The Big Picture
On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al. (AHM v. FDA), marking the Court’s first return to the abortion debate since overturning the constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization. The Court’s ruling in this case could significantly restrict access to mifepristone, one of two drugs that comprise the most common regimen for medication abortion (MAB), and could also have implications for FDA’s oversight of drugs more generally. In addition, on November 3, 2023, three states—Missouri, Idaho and Kansas—requested permission to join AHM v. FDA, offering a separate theory for standing and challenging the 2019 approval of generic mifepristone.1 This newsletter provides an update on the AHM litigation, analyzes the states’ pending motion to intervene and summarizes additional cases that present questions of federal law relevant for abortion access in a post-Roe world.
Background on AHM v. FDA
As we have previously discussed (here and here), anti-abortion physician organizations led by AHM sued FDA last year, challenging FDA’s original approval of mifepristone from 2000, subsequent changes to mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) in 2016 and 2021, and the approval of a generic version of mifepristone in 2019. After a federal district court in Texas suspended mifepristone’s 2000 approval, the Fifth Circuit, in a 2–1 decision, disagreed in part, finding plaintiffs’ challenge to FDA’s original 2000 approval of mifepristone as untimely and that plaintiffs did not introduce evidence showing that they were likely to be injured by FDA’s 2019 approval of generic mifepristone.
However, the Fifth Circuit agreed with the district court that the plaintiff physician organizations had “standing to sue” to challenge FDA’s actions (as discussed below), and affirmed the injunction suspending FDA’s 2016 and 2021 actions that lifted various restrictions on the prescribing and dispensing of mifepristone.2 In the interim, however, an emergency order from the Supreme Court prevented the injunction from taking effect until the Supreme Court has the opportunity to weigh in. Absent that emergency order, the Fifth Circuit’s ruling would have eliminated the option for telehealth-based mifepristone prescribing, prohibited pharmacies from dispensing mifepristone and restricted mifepristone to the first seven weeks of pregnancy (down from the current limit of ten weeks).
The Supreme Court Accepts Review of AHM v. FDA
After both sides petitioned the Supreme Court to review the case, the Supreme Court granted FDA’s and Danco Laboratories’ petition and denied AHM’s petition that asked the Supreme Court to reconsider FDA’s 2000 approval of mifepristone. In its arguments to the Supreme Court, FDA not only maintains that its mifepristone-related actions were legally justified but also asserts that the plaintiff physician organizations lack standing to sue because FDA’s actions have not caused them any injury that is sufficient to form the basis for a lawsuit, given that the plaintiff physicians do not themselves prescribe mifepristone.
Numerous life sciences companies and patient advocacy organizations have submitted amicus briefs asserting that allowing AHM’s challenge to FDA’s actions relating to mifepristone risks establishing a precedent that could undermine patients’ access to medications already on the market and weaken industry’s incentive to develop and market new drugs.
The Supreme Court will likely hear oral arguments in the case in the spring and issue a decision by the end of June.
Three States Seek to Intervene in the District Court in AHM v. FDA
On November 3, 2023, three states—Missouri, Idaho and Kansas—filed a motion with the Texas district court requesting permission to join AHM v. FDA. Although these states could have filed new legal challenges in one or more of their own federal courts, thereby setting up parallel litigation, they have instead sought to shore up the existing AHM lawsuit, which has already received favorable treatment by the district court and Fifth Circuit judges. The states’ substantive legal claims largely mirror those of the AHM plaintiffs; the key difference in their filing concerns their bases for standing to sue:
- First, the states assert that increased access to mifepristone results in more medical complications due to MAB, which causes economic harm to the states because they pay for the resulting medical care through public insurance (e.g., Medicaid).
- Second, the states argue that FDA’s mifepristone actions infringe on their sovereign interest in the creation and enforcement of their own laws, both because out-of-state practitioners are dispensing mifepristone to state residents and because some courts have ruled that FDA’s policies preempt conflicting state laws.
- Finally, the states argue that FDA has underestimated the risks associated with mifepristone and, in so doing, infringed upon their “quasi-sovereign interest” in protecting the health and well-being of their citizens.
If the Supreme Court concludes that AHM lacks standing and dismisses the appeal on that basis, without reaching the merits, the intervenor states’ alternative bases for standing could offer the Texas district court an opportunity to reissue a substantially similar injunction, thereby setting up another round of appeals.
As noted above, the Supreme Court has stayed the district court’s existing injunction against FDA’s mifepristone-related actions and granted FDA’s and Danco Laboratories’ petitions to hear the case. Importantly, the stay order applies only to the district court’s original order, as modified by the Fifth Circuit. Thus, the district court could theoretically allow the intervenor states to join the lawsuit and issue a new injunction as to their claims even before the Supreme Court issues a ruling, although the district court may choose instead to wait for the high court to weigh in, given the overlap in substantive legal arguments.
Litigation Roundup
In addition to the AHM litigation, several other lawsuits are working their way through the federal court system, including a number of cases that involve FDA-related issues. Notably, in a mirror image to the AHM challenge, three pending lawsuits argue that FDA’s mifepristone actions are too restrictiveand should be broadened to expand access:
- In Washington v. FDA, as we’ve previously discussed, a group of states seek to expand access to mifepristone, arguing that FDA should remove the conditions under REMS based on its 23-year history of safe use. On April 7, 2023, the court granted plaintiff states’ motion for a preliminary injunction in part, requiring FDA to make no changes to the availability of mifepristone in the plaintiff states until a final determination on the merits preserving the status quo.3
- In Chelius v. Becerra, a Hawaiian physician and several other health care associations challenge the constitutionality of FDA’s REMS for mifepristone, arguing the REMS severely restricts access to abortion care with no medical basis. Plaintiffs submitted an amended complaint in April 2023.
- In other cases, plaintiffs have sued seeking to prevent FDA from modifying the current approval conditions, effectively seeking orders contrary to the original AHM injunction.4
Meanwhile, in other cases, life sciences companies and providers have challenged state restrictions on mifepristone, arguing that these state policies are preempted by the access policies codified in FDA’s approval and REMS.
- In GenBioPro v. Sorsaia, the manufacturer of generic mifepristone argues that FDA’s regulation of mifepristone preempts West Virginia’s law banning nearly all uses of mifepristone. On August 25, 2023, the court partially dismissed the lawsuit, concluding GenBioPro may proceed only on its claim concerning telehealth-based prescribing of mifepristone.5 GenBioPro has appealed this decision to the Fourth Circuit Court of Appeals.
- In Bryant v. Stein, a physician challenged North Carolina’s requirements that mifepristone be provided in person by a physician in a specially certified facility after counseling, a 72-hour wait period and an ultrasound. The state has filed a motion to dismiss.6
In addition to these FDA-related cases, other pending cases address issues such as:
- Whether states can impose penalties on people who travel across state lines seeking abortion or on those who assist them in doing so (including a new filed statement of interest by the Department of Justice arguing that the Constitution protects the right to travel across state lines and engage in conduct that is legal in the destination state);7
- The validity of federal guidance from the Centers for Medicare & Medicaid Services (CMS) directing hospitals to provide emergency abortions under the Emergency Medical Treatment and Labor Act (EMTALA);8 and
- Whether the First Amendment right to free speech protects an individual’s ability to provide information, financial support or logistical assistance to someone who seeks to travel from a state where abortion is criminalized to seek a legal abortion in another state.9
Conclusion
The Supreme Court’s decision in AHM v. FDA could have a monumental impact not only on access to mifepristone, one of the most commonly used forms of abortion, but also on our current system of approving drugs in the United States. Depending on how the Court rules, it may become easier for stakeholders to file legal challenges against FDA’s approvals of drugs and medical devices, both in terms of who has standing to bring these cases in the first place and in terms of how deferential a court will be to FDA’s scientific and medical expertise. Beyond the AHM litigation, the lawsuits discussed above illustrate the ever-mounting legal complexities of our post-Roe world, with implications for access to abortion and medical care more broadly. The cases regarding travel and free speech have implications for other sensitive services that have been criminalized in certain states, like gender-affirming care for minors.
1 For a detailed look at the state intervenors’ substantive arguments, review the Complaint and Suggestions in Support of Intervenors’ Motion to Intervene.
2 Alliance for Hippocratic Medicine v. FDA, No. 23-10362 (5th Cir. 2023).
3 Washington v. FDA, No. 1:23-CV-3026, 2023 WL 2825861 (E.D. Wa. Apr. 7, 2023) (order granting plaintiffs’ motion for preliminary injunction in part).
4 Whole Women’s Health Alliance v. FDA, No. 3:23-cv-0019 (W.D. Va. Aug. 21, 2023) (denying preliminary injunction); GenBioPro Inc. v. FDA, No. 1:23-cv-0105 (D. Md.) (voluntarily dismissed by the plaintiff).
5 GenBioPro v. Sorsaia, No. 3:23-0058, 2023 WL 5490179 (S.D.W. Va. Aug. 24, 2023).
6 Bryant v. Stein, No. 1:23-CV-00077 (M.D.N.C.).
7 Matsumoto v. Labrador, No. 1:23-cv-00323-DKG, 2023 WL 7388852 (D. Id. Nov. 8, 2023) (granting plaintiffs’ motion for a preliminary injunction and enjoining Idaho’s abortion travel ban from enforcement); West Alabama Women’s Center v. Marshall, No. 2:23-CV-00451 (M.D. Al. July 31, 2023).
8 Texas v. Becerra, 623 F. Supp. 3d 696 (N.D. Tx. 2023) (granting a preliminary injunction to halt enforcement of Department of Health and Human Services emergency abortion services guidance), appeal filed No. 23-10246 (5th Cir.); United States v. Idaho, No. 1:22-CV-00239 (D. Id. Aug. 8, 2022) (granting preliminary injunction to halt enforcement of Idaho’s abortion laws in emergencies), appeal filed No. 23-35440 (9th Cir).
9 Fund Texas Choice v. Paxton, No. 1:22-CV-859 (W.D. Tex. Feb. 24, 2023).