During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. While the U.S. Supreme Court acted on the afternoon of Friday, April 21, 2023 to preserve access to the drug mifepristone while the case continues in the United States Court of Appeals for the  Fifth Circuit, the future of mifepristone—and the FDA’s authority to approve new drugs—will continue to be debated on appeal.

What Happened?

Since a federal District Court judge in Texas stayed the FDA’s 23-year-old approval of Mifeprex (the brand name of mifepristone) on April 7, 2023, drug manufacturers, suppliers, distributors, physicians, providers, hospitals, and patients have been preparing for the impact of the removal of the drug from the market, which was set to take effect on Saturday, April 15, 2023, before the U.S. Supreme Court issued an initial stay, which it then affirmed with last Friday’s “shadow docket” order. Prior to the Supreme Court’s stay, while health care providers made continuity-of-care plans for their patients in need of abortion and miscarriage care. Drug and device manufacturers, and the life sciences industry, generally, have scrambled to understand the impact of the District Court’s and the Fifth Circuit’s respective stays.

The Texas District Court ruling had the effect of suspending the FDA’s approval of mifepristone. In its decision, the District Court accused the FDA of “acquiesce[ing] on its legitimate safety concerns . . . based on plainly unsound reasoning and studies that did not support its conclusions.” In doing so, the District Court unanimously sided with each of the plaintiffs’ contentions, holding that:

  • Plaintiffs had standing to assert their claims because they alleged women may experience adverse events from the use of mifepristone and that such adverse events may place pressure and stress on physicians who serve in emergency rooms;
  • The statute of limitations was not tolled because the FDA “reopened” its earlier decisions when the agency revised the mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) in 2016 and 2021 and the equitable tolling doctrine applied due to the FDA’s “unreasonable delay” in responding to the plaintiffs’ 2002 and 2019 petitions;
  • The FDA did not have the authority to change the in-person dispensing requirement for mifepristone in 2021 under its discretionary authority;
  • Defendant’s claim that plaintiffs failed to exhaust their administrative remedies was excusable because, among other reasons, the FDA demonstrated that it would clearly reject plaintiffs’ claims even if they had exhausted their remedies;
  • Plaintiffs were likely to succeed on the merits of their claim that the FDA’s elimination of the 2021 in-person dispensing requirement violated the Comstock Act, which prohibits the mailing of “chemical abortion drugs” and therefore these actions violate the Administrative Procedure Act (“APA”); and
  • Plaintiffs also were likely to succeed on the merits of their claims that the FDA’s pre-2021 actions violated its own regulations to ensure drugs are safe and effective to use and that these actions were arbitrary and capricious in violation of the APA. 

At midnight on April 12, 2023, the Fifth Circuit responded to the government and the manufacturer of Mifeprex’s emergency stay requests by halting only the District Court’s stay of the original 2000 FDA-approval of Mifeprex. However, the Fifth Circuit allowed all other FDA actions after 2016 with regard to Mifeprex, including a 2023 REMS change that had not been previously a part of the case, to be stayed. Whether intended or in error, a practical effect of the Fifth Circuit’s ruling was to remove FDA-approval of the chemically-identical, generic version of the drug, which was not approved until 2019, and was thus subject to the Fifth Circuit’s approval of portions of the District Court’s original stay. As GenBioPro, the manufacturer of the generic mifepristone, pleaded to the U.S. Supreme Court, the Fifth Circuit’s singling out of its product, while leaving the brand-name drug in place, “make[s] no sense” and “is . . . wreaking havoc for GenBioPro, throwing the marketplace into disarray, and creating massive confusion” among patients, providers, and the industry.

Adding to the confusion taking place in the Fifth Circuit is a near-simultaneous Washington federal District Court ruling enjoining the FDA from taking any adverse action to the approval of mifepristone in the seventeen plaintiff states and the District of Columbia. In the proceedings for Washington v. FDA, the FDA moved the U.S. District Court for the Eastern District of Washington  to clarify its position in light of the Texas case, and on April 13, 2023, the Washington District Court reaffirmed its order “regardless” of the Texas court’s or the Fifth Circuit’s proceedings. 

An "Unworkable" and "Impossible" Change to the FDA’s Approval Process

Among the most concerning rationale of the district court’s stay order for the drug and device industry was the seemingly new requirement that in order to withstand judicial scrutiny, drugs (or devices) approved through New Drug Applications, supplemental New Drug Applications, and FDA-ordered labeling changes, would need to be supported by one global study containing every element of use “as a whole” to serve as the basis for the FDA’s approval, without deviation from the global study’s elements. As an amicus brief authored by over 150 members of the drug and device industry argued before the Fifth Circuit, “it is unlikely that a single [drug] would have been approved” that exists in the market today under this standard.[1] Industry members had earlier warned, “[a]s an industry, we count on FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for evaluation and approval” and that “adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment[.]” Industry repeated these claims as amici before the Supreme Court.

As a consequence of adding both expense and time to an already expensive and time-consuming process, the Texas District Court’s and the Fifth Circuit’s “new” new drug approval standard may have the effect of chilling investment in new drug and device development, where, in addition to budgeting for and designing an additional “global’ study, investors and manufacturers could be impacted by these lowered standards to sue the agency over its approvals. Both the Texas District Court and the Fifth Circuit found that the plaintiffs, who claimed they had treated patients who had been harmed by mifepristone and felt that they would be harmed in the future by mifepristone’s continued approval, had demonstrated sufficient harm to establish constitutional standing. Typically, courts have demanded a higher standard to establish a case or controversy before the court—past harm alone is not typically sufficient to show the imminent likelihood of future harm under the court’s existing standards. The Texas District Court and the Fifth Circuit were both persuaded by the plaintiffs’ account of a colleague’s alleged treatment of a patient who had presented to an emergency room with complications due to what the plaintiff’s colleague attributed to mifepristone.[2]

Drug and device manufacturers may fear a future where a lowered bar to challenge agency action results in competitors using the courts to enjoin access to successful, profitable drugs. Much like the Fifth Circuit’s decision to leave Mifeprex’s approval in place while staying the FDA’s approval of the generic mifepristone may have unintentionally created a temporary market advantage to Mifeprex, the court’s decision in this instance could be used similarly as a legal strategy in the future. Ultimately, patients may bear the cost of such exclusionary efforts.

Conflicting, Practical Implications of the Texas District Court, Fifth Circuit, and Washington District Court Rulings

Patients and providers must also grapple with uncertainty over a future without a drug that has been available for 23 years. If the Fifth Circuit’s stay had been allowed to take effect, access was not necessarily guaranteed in spite of the appellate court’s stay of the original 2000 approval. The effect of the Fifth Circuit ruling was to “reset” the REMS for Mifeprex to its 2011 version, since the Fifth Circuit effectively invalidated the 2016 REMS and all subsequent FDA actions pertaining to Mifeprex. While the Fifth Circuit claimed that Danco (the manufacturer of brand name Mifeprex) could suffer no harm from returning to operations it had employed for 16 years, the Fifth Circuit misunderstood the effect of its stay—in order to lawfully market Mifeprex under the 2011 REMS, Danco would need to submit a new supplemental New Drug Application to the FDA to approve the resurrected accompanying forms and labeling requirements under the earlier REMS. Under the Washington District Court’s order, FDA arguably is enjoined from approving any action to disturb the 2023 REMS, a catch-22 that Danco identified to the U.S. Supreme Court in its April 14, 2023 stay petition. While Danco would have been in limbo regardless, due to the rest of the Fifth Circuit’s order, there would have been no FDA-approved generic mifepristone either. Although in his dissent to the April 21, 2023 stay, Justice Alito expressed skepticism as to how this “reset” process would work and the applicability of the Eastern District of Washington’s injunction to the FDA’s ability to approve new forms.

Even if it were possible to navigate the regulatory confusion, hospitals and health care providers would have struggled to adapt to a two-tiered approval system for mifepristone access. While multi-state providers often have modified compliance programs for each state or territory, it is unlikely that even the most sophisticated provider would be able to develop the internal and technology systems necessary to permit ordering the drug in states subjected to different REMS with accompanying manufacturer and supplier requirements.

While the U.S. Supreme Court’s stay grant for the pendency of the litigation provides some temporary relief from the confusion by maintaining mifepristone’s unrestricted status quo, this week’s judicial activity may serve as a lesson on the importance of a comprehensive, national drug and device regulatory scheme supported by careful scientific analysis.

Looking Ahead

While the U.S. Supreme Court’s stay order did not shed light on the rationale behind the decision, the Court’s stay determination included a consideration of whether the FDA had demonstrated “likelihood of success on the merits” in order to grant the stay, which should be influential on the lower courts. However, this case is not yet over. The Fifth Circuit will continue to hear the merits of the appeal of the Texas District Court’s injunction, with briefing underway. Oral arguments will be heard on May 17, 2023. Depending on the outcome of those proceedings, the case could go before the U.S. Supreme Court again for a more fulsome determination. And, depending on how the U.S. Supreme Court rules, the case could be before the U.S. District Court again for a final ruling on the merits.

[1] Pharmaceutical Companies’ Amicus Br., 5th 29 Cir. ECF No. 118.

[2] App. 16a-17a and D. Ct. ECF No. 1-8 at 5.

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