In 2000, the FDA approved the use of mifepristone to induce abortion. More than twenty years later, in 2022, the Alliance for Hippocratic Medicine challenged the FDA rule in a pending case in the Northern District of Texas. The plaintiffs request a preliminary injunction, and U.S. District Judge Matthew J. Kacsmaryk might enjoin the FDA’s approval and block the prescription and distribution of mifepristone.
This result would miss a simple, old-fashioned rule of law: the six-year default statute of limitations, located at 28 U.S.C. § 2401(a), for suits against the federal government. The government and other commentators have briefly argued that this statute blocks the petitioners’ core claims. Plaintiffs respond that the “reopening” doctrine means that the 2000 approval is still vulnerable to challenge. But the government has the better rule-of-law argument. (For more on the doctrine, policy, and history of 28 U.S.C. § 2401(a), see Old Regs, forthcoming in the George Mason Law Review.)
The argument that challenges to the 2000 FDA approval are time-barred is especially strong in the Fifth Circuit. Fifth Circuit case law confirms that the six-year period starts to run when an agency takes a final action, like the approval of a drug. The Fifth Circuit also says (contrary to other circuits’ view) that 28 U.S.C. § 2401(a) is jurisdictional. Finally, Fifth Circuit case law confirms that the “reopening” doctrine would only apply if the agency reconsidered its 2000 approval. This the FDA did not do. Its subsequent actions, which loosened some prescription and distribution requirements, took the 2000 approval as an unquestioned given.
Classic reasons for limitations periods explain why it makes policy sense to time-bar a challenge to the FDA’s 2000 mifepristone approval. The law has an interest in repose, which increases with the passage of time due to increasing reliance interests. FDA scholars explain that reliance interests in Hippocratic Medicine include not only patients but also the pharmaceutical industry, since uncertainty disincentivizes drug research, development and manufacturing. Also, the law has an interest in examining claims before contemporaneous evidence goes stale. For these reasons, limitations periods encourage plaintiffs to raise their claims promptly.
To explain why it makes doctrinal rule-of-law sense to time-bar the core claims in Hippocratic Medicine, let’s look first at the facts in the case. Here’s the chronology:
2000: The FDA approved mifepristone pursuant to FDA regulations and under the clinical trial procedures established by the Federal Food, Drug, and Cosmetic Act (FFDCA).
2002: A citizen petition brought by American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), and others challenged the 2000 approval.
2016: In March, the FDA denied the citizen petition.
2016: Also in March, the FDA made changes to loosen the restrictions around providing mifepristone to patients, including increasing the maximum gestational age from 49 to 70 days, allowing at-home administration, and allowing a broader set of providers to prescribe mifepristone.
2019: A citizen petition brought by AAPLOG and others challenged the 2016 changes.
2019: The FDA approved a generic version of mifepristone.
2021: The FDA removed in-person dispensing requirements.
2022: In November, the Alliance for Hippocratic Medicine, joined by AAPLOG and others, filed the pending lawsuit requesting a preliminary injunction that would order the FDA to “withdraw” its approval of mifepristone.
The Fifth Circuit has held that the six-year period of 28 USC § 2401(a) accrues at the time of final agency action for administrative procedure claims. The Second, Fourth, Sixth, Ninth, Eleventh, and Federal Circuits agree. In the Hippocratic Medicine case, the final agency action that starts the running of the six-year period is the 2000 approval, rather than the earlier FDA regulation that authorized that approval or the later responses to the citizen petitions that challenged that approval.
The claims in Hippocratic Medicine (except for a claim about using the mail and common carriers for abortifacients) turn on the FDA’s 2000 approval. One core claim, a claim of “arbitrary and capricious” action under § 706(2) of the Administrative Procedure Act, is about regulatory interpretation. The argument is that because pregnancy is not an “illness,” the 2000 approval violated the language of the FDA’s authorizing regulation at 21 CFR § 314, Subpart H, which authorizes drugs to treat illness. The second core claim is about violation of clinical trial procedures set forth in the FFDCA. This argument is that the FDA’s 2000 approval did not follow clinical trial requirements since some of the conditions used for clinical trials (for example, ultrasound imaging) were not required in the drug label.
In an analogous case, a Record of Decision approved a bypass highway in Maryland pursuant to Federal Highway Administration and other regulations in 1989. After interim requests for reconsideration, a neighborhood association filed a lawsuit in 1997 claiming that the 1989 approval process was discriminatory and had violated authorizing regulations and procedural requirements by failing to notify them, using inaccurate data, and not considering alternative sites. The court decided that the final agency action occurred on the issuance of the Record of Decision, not the earlier regulation or the agency’s later response to the plaintiff’s administrative complaint. The Fourth Circuit held the association’s claim time-barred under 28 USC § 2401(a).
Note that the time of accrual may be later for an ultra vires claim that an administrative action violates the terms of an authorizing statute. Under the Wind River doctrine, the limitations period for such an ultra virescase accrues when a specific plaintiff acquires standing . The Fifth Circuit has said that the period also would accrue later for a Constitutional claim. But Hippocratic Medicine raises neither ultra vires nor Constitutional challenges.
The Hippocratic Medicine plaintiffs might explore the idea that the six-year period should expire later because it took the FDA 14 years to respond to the 2002 citizen petition challenging the 2000 approval. A problem with this argument is that the Fifth Circuit says that 28 USC § 2401(a) is jurisdictional, and the Supreme Court has made clear, including in the 2022 Boechler case, that a jurisdictional limitations period is not subject to equitable tolling. In any case, even if the six-year period were tolled between 2002 and 2016, it still would have expired with respect to the FDA’s 2000 approval before the Hippocratic Medicine lawsuit was filed in November 2022.
A final limitations period question relates to FDA actions in 2016. (As to actions later than that, the citizen petition remedy has not been exhausted, which means dismissal of the claims is required.) The November 2022 lawsuit was filed more than six years after the March 2016 modifications were issued. In the Fifth Circuit, this means that challenges to the March 2016 modifications are time-barred. The Fifth Circuit can’t entertain the possibility of equitable tolling because it treats the statute of limitations as jurisdictional.
If the case makes it to the Supreme Court, though, the question of equitable tolling might arise. The better view, contrary to the Fifth Circuit’s case law but consistent with Supreme Court precedents Irwin v. Department of Veterans’ Affairs and United States v. Kwai Fun Wong (as both the D.C. and Sixth Circuits have explained) is that 28 USC § 2401(a) is not jurisdictional and, thus, is subject to equitable tolling. So it is possible that the plaintiffs might try to argue for equitable tolling of the 6-year statute as applied to 2016 FDA actions during the 2019-2021 period when the second citizen petition was pending.
It’s not clear how such an equitable tolling claim would come out. One likely relevant authority is § 355(q)(2)(A) of the Federal, Food, Drug, and Cosmetic Act, enacted in 2007, and related regulations, which indicate that if the FDA has not responded within 150 days, a lawsuit can be filed. This suggests that any equitable tolling might be limited to 150 days, which would mean that the six-year limitations period for the 2016 modifications would finish running sometime in August 2022 – several months before the pending lawsuit was filed.
In the Fifth Circuit, the “reopening” doctrine provides plaintiffs’ only argument that their challenge to the FDA’s 2000 approval are not time barred. They argue that the FDA’s later actions taken in 2016 (which loosened restrictions, including allowing at-home administration) and 2021 (which removed in-person dispensing requirements) “reopened” the 2000 approval of mifepristone. The plaintiff’s go-to case is Sierra Club v. EPA, a 2008 D.C. Circuit case that held that the EPA reopened rules when it relaxed the requirements that a factory or other pollution source had to file and follow a pollution management plan in order to get a permit.
But the logic of the plaintiffs’ analogy does not hold up. In Sierra Club, the relaxed pollution management plan requirements changed the conditions that a pollution source must meet before having permission to pollute. It would be analogous if the FDA decided all drug manufacturers could change the conditions under which the drug is manufactured without getting approval from the FDA. In Hippocratic Medicine, the loosened distribution and prescription requirements did not change the conditions that a drug manufacturer must meet before it has permission to produce and sell mifepristone. The EPA made changes to the overall regulatory structure regarding having permission to pollute, while the FDA did not reconsider the regulatory structure for getting drug approval, nor did it reopen the initial mifepristone approval.
A better approach than the EPA case for the reopening doctrine is the three-factor framework laid out by theD.C. Circuit in National Association of Reversionary Property Owners v. Surface Transportation Board and adopted by the Fifth Circuit in Texas v. Biden. Biden, cited by both plaintiffs and defendants in Hippocratic Medicine, involved the Biden administration’s June 2021 termination of certain immigration restrictions implemented by the Trump administration. The Fifth Circuit held that an October 2021 memorandum further explaining the June 2021 termination did not reopen the earlier decision. The Fifth Circuit’s analysis embraced a three-factor test established by the D.C. Circuit. The first factor is whether the agency asks for comments on the issue it allegedly “reopened” – such as the approval of mifepristone. The second factor is whether the agency discusses comments. In Hippocratic Medicine, as in Texas v. Biden, no comments about the original agency action were solicited, submitted, or discussed in connection with the later agency actions.
The third factor is whether the later agency actions change the “overall context” of the rulemaking. In Reversionary Property Owners, the D.C. Circuit concluded that the Surface Transportation Board did not reconsider certain notice requirements established in an original rule, but rather made incremental adjustments and updates to the existing regulations. As the Reversionary Property Owners court explained, “when an agency invites debate on some aspects of a broad subject … it does not automatically reopen all related aspects including those already decided.” Similarly, when an agency reconsiders rules regarding access to a drug, it does not automatically consider the drug’s initial approval each time. In Hippocratic Medicine, the requirements and conditions for the approval of mifepristone happened in 2000, and the adjustments after that assumed and did not question the starting point that the drug had been approved for manufacture and sale.
The solution in Hippocratic Medicine is plain. The core claims challenging the approval of mifepristone are time-barred under blackletter law, especially in the Fifth Circuit. They simply come too late – and the time-tested, even boring policies of repose and reliance help show why this old-fashioned rule-of-law answer makes sense in this case.
Susan C. Morse is the Angus G. Wynne, Sr. Professor in Civil Jurisprudence and the Associate Dean for Academic Affairs at the University of Texas at Austin School of Law. Leah R. Butterfield is a JD Candidate at the University of Texas at Austin School of Law.