The Supreme Court will hear arguments on March 26 in a conflict that began in 2002 over how the Food and Drug Administration (FDA) has regulated the abortion drug mifepristone. The Fifth Circuit held on August 16, 2023, that the FDA violated the Administrative Procedure Act (APA) by dropping longstanding safety rules for obtaining and using the drug.

Federal Drug Regulation

Federal law prohibits introducing into interstate commerce a prescription drug that has not been approved by the FDA as “safe and effective” for its “proposed indication and under the proposed conditions of use.” The burden is on the applicant to provide substantial evidence that meets this standard.

The FDA website explains that, for a medication with “serious safety concerns,” its approval may be conditioned on implementation of extra safety restrictions. Since enactment of the FDA Amendments Act of 2007, those additional restrictions have been referred to as a “risk evaluation and mitigation strategy” (REMS) and go beyond “routine risk minimization measures.” The extra REMS safety measures may result in approval of drugs that might have been kept off the market under ordinary safety standards.

The APA sets standards for how executive branch agencies make decisions. It requires courts to “hold unlawful and set aside agency action, findings, and conclusions found to be . . . arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” The Supreme Court has explained that an agency action is “arbitrary and capricious” if, for example, its decision ran counter to the evidence, the agency failed to consider an important aspect of the problem, or it provided an unsatisfactory explanation of the connection between the facts and its decision.

Mifepristone

Pharmaceutical manufacturer Roussel Uclaf first developed RU-486 in 1980 by synthesizing mifepristone, which suppresses progesterone, a hormone necessary for a fertilized egg to attach to the uterine wall. The FDA expressed concern about the drug’s safety from the start, initially prohibiting its importation for personal use because of the significant risks of using the drug without close physician supervision.

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The Population Council, which had the right to market RU-486 in the United States, applied for FDA approval in March 1996, and an FDA advisory panel again emphasized the need for close medical supervision. The FDA approved mifepristone, under the brand name Mifeprex, on September 28, 2000, outside of its ordinary evaluation process. The FDA instead used an accelerated process reserved for drugs that treat “serious or life-threatening illnesses” such as cancer or HIV. This approval came with a REMS that listed significant restrictions for obtaining and using the drug.

Mifeprex, for example, was approved for use only in the first seven weeks of pregnancy and only after obtaining a prescription from a physician with specific training to handle certain complications. The drug could be dispensed only in person by a certified provider, and the process of using it required three in-person office visits and physician reporting of all medical complications. These safety rules would remain in place for more than 15 years.

Citizen Petitions

The Federal Food, Drug, and Cosmetic Act provides for the filing of citizen petitions asking the FDA to take, change, or revoke certain actions or decisions. The agency’s response, which it must provide within 180 days, constitutes a final action that petitioners have six years to challenge in court. Three organizations, including two medical associations, filed a citizen petition in August 2002, asking the FDA to revoke its approval of Mifeprex and conduct a full audit of the studies on which that approval was based.

The FDA did not respond to this petition for nearly 14 years. On March 29, 2016, it denied the petition and revised the Mifeprex REMS, extending the drug’s use to 10 weeks, allowing non-physicians to prescribe and administer it, requiring only a single office visit, and dropping the requirement that doctors report non-fatal medical complications.

Two medical groups filed a citizen petition in March 2019, asking the FDA to retain the previous safety restrictions and conduct a “formal study of outcomes for at-risk populations,” including minor girls. The FDA did not respond to this petition until December 16, 2021, when it denied the petition and again revised the Mifeprex REMS. The FDA made permanent its decision, initially made to reduce patient-doctor contact during the COVID pandemic, to drop the in-person dispensing requirement, allowing women to obtain mifepristone by mail or through a mail-order pharmacy.

Four medical associations and four individual doctors filed suit on November 18, 2022, alleging that the FDA’s original 2000 approval of Mifeprex and its 2016 and 2021 decisions to eliminate the safety rules for obtaining and using it violated the APA. The suit presented both jurisdictional and merits issues.

Jurisdictional Issues

Standing

Legal standing requires the plaintiff to establish a cognizable injury caused by the defendant that a court can remedy. The medical groups asserted both associational standing on behalf of their members who practice obstetrics and gynecology or emergency medicine, and organizational standing for themselves. They argued that, by approving Mifeprex and eliminating its safety restrictions, the FDA increased both the number of patients and the range of complications that doctors must treat. In addition, by eliminating any reporting of most medical complications, the FDA made it more difficult to fully inform either patients or the public of the drug’s risks.

The individual doctors also argued that they had standing to challenge the FDA’s decisions. By increasing the number of patients suffering from complications, for example, the FDA’S decisions increase the likelihood that doctors must perform surgical abortions after chemical abortions fail. This, the doctors argued, created a serious conflict with their moral and religious beliefs. Treating patients with mifepristone complications, they asserted, also imposes unique mental and emotional stress and diverts attention and resources away from their ordinary practice. The Fifth Circuit affirmed the district court’s decision that the plaintiffs had established each of these bases for standing.  

Timeliness

As noted above, plaintiffs have six years to challenge FDA decisions. While the parties agreed that the challenges to the FDA’s 2016 and 2021 decisions to drop safety rules were timely, they disagreed about when the six-year clock regarding the challenge to the original approval of Mifeprex began.  

The FDA has never explained why it waited 14 years to deny the citizen petition challenging its original approval of Mifeprex. Nonetheless, it agreed that denial on March 29, 2016, constituted a final agency action that could be challenged in court. The FDA argued that the six-year clock for challenging its original approval of Mifeprex began on that date and that, therefore, the plaintiffs’ November 18, 2022, challenge came too late.

The plaintiffs argued that the FDA’s 2021 revision of the Mifeprex REMS was so sweeping that it, in effect, amounted to a reconsideration of the original approval, “reopening” that decision and re-starting the six-year clock. The district court agreed and, therefore, considered the lawsuit challenging the FDA’s original approval of Mifeprex timely. However, while acknowledging that it was “a close call,” the Fifth Circuit disagreed, concluding that while dropping safety restrictions changed “the legal framework governing mifepristone distribution,” the change was not so comprehensive that it amounted to a full reconsideration of the initial approval.

Merits Issues

The substantive legal question in this litigation is whether the FDA’s decisions regarding mifepristone violated the APA because they were “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” That standard, the Supreme Court has held, requires that an agency “reasonably consider[] the relevant issues and reasonably explain[]” its actions.

The plaintiffs made two kinds of arguments. First, they highlighted alleged acts or omissions by the FDA that undermined its conclusion that mifepristone not only was safe and effective when first approved, but it remained so in the absence of the safety rules FDA had maintained for many years. Specifically, the plaintiffs pointed to the fact that the FDA had accelerated the review process by deeming pregnancy a “life-threatening illness”; the absence of studies or data about how dropping safety rules would impact certain patient populations such as minors; the termination of safety rules based on studies that followed those very rules; and the failure to evaluate how dropping multiple safety rules simultaneously would impact safety and effectiveness.

Second, the plaintiffs focused on the FDA’s 2021 decision to drop the in-person dispensing requirement by citing the lack of non-fatal complications. The absence of that data, however, resulted directly from the FDA’S 2016 decision to no longer require reporting such complications. The Fifth Circuit found this “deeply troubling,” concluding that “[i]t’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.”

Supreme Court Issues

In sum, the Fifth Circuit held that the medical groups and individual doctors had standing, that their challenge to the 2000 approval of Mifeprex was untimely, and that the FDA’s 2016 and 2021 decisions to drop virtually all of its previous safety rules violated the APA. That decision drew three petitions for certiorari. The plaintiffs appealed the decision dismissing their challenge to the original Mifeprex approval, and the FDA and Mifeprex manufacturer Danco Laboratories appealed the Fifth Circuit’s decision regarding the safety rules.

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On December 13, 2023, the Supreme Court denied the plaintiffs’ petition, granted the other two, and consolidated them into a single case. As a result, the Supreme Court will not address the issues surrounding the FDA’s original approval of Mifeprex, but will decide whether the plaintiffs had standing to challenge the FDA’s 2016 and 2021 decisions regarding safety rules and whether those decisions violated the APA.

On standing, the FDA and Danco Labs argue that the plaintiffs have not suffered a legal injury because they are not required to prescribe mifepristone and, therefore, their objection to mifepristone should be directed to the FDA or Congress, not to the courts. The plaintiffs, they say, rely on statistical probabilities but have not identified any actual member physicians who face “an imminent injury to a legally protected interest.” In addition, they argue, the plaintiffs have failed to establish that these purported injuries are “fairly traceable” to the FDA’s decisions. While the FDA “authorized . . . [the distribution] of mifepristone under specified conditions,” it did not “require any healthcare provider to prescribe the drug or any patient to take it.”

On the merits, the FDA and Danco argue that disagreement over “matters relating to public health” cannot overcome the deference that the courts should give to agencies such as the FDA. They point to the “voluminous body of medical evidence” regarding the use of mifepristone that led to the FDA concluding that the “benefit-risk profile for Mifeprex continues to be favorable” despite elimination of multiple safety rules.

Much of the coverage and commentary surrounding this case has suggested, or even claimed, that the Supreme Court will decide whether mifepristone should be on the market and will be available in the future. The Court, however, will not tackle that policy issue. Instead, this case concerns the power of both courts and executive branch agencies. Judicial power is implicated in the threshold questions of standing and timeliness, which go to whether a court has jurisdiction to consider a case at all. And, most importantly, this case is about whether agencies that make decisions with a potentially enormous impact on Americans’ lives follow the law, especially when political tensions threaten to interfere.