On June 13, 2024, the Supreme Court issued its opinion in Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al., a case challenging the lawfulness of several Food and Drug Administration (FDA) regulatory actions with respect to a tablet used to terminate pregnancies. In a 9-0 opinion by Justice Kavanaugh, the Court held that the plaintiffs lacked Article III standing to challenge the FDA’s actions. The opinion contains an important discussion on physicians’ standing to challenge FDA regulations as well as associational standing itself. The decision underscores the importance of the separation of powers, and that to obtain a federal court determination of what the law is, a plaintiff must have a “personal stake” in the outcome.
FDA’s Regulation of Mifepristone:
In 2000, the FDA approved a new drug application for “Mifeprex,” a brand of mifepristone tablets used to terminate pregnancies up to seven weeks. In approving the drug, the FDA placed several restrictions on Mifeprex’s use—including requiring three in-person visits by the patient with the doctor prior to receiving the drug, directing prescribing physicians to report certain adverse events and other incidents to the drug sponsor, and only allowing physicians to prescribe or supervise the prescription of Mifeprex.
In 2016, the FDA approved a supplemental new drug application submitted by Mifeprex’s distributor to amend the drug’s labeling and to ease some of the FDA’s restrictions on its use and distribution. Specifically, the FDA deemed Mifeprex safe to terminate pregnancies up to ten weeks, permitted non-physician providers (such as nurse practitioners) to prescribe Mifeprex, reduced the number of required in-person visits from three to one, and relaxed reporting requirements by only requiring prescribing providers to report fatalities. In 2019, the FDA approved an application for generic mifepristone and established the same conditions of use for generic mifepristone as those for Mifeprex.
After COVID-19, the FDA announced that it would no longer enforce the initial in-person visit requirement for Mifeprex and generic mifepristone. Coupled with the FDA’s 2019 approval of generic mifepristone, these changes “made it easier for doctors to prescribe and pregnant women to obtain mifepristone.”1
Procedural History
Following the FDA’s announcement and submission of two joint citizen petitions to the FDA, four medical associations and several individual physicians opposed to the use of Mifeprex sued the FDA in 2022 in the U.S. District Court for the Northern District of Texas. These associations did not have physician members who prescribed Mifeprex, nor was it evident that they treated patients allegedly harmed by it. The same was true of the individual physicians. Brought under the Administrative Procedure Act, the lawsuit challenged “the lawfulness of FDA’s 2000 approval of Mifeprex; FDA’s 2019 approval of generic mifepristone; and FDA’s 2016 and 2021 actions modifying mifepristone’s conditions of use” and sought a preliminary injunction requiring the FDA to rescind either its approval of mifepristone or its 2016 and 2021 regulatory actions relaxing the drug’s use, distribution, and reporting requirements.2 Danco Laboratories, Mifeprex’s sponsor, intervened in the action.
Agreeing with the plaintiffs, the District Court effectively “enjoined FDA’s approval of mifepristone, thereby ordering mifepristone off the market.”3 FDA and Danco Laboratories appealed to the Fifth Circuit Court of Appeals and moved to stay the District Court’s order pending appeal. The Fifth Circuit granted the motion to stay in part and temporarily reinstated FDA’s approval of Mifeprex. However, it declined to stay the rest of the District Court’s order—creating an unusual situation in which Mifeprex would remain on the market (under the more stringent requirements imposed when the FDA initially approved Mifeprex in 2000), but generic mifepristone would not. The FDA and Danco Laboratories then appealed to the Supreme Court and sought a full stay of the District Court’s order. The Supreme Court granted the stay pending resolution of the case, allowing both Mifeprex and generic mifepristone to “remain[] available as allowed by FDA’s relaxed 2016 and 2021 requirements.”4
Following a complicated procedural history, the Supreme Court eventually granted certiorari to determine whether the plaintiffs had Article III standing to challenge the FDA actions.
Physician-Plaintiffs’ Standing
The Court ultimately held that the plaintiffs “failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact.”5 In an attempt to tie the FDA’s actions to their alleged injuries in fact, the individual physician-plaintiffs advanced two main causation theories that the Court analyzed and rejected: conscience injuries and economic injuries.
First, the physician-plaintiffs argued that the FDA’s actions could cause “downstream conscience injuries to the individual doctor plaintiffs and the specified members of the plaintiff medical associations, who are also doctors.”6 In defining these “conscience injuries,” the physicians alleged that the FDA’s actions would increase the number of pregnant women who suffer complications from mifepristone and the number of emergency abortions by doctors. Based on this hypothetical increase, the physician-plaintiffs argued that “they therefore may be required—against their consciences—to render emergency treatment completing the abortions or providing other abortion-related treatment.”7
However, the Court rejected this argument—citing to both federal and state conscience laws protecting physicians “from being required to perform abortions or to provide other treatment that violates their consciences.”8 And with respect to the physicians’ contention that the Emergency Medical Treatment and Labor Act (EMTALA) could be interpreted to “override [] federal conscience laws and to require individual emergency room doctors to participate in emergency abortions in some circumstances,” the Court disagreed—noting that the government had disclaimed such an interpretation of EMTALA and that “EMTALA does not impose obligations on individual doctors.”9
Second, the physician-plaintiffs argued that the FDA’s actions could cause hypothetical “downstream economic injuries to the doctors.”10 Specifically, the physicians contended that the FDA’s actions could “divert[] resources and time from other patients to treat patients with mifepristone complications; increas[e] risk of liability suits from treating those patients; and potentially increas[e] insurance costs.”11
The Court also rejected this argument. In responding to these specific allegations, the Court concluded that the physicians had not offered any evidence suggesting that the FDA’s actions had caused such a diversion of time and resources, identifying any instances where they had been sued or required to pay higher insurance costs, or showing that the future would bring such injuries into fruition. However, more broadly, the Court was concerned by the effects of recognizing such a causal link:
In any event, and perhaps more to the point, the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries. Stated otherwise, there is no Article III doctrine of “doctor standing” that allows doctors to challenge general government safety regulations. Nor will this Court now create such a novel standing doctrine out of whole cloth.12
If it were to allow physicians and providers to oppose safety regulations on the premise that they were “unlawfully lax,” the Court concluded that it would create an environment where essentially any healthcare provider could “challenge any FDA decision approving a new drug.”13
The Court also rejected the premise that the associations had standing because the FDA’s actions supposedly had caused them to incur costs to study the effects of Mifeprex. The Court rejected that, reasoning that an “organization that has not suffered a concrete injury caused by a defendant’s action cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action.”14 Instead, the Court emphasized that an organization may have standing if the organization itself has suffered injury in fact, causation, and redressability.15 In his concurrence, Justice Thomas went further and suggested that the Court reconsider associational standing broadly because the parties that need the remedy—the injured members—are not before the Court.
Implications of Opinion
Apart from the reproductive rights and abortion issues involved, this case was being closely monitored for its potential implications on the FDA’s regulatory authority. However, interestingly, the Court did not discuss the FDA’s authority to approve Mifeprex/generic mifepristone or to modify the drug’s conditions of use—making it difficult to ascertain how much deference this Court gives the FDA in its approval and regulatory processes.
The Morris, Manning & Martin, LLP healthcare team will continue to monitor issues related to the FDA’s regulatory authority. If you have any questions about this legal update, please contact a member of the healthcare team.
1 Food & Drug Admin. v. All. for Hippocratic Med., No. 23-235, 2024 WL 2964140 (U.S. June 13, 2024).
2 Id. at 4.
3 Id.
4 Id. at 5.
5 Id. at 24. At the outset of its opinion, the Court emphasized that the plaintiffs—four medical associations and several individual physicians—were essentially “unregulated parties who seek to challenge FDA’s regulation of others.” Id. at 13 (emphasis in original). In these situations, the Court explained that standing is “‘ordinarily substantially more difficult to establish’” because unregulated parties often have difficulty establishing causation. Id. at 10 (citation omitted). This difficulty was exacerbated by the Court’s recognition that the plaintiffs did not prescribe, use, manufacture, sell, or advertise mifepristone or sponsor a competing drug.
6 Id. at 13.
7 Id. at 14.
8 Id. at 14–15.
9 Id. at 16.
10 Id. at 14.
11 Id. at 18.
12 Id. at 18–19.
13 Id. at 19.
14 Id. at 22.
15 Id. at 21.
