⁸³ That would potentially lower the effectiveness of the drugs at issue, raise safety concerns for those drugs, and potentially result in the removal of the drug from the market (because it is out of compliance with FDA standards).²⁸⁴ There is a serious public interest in making sure that the drugs distributed in Arkansas are administered safely and effectively, and that Arkansans maintain access to Novartis's drugs.

For the foregoing reasons, the merged balance of equities and public interest factor tips very slightly in Novartis's favor.

CONCLUSION AND PRELIMINARY INJUNCTION

For the foregoing reasons, Novartis's Motion for a Preliminary Injunction (Doc. 2) is GRANTED. The Court therefore ORDERS that:

1. Defendants Rodney Richmond in his official capacity as President of the Arkansas Board of Pharmacy, Debbie Mack in her official capacity as Vice-President and Secretary of the Arkansas Board of Pharmacy, Brian Jolly in his official capacity as a member of the Arkansas Board of Pharmacy, Lenora Newsome in her official capacity as a member of the Arkansas Board of Pharmacy, Clint Boone in his official capacity as a member of the Arkansas Board of Pharmacy, Lyn Fruchey in his official capacity as a member of the Arkansas Board of Pharmacy, Harold Simpson in his official capacity as a member of the Arkansas Board of Pharmacy, and Beth Ann Davenport in her official capacity as a member of the Arkansas Board of Pharmacy are hereby enjoined from enforcing any and all aspects of Arkansas's Act 630 of 2025—codified at Ark. Code Ann. § 20-64-105—against Novartis Pharmaceuticals Corporation or any of its affiliates, officers, agents, representatives, or contractors until a final judgment is issued in the instant litigation.

2. All officers, agents, servants, employees, and attorneys of the people listed in section (1) of this Preliminary Injunction, as well as all persons who are in active concert or participation with the people listed in section (1) of this Preliminary Injunction or with their officers, agents, servants, employees, or attorneys, are hereby enjoined from enforcing any and all aspects of Arkansas's Act 630 of 2025—codified at Ark. Code Ann. § 20-64-105—against Novartis Pharmaceuticals Corporation or any of its affiliates, officers, agents, representatives, or contractors until a final judgment is issued in the instant litigation.

IT IS SO ORDERED this 17th day of May 2026.

FOOTNOTES

1.   See generally Ex. 2 (Act 630) to Defs.' Mot. to Dismiss (Doc. 18-2); Verified Compl. (Doc. 1). Some documents refer to the challenged law as “H.B. 1531.” See Pl.'s Opp'n to Defs.' Mot. to Dismiss and Reply in Supp. of Pl.'s Mot. for Prelim. Inj. (Doc. 24) at 8 n.1. For clarity, however, the parties have agreed to refer to the challenged law as “Act 630.” Id. The Court adopts this naming convention throughout the Order. Act 630 is codified as Ark. Code Ann. § 20-64-105.

2.   See Verified Compl. (Doc. 1) ¶¶ 42–49; Ark. Code Ann. § 20-64-105.

3.   See generally Verified Compl. (Doc. 1).

4.   See generally id. The Arkansas Board of Pharmacy is an eight-member body with the “authority to make reasonable rules, not inconsistent with law, to carry out the purposes and intentions of ․ chapter [92 — Pharmacists and Pharmacies] and the pharmacy laws of [Arkansas] that the board deems necessary to preserve and protect the public health.” Ark. Code Ann. § 17-92-201, 17-92-205.

5.   See generally Verified Compl. (Doc. 1).

6.   See id. ¶¶ 131–53. Many of our Nation's leading jurists have credibly questioned whether the so-called Dormant Commerce Clause is actually a real constitutional thing. See, e.g., Paul's Indus. Garage, Inc. v. Goodhue Cnty., 35 F.4th 1097, 1100 (2022) (Stras, J., concurring) (“History confirms what common sense already suggests: the Commerce Clause allows Congress ‘to regulate Commerce ․ among the several States,’ but it does not prohibit states from doing so too․ A grant of power to one body does not withdraw it from another ․ absent an express ‘negative clause’ ” (cleaned up) (first citing U.S. Const. art. I, § 8, cl. 3.; then citing License Cases, 46 U.S. 5 How. 504, 583, 12 L.Ed. 256 (1847), overruled by, Leisy v. Hardin, 135 U.S. 100, 10 S.Ct. 681, 34 L.Ed. 128 (1890); and then citing The Federalist No. 32, at 201 (Alexander Hamilton) (Clinton Rossiter ed., 1961))). Whatever the merit of that position—and this Court believes there is great merit to that position—binding precedent requires this Court to accept the existence and current contours of the Dormant Commerce Clause doctrine.

7.   See Verified Compl. (Doc. 1) at 43.

8.   See Pl.'s Mot. for Prelim. Inj. (Doc. 2). Act 630 was signed into law on April 16, 2025, but will not be enforced until September 1, 2026. See Ex. 2 (Act 630) to Defs.' Mot. to Dismiss (Doc. 18-2) at 5; Verified Compl. (Doc. 1) ¶¶ 2, 17.

9.   See Pl.'s Mot. for Prelim. Inj. (Doc. 2). In addition to responding to the Preliminary Injunction Motion, Defendants filed a Motion to Dismiss seeking to (1) dismiss the Attorney General, (2) dismiss all claims on ripeness grounds, and (3) dismiss all claims for failure to state a viable cause of action. See Defs.' Mot. to Dismiss (Doc. 18) ¶¶ 3–4. The Court will formally address the Motion to Dismiss in a separate order. But, of course, for the purposes of today's Order, the Court has considered the arguments in the Motion to Dismiss to the extent those arguments bear on the likelihood of success of the dormant Commerce Clause doctrine.

10.   Two procedural points are worth mentioning here. First, as alluded to in footnote 9, Defendants' Motion to Dismiss asked that Arkansas Attorney General Tim Griffin be dismissed from this case. See Defs.' Mot. to Dismiss (Doc. 18) ¶ 3. Novartis does not oppose that request. See Pl.'s Opp'n to Defs.' Mot. to Dismiss and Reply in Supp. of Pl.'s Mot. for Prelim. Inj. (Doc. 24) at 10. Indeed, all parties agree that Attorney General Griffin has sovereign immunity and that the Ex Parte Young exception does not apply because Attorney General Griffin has no role in enforcing Act 630. See Prelim. Inj. Hr'g Tr. (Doc. 40) at 162:12–163:4; Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 21–22; Pl.'s Opp'n to Defs.' Mot. to Dismiss and Reply in Supp. of Pl.'s Mot. for Prelim. Inj. (Doc. 24) at 10. Because the Court will dismiss the Attorney General in a later order addressing Defendants' Motion to Dismiss, the preliminary injunction issued today will not apply to the Attorney General.Second, Defendants contend that Novartis's Preliminary Injunction Motion failed to comply with Local Rule 7.2(e). See Defs.' Mot. to Dismiss (Doc. 18) ¶ 3; Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 18–19. That Rule explains that “pretrial ․ motions for preliminary injunctions shall not be taken up and considered unless set forth in a separate pleading accompanied by a separate brief.” Local Rule 7.2(e). Although Defendants are technically correct, it would be a waste of the Court's time (and the parties' time) to not reach the merits of a fully briefed and argued preliminary injunction motion just to have Novartis refile the same document in two separate filings. Accordingly, in the interest of judicial economy, the Court will reach the merits of this Motion despite Novartis's imperfect compliance with the local rules. See Silberstein v. IRS, 16 F.3d 858, 860 (8th Cir. 1994) (“[T]he district court has considerable leeway in the application of its local rules. Indeed, ‘[i]t is for the district court to determine what departures from its rules may be overlooked.’ (alteration in original) (internal citations omitted) (first citing Morgan Distrib. Co. v. Unidynamic Corp., 868 F.2d 992, 996 (8th Cir.1989); and then quoting Braxton v. Bi–State Dev. Agency, 728 F.2d 1105, 1107 (8th Cir. 1984))).

11.   See Verified Compl. (Doc. 1) ¶¶ 26–27, 33.

12.   See id. ¶¶ 1, 27; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 9–10.

13.   See Verified Compl. (Doc. 1) ¶ 26; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 2.

14.   See Verified Compl. (Doc. 1) ¶ 26.

15.   Id.

16.   Id.

17.   Id.

18.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 14; Verified Compl. (Doc. 1) ¶ 27.

19.   Verified Compl. (Doc. 1) ¶ 27.

20.   Id.; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 6.

21.   Verified Compl. (Doc. 1) ¶ 28. Three wholesaler distributors conduct the majority of drug distribution across the country. Id. None are located in Arkansas. Id. Consequently, the drug distribution contracts that Novartis enters into are usually negotiated outside of Arkansas. Id. ¶ 33; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 8.

22.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 7; Verified Compl. (Doc. 1) ¶ 28.

23.   See Verified Compl. (Doc. 1) ¶ 29; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 7, 9–10.

24.   Verified Compl. (Doc. 1) ¶ 29.

25.   Id. ¶ 1.

26.   Id. ¶¶ 1, 29. Although there is nothing solid in the record concerning profit motive, the Court is not blind to the fact that, as a for-profit company, one of Novartis's goals in selecting a particular distribution strategy is likely to include maximizing profit (to the extent feasible given other goals and constraints).

27.   Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 9.

28.   See id. ¶¶ 9–10.

29.   See id. ¶¶ 9–10, 19.

30.   Id. ¶ 9.

31.   See id. ¶¶ 9, 12, 19.

32.   See id.

33.   Id. ¶ 19.

34.   Id. ¶ 10.

35.   See id.; Verified Compl. (Doc. 1) ¶ 29; Prelim. Inj. Hr'g Tr. (Doc. 40) at 7:17–8:6.

36.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 24–27.

37.   See id. ¶¶ 9–10, 12, 19.

38.   See Verified Compl. (Doc. 1) ¶ 15; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 19–20; Prelim. Inj. Hr'g Tr. (Doc. 40) at 8:7–8:15.

39.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 19–20.

40.   See id. ¶¶ 15–20.

41.   Id. ¶ 16.

42.   Id.

43.   Id.

44.   Id. ¶ 16. These dispenser-based restrictions are usually combined with the selection of a specialty distributor. Id.

45.   See id. ¶ 17.

46.   See id. ¶¶ 13, 17, 48.

47.   See id. ¶¶ 17, 48.

48.   Id. ¶ 17.

49.   See id. ¶ 17.

50.   See id. ¶¶ 16–17.

51.   Id. ¶ 18.

52.   Verified Compl. (Doc. 1) ¶ 30 (internal quotation marks omitted) (cleaned up) (quoting Utilization Rev. Accreditation Comm'n, URAC Five-Year Specialty Pharmacy Report: Making a Difference with Measurement 4–5 (2024)).

53.   Verified Compl. (Doc. 1) ¶ 30; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 11.

54.   Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 18.

55.   Id. ¶ 21.

56.   See id. ¶ 24.

57.   See id. ¶¶ 29, 36–38.

58.   Id. ¶ 36.

59.   See id. ¶ 36.

60.   See id. ¶¶ 24, 36.

61.   Id. ¶ 36.

62.   See id. ¶¶ 36–37.

63.   Id. ¶ 26.

64.   Id. ¶ 42.

65.   Id. ¶ 25.

66.   Id. ¶ 25.

67.   See Decl. of Stephen Carroll (Doc. 37) ¶¶ 12–13; Decl. of Artemisa Hoxholli (Doc. 39) ¶ 6.

68.   See Decl. of Artemisa Hoxholli (Doc. 39) ¶ 6; Decl. of Stephen Carroll (Doc. 37) ¶ 13.

69.   See Decl. of Artemisa Hoxholli (Doc. 39) ¶¶ 6–7.

70.   See id. ¶¶ 5–8.

71.   See Verified Compl. (Doc. 1) ¶ 15; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 39.

72.   Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 39.

73.   Id. ¶ 39.

74.   Id. ¶ 39. The Court takes judicial notice that KYMRIAH is administered by intravenous infusion. See generally U.S. Food & Drug Admin., Package Insert and Medication Guide – KYMRIAH (June 2025).

75.   Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 39. Novartis also contends that limited distribution schemes—at least the ones where dispensers get drugs directly from the manufacturer—have significant benefits for dispensers. Id. ¶ 28. For example, when certain dispensers can get a drug directly from a manufacturer on demand, those dispensers are able to maintain a smaller inventory and thus reduce storage and operational expenses. See id. But a manufacturer cannot maintain these close relationships with more than a few dispensers, so it must (at some point) resort to selling a drug through distributors as it expands distribution of that drug. See id.

76.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 21.

77.   Verified Compl. (Doc. 1) ¶ 34.

78.   21 U.S.C. § 355(d). See also Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 476, 133 S.Ct. 2466, 186 L.Ed.2d 607 (2013) (“Under the Federal Food, Drug, and Cosmetic Act (FDCA) ․ drug manufacturers must gain approval from the [FDA] before marketing any drug in interstate commerce․ The FDA may approve [a new-drug application] only if it determines that the drug in question is ‘safe for use’ under ‘the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.’ ” (first citing 21 U.S.C. § 355(a); and then quoting id. § 355(d))).

79.   Mut. Pharm. Co., 570 U.S. at 476, 133 S.Ct. 2466 (2013) (internal quotations marks omitted) (quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 140, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000)).

80.   See generally 21 U.S.C. § 355-1.

81.   See 21 U.S.C. § 355-1; Verified Compl. (Doc. 1) ¶ 36.

82.   21 U.S.C. § 355(p)(l)(B) (“A person may not introduce or deliver for introduction into interstate commerce a new drug if ․ a risk evaluation and mitigation strategy is required under section 355-1 of this title with respect to the drug and the person fails to maintain compliance with the requirements of the approved strategy or with other requirements under section 355-1 of this title, including requirements regarding assessments of approved strategies.”).

83.   21 U.S.C. § 355-1(f)(1).

84.   Id. See also Verified Compl. (Doc. 1) ¶ 37.

85.   See 21 U.S.C. § 355-1(f)(3); Verified Compl. (Doc. 1) ¶ 37.

86.   Verified Compl. (Doc. 1) ¶ 37; 21 U.S.C. § 355-1(f)(3)–(4).

87.   Verified Compl. (Doc. 1) ¶¶ 39–40; 21 U.S.C. §§ 355-l(c)–(d) (requiring a timetable for submission of periodic assessments); id. § 355-l(g)(2) (outlining required assessments).

88.   Verified Compl. (Doc. 1) ¶¶ 39–40; 21 U.S.C. §§ 355-l(c)–(d), (g)(2).

89.   See, e.g., Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 79–80 (detailing certain data that Novartis must collect and maintain to comply with FABHALTA's REMS); Verified Compl. (Doc. 1) ¶¶ 40–41.

90.   See, e.g., Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 79–80 (putting the onus on Novartis to collect data); Verified Compl. (Doc. 1) ¶¶ 40–41.

91.   See, e.g., Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 79–80; Verified Compl. (Doc. 1) ¶¶ 54–58 (describing what Novartis requires of its dispensers to ensure that it can collect the data it needs to comply with FABHALTA's REMS).

92.   See Verified Compl. (Doc. 1) ¶¶ 41, 55; 21 U.S.C. § 355(p)(l)(B). See also 21 U.S.C. § 331(d) (“The following acts and the causing thereof are prohibited ․ [t]he introduction or delivery for introduction into interstate commerce of any article in violation of section ․ 355 ․ of this title.”).

93.   Verified Compl. (Doc. 1) ¶ 41; 21 U.S.C. § 355(p)(l)(B).

94.   See 21 U.S.C. § 333(f)(4)(A).

95.   See Verified Compl. (Doc. 1) ¶ 51; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 50–51.

96.   See Verified Compl. (Doc. 1) ¶ 53; Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 74 (identifying the risk of “serious infections caused by encapsulated bacteria” in FABHALTA's REMS).

97.   See generally Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 74–81; Verified Compl. (Doc. 1) ¶ 53.

98.   See Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 74, 81.

99.   See id. at 81; Verified Compl. (Doc. 1) ¶ 53.

100.   Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 81. References to section 505-1 of the Federal Food, Drug, and Cosmetic Act are found at 21 U.S.C. § 355-1 as that is where section 505-1 was codified. See id.; U.S. Food & Drug Admin., REMS: FDA's Application of Statutory Factors in Determining When a REMS Is Necessary 1–2 (2019). It is important to acknowledge that, although these two sections of law require special certification, they also seem to require that any willing provider in a “frontier area” have the opportunity to become specially certified. 21 U.S.C. § 355-1(f)(3)(A)–(B). Specifically, § 355-1(f)(3)(A) provides that “the opportunity to obtain such ․ certification with respect to the drug shall be available to any willing provider from a frontier area in a widely available ․ certification method (including an on-line course or via mail) as approved by the Secretary at reasonable cost to the provider ․” And § 355-1(f)(3)(B) provides that “the opportunity to obtain such certification shall be available to any willing provider from a frontier area ․” Neither this statute nor the corresponding regulations define the term “frontier area.” The parties have not defined the term, which is not surprising since neither party brought this statutory language to the Court's attention. The Court has no idea whether all, some, or none of Arkansas is considered a “frontier area” for purposes of § 355-1(f)(3). As best as the Court can tell, a “frontier area” is “a county in which the population per square mile is less than 6.” Cf. 42 U.S.C. § 254c-1b(c)(2); § 1395ww(d)(3)(E)(iii)(III).

101.   See Verified Compl. (Doc. 1) ¶¶ 53–56.

102.   See id. ¶ 55.

103.   See id.

104.   See id.; Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 79–80 (detailing some data that Novartis must collect and maintain to comply with FABHALTA's REMS).

105.   See Verified Compl. (Doc. 1) ¶ 55; Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 76–77 (“Outpatient pharmacies that dispense FABHALTA must ․ [a]t all times ․ [c]omply with audits carried out by Novartis Pharmaceuticals Corporation or a third party acting on behalf of Novartis Pharmaceuticals Corporation to ensure that all processes and procedures are in place and are being followed.”); id. at 77–78 (“Inpatient pharmacies that dispense FABHALTA must ․ [a]t all times ․ [c]omply with audits carried out by Novartis Pharmaceuticals Corporation or a third party acting on behalf of Novartis Pharmaceuticals Corporation to ensure that all processes and procedures are in place and are being followed.”).

106.   Verified Compl. (Doc. 1) ¶ 55.

107.   See, e.g., Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 75–78.

108.   See Verified Compl. (Doc. 1) ¶ 54; Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 75–78.

109.   See Verified Compl. (Doc. 1) ¶ 54; Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 74–78.

110.   See Verified Compl. (Doc. 1) ¶ 54; Ex. 2 (FABHALTA REMS) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 74–78.

111.   See generally Prelim. Inj. Hr'g Tr. (Doc. 40). Some of Mr. Kirtley's testimony at the preliminary injunction hearing was objected to on hearsay grounds. See id. at 10:15–11:10. The Court reserved ruling on the hearsay objection and provisionally allowed Mr. Kirtley to testify fully about the complaints that the Board has received. See id. at 11:9–11:25. The rules for hearsay in preliminary injunction hearings are not as strict as they are at trial. See Univ. of Tex. v. Camenisch, 451 U.S. 390, 395, 101 S.Ct. 1830, 68 L.Ed.2d 175 (1981) (“[A] preliminary injunction is customarily granted on the basis of procedures that are less formal and evidence that is less complete than in a trial on the merits.”). Nonetheless, the rules for hearsay are not entirely abandoned at this stage. See id. Fortunately, the Court need not delve into whether the contested evidence crosses the line between acceptable hearsay and unacceptable hearsay at the preliminary injunction stage. That is because, even assuming the admissibility of all the contested hearsay evidence, Novartis still prevails for the reasons discussed later in this Order. Moreover, that outcome is not dependent on the amount of weight and significance that the Court gives the contested hearsay evidence.

112.   See Prelim. Inj. Hr'g Tr. (Doc. 40) at 8:7–9:5, 30:20–31:21.

113.   See id. at 10:15–11:1, 12:14–13:2.

114.   See id. at 10:15–11:8, 14:4–14:12.

115.   See id. at 10:24–11:1; 13:6–14:3.

116.   See id. at 12:14–14:3.

117.   See id. at 14:4–15:1.

118.   See id. at 14:4–14:12.

119.   See id. at 16:23–17:9.

120.   See generally Ex. 4 (Decl. of Adam Head) to Defs.' Mot. to Dismiss (Doc. 18-4).

121.   See id. ¶ 4.

122.   See id.

123.   See id.

124.   Id.

125.   See generally Decl. of Stephen Carroll (Doc. 37).

126.   See id. ¶¶ 2, 9–12.

127.   Id. ¶ 11.

128.   Id.

129.   See id.

130.   See id. ¶¶ 13–14. KISQALI is a complex drug but is not subject to any evaluation and mitigation strategy. Id. ¶ 13.

131.   Decl. of Stephen Carroll (Doc. 37) ¶ 13.

132.   Id.

133.   See id. ¶ 14.

134.   The only explanation in the record comes from an email sent to Dr. Carroll from Bella Tricomi of Novartis stating in pertinent part:Novartis maintains an unwavering commitment to facilitating access to care for patients. As a part of this commitment, Novartis recognized an opportunity to optimize dispensing of KISQALI to foster patient-centric care and provide pharmacy support to providers and patients. Effective November 1, 2025, the intended network will include the full-service specialty pharmacies (SPs) listed below, in addition to hospital outpatient pharmacies and outpatient clinic/practice pharmacies.Id. at 7. See also id. ¶ 16 (explaining the context of Ms. Tricomi's email).

135.   Id. ¶¶ 15, 18.

136.   Id. ¶ 19. Novartis disputes this assertion and insists that KISQALI is available through the following pharmacies with physical locations in Arkansas: Central Arkansas Radiation Therapy Institute (CARTI) in Little Rock; the University of Arkansas for Medical Sciences (UAMS) in Little Rock; Jefferson Regional Medical Center in Pine Bluff; Saint Bernards Medical Center in Jonesboro; and Highlands Oncology Group with locations in Fayetteville, Springdale, Rogers, and Mountain Home. See Decl. of Artemisa Hoxholli (Doc. 39) ¶ 4.

138.   See Ex. 2 (Act 630) to Defs.' Mot. to Dismiss (Doc. 18-2) at 1.

139.   Ark. Code Ann. § 20-64-105(a). Although this Court has significant concerns about the use of legislative history in statutory interpretation, those concerns have far less force here where the legislative findings have been enacted into law by the General Assembly and Governor. See Antonin Scalia & Bryan A. Garner, Reading Law: The Interpretation of Legal Texts 218 (2012) (“[T]he prologue [of an Act] does set forth the assumed facts and the purposes that the majority of the enacting legislature ․ had in mind, and these [assumed facts and purposes] can shed light on the meaning of the operative provisions that follow.”). But see id. at 219, 92 S.Ct. 839 (“There are, however, two serious limitations on the use of prologues. First, an expression of specific purpose in the prologue will not limit a more general disposition that the operative text contains․ Second, an expansive purpose in the preamble cannot add to the specific dispositions of the operative text.”).

140.   Ark. Code Ann. § 20-64-105(a)(1).

141.   Id. § 20-64-105(a)(2).

142.   Id. § 20-64-105(a)(3).

143.   Id. § 20-64-105(a)(4).

144.   Id. § 20-64-105(a)(5).

145.   Id. § 20-64-105(c)(1). Three points bear mentioning. First, Subsection (c)(2) is not relevant to the Court's resolution of the Motion at bar. Second, the codified version of Act 630 set out above reads “without having similar access and allowing for upon request or application by a pharmacy at least ․” Id. § 20-64-105(c)(1)(B) (emphasis added). This codified language in § 20-64-105(c)(1)(B) differs slightly from the non-codified version of Act 630, which does not contain an “a” before pharmacy. See Ex. 2 (Act 630) to Defs.' Mot. to Dismiss (Doc. 18-2) (reading “without having similar access and allowing for upon request or application by pharmacy at least ․” (emphasis added)). The distinction makes no difference for the Court's analysis of Act 630. Third, as used in Act 630, the words “pharmacy” or “pharmacies” cover all the entities that the Court refers to as dispensers. See Ark. Code Ann. § 17-92-101(14) (“ ‘Pharmacy’ means the place licensed by the Arkansas State Board of Pharmacy in which drugs, chemicals, medicines, prescriptions, and poisons are compounded, dispensed, or sold at retail ․”). Those words are consonant with the word “dispensers” as used in today's Order; the Court has used “dispensers” as a broad description that covers standalone pharmacies and various other entities in Arkansas that have pharmacies embedded into their facilities.

146.   Cf. N. Oil and Gas, Inc. v. EOG Resources, Inc., 970 F.3d 889, 892 (8th Cir. 2020) (“In interpreting state law, we are bound by the decisions of the state's highest court․ When there is no state supreme court case directly on point, our role is to predict how the state supreme court would rule if faced with the same issue before us.” (internal quotation marks and citations omitted) (first quoting Cty. of Ramsey v. MERSCORP Holdings, Inc., 776 F.3d 947, 950 (8th Cir. 2014); and then quoting Blankenship v. USA Truck, Inc., 601 F.3d 852, 856 (8th Cir. 2010))).

147.   See Gurley v. Rhoden, 421 U.S. 200, 208, 95 S.Ct. 1605, 44 L.Ed.2d 110 (1975) (“[A] State's highest court is the final judicial arbiter of the meaning of state statutes ․” (citing Alabama v. King & Boozer, 314 U.S. 1, 9–10, 62 S.Ct. 43, 86 L.Ed. 3 (1941))).

148.   Thomas v. State, 315 Ark. 79, 80, 864 S.W.2d 835, 836 (1993) (citing Mountain Home Sch. Dist. v. T.M.J. Builders, Inc., 313 Ark. 661, 858 S.W.2d 74 (1993)).

149.   Simpson v. Cavalry SPV I, LLC, 2014 Ark. 363, at 3, 440 S.W.3d 335, 337 (citing Calaway v. Prac. Mgmt. Servs., Inc., 2010 Ark. 432, 2010 WL 4524659).

150.   Standridge v. Fort Smith Pub. Schs., 2025 Ark. 42, at 4, 708 S.W.3d 773, 777 (internal quotation marks omitted) (cleaned up) (quoting Lewallen v. Progress for Cane Hill, 2024 Ark. 167, at 2, 699 S.W.3d 101, 103).

151.   See id. at 14, 708 S.W.3d at 782 (Hudson, J., concurring in part and dissenting in part) (“The primary rule of statutory interpretation is to give effect to the intent of the legislature.” (quoting Keep Our Dollars in Indep. Cnty. v. Mitchell, 2017 Ark. 154, at 7, 518 S.W.3d 64, 68)). Although Justice Hudson technically concurred in part and dissented in part, the Court refers to her opinion as a dissent because Justice Hudson dissented on the statutory interpretation portion of the majority opinion. See id. at 13, 62 S.Ct. 43, 708 S.W.3d at 781 (“I concur with the majority's decision to affirm the dismissal of Standridge's claims regarding equal protection, right to parent, and abuse of power. However, I dissent from the majority's interpretation of Act 768 of 2023.”).

152.   Cf. Kisor v. Wilkie, 588 U.S. 558, 622, 139 S.Ct. 2400, 204 L.Ed.2d 841 (2019) (Gorsuch, J., concurring) (“Today it is even said that we judges are, to one degree or another, ‘all textualists now.’ ” (quoting Diarmuid O'Scannlain, “We Are All Textualists Now”: The Legacy of Justice Antonin Scalia, 91 ST. JOHN'S L. REV. 303, 313 (2017)). This movement is clearly correct. A law only has the force of the law (i.e., the ability to bind people) because it has been adopted by the people's elected representatives in two different houses and signed by the Executive (or re-passed over a veto). See, e.g., Conroy v. Aniskoff, 507 U.S. 511, 519, 113 S.Ct. 1562, 123 L.Ed.2d 229 (1993) (Scalia, J., concurring) (“The greatest defect of legislative history is its illegitimacy. We are governed by laws, not by the intentions of legislators. As the [Supreme] Court said in 1844: ‘The law as it passed is the will of the majority of both houses, and the only mode in which that will is spoken is in the act itself ’ ” (emphasis in original) (quoting Aldridge v. Williams, 44 U.S. 3 How. 9, 24, 11 L.Ed. 469 (1845))). Only the text has gone through that process. See id. So only the ordinary and common meaning of a text—not what some legislators thought the text meant—has the binding force of law. See id. Moreover, the entire idea of finding legislative intent is not much better than a fool's errand. One would have to assume that all (or at least many) of the legislators passing the statute in one legislative house had the same intent as to the particular portion of the Act at issue, that this shared intent was the same as the shared intent of all (or at least many) of the legislators in the other legislative house, and that this shared intent was the same as the intent of the Executive in cases where the Executive signed the Act. Then, one would have to somehow divine this shared intent. Good luck with that. Cf. Church of Lukumi Babalu Aye, Inc. v. City of Hialeah., 508 U.S. 520, 558, 113 S.Ct. 2217, 124 L.Ed.2d 472 (1993) (Scalia, J., concurring) (“[I]t is virtually impossible to determine the singular ‘motive’ of a collective legislative body ․” (citing Edwards v. Aguillard, 482 U.S. 578, 636–39, 107 S.Ct. 2573, 96 L.Ed.2d 510 (1987) (Scalia, J., dissenting)); Exxon Mobil Corp. v. Allapattah Servs., Inc., 545 U.S. 546, 568, 125 S.Ct. 2611, 162 L.Ed.2d 502 (2005) (“[L]egislative history in particular is vulnerable to ․ serious criticisms․ [L]egislative history is itself often murky, ambiguous, and contradictory. Judicial investigation of legislative history has a tendency to become, to borrow Judge Leventhal's memorable phrase, an exercise in looking over a crowd and picking out your friends.” (internal quotation marks omitted) (citing Patricia M. Wald, Some Observations on the Use of Legislative History in the 1981 Supreme Court Term, 68 IOWA L. REV. 195, 214 (1983)).

153.   See New Prime Inc. v. Oliveira, 586 U.S. 105, 106, 139 S.Ct. 532, 202 L.Ed.2d 536 (2019) (“It's a fundamental canon of statutory construction that words generally should be interpreted as taking their ordinary ․ meaning ․ at the time Congress enacted the statute.” (internal quotation marks omitted) (cleaned up) (quoting Wisconsin Cent. Ltd. v. United States, 585 U.S. 274, 277, 138 S.Ct. 2067, 201 L.Ed.2d 490 (2018))); Scalia & Garner, supra note 139, at 16 (“In their full context, words mean what they conveyed to reasonable people at the time they were written.”); Standridge, 2025 Ark. 42, at 4, 708 S.W.3d at 777 (“We construe statutes just as they read, giving the words their ordinary and usually accepted meaning in common language.” (internal quotation marks omitted) (cleaned up) (quoting Lewallen, 2024 Ark. 167, at 2, 699 S.W.3d at 103)).

154.   The Court does not mean to suggest it agrees with the use of legislative intent or legislative history at all. Rather, the Court understands current Supreme Court and Eighth Circuit precedent to authorize the use of legislative intent or legislative history in such circumstances. Cf. Exxon Mobil Corp., 545 U.S. 568 (2005) (“Extrinsic materials have a role in statutory interpretation only to the extent they shed a reliable light on the enacting Legislature's understanding of otherwise ambiguous terms.”); United States v. Smith, 171 F.3d 617, 620 (8th Cir. 1999) (“Only if the statute is ambiguous do we look to the legislative history to determine Congress's intent.”). In any event, the Court is dubious that, in the real world, two statutory interpretations will ever be equally likely after all the tools of statutory interpretation outside of legislative intent are exhausted.

155.   Cf. Thurston v. Safe Surgery Ark., 2021 Ark. 55, at 8, 619 S.W.3d 1, 7–8 (“When a statute is clear, it is given its plain meaning, and [the Arkansas Supreme Court] will not search for legislative intent; rather, that intent must be gathered from the plain meaning of the language used. In other words, if the language of the statute is plain and unambiguous, the analysis need go no further․ This court is very reluctant to interpret a legislative act in a manner contrary to its express language unless it is clear that a drafting error or omission has circumvented legislative intent.” (internal citation omitted) (quoting Yamaha Motor Corp., U.S.A. v. Richard's Honda Yamaha, 344 Ark. 44, 52, 38 S.W.3d 356, 360 (2001))). See also Scalia & Garner, supra note 139, at 219–20 (explaining that legislative intent, even if it comes in the form of a “purpose clause,” cannot “override the operative language” of a statute.). If after using all the semantic and contextual canons—and any other language-based tools to resolve statutory ambiguity—a court concludes that one reading of the statute is more likely to be correct than the other reading, selecting the worse reading because it better aligns with legislative intent is akin to allowing legislative intent to override the operative language of a statute.

156.   Scalia & Garner, supra note 139, at 219–20 (explaining that legislative intent, even if it comes in the form of a “purpose clause,” cannot be used to “do grievous violence” to the statutory language of an act's operative provisions).

157.   See supra note 139.

158.   Scalia & Garner, supra note 139, at 167 (“Perhaps no interpretive fault is more common than the failure to follow the whole-text canon, which calls on the judicial interpreter to consider the entire text, in view of its structure and of the physical and logical relation of its many parts․ Context is a primary determinant of meaning. A legal instrument typically contains many interrelated parts that make up the whole. The entirety of the document thus provides the context for each of its parts.”).

159.   See supra note 139; Scalia & Garner, supra note 139, at 168 (“The [whole-text] canon can lend itself to abuse. Properly applied, it typically establishes that only one of the possible meanings that a word or phrase can bear is compatible with use of the same word or phrase elsewhere in the statute; or that one of the possible meanings would cause the provision to clash with another portion of the statute. It is not a proper use of the canon to say that since the overall purpose of the statute is to achieve x, any interpretation of the text that limits the achieving of x must be disfavored. As we have said, limitations on a statute's reach are as much a part of the statutory purpose as specifications of what is to be done.”).

160.   See Ark. Code Ann. § 20-64-105(c)(1)(B) (“A pharmaceutical manufacturer ․ [s]hall not restrict or limit prescription medications more than three (3) months after a launch of a new product to a limited distribution network of pharmacies without having similar access and allowing for upon request or application by a pharmacy at least ․” (emphasis added)). Act 630's requirements concerning a pharmaceutical manufacturer's treatment of pharmacies that are not initially included in its limited distribution network run only to pharmacies that are physically present in Arkansas. Beyond the title of the Act, numerous textual cues in the Act confirm that the requirements only apply to this geographic subset of pharmacies. The Court need not waste time discussing these cues because the State has conceded the proposition. See, e.g., Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 31–32 (explaining that Act 630 “applies equally to locally-owned and non-locally-owned specialty pharmacies that have a physical in the State”); Prelim. Inj. Hr'g Tr. (Doc. 40) at 66:6–66:8 (Dr. Kirtley's testimony confirming that only “an in-state pharmacy” would have “an opt-in mechanism for the law.”).

161.   See Ark. Code Ann. § 20-64-105(c)(1)(B) (“A pharmaceutical manufacturer ․ [s]hall not restrict or limit prescription medications more than three (3) months after a launch of a new product to a limited distribution network of pharmacies without having similar access and allowing for upon request or application by a pharmacy at least ․” (emphasis added)). The only way to give both phrases—“having similar access for” and “allowing for”—independent meaning is to interpret this language as requiring pharmaceutical manufacturers to give certain pharmacies both the opportunity to apply to, and admission into, the limited distribution network. See Scalia & Garner, supra note 139, at 174 (“If possible, every word and every provision is to be given effect ․ None should be ignored. None should needlessly be given an interpretation that causes it to duplicate another provision or to have no consequence.” (footnote omitted) (defining the surplusage canon)). And such an interpretation is consistent with the ordinary meaning of the words “access” and “allow.” The ordinary meaning of “access,” given the context here, is the “right to enter, approach, or use.” Access, Collins Online Dictionary, https://www.collinsdictionary.com/us/dictionary/english/access (last visited May 15, 2026). The ordinary meaning of “allow,” given the context here, is “permit” or “let enter.” Allow, Collins Online Dictionary, https://www.collinsdictionary.com/us/dictionary/english/access (last visited May 15, 2026).

162.   See Ark. Code Ann. § 20-64-105(c)(1)(B)(i) (explaining that the pharmaceutical manufacturer must “allow[ ] for upon request or application by a pharmacy at least ․ [a] local network of public institution academic medical center access ․” (emphasis added)).

163.   See id. § 20-64-105(c)(1)(B)(ii) (explaining that the pharmaceutical manufacturer must “allow[ ] for upon request or application by a pharmacy at least ․ [g]eographic diversity of access within the state ․” (emphasis added)).

164.   See id. § 20-64-105(c)(1)(B)(iii) (explaining that the pharmaceutical manufacturer must “allow[ ] for upon request or application by a pharmacy at least ․ diverse access for local for-profit and nonprofit pharmacies in good standing with the board and that have experience or accreditation in managing expensive specialty or limited distribution medications ․” (emphasis added)).

165.   See id. § 20-64-105(c)(1)(B)(iv).

166.   See id. § 20-64-105(c)(1).

167.   See id. § 20-64-105(c)(1)(B).

168.   See id. § 20-64-105(c)(1)(B)(i)–(iv).

169.   See Pulsifer v. United States, 601 U.S. 124, 133, 144 S.Ct. 718, 218 L.Ed.2d 77 (2024) (“ ‘And,’ in grammatical terms, is of course a conjunction—a word whose function is to connect specified items.”). Compare Scalia & Garner, supra note 139, at 116 (explaining that in a “conjunctive list”—a list that says “[y]ou must do A, B, and C”—“all three things are required”), with id. (explaining that in a “disjunctive list”—a list that says “[y]ou must do A, B, or C[,]”—“at least one of the three is required, but any one (or more) of the three satisfies the requirement.”).

170.   The recognition that an applying dispenser can be excluded if the numbered list category into which the applying dispenser fits has already been accounted for by the current dispensers in the distribution network is a function of the “at least” language in the first portion of (c)(1)(B). See Ark. Code Ann. § 20-64-105(c)(1)(B) (“A pharmaceutical manufacturer ․ [s]hall not restrict or limit prescription medications more than three (3) months after a launch of a new product to a limited distribution network of pharmacies without having similar access and allowing for upon request or application by a pharmacy at least ․” (emphasis added)).

171.   Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 14.

172.   Id. at 14–15.

173.   See id. at 14–15, 39.

174.   See id. at 34–35 (explaining how the legislative intent matches the State's interpretation of the statute). See also id. at 16 (using statements from legislative testimony to bolster the State's reading of the statutory text).

175.   See Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 34–35.

176.   Id. at 14–15.

177.   Ark. Code Ann. § 20-64-105(c)(1)(B)(i).

178.   Id. § 20-64-105(c)(1)(B) (“A pharmaceutical manufacturer ․ [s]hall not restrict or limit prescription medications ․ to a limited distribution network of pharmacies without having similar access and allowing for upon request or application by a pharmacy at least ․” (emphasis added)).

179.   See Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 39.

180.   Ark. Code Ann. § 20-64-105(c)(1)(B)(i).

181.   See Prelim. Inj. Hr'g Tr. (Doc. 40) at 130:8–130:13 (“THE COURT: ․ Is your point that's (i), (ii), and (iii), but then (iv) somehow switches from becoming a checklist to some other statement that maybe really shouldn't be under (B)(iv) but should just be some other statement but they accidentally drafted it wrong? MS. PURVIS: Yes, Your Honor.”).

182.   See Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 34–35. See also supra p. 25 (describing the whole-text canon); Ark. Code Ann. § 20-64-105(a) (the legislative findings section of Act 630).

183.   See Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 34–35.

184.   See supra pp. 29–32. It is for this same reason that the State's preemption-avoidance argument is unavailing. See Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 41 (“One can interpret Act 630 to comply with Federal law as articulated above, so that is the interpretation that Act 630 must be given.”) The Court doesn't get to rewrite state statutes in order to avoid federal preemption problems. And the State's interpretation of this statute is so off-base that accepting it would amount to a rewriting of the statute.

185.   There is no question that the legislative findings articulate a legislative desire for patients across Arkansas to be able to “access safe and effective prescription medications” and to be able to “utilize local trusted medication experts” who can provide patients “with advice and guidance for safe and effective use of these medications ․” Ark. Code Ann. § 20-64-105(a)(1). Similar themes of patient safety are found throughout the legislative findings. See id. § 20-64-105(a). But featured just as prominently in those findings is a legislative desire for “patient freedom of choice” and “same day patient access” to drugs. See id. § 20-64-105(a)(1). And the legislative findings do not tell us how exactly the legislature intended to balance these two sometimes antagonistic and sometimes mutually reinforcing goals. Moreover, the legislative findings are not explicit as to what, in the Legislature's view, makes a drug dispenser safe and what safety requirements are enough. Without more explicit detail or intent, there is nothing to suggest that the Court's interpretation of (c)(1)(B) is inconsistent with Act 630's legislative findings.

186.   Ark. Code Ann. § 20-64-105(d)(1).

187.   Id. § 20-64-105(d)(1)(A).

188.   See id. § 20-64-105(d)(1)(B); Prelim. Inj. Hr'g Tr. (Doc. 40) at 57:14–59:4, 60:15–60:19. Unlike the State's position on subsection (c)(1), the State concedes that subsection (d) applies whether or not any Arkansas dispenser has sought to become a part of the distribution network for whatever drug is at issue. Defs.' Reply in Supp. of Defs.' Mot. to Dismiss (Doc. 30) at 10–11 (“The [Board of Pharmacy's] plan for implementation is consistent with Defendants' interpretation of the plain text—namely, that a manufacturer's obligation is triggered only if a pharmacy requests entry into a preexisting limited network or when the manufacturer wishes to obtain authorization to prevent entry into a restricted network for six months or longer.” (emphasis added)); Prelim. Inj. Hr'g Tr. (Doc. 40) at 58:25–59:4, 136:8–138:3.

189.   Ark. Code Ann. § 20-64-105(d)(2)(A). The factors the Board must consider include costs, logistics, patient caseload, rarity of the drug, and rarity of the disease or condition it treats. Id.

190.   Ark. Code Ann. § 20-64-105(d)(2)(B).

191.   Id. § 20-64-105(d)(4). Although the definition is not essential to today's Order, the Court understands that a Class A pharmacy is defined as “a pharmacy that has:” (1) “[a] pharmacy permit with a pharmacist on duty at least forty (40) hours per week;” (2) “[n]o unsatisfactory deficiency;” and (3) “[n]o more than three noncompliant deficiencies noted on its last Board inspection.” Ark. Code R. § 007.39.2-02-01-0003(d).

192.   See Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 15–16, 33; Prelim. Inj. Hr'g Tr. (Doc. 40) at 130:14–132:9.

193.   Ark. Code Ann. § 20-64-105(d)(3).

194.   See Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 15–16, 33; Prelim. Inj. Hr'g Tr. (Doc. 40) at 130:14–132:9.

195.   See supra pp. 25–32. Unlike section (c)(1)(B), there is not even syntactically confusing language in section (d). The State tries to create ambiguity by suggesting that subsection (d)(2)(B) implicitly calls back to the purported requirements set out in (c)(1)(B). See Prelim. Inj. Hr'g Tr. (Doc. 40) at 130:14–132:9. The State implies this callback from the fact that both subsections use the phrase “upon request or application.” See id. The Court is not persuaded that (d)(2)(B) includes any such callback reference. If the Arkansas Legislature wanted to include a callback (or cross reference) to (c)(1)(B) in (d)(2)(B), it would have done so explicitly. See id. Indeed, it did so elsewhere in the same statute. See, e.g., Ark. Code Ann. § 20-64-105(d)(1)(B) (“The request under subdivision (d)(1)(A) of this section shall not be effective until the request is approved by the board.” (emphasis added)).

196.   Ark. Code Ann. § 20-64-105(d)(3). The State seems to put a lot of stock in the waiver provision when it analyzes the requirements of subsection (d). See, e.g., Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 29–30; Defs.' Reply in Supp. of Defs.' Mot. to Dismiss (Doc. 30) at 7. The Court does not. The statute does not require or even counsel the Board to use the waiver power in any specific set of circumstances. Rather, the waiver provision seems entirely in the nature of generalized executive grace. See Ark. Code Ann. § 20-64-105(d)(3) (“The [Board of Pharmacy] may issue a temporary waiver or temporary limited use allowance for utilization, payment, or coverage of prescription drugs from a pharmaceutical manufacturer or a pharmaceutical manufacturer for Medicaid for coverage and payment for a state government and public plan sponsor for a health benefit plan to protect public health and access.” (emphasis added)).

197.   Ark. Code Ann. § 20-64-105(e) (“A state government and public plan sponsor for a health benefit plan shall not pay for prescription drugs from a pharmaceutical manufacturer or a pharmaceutical manufacturer for Medicaid who is noncompliant with this section unless the board has granted a temporary waiver or temporary allowance to protect public health and access.”); Id. § 20-64-105(f) (“If a pharmaceutical manufacturer or a pharmaceutical manufacturer for Medicaid is not in compliance with this section, the board shall fine the pharmaceutical manufacturer or the pharmaceutical manufacturer for Medicaid ten thousand dollars ($10,000) per day of noncompliance.”).

198.   See Decl. of Artemisa Hoxholli (Doc. 39) ¶ 14. Novartis imminently intends to employ more limited distribution networks for current drugs on the market and other drugs that have not yet launched. See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 40; Verified Compl. (Doc. 1) ¶ 52.

199.   See Decl. of Artemisa Hoxholli (Doc. 39) ¶ 11; Verified Compl. (Doc. 1) ¶ 51. There are ten pharmacies that are currently certified to dispense FABHALTA, none of which are located in Arkansas. Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 33. There are currently eight Arkansas patients taking FABHALTA. Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 34.

200.   See Decl. of Artemisa Hoxholli (Doc. 39) ¶ 12 (“These products may, for example, be engineered from a specific patient's cells, or may contain radioactive material with precise storage and disposal requirements that most pharmacies cannot meet.”). This fact assertion in Hoxholli's Declaration is not contested by Defendants.

201.   See id. ¶ 13 (explaining that, as to these seven drugs, “Novartis has chosen—for one or more of the reasons outlined in its Verified Complaint and other filings in this case—to distribute the [drug] to a select group of pharmacies and/or healthcare providers.”).

202.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 44–46; Verified Compl. (Doc. 1) ¶ 124.

203.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 44–46; Verified Compl. (Doc. 1) ¶ 124.

204.   See Ark. Code Ann. § 20-64-105(e)–(f).

205.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 52–58.

206.   Id. ¶ 58.

207.   See generally Verified Compl. (Doc. 1).

208.   See generally Pl.'s Mot. for Prelim. Inj. (Doc. 2).

209.   See Clerk's Minutes (Doc. 38).

210.   See generally Prelim. Inj. Hr'g Tr. (Doc. 40). Unusually, Novartis filed its Motion for a Preliminary Injunction well before the time it needed such relief. But, as Novartis presciently forecasted, this Motion and the underlying facts and law were complicated enough to require a long runway for analysis. See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 44–45. The Court recognizes that not every litigant would have taken the risk of requesting a preliminary injunction so far in advance of when it was needed. In the circumstances of this case, however, the Court appreciates Novartis's decision, which conforms to the highest level of professionalism.

211.   See Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 25–39.

212.   See id. at 39–50.

213.   See Starbucks Corp. v. McKinney, 602 U.S. 339, 345, 144 S.Ct. 1570, 219 L.Ed.2d 99 (2024) (“A preliminary injunction is an ‘extraordinary’ equitable remedy that is ‘never awarded as of right.’ ” (quoting Winter v. Nat. Res. Def. Couns., Inc., 555 U.S. 7, 24, 129 S.Ct. 365, 172 L.Ed.2d 249 (2008))).

214.   Cigna Corp. v. Bricker, 103 F.4th 1336, 1342 (8th Cir. 2024) (quoting Winter, 555 U.S. at 24, 129 S.Ct. 365). In the Eighth Circuit, this test is also known as the Dataphase test. See id. at 1343; Dataphase Sys., Inc. v. C L Sys., Inc., 640 F.2d 109, 113 (8th Cir. 1981).

215.   See Roudachevski v. All-Am. Care Centers, Inc., 648 F.3d 701, 706 (8th Cir. 2011) (“Success on the merits has been referred to as the most important of the four factors․ But it is insufficient on its own․ Even when a plaintiff has a strong claim on the merits, preliminary injunctive relief is improper absent a showing of a threat of irreparable harm.” (internal citations omitted)).

216.   See Eggers v. Evnen, 48 F.4th 561, 565 (8th Cir. 2022) (quoting Planned Parenthood Minn., N.D., S.D. v. Rounds, 530 F.3d 724, 732–33 (8th Cir. 2008) (en banc) (characterizing the likely-to-prevail-on-the-merits standard as “more rigorous” than the fair-chance-of-success-on-the-merits standard)).

217.   Hotchkiss v. Cedar Rapids Cmty. Sch. Dist., 115 F.4th 889, 893 (8th Cir. 2024) (“[T]he failure of a movant to show irreparable harm is an ‘independently sufficient basis upon which to deny a preliminary injunction.’ ” (quoting Sessler v. City of Davenport, 990 F.3d 1150, 1156 (8th Cir. 2021))). As for the balance of equities and public interest factors, those merge where (as here) the plaintiff is seeking a preliminary injunction against state officials in their official capacities. Eggers, 48 F.4th at 564–65. The most important factor is the likelihood of success on the merits, the Court begins its analysis with that factor. Jet Midwest Int'l Co., Ltd. v. Jet Midwest Grp., LLC, 953 F.3d 1041, 1044 (8th Cir. 2020).

218.   U.S. Const. art. I, § 8, cl. 3.

219.   Nat'l Pork Producers Council v. Ross, 598 U.S. 356, 368, 143 S.Ct. 1142, 215 L.Ed.2d 336 (2023) (alteration in original) (quoting Oklahoma Tax Comm'n v. Jefferson Lines, Inc., 514 U.S. 175, 179, 115 S.Ct. 1331, 131 L.Ed.2d 261 (1995)).

220.   Styczinski v. Arnold, 46 F.4th 907, 912 (8th Cir. 2022) (quoting Tennessee Wine & Spirits Retailers Ass'n v. Thomas, 588 U.S. 504, 514, 139 S.Ct. 2449, 204 L.Ed.2d 801 (2019)).

221.   Tennessee Wine & Spirits, 588 U.S. at 514, 139 S.Ct. 2449 (citing New Energy Co. of Ind. v. Limbach, 486 U.S. 269, 273, 108 S.Ct. 1803, 100 L.Ed.2d 302 (1988)).

222.   Styczinski, 46 F.4th at 912 (internal quotation marks and footnote omitted) (quoting Grand River Enters. Six Nations, Ltd. v. Beebe, 574 F.3d 929, 942 (8th Cir. 2009)).

223.   The Court acknowledges that the parties have asked it to also address other grounds for granting or denying a preliminary injunction, including preemption and other potential violations of the Dormant Commerce Clause doctrine. See Prelim. Inj. Hr'g Tr. (Doc. 40) at 110:16–11:9, 142:7–143:17. But, given the Court's ruling on facial discrimination and discriminatory effect below, the Court need not address those other grounds. There are various judicial-restraint reasons to go no further than necessary. For example, with respect to allegations of discriminatory purpose, the Court is hesitant to ascribe an unconstitutional purpose to a popularly elected state legislature on anything less than a full record. See Anthony DiSarro, A Farewell to Harms: Against Presuming Irreparable Injury in Constitutional Litigation, 35 Harv. J. L. & Pub. Pol'y 743, 763 (2012) (“In preliminary injunction proceedings, important constitutional questions will be decided tentatively and usually upon an incomplete evidentiary record produced at abbreviated and rushed hearings.”). Values underlying both federalism and separation of powers caution against such a ruling at this preliminary stage. For another example, although the Court's statutory interpretation of Act 630 strongly suggests the Act will (at least partially) be preempted by federal law, preliminary relief on such a claim would be more circumspect than preliminary relief calibrated to the likely Dormant Commerce Clause doctrine violation found in today's Order. Because the Court provides the broader injunctive relief calibrated to a Dormant Commerce Clause doctrine violation, a preliminary resolution of the preemption claim is unnecessary and therefore inadvisable. For a third example, the intricacies of the extraterritoriality portion of the Dormant Commerce Clause doctrine counsels against unnecessary and premature pronouncements in that area. Compare Ass'n for Accessible Medicines v. Ellison, 140 F.4th 957, 961–62 (8th Cir. 2025) (“In National Pork Producers Council v. Ross, the Supreme Court rejected the argument that the extraterritoriality doctrine created an ‘almost per se rule forbidding enforcement of state laws that have the practical effect of controlling commerce outside the State.’ ” (quoting National Pork Producers Council, 598 U.S. at 371, 143 S.Ct. 1142)), with id. (“The Court did not overturn ‘the rule that was applied in Baldwin and Healy’ preserving its precedent that a state violates the extraterritoriality principle when it enacts ‘price control or price affirmation statutes that tie[ ] the price of in-state products to out-of-state-prices.’ ” (quoting National Pork Producers Council, 598 U.S. at 371, 143 S.Ct. 1142)). See also Prelim. Inj. Hr'g Tr. (Doc. 40) at 104:20–107:5, 148:11–149:4 (discussing the debate over what is left of the extraterritoriality doctrine post-National Pork Producers).

224.   U & I Sanitation v. City of Columbus, 205 F.3d 1063, 1067 (8th Cir. 2000).

225.   Id. (quoting Oregon Waste Sys., Inc. v. Dep't of Env't Quality of Or., 511 U.S. 93, 99, 114 S.Ct. 1345, 128 L.Ed.2d 13 (1994)).

226.   See Oregon Waste Sys., Inc., 511 U.S. at 100, 114 S.Ct. 1345 (“Consequently, even if the surcharge merely recoups the costs of disposing of out-of-state waste in Oregon, the fact remains that the differential charge favors shippers of Oregon waste over their counterparts handling waste generated in other States. In making that geographic distinction, the surcharge patently discriminates against interstate commerce.”); Jones v. Gale, 470 F.3d 1261, 1267–68 (8th Cir. 2006) (“[The challenged law] is facially discriminatory because its prohibition against farming by corporations and syndicates does not apply to family farm corporations or limited partnerships in which at least one family member resides on or engages in the daily labor and management of the farm. We agree ․ that [the challenged law] on its face, therefore, favors Nebraska residents, and people who are in such close proximity to Nebraska farms and ranches that a daily commute is physically and economically feasible for them.”).

227.   Ark. Code Ann. § 20-64-105(c)(1).

228.   See supra p. 27.

229.   See supra pp. 26–28.

230.   See id.; Ark. Code Ann. § 20-64-105(c)(1)(B) (“A pharmaceutical manufacturer ․ [s]hall not restrict or limit prescription medications ․ to a limited distribution network of pharmacies without having similar access and allowing for upon request or application by a pharmacy at least ․” (emphasis added)).

231.   See Ark. Code Ann. § 20-64-105(c)(1) (“A pharmaceutical manufacturer ․ [s]hall not restrict or limit prescription medications ․ to a limited distribution network of pharmacies without ․ allowing for upon request or application by a pharmacy at least․ [a] local network of public institution academic medical center access ․ [g]eographic diversity of access within the state [and] diverse access for local for-profit and nonprofit pharmacies ․”). This understanding of Act 630 flows directly and ineluctably from the Court's statutory interpretation of subsection (c)(1)(B). See supra pp. 23–32, 129 S.Ct. 365.

232.   See Verified Complaint ¶ 81 (explaining that Act 630's required admittance into certain limited distribution networks for drugs with small patient populations “makes it less likely that non-Arkansas pharmacies will be selected to distribute a manufacturer's products[,]” and depending on the product and how many Arkansas pharmacies a manufacturer must admit, Novartis “may need to cut ties with existing dispensers to make room for [Arkansas pharmacies] ․”). Even on the State's reading of subsection (c)(1)(B) of Act 630, there is facial discrimination. On that reading, the Act gives in-state pharmacies (and only in-state pharmacies) a second bite at the apple to gain access to limited distribution networks if they are denied by a manufacturer. Defs.' Reply in Supp. of Defs.' Mot. to Dismiss (Doc. 30) at 13. The State concedes that subsection (c)(1) related to three-month limited distribution networks provides “a backstop if pharmaceutical manufacturers are arbitrarily denying access to a qualified pharmacy.” Id. at 13, 129 S.Ct. 365. That is, on the State's reading of the statute, if the Board does not agree with the manufacturer's reasons for denying an in-state pharmacy admittance or thinks the reasons given are insufficient or arbitrary, it could force the manufacturer to give the in-state pharmacy (and only in-state pharmacies) access. See id.

233.   Ark. Code Ann. § 20-64-105(d)(2)(B). Recall that out-of-state pharmacies without a physical presence in Arkansas rely extensively on mail delivery to send drugs to patients (rather than the use of physical locations) because keeping inventory of these drugs in locations with only a few patients in the vicinity (or no patients in the area at all) is inefficient. Verified Compl. (Doc. 1) ¶ 30; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Mot. for Prelim. Inj. (Doc. 2) ¶ 11.

234.   Ark. Code Ann. § 20-64-105(d)(1)(A)–(B), (d)(2)(B), (e). As the Court explained in its earlier section on statutory interpretation, the language of subsection (d)(2)(B) means exactly what it says. See supra pp. 34–35, 129 S.Ct. 365. Absent a discretionary waiver by the Board, a pharmaceutical manufacturer may not have a limited distribution network for six-months or more if that network does not include pharmacies in Arkansas (assuming one or more pharmacies in Arkansas applied for admittance). See id.

235.   Moreover, requests for permanent limited distribution networks that exclude any state-based Class A pharmacies (assuming such pharmacies apply for inclusion in the network) require a public hearing. Ark. Code Ann. § 20-64-105(d)(4). Act 630 does not require a public hearing if only out-of-state pharmacies are excluded from the network.

236.   Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 26.

237.   Id. at 26.

238.   Id. at 27.

239.   Id.

240.   See supra note 226.

241.   470 F.3d at 1264–65.

242.   Id. at 1265 (quoting Neb. Const. art. XII, sec. 8).

243.   Id. at 1268 (internal quotations omitted) (quoting Jones v. Gale, 405 F. Supp. 2d 1066, 1081 (D. Neb. 2005)).

244.   Ark. Code Ann. § 20-64-105(c)(1); Ark. Code Ann. § 20-64-105(d)(1)–(4).

245.   See Oregon Waste Sys., 511 U.S. at 100, 114 S.Ct. 1345. To make an abstraction into something a little more real, consider how Act 630 might apply to Walgreens. On the one hand, even though Walgreens is an out-of-state company, Act 630 would still protect (and favor) a Walgreens pharmacy in Little Rock. On the other hand, Act 630 would not give this special solicitude to a Walgreens specialty pharmacy in Memphis that is 10 minutes from the Arkansas border and could service eastern Arkansas.

246.   35 F.4th 1097. See also Prelim. Inj. Hr'g Tr. (Doc. 40) 140:8–141:3.

247.   Paul's Industrial Garage, 35 F.4th at 1099–1100 (emphasis in original) (quoting Gen. Motors Corp. v. Tracy, 519 U.S. 278, 298, 117 S.Ct. 811, 136 L.Ed.2d 761 (1997)).

248.   Id. at 1100 (internal citations omitted).

249.   Id. at 1100 (quoting Gen. Motors Corp., 519 U.S. at 300, 117 S.Ct. 811).

250.   IESI AR Corp. v. N.W. Arkansas Regl. Solid Waste Mgmt. Dist., 433 F.3d 600, 605 (8th Cir. 2006) (“A regulation discriminates in effect if it favors in-state economic interests over out-of-state interests.”). See also Hunt v. Washington State Apple Advert. Comm'n., 432 U.S. 333, 351–52, 97 S.Ct. 2434, 53 L.Ed.2d 383 (1977) (“[T]he challenged statute has the practical effect of not only burdening interstate sales of Washington apples, but also discriminating against them. This discrimination takes various forms. The first ․ is the statute's consequence of raising the costs of doing business in the North Carolina market for Washington apple growers and dealers, while leaving those of their North Carolina counterparts unaffected․ Second, the statute has the effect of stripping away from the Washington apple industry the competitive and economic advantages it has earned for itself through its expensive inspection and grading system․ Third, by prohibiting Washington growers and dealers from marketing apples under their State's grades, the statute has a leveling effect which insidiously operates to the advantage of local apple producers.” (emphasis added)).

251.   See Verified Compl. (Doc. 1) ¶¶ 72–73, 81; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Mot. for Prelim. Inj. (Doc. 2) ¶ 28.

252.   See supra pp. 27–35.

253.   Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Mot. for Prelim. Inj. (Doc. 2) ¶ 34. Indeed, the entire premise of Act 630 appears to be that some (if not most) Arkansans would prefer obtaining specialty drugs from in-person pharmacies as opposed to through the mail.

254.   IESI AR Corp., 433 F.3d at 605. See also West Lynn Creamery, Inc. v. Healy, 512 U.S. 186, 203–04, 114 S.Ct. 2205, 129 L.Ed.2d 157 (1994) (“More fundamentally, respondent ignores the fact that Massachusetts dairy farmers are part of an integrated interstate market․ [T]he purpose and effect of the pricing order are to divert market share to Massachusetts dairy farmers. This diversion necessarily injures the dairy farmers in neighboring States.”).

255.   See Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 31–32.

256.   See id.

257.   Defs.' Reply in Supp. of Defs.' Mot. to Dismiss (Doc. 30) at 18.

258.   See supra pp. 44–45.

259.   See Verified Compl. (Doc. 1) ¶¶ 72–73, 81; Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Mot. for Prelim. Inj. (Doc. 2) ¶ 28.

260.   Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Mot. for Prelim. Inj. (Doc. 2) ¶¶ 48–49; Verified Compl. (Doc. 1) ¶¶ 64, 124.

261.   South Dakota Farm Bureau v. Hazeltine, 340 F.3d 583, 593 (8th Cir. 2003) (brackets omitted) (quoting C & A Carbone, Inc. v. Town of Clarkstown, 511 U.S. 383, 392, 114 S.Ct. 1677, 128 L.Ed.2d 399 (1994)). This is a very high threshold. Indeed, Supreme Court precedent “require[s] that justifications for discriminatory restrictions on commerce pass the ‘strictest scrutiny.’ ” Oregon Waste Sys., Inc., 511 U.S. at 101, 114 S.Ct. 1345 (quoting Hughes v. Oklahoma, 441 U.S. 322, 337, 99 S.Ct. 1727, 60 L.Ed.2d 250 (1979)).

262.   See, e.g., Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 32–33; Ark. Code Ann. § 20-64-105(a).

263.   See supra pp. 16–19.

264.   The Court has also considered the study that Defendants have attached to their Motion to Dismiss and that Defendants discuss in passing in their briefing. See Ex. 3 (Study on Impact of Limited Distribution Networks) to Defs.' Mot. to Dismiss (Doc. 18-3); Defs.' Br. in Supp. of Defs.' Mot. to Dismiss and Opp'n to Pl.'s Mot. for Prelim. Inj. (Doc. 19) at 11–12. The study discusses limited distribution models that go through external pharmacies as inefficient and potentially being a barrier to effective treatment. See Ex. 3 (Study on Impact of Limited Distribution Networks) to Defs.' Mot. to Dismiss (Doc. 18-3). But the study is not specific to Arkansas, see id., and does not provide much to change the Court's overall assessment that most of the problems being solved here are either abstract or related more to the economic interests of in-state dispensers. See infra note 265.

265.   See supra pp. 16–19; Prelim. Inj. Hr'g Tr. (Doc. 40) at 14:4–14:12 (“[Dr. Kirtley]: You know, Highlands Oncology, CARTI, UAMS, where we have facilities that are very frustrated that they have been involved in the development of drugs actually as primary research sites for different medications, and then once a medication is approved, they are frustrated that they are unable to get access to those drugs.”); Decl. of Stephen Carroll (Doc. 37) ¶¶ 18–20.

266.   The Eighth Circuit has expressed skepticism at local laws that do nothing to advance their purported goals. See SDDS, Inc. v. State of S.D., 47 F.3d 263, 271 (8th Cir. 1995).

267.   South Dakota Farm Bureau v. Hazeltine, 340 F.3d 583, 597 (8th Cir. 2003) (“The focus of this test of the ‘strictest scrutiny,’ however, does not concern the strength of the interests advanced by the challenged law. Rather, the question is whether reasonable non-discriminatory alternatives exist to advance the interests. The Defendants bear the burden of demonstrating there is no such alternative.” (citing Oregon Waste Sys., 511 U.S. at 100–01, 114 S.Ct. 1345)).

268.   The Court acknowledges the State's professed interest in Arkansans' “freedom of choice to utilize local trusted medication experts and state-based local pharmacists who support patients with advice and guidance for safe and effective use of these medications.” Ark. Code Ann. § 20-64-105(a)(1). See also Prelim. Inj. Hr'g Tr. (Doc. 40) at 146:21–148:9. But this is not a legitimate interest as much as it is lawyer-speak for discrimination against pharmacies without locations in Arkansas. Freedom of choice in general may well be a legitimate interest. But it becomes illegitimate when it morphs into insisting on the ability to choose a local proprietor for no reason other than the fact that the proprietor is local. Cf. West Lynn Creamery, Inc., 512 U.S. at 205, 114 S.Ct. 2205 (“If we were to accept these arguments, we would make a virtue of the vice that the rule against discrimination condemns. Preservation of local industry by protecting it from the rigors of interstate competition is the hallmark of the economic protectionism that the Commerce Clause prohibits.”). The State might respond that there are secondary benefits associated with using a local proprietor. But such benefits—safety and access—can be achieved with the readily-available, nondiscriminatory, and otherwise lawful alternatives already discussed in the main text. See supra p. 50, 129 S.Ct. 365; Pl.'s Mot. for Prelim. Inj. (Doc. 2) at 38–39 (proposing additional alternatives to achieving the State's purported interests).

269.   To the extent the State has pressed standing and ripeness arguments against Novartis's dormant Commerce Clause doctrine claims, the Court is not persuaded. First, it is of no moment that the alleged constitutional violation directly injures the out-of-state pharmacies as opposed to manufacturers like Novartis. See Hazeltine, 340 F.3d at 592 (“[I]n Commerce Clause jurisprudence, cognizable injury is not restricted to those members of the affected class against whom states or their political subdivisions ultimately discriminate.” (quoting Houlton Citizens' Coal. v. Town of Houlton, 175 F.3d 178, 183 (1st Cir.1999))); Jones, 470 F.3d at 1267 (“[P]laintiffs have standing to challenge the constitutionality of a law that has a direct negative effect on their ‘borrowing power, financial strength, and fiscal planning ․’ ” (internal quotation marks omitted) (quoting Hazeltine, 340 F.3d at 592.)). Second, contrary to the State's primary ripeness argument, the heart of Act 630 is not dependent on (or triggered by) an application from an Arkansas dispenser. Recall that subsection (d) requires a manufacturer that wishes to maintain a limited distribution network for six months or longer to get approval from the Board of Pharmacy. This requirement is not triggered by a dispenser's application or request. See supra note 188; Ark. Code Ann. § 20-64-105(d)(1)(A). Thus, for at least the twelve of Novartis's limited distribution network drugs currently sold in Arkansas, Novartis will need to immediately file applications and go through any additional Board of Pharmacy approval processes before September 1, 2026, the enforcement date. See Decl. of Artemisa Hoxholli (Doc. 39) ¶ 14; Ex. 2 (Act 630) to Defs.' Mot. to Dismiss (Doc. 18-2) at 5; Verified Compl. (Doc. 1) ¶ 17. This process will self-evidently cost Novartis time and money. And if Novartis fails to file an application for one of these drugs, or if the Board does not approve one of these applications before September 1, 2026, Novartis risks serious financial penalties. See supra pp. 36–37, 129 S.Ct. 365. These penalties include the loss of Medicaid funding for all of its drugs in Arkansas and penalties of up to $10,000 per day. See Ark. Code Ann. § 20-64-105(e)–(f). Novartis “need not ‘await the consummation of [these] threatened injuries to obtain preventive relief ․ [because] [,]if the injury is certainly impending, that is enough.” Parrish v. Dayton, 761 F.3d 873, 875–76 (8th Cir. 2014) (quoting Babbitt v. United Farm Workers Nat'l Union, 442 U.S. 289, 298, 99 S.Ct. 2301, 60 L.Ed.2d 895 (1979)). Third, even as to the provisions that are dependent upon (or triggered by) a dispenser's application, Novartis' potential injury from the provisions is not speculative. Dr. Carroll has already complained about losing access to KISQALI for his specialty pharmacy in Little Rock, and he has made clear that he wishes to regain access. See Ex. 1 (Dr. Carroll's Email) to Decl. of Eileen Zimmer (Doc. 35-1) at 2. Similarly, Dr. Kirtley testified that he received complaints from Arkansas dispensers about the lack of access to certain specialty drugs after Act 630's passage. See Prelim. Inj. Hr'g Tr. (Doc. 40) at 14:4–15:1. Dr. Kirtley has explained to these dispensers that these concerns can be addressed once Act 630 enforcement date rolls around. See id. And Dr. Kirtley admits that, based on conversations he has had with pharmacies and manufacturers “there's a handful of pharmacies in [Arkansas] that are very interested in access to specific drugs.” Id. at 25:18–25:21. This record evidence is more than enough to conclude that (1) the subsections that need to be triggered by an application will likely be triggered, (2) Novartis will have to adjust their distribution networks now to prepare for that likely event, and (3) Novartis will face imminent injury in the form of having to comply with an unconstitutional law or risk severe penalties for non-compliance. Given the current state of the record and considering the governing standing and ripeness tests, Novartis has shown it is likely to prevail on those questions. See Spokeo, Inc. v. Robins, 578 U.S. 330, 338, 136 S.Ct. 1540, 194 L.Ed.2d 635 (“[S]tanding consists of three elements․ The plaintiff must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” (first quoting Lujan v. Defs. Of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992); and then citing id. at 560–61, 112 S.Ct. 2130)); Parrish, 761 F.3d at 875–76 (“The touchstone of a ripeness inquiry is whether the harm asserted has matured enough to warrant judicial intervention․ A claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all.” (internal quotation marks omitted) (first quoting Vogel v. Foth & Van Dyke Assocs., Inc., 266 F.3d 838, 840 (8th Cir. 2001); and then quoting Texas v. United States, 523 U.S. 296, 300, 118 S.Ct. 1257, 140 L.Ed.2d 406 (1998))).

270.   See supra note 217.

271.   To be more technical about it, “[i]rreparable harm occurs when a party has no adequate remedy at law, typically because its injuries cannot be fully compensated through an award of damages.” Gen. Motors Corp. v. Harry Brown's, LLC, 563 F.3d 312, 319 (8th Cir. 2009). Irreparable harm requires the plaintiff to “show that the harm is certain and great and of such imminence that there is a clear and present need for equitable relief.” Dakotans for Health v. Noem, 52 F.4th 381, 392 (8th Cir. 2022) (cleaned up). The plaintiff must also demonstrate that the harm is “not merely a possibility but is likely to occur absent preliminary injunctive relief.” Morehouse Enters., 78 F.4th at 1017 (cleaned up).

272.   See Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶¶ 44–46; Verified Compl. (Doc. 1) ¶¶ 64–65, 124.

273.   Ex. 1 (Decl. of W.M. Ambrose Delpino Jr.) to Pl.'s Mot. for Prelim. Inj. (Doc. 2) ¶ 45 (“That process would consume significant resources (if it can be implemented in the first place). Novartis employees would need to be re-assigned from their usual duties to effectuate and review the required changes. And Novartis would incur additional costs for outside counsel to review the revisions to its distribution contracts. These costs would reduce the resources available to support Novartis's core mission of innovating new and improved drugs.”). In addition to the costs of renegotiations contracts, there would be the immediate cost of preparing applications for the twelve limited distribution drugs that Novartis tells us Act 630 directly impacts. See Decl. of Artemisa Hoxholli (Doc. 39) ¶ 14; Ex. 2 (Act 630) to Defs.' Mot. to Dismiss (Doc. 18-2) at 5; Verified Compl. (Doc. 1) ¶ 17. Indeed, Novartis must act quickly because if those applications are not approved by the Board of Pharmacy before the enforcement date of September 1, 2026, Novartis will be out of compliance with Act 630 for those drugs and will be vulnerable to Act 630's serious penalties. See supra note 269.

274.   Thunder Basin Coal Co. v. Reich, 510 U.S. 200, 220-21, 114 S.Ct. 771, 127 L.Ed.2d 29 (1994) (Scalia, J., concurring in part). See also Iowa Utilities Bd. v. FCC, 109 F.3d 418, 426 (8th Cir. 1996) (“The threat of unrecoverable economic loss ․ [qualifies] as irreparable harm.”).

275.   Morehouse Enters., 78 F.4th 1011 at 1017 (“In most instances, constitutional violations constitute irreparable harm.”).

276.   See supra pp. 27–35.

277.   See supra pp. 11–13 (explaining that Novartis is ultimately responsible for making sure that everyone down the distribution chain complies with a specific drug's REMS and ETASUs because it cannot legally market a drug that is out of compliance with these (often onerous) federal requirements); Verified Compl. (Doc. 1) ¶¶ 51–58.

278.   Verified Compl. (Doc. 1) ¶¶ 16, 125. See also Iowa Utilities Bd. v. FCC, 109 F.3d 418, 426 (8th Cir. 1996) (“[P]otential loss of consumer goodwill qualifies as irreparable harm.”). This worry about certain pharmacies not keeping up to date with requirements for drugs the way Novartis's current specialty dispensers do is not theoretical. It was demonstrated in real time by Novartis when cross-examining Dr. Kirtley. Dr. Kirtley's declaration discussed the risk and mitigation strategy for Novartis's drug KYMRIAH. See Ex. 1 (Decl. of John Kirtley) to Defs.' Reply in Supp. of Defs.' Mot. to Dismiss (Doc. 30-1) ¶ 6. But Dr. Kirtley was not aware that when he signed his Declaration in September of 2025, KYMRIAH's risk evaluation and mitigation strategy had already been rescinded as of June of 2025. See Prelim. Inj. Hr'g Tr. (Doc. 40) at 59:8–59:25; Ex. 1 (Decl. of John Kirtley) to Defs.' Reply in Supp. of Defs.' Mot. to Dismiss (Doc. 30-1) at 4.

279.   Cf. Carson v. Simon, 978 F.3d 1051, 1061 (8th Cir. 2020) (explaining that it is in the public interest to preserve the ability to uphold duly-enacted state laws).

280.   Cf. id. (“[I]t is always in the public interest to protect constitutional rights.” (quoting Phelps-Roper v. Nixon, 545 F.3d 685, 690 (8th Cir. 2008), overruled on other grounds by Phelps-Roper v. City of Manchester, 697 F.3d 678, 692 (8th Cir. 2012) (en banc))). See also Ass'n for Accessible Medicines, 140 F.4th at 961–62 (noting the tension between the public's interest in enforcing state laws and the public's interest in protecting constitutional rights).

281.   See supra p. 50.

282.   This is especially true because the preliminary injunction against enforcement of Act 630 would be limited to enforcement against Novartis. See Trump v. CASA, Inc., 606 U.S. 831, 844, 145 S.Ct. 2540, 222 L.Ed.2d 930 (2025) (“[N]either declaratory nor injunctive relief ․ can directly interfere with enforcement of contested statutes or ordinances except with respect to the particular federal plaintiffs.” (quoting Doran v. Salem Inn, Inc., 422 U.S. 922, 931, 95 S.Ct. 2561, 45 L.Ed.2d 648 (1975))); id. at 851, 145 S.Ct. 2540 (“The equitable tradition has long embraced the rule that courts generally ‘may administer complete relief between the parties.’ ” (alterations in original) (quoting Kinney-Coastal Oil Co. v. Kieffer, 277 U.S. 488, 507, 48 S.Ct. 580, 72 L.Ed. 961 (1928))). See also Gregory v. Stetson, 133 U.S. 579, 586, 10 S.Ct. 422, 33 L.Ed. 792 (1890) (“It is an elementary principle that a court cannot adjudicate directly upon a person's right without having him either actually or constructively before it. This principle is fundamental.”). Only Novartis will be operating under the current system. Because no other pharmaceutical manufacturer has brought suit, Act 630 will go into effect as to all such manufacturers except Novartis.

283.   See supra pp. 27–35; Verified Compl. (Doc. 1) ¶¶53–58.

284.   See Verified Compl. (Doc. 1) ¶¶53–58 (explaining the difficulty and cost of getting pharmacies up to compliance standards).

LEE P. RUDOFSKY, UNITED STATES DISTRICT JUDGE