Attorneys general across the country have joined in litigation related to mifepristone, a drug used for medication abortions. A case currently before the Supreme Court, FDA v. Alliance for Hippocratic Medicine, could affect access to the drug by invalidating FDA guidelines from 2016 and 2021 that loosened restrictions on prescribing and administering mifepristone.
A key issue in the case relates to telehealth services. Republican states fear that patients' ability to receive mifepristone by mail – coupled with shield laws in some Democratic states that shelter providers from out-of-state abortion prosecution – could threaten their ability to enforce abortion bans. Three Republican states unsuccessfully moved to intervene as parties in the Supreme Court case, citing these concerns.
A coalition of 23 Democratic attorneys general filed an amicus brief supporting the FDA's regulations and defending states' rights to expand abortion access. The amicus brief does not take a stance on whether current FDA guidelines give providers in their states the right to mail mifepristone to out-of-state patients. But in a letter to CVS and Walgreens, the coalition urged the pharmacies to continue mailing the drug to all 50 states.
Oral argument for the case is set for March 26.
Background on FDA v. Alliance for Hippocratic Medicine
The Alliance for Hippocratic Medicine, an anti-abortion organization, sued the FDA in an attempt to overturn the agency's decades-old approval of mifepristone. The lawsuit, filed in federal district court in Texas, challenged (1) the FDA's initial approval of the drug in 2000, (2) revisions to the approval conditions in 2016 that loosened restrictions on the drug, (3) the FDA's approval of a generic version of the drug in 2019, and (4) revisions to the approval conditions in 2021 that eliminated in-person requirements to prescribe and obtain the drug.
The 2016 regulations increased the maximum gestational age for use of mifepristone from seven weeks to ten weeks; reduced the number of in-office appointments required to administer the drug; reduced physicians' reporting requirements for adverse events associated with mifepristone; and allowed certain nonphysicians such as nurse practitioners to prescribe mifepristone.
The 2021 restrictions, which had been revised in response to Covid-19 safety concerns, eliminated the requirement for an in-person visit to receive the drug and permitted the drug to be dispensed by mail. In January 2023, the FDA made this change permanent.
The district court ruled in favor of the Alliance, staying the FDA's initial approval of the drug and subsequent revisions. On appeal, the Fifth Circuit affirmed in part and vacated in part. The decision vacated the lower court's ruling on the initial approval of mifepristone on statute of limitations grounds, and vacated the lower court's ruling on the generic approval because the plaintiffs did not establish a distinct organizational injury based on use of the generic drug. However, the court found that the 2016 and 2021 revisions were arbitrary and capricious under the APA.
The questions presented to the Supreme Court are:
- Whether the Alliance has standing to challenge the FDA's 2016 and 2021 revisions.
- Whether the FDA's 2016 and 2021 actions were arbitrary and capricious under the APA.
- Whether the district court properly granted preliminary injunctive relief.
Democratic Attorneys General File Amicus Brief Defending States' Rights to Expand Abortion Access
The amicus brief of 23 Democratic attorneys general urged the Court to reverse the Fifth Circuit's decision. The states argue that access to mifepristone is a key factor in expanding abortion care in their states, and that such expansion is supported by the decision in Dobbs.
Continued access to mifepristone is especially important, the states argue, in managing the increased demand for clinics caused by an influx of out-of-state patients seeking abortion care. Restricting mifepristone would reduce the availability of care to both in-state and out-of-state patients and push more patients toward procedural abortion or obtaining medication illicitly from another country, the states claim. The brief also points to the importance of telehealth services in expanding care to rural and underserved areas.
Notably, the focus of the amicus brief is the expansion of abortion care within amici's own states. How that argument will intersect with Republican states' contention that Democratic states are attempting to flout abortion bans remains to be seen.
Missouri, Idaho, and Kansas Move to Intervene in Supreme Court Case; Court Denies Motion
Attorneys general from Missouri, Idaho and Kansas filed a motion to intervene as plaintiffs in the case, hoping to circumvent the Alliance's potential standing issues and ensure a ruling on the merits. Although the states successfully intervened in the district court case, the Supreme Court denied their motion.
Standing issues
Whether the Alliance has Article III standing is a key issue. The
Fifth Circuit held that the Alliance has associational
standing because a certain percentage of people who take
mifepristone will experience adverse events or require surgical
abortions; that some percentage will seek emergency care; and that
some of the organization's members are likely to treat women
who experience such adverse effects. The circuit court found a
cognizable injury where (1) treatment may violate the conscience of
physicians, and (2) treatment will divert time and resources away
from other patients and may expose physicians to greater liability
and insurance costs.
However, the FDA vigorously contests that the Alliance has standing. The agency says the Alliance's standing argument is based on a "statistical probability that some of their unidentified members might be asked to treat women" who were prescribed the drug and experienced adverse effects. This statistical probability approach to standing, the FDA argues, is too attenuated and has been rejected by the Supreme Court.
Intervenors' claims
In their motion to intervene, Missouri, Idaho, and Kansas claimed the states could "assert many
harms the private plaintiffs cannot." Specifically, the states
alleged their emergency rooms and Medicaid programs bear the costs
incurred by adverse effects of mifepristone. The motion also argued that current mifepristone approval
conditions harm states' sovereign interests because
"organizations are relying on the 'FDA-approved
pipeline' to mail abortion pills into all 50 States,
frustrating the ability of States to enforce their laws."
Pending District Court Cases
Several related cases related to mifepristone access have been filed in federal district courts, with final outcomes likely dependent on the Supreme Court's decision. In State of Washington v. FDA, attorneys general from 17 states and the District of Columbia sued the FDA, alleging that the organization had "singled out" mifepristone for unnecessary restrictions. The federal district court blocked the FDA from taking any action to reduce mifepristone's availability in the plaintiff states, but denied to issue a nationwide injunction.
In GenBioPro Inc. v. Raynes, the generic manufacturer of mifepristone sued officials in West Virginia, claiming the state's abortion ban was preempted by the FDA's mifepristone regulations. The federal district court largely rejected the preemption argument. But the court held that one provision of the law, which banned telemedicine prescriptions of mifepristone, was preempted. The case is now on appeal in the Fourth Circuit. GenBioPro also sued the FDA in district court in Maryland, seeking to prevent the agency from complying with any court orders to suspend approval of the drug. That case is suspended pending the outcome of the Supreme Court case.
To view Foley Hoag's State AG Insights blog click here
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
