Key Takeaways:

  • Two competing federal court preliminary injunction orders were issued April 7, 2023, which have put the continued availability of mifepristone, the primary drug used for the medical termination of pregnancy, in flux.
  • A Texas district court ruling will suspend the Food and Drug Administration's (FDA) approval of the drug pending a trial on the merits, unless the Fifth Circuit grants the government's emergency motion for a stay before the end of the week.
  • A Washington district court ruling orders FDA to continue to make the drug available in 17 states and the District of Columbia under the current distribution restrictions to ensure continued access to mifepristone. The order enjoins FDA from "altering the status quo and rights as it relates to the availability" of the drug under the current labeling instructions and distribution restrictions.
  • Both cases will require FDA to defend certain decisions it has made with respect to the drug's approval, but the level of deference that the two courts will apply to FDA's scientific expertise could vary greatly.

In a much-anticipated ruling, a U.S. District Court judge in Texas has suspended the Food and Drug Administration's 23-year-old approval of mifepristone, the primary drug used in a two-step regimen for the medical termination of early pregnancy, and all subsequent FDA approvals related to the original approval in 2000.1 On April 7, 2023, in Alliance for Hippocratic Medicine v. FDA, Judge Matthew Kacsmaryk, the sole judge in the Amarillo, Texas court, granted in part a motion for preliminary injunction filed by the plaintiffs, a group of anti-abortion advocacy organizations and four doctors, based on the plaintiffs' allegations of missteps by FDA in its review and approval of mifepristone. At the same time, the court delayed implementation of the order for seven days to allow FDA and other government defendants, represented by the Department of Justice (collectively "FDA" or "the government"), to seek emergency relief from the Fifth Circuit Court of Appeals. FDA filed an emergency motion to stay the district court's order on April 10, 2023. Unless the Fifth Circuit stays the district court order pending appeal, the order will go into effect on April 14, 2023, essentially rendering mifepristone an unapproved drug for the duration of the lawsuit. FDA indicated in its emergency motion its intent to appeal to the U.S. Supreme Court if the appellate court does not stay the district court's order before April 14, 2023.

Also on April 7, 2023, in another federal lawsuit brought against FDA, State of Washington v. FDA, a U.S. District Court in Washington state granted in part a motion for preliminary injunction filed by the plaintiffs, a group of 17 states and the District of Columbia, against FDA to ensure continued access to mifepristone.2 The order enjoins FDA from "altering the status quo and rights as it relates to the availability" of the drug under FDA's current operative Risk Evaluation and Mitigation Strategy (REMS) requirements. The Washington court order would prevent FDA from taking any action that would preclude mifepristone's availability in the 17 states and the District of Columbia.3 Given the significant tension between the two orders, the government has filed a motion to clarify FDA's obligations in the event that the order in the Texas case takes effect.

The Texas Case: Alliance for Hippocratic Medicine v. FDA

In his consideration of the plaintiff's motion for preliminary injunction, which we discussed previously here, Judge Kacsmaryk concluded that:

  • the plaintiffs had standing to sue;
  • none of their claims were barred by a six-year statute of limitations;
  • the plaintiffs were not required to exhaust all administrative remedies;
  • the plaintiffs had a substantial likelihood of success on the merits;
  • the plaintiffs faced substantial threat of irreparable harm and that the threatened harm outweighed any harm that would result from the court's action; and
  • the court's action was in the public interest.

The court also made the following findings on the merits:

  • FDA's actions were arbitrary and capricious based on the court's assessment of the allegations made by the plaintiffs.
  • FDA's 2000 approval of mifepristone improperly relied on FDA's regulations referred to as Subpart H, because pregnancy is not an illness and chemical abortion drugs provide no meaningful therapeutic benefit.
  • The Comstock Act, a law passed in 1873, prohibited FDA from removing the in-person dispensing requirement from the mifepristone REMS Program.

Standing to Sue

To have standing in federal court, a person must show "(i) that he suffered an injury in fact that is concrete, particularized, and actual or imminent; (ii) that the injury was likely caused by the defendant; and (iii) that the injury would likely be redressed by judicial relief."4 The judge concluded that the plaintiffs have shown an "injury in fact" because their members alleged, among other things: "enormous pressure and stress" from a medical system "overwhelm[ed]" by adverse events from chemical abortions; "fac[ing] increased exposure to allegations of malpractice and potential liability;" having patients who have suffered injuries; and not being able to practice "evidence-based medicine" and obtain adequate informed consent because FDA failed to require reporting of all adverse events related to the drug.5 The court concluded that FDA was responsible for these injuries and that judicial action can redress at least some of the injuries, "even if relief must filter downstream through third parties uncertain to comply with the result."6

Procedural Arguments

The court rejected the government's statute of limitations argument, concluding that FDA's response to the plaintiffs' 2019 citizen petition "undertook a full review of Mifepristone REMS Program" and "significantly departed from the agency's original approval of the abortion regime," thus it reopened the issue of the agency's original approval of mifepristone in 2000. To recap:

  1. The first citizen petition, filed in August 2002, challenged the agency's approval of the drug in 2000 was denied by FDA in March, 2016.
  2. The second citizen petition, filed in March 2019, challenged certain changes that FDA had permitted to the regimen and prescriber instructions in the drug's labeling and requested that REMS restrictions, such as in-person dispensing requirements, be retained. This petition did not challenge the original approval of mifepristone. FDA granted in part and denied in part the petition in December, 2021.

Judge Kacsmaryk also considered the years FDA took to respond to the citizen petitions to be an unreasonable delay as justification for "equitable tolling" of the statute of limitations.

Although the government argued that the plaintiffs were required to exhaust their administrative remedies by submitting a citizen petition regarding FDA's approval of the generic version of the drug in 2019, the judge disagreed. Citing the Biden administration's stated intent to ensure access to medication abortion in the wake of Dobbs,7 the judge determined that requiring the plaintiffs to exhaust their administrative remedies for this remaining challenge was "futile."

Standard for Preliminary Injunction

To obtain a preliminary injunction, a plaintiff must demonstrate: (1) a likelihood of success on the merits or that there are "serious questions going to the merits;" (2) a likelihood of irreparable injury in the absence of preliminary relief; (3) that a balancing of the hardships weighs in plaintiff's favor; and (4) that a preliminary injunction will advance the public interest.8 In this case, plaintiffs had to show a likelihood of success on the merits of their claims that FDA acted improperly and its approval of mifepristone should be overturned.

The Administrative Procedure Act

Under the Administrative Procedure Act (APA), a court can invalidate a federal agency action if it finds it to be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."9 The district court determined that the plaintiffs did have a substantial likelihood of success on the merits because FDA's actions were "arbitrary and capricious" and "not in accordance with law."

First, the court held that FDA violated its own regulations, which establish a mechanism for FDA to impose safety conditions on drugs that are intended to treat serious and life-threatening illnesses and provide a meaningful therapeutic benefit over existing therapy or to meet an unmet medical need. As a fundamental point, FDA approved mifepristone pursuant to its statutory authority under Section 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) 10 but imposed restrictions to assure safe use under the "Subpart H" regulatory framework.11 But the court concluded that "Subpart H doubly forecloses FDA's approval of mifepristone" because "pregnancy is not an illness" and because "chemical abortion drugs do not provide a meaningful therapeutic benefit" of any kind.12 In so doing, the court rejected FDA's arguments that it has consistently interpreted the regulation to apply to "conditions" (which includes pregnancy) and that chemical abortion provides therapeutic benefits over surgical abortion for some women. FDA further maintained that any defect that arguably could have derived from the agency's imposition of restrictions pursuant to its Subpart H regulations was cured when the drug's safety conditions were converted to REMS restrictions after the Food and Drug Administration Amendments Act of 2007 (FDAAA) was enacted. The court rejected this argument as well.

Second, the court concluded that FDA acted in an arbitrary and capricious manner when it reviewed the safety data for mifepristone because the agency did not take into account the adverse events reported by the plaintiffs and others. However, a court's review of an agency's action under the "arbitrary and capricious" standard is supposed to be narrow in scope, and a court is not permitted to substitute its judgment for that of the agency. The agency "must examine the relevant data and articulate a satisfactory explanation for its action, including a rational connection between the facts found and the choice made." The court acknowledged that courts "must uphold an agency action unless it (1) 'relied on factors which Congress has not intended it to consider;' (2) 'entirely failed to consider an important aspect of the problem;' (3) 'offered an explanation for its decision that runs counter to the evidence before the agency;' or (4) the 'decision is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.'"13

The court found that FDA's approval "entirely failed to consider an important aspect of the problem" by "omitting any evaluation of the psychological effects of the drug or the long-term medical consequences of the drug" in 2000 when it approved mifepristone. In addition, the court concluded that FDA had stated that there was "insufficient information to determine whether such drug is safe" and, therefore, FDA had been required not to approve the drug. Moreover, the court posited that significant political pressure to increase access to chemical abortion may have played a part in FDA's actions.

Finally, the court concluded that all of the changes FDA made to the mifepristone REMS and conditions of use in 2016 were arbitrary and capricious, including: (1) eliminating the requirement for prescribers to report all nonfatal serious adverse events; (2) extending the maximum gestational age from 49 days to 70 days; (3) eliminating the requirement that administration of misoprostol (the second drug in the approved regimen) occurs in-clinic; (4) removing the requirement for an in-person follow-up exam; and (5) allowing "healthcare providers" other than physicians to dispense chemical abortion drugs. According to the court, FDA failed to "cogently explain" why the studies required (1) an ultrasound; (2) an in-person follow-up exam; and (3) a physician to be able to perform a surgical abortion, if necessary, but the labeling for the approved product did not require the same restrictions.14

Safety Data

The court found that FDA's actions were arbitrary and capricious after citing a litany of adverse events alleged by the plaintiffs to be associated with mifepristone. In its emergency motion to the Fifth Circuit, FDA noted that the court's decision was "largely based on the court's own interpretation of extra-record publications submitted by plaintiffs."15 The district court order did not acknowledge, describe, or evaluate the extensive safety data FDA considered in approving mifepristone in 2000 or in its 2016 approval of changes to the REMS requirements.

As explained above, the court also found FDA's changes to the 2016 REMS program to be arbitrary and capricious because FDA did not impose the same conditions in the labeling and in the REMS program that were included in the clinical studies that supported FDA's decisions. For example, the 2016 approval did not require an ultrasound prior to dispensing or an in-person follow-up exam, and it did not require the prescribing healthcare provider to be qualified to perform a surgical procedure if necessary. The 2016 approval also modified the REMS requirement that prescribers report "any hospitalization, transfusion or other serious event" to the manufacturer and instead only required that prescribers report any deaths to the manufacturer. The court referred to this revised requirement as "lax" reporting, ignoring the fact that—for the vast majority of drugs on the market—adverse event reporting by healthcare professionals is voluntary. Conversely, manufacturers are required to report serious adverse events to FDA, and the 2016 approval did not absolve mifepristone's manufacture from this requirement.

The Comstock Act

In April 2021, FDA announced that it would temporarily exercise enforcement discretion regarding the in-person dispensing element of the REMS Program during the COVID-19 public health emergency. The announcement also stated that FDA would exercise enforcement discretion during the pandemic with respect to the dispensing of mifepristone through the mail under the supervision of a certified provider. FDA approved an amendment to the REMS Program in January 2023 which permanently removed the in-person dispensing requirement. The court concluded that FDA violated the Comstock Act by not enforcing and by permanently removing the REMS requirement for in-person dispensing. The court found that the Comstock Act unambiguously makes distributing an abortion drug via mail a crime and that the government's interpretation (that it does not apply unless there is an intent to use the drug illegally) does not have merit. FDA has countered in its emergency motion to the Fifth Circuit that the Comstock Act is not relevant to FDA's exercise of authority under the FDCA, which does not require FDA to address the Comstock Act or a number of other laws that restrict a drug's distribution or use, such as the Controlled Substances Act.16

Balance of Harm and Public Interest

Although more than 20 years have passed since mifepristone was first approved, Judge Kacsmaryk found that enjoining the approval of the drug would serve the public interest by ensuring that women and girls "are protected from unnecessary harm and that Defendants do not disregard federal law."17 The court found this interest to be more important than preserving the interests of women who choose medication abortion for a variety of reasons, ignored the injunction's potential effect on the healthcare system if medication abortion is no longer available, and dismissed FDA's institutional interest in maintaining the administrative framework that Congress created, which entrusted FDA to make complex scientific determinations about the safety and efficacy of drugs and other medical products. FDA's emergency motion points to these government and public interests, which it argues "overwhelmingly favor a stay" of the district court's order.18

The Washington Case: State of Washington v. FDA

In State of Washington v. FDA, the district court in Washington was asked to protect access to mifepristone by enjoining FDA from enforcing or applying the 2023 REMS and from "taking any action to remove mifepristone from the market or otherwise cause the drug to become less available."19 The 18 plaintiffs, a group of 17 states and the District of Columbia, allege that the 2023 REMS restrictions place an economic and administrative burden on patients and providers that create barriers to access the medication, without any corresponding medical benefit, particularly given the "exceedingly rare" instances of serious adverse events associated with the drug.20 The 2023 REMS program removed the in-person dispensing requirements and permitted mifepristone to be dispensed by certified pharmacies.

Weighing the Burden of the 2023 REMS Restrictions

Although the 2023 REMS program is in many ways less restrictive than earlier versions of the program, plaintiffs contend that the requirement for pharmacies to first be certified to dispense the drug, and the attendant communication, verification, and recordkeeping requirements, are overly burdensome. Plaintiffs similarly contend that the REMS requirements that prescribing or dispensing health care providers be certified and that patients first sign a Patient Agreement Form before receiving the drug are overly burdensome, particularly in light of increasing criminalization and penalization of abortion following the Dobbs decision in other states. Plaintiffs also assert that the REMS program imposes certain costs on the state that are not compensable through the ordinary course of litigation. According to plaintiffs, the REMS program restricts access to mifepristone, causing some patients to miss the window when they could safely take the drug, leaving those patients with options that impose higher costs on state-run health care programs: obtaining a procedural abortion or carrying a pregnancy to term.

Judge Thomas Rice found that the plaintiffs had satisfied all four elements of the preliminary injunction standard, including that they were likely to succeed on their claim that FDA violated the APA because it failed to "adequately consider an important aspect of the problem" when it assessed whether mifepristone should be subject to a REMS.21 The court stated that "based on the present record, FDA did not assess whether mifepristone qualifies for REMS and ETASU [Elements to Assure Safe Use] based on the criteria set forth under [the statutory requirements for REMS]. *** Even under a deferential review, it appears FDA failed to consider [this] important aspect of the problem. *** Moreover, the record demonstrates potentially internally inconsistent FDA findings regarding mifepristone's safety profile."22

Maintaining the Status Quo

Nevertheless, the court declined to enjoin FDA from applying any REMS, as requested by plaintiffs because it would be "well beyond the status quo." Moreover, returning to the REMS program that existed before the 2023 modifications would reduce the availability of the drug (by eliminating the ability of pharmacies to dispense the drug), which is inconsistent with plaintiffs' other request to enjoin the agency from making mifepristone less available in the Plaintiff states. The court, therefore, decided to preserve the status quo by enjoining FDA from taking any action that would alter the status quo as to the availability of mifepristone under the current REMS until a determination is made on the merits of the case.

The parties have the right to seek an appeal to the Ninth Circuit Court of Appeals. In the meantime, FDA filed a motion for clarification on April 10, 2023 to ask that the Washington court clarify the government's obligations pursuant to its preliminary injunction in the event that the order in the Texas case (which was issued 20 minutes before the Washington order) takes effect and stays the approval of mifepristone.

Conflict Between Circuits/Next Steps

The Texas court order has stayed FDA's approval of mifepristone, effectively rendering the drug unapproved. The Texas court order may implicitly require FDA to take appropriate action such as informing the holders of the Mifeprex and generic mifepristone marketing applications to cease manufacturing and distributing an unapproved drug. However, the Washington court order precludes FDA from taking any action that would make mifepristone unavailable. FDA has already filed notice of appeal in the Texas case with the Fifth Circuit and has requested a stay of the order. If a stay is granted, the status quo, as described in the Washington case, would be maintained pending the appeal. If a stay is not granted, FDA has indicated it will appeal to the Supreme Court to resolve the conflict between the circuits.

Footnotes

1. The case is Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., Case No. 2:22-cv-00223 (N.D. Tex.).

2. The case is State of Washington et al. v. U.S. Food and Drug Administration et al., Case No. 1:23-cv-03026 (E.D. Wash.).

3. The states include: Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, District of Columbia, Hawaii, Maine, Maryland, Minnesota, Oregon, Pennsylvania, and Washington.

4. TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2203 (2021).

5. Memorandum Opinion and Order, Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., Case No. 2:22-cv-00223, Doc. No. 137 (N.D. Tex. Apr. 7, 2023) [hereinafter, "Alliance Opinion"}.

6. Alliance Opinion at 16.

7. Dobbs v. Jackson Women's Health Org., 142 S. Ct. 2228 (2022).

8. See, Order Granting in Part Plaintiffs' Motion for Preliminary Injunction at 17-18, State of Washington et al. v. U.S. Food and Drug Administration et al., Case No. 1:23-cv-03026, Doc. No. 80 (E.D. Wash., Apr. 7, 2023) [hereinafter, "Washington Order"} and cases cited therein.

9. 5 U.S.C. §§ 706(2)(A) & (C).

10. 21 U.S.C. § 355(c).

11. 21 C.F.R. Part 314 Subpart H.

12. Alliance Opinion at 48.

13. Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983).

14. Alliance Opinion at 60.

15. Emergency Motion Under Circuit Rule 27.3 for a Stay Pending Appeal, Alliance for Hippocratic Medicine et. al v. U.S. Food & Drug Admin. et. al, Case No. 23-10362, Doc. No. 20, (5th Cir. Apr. 10, 2023).

16. Emergency Motion at 21-22.

17. Id. at 64.

18. Emergency Motion at 25-26.

19. Plaintiff States' Motion for a Preliminary Injunction at 34. State of Washington et al. v. U.S. Food and Drug Administration et al., Case No. 1:23-cv-03026, Doc. No. 3 (E.D. Wash. Feb. 24, 2023).

20. Id. at 17.

21. Id. at 21.

22. Id.

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