Federal Courts Divided: Medication Abortion and the Uncertain Future of FDA’s Drug Oversight

Health Highlights

The Big Picture

Less than one year after the Supreme Court overturned the federal constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization and “returned [the issue of abortion back] to the people and their elected representatives,”1 access to safe and legal abortion has once again reached the Supreme Court’s docket. Recent weeks have seen significant judicial activity—and conflicting injunctions—regarding Food and Drug Administration (FDA) oversight of mifepristone, one of two drugs taken as part of a medication abortion (MAB) regimen, which currently accounts for more than half of all abortions performed in the United States.

Last week, a federal court in Texas ruled that mifepristone must be removed from the market—a ruling that has since been at least temporarily narrowed on appeal to permit the continued marketing of the drug as originally approved, but without any of the access-expanding measures FDA has authorized since 2016, such as authorizations for telehealth-based prescribing or pharmacy dispensing. Meanwhile, a district court in Washington ordered FDA to maintain its current requirements regarding the prescribing and dispensing of mifepristone. Both cases have implications for the federal framework governing FDA’s review and approval of drugs, in addition to their implications for abortion access nationwide, including in states in which abortion remains legal.

As of the time of publication, the Department of Justice (DOJ) and Danco Laboratories, the manufacturer of Mifeprex (the brand version of mifepristone), have filed emergency applications in the Supreme Court for a stay of the Texas district court judgment in its entirety pending appeal.2 Supreme Court Justice Samuel Alito—who preliminarily decides stay requests from the 5th Circuit Court of Appeals—granted a 5-day stay, preserving the status quo while the full Court considers next steps.

The Texas Litigation: Alliance for Hippocratic Medicine v. FDA

The District Court Opinion. On Friday, April 7, in a long-awaited opinion in the case Alliance for Hippocratic Medicine v. FDAa federal district judge in Texas took the unprecedented step of issuing a nationwide “stay” that suspends FDA’s approval for a drug product.

As a preliminary matter, the court concluded that, although the members of the plaintiff medical associations oppose abortion and do not prescribe mifepristone, the associations nonetheless had “standing to sue”—i.e., the right to file a lawsuit challenging FDA’s approval of mifepristone—because individual physicians had treated, or may in the future treat, patients who experienced complications due to mifepristone. The court further concluded that, although federal agency actions are generally subject to legal challenge only within a six-year window of the challenged agency action, the plaintiffs nonetheless had the ability to challenge all of FDA’s actions regarding mifepristone, back to the original approval in 2000.

Turning to the merits, the court cited numerous bases for rejecting FDA’s initial decision to approve mifepristone, which included restrictions that limited mifepristone to in-person prescribing and dispensing by specially certified physicians, as well as FDA’s more recent actions that modified the Risk Evaluation and Mitigation Strategy (REMS) to expand access to MAB, including by enabling telehealth visits and pharmacy dispensing. Among other rationales, the court faulted FDA for:

  • Failing to appropriately weigh the risks and benefits of mifepristone, based on the court’s assessment of the medical evidence;
  • Failing to include the same conditions of use from the premarket clinical trials establishing mifepristone’s safety and efficacy in the approved labeling for mifepristone (on most FDA-approved drugs, conditions of use in clinical trials do not match the approved labeling);
  • With respect to mifepristone’s initial approval, impermissibly relying on the “accelerated approval” pathway; and
  • Impermissibly authorizing mifepristone to be dispensed by mail, whereas the federal Comstock Act prohibits the mailing of any items “intended for producing abortion, or for any indecent or immoral use.” The Comstock Act was enacted in 1873, a century before Roe v. Wade, and DOJ had argued that modern courts have interpreted the Comstock Act as applying only to knowingly furnishing the means for illegal abortions.

Although the district court ordered a total suspension of FDA’s approval for mifepristone—which would preclude the distribution or sale of this drug nationwide—the court delayed the effective date of its order by seven days to allow time for the government to file an appeal with the U.S. Court of Appeals for the 5th Circuit.

The 5th Circuit’s Stay Order. On appeal, DOJ asked the 5th Circuit to stay the district court’s order until the appeal is resolved. Among other arguments, DOJ noted that preliminary injunctions are generally issued to preserve the status quo, whereas the district court’s order would suddenly halt the “distribution of a drug that has been … available to millions of patients for more than two decades.”

On April 13, in a 2-1 decision, the 5th Circuit granted DOJ’s request, but only in part. The 5th Circuit stayed the district court’s suspension of FDA’s original 2000 approval of mifepristone, concluding that the plaintiffs’ challenge was likely time-barred. However, the 5th Circuit expressed preliminary agreement with the other elements in the district court’s order and so declined to issue a stay of the judgment in its entirety, resulting in a suspension of all of FDA’s modifications to the REMS since 2016. This means that—setting aside the potential impacts of the Washington injunction, discussed below—mifepristone is again subject to the original 2000 REMS, which included:

  • Limiting the drug to pregnant women and girls for use through seven weeks’ gestation (down from the current limit of 10 weeks);
  • Requiring three in-person office visits (and so prohibiting telehealth-based prescribing): the first to administer mifepristone, the second to administer misoprostol, and the third to assess any complications and ensure there were no fetal remains in the womb;
  • Requiring the supervision of a qualified physician (and thereby restricting dispensing in the pharmacy setting); and
  • Requiring the reporting of all adverse events from the drugs. 

When the appeal is briefed and argued on the merits, the 5th Circuit is free to revisit its legal conclusions in the stay order.

Soon after the 5th Circuit issued this ruling, DOJ announced that it would seek “emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.” As noted above, DOJ, along with the drug manufacturer, has now applied to Supreme Court for an immediate stay of the district court’s judgment in its entirety for the duration of the appeal. Justice Alito granted a 5-day stay of the AHM injunction, delaying any impacts until next week.

The Washington Litigation: Washington v. FDA

In this case, filed in a federal district court in Washington State, 18 Democratic attorneys general sued FDA seeking to expand access to MAB, arguing that mifepristone should be available without any conditions under a REMS given the 23-year history of safe use. Like the Alliance for Hippocratic Medicine (AHM) litigation, this case seeks judicial intervention in FDA’s oversight of approved drugs. Washington builds on litigation earlier in the COVID‑19 pandemic (American College of Obstetricians and Gynecologists (ACOG) v. FDA) in which a federal court in Maryland temporarily suspended the then-current requirement that mifepristone be dispensed in person, based on ACOG’s argument that in-person dispensing presented elevated risks during the pandemic and, although FDA had lifted similar in-person requirements for other drugs, it had not offered a compelling rationale for failing to do so with respect to mifepristone. After President Biden took office, FDA modified the REMS to remove the in-person dispensing requirement, as noted above.

On April 7—the same day as the AHM injunction—the Washington court issued a preliminary injunction ordering FDA to retain the “status quo and rights as it relates to the availability of mifepristone” under the current REMS. Unlike the AHM order, which appears to apply nationwide, the Washington court’s order is limited to the plaintiff states.3

As a result of the conflicting district court opinions, on April 10, the DOJ asked the Washington court to “clarify [the federal government’s] obligations under its preliminary injunction in the event that the Alliance order takes effect and stays the approval of mifepristone.” In response, the court reiterated its order requiring FDA to maintain the “status quo” in the plaintiff states “irrespective” of the orders from the Texas district court or the 5th Circuit.

Next Steps in the Litigation

In the wake of the AHM ruling, President Biden issued a statement assuring the public that his administration would “fight this ruling.” Now that DOJ and Danco have filed requests for emergency relief and Justice Alito has granted a 5-day stay, the full Supreme Court will decide whether to stay the AHM judgment until appeals can be resolved after full briefing and oral argument, up to and including full review by the Supreme Court itself.

Although such requests are typically addressed in a timely fashion, the Supreme Court is not bound by any fixed timeline. In 2020, for example, when DOJ sought an emergency stay of the 2020 injunction in ACOG v. FDA that suspended mifepristone’s in-person dispensing requirement, the motion was left pending for over a month, at which point the Supreme Court declined to issue a stay and directed the district court to issue an updated ruling in light of the government’s argument about changed circumstances. (In AHM, the government has asked for an immediate administrative stay while the Court decides the emergency application, because the AHM preliminary injunction will otherwise go into effect on Saturday.)

In the 2020 ACOG case, after the district court decided to maintain the stay on the in-person dispensing requirement, the Supreme Court then granted DOJ’s request for an emergency stay in January 2021, effectively reinstating the requirement until it was later repealed under the Biden Administration. Although the Court did not issue a full opinion on this procedural order, Chief Justice John Roberts wrote separately to concur on the outcome, framing the key question as “whether the District Court properly ordered the Food and Drug Administration to lift those established requirements [in the REMS] because of the court’s own evaluation” of the available evidence, and emphasizing that “courts owe significant deference to the politically accountable entities with the background, competence, and expertise to assess public health.”

Potential Implications of These Cases

Implications for Abortion Access. If mifepristone’s approval is ultimately revoked or the REMS significantly narrowed, access to abortion may be significantly curtailed. Notably, even as the proportion of abortions via MAB rises past the 50% mark, facilities that offer surgical abortions have seen increased wait times, as people who cannot access legal abortion where they live are traveling ever-greater distances seeking assistance to terminate their pregnancies.

Due to the uncertainty of the future of MAB access in the United States, individual states have begun to stockpile both mifepristone and misoprostol, the second drug used in MAB. Notably, misoprostol can be used on its own to induce abortions, albeit with a higher risk of complications as compared to the two-drug regimen. This week, the governors of Massachusetts and Washington announced that they have stockpiled a year’s worth and three years’ worth, respectively, of mifepristone. Additionally, both California and New York have started emergency stockpiles of misoprostol to ensure their citizens have access to a form of MAB, regardless of the legal status of mifepristone.

Implications for FDA Oversight. Leaders in the pharmaceutical industry have also expressed their concern about the broader implications of the AHM decision. Hundreds of biopharmaceutical CEOs and other executives issued a letter and filed an amicus brief in the 5th Circuit supporting DOJ’s request to stay the AHM ruling. The biopharmaceutical executives stated that the “decision ignores decades of scientific evidence and legal precedent” and “has set a precedent for diminishing FDA’s authority over drug approvals,” creating uncertainty for the entire industry.

As this amicus brief suggests, these pending cases may have broad implications for FDA’s authority to regulate drugs in the United States, in addition to their immediate impacts on access to MAB. If the unprecedented reasoning in the Texas district court and the 5th Circuit is upheld—such as the purported requirement for FDA to mimic the conditions of use for a drug’s supporting clinical trials on the FDA-approved label for that drug—it is likely that similar cases will be brought in the future with respect to other drugs. That result could undermine the FDA’s role as the expert arbiter of scientific and medical expertise regarding drug safety and efficacy, destabilizing the incentives for innovation in the biopharmaceutical industry, and potentially depriving patients of access to needed medications. 

1 Dobbs v. Jackson Women’s Health Organization, 597 U.S. __, 69 (2022).

2 Both filings are available online here and here.

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



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