Editor’s Note: To help you easily access all of Manatt Health’s thought leadership on Dobbs and other reproductive health issues, we have created a new Reproductive Health “hot topics” page on our website. Now one click takes you to our full library of white papers, webinars, newsletters and articles on reproductive health topics, including the post-Dobbs abortion landscape, medication abortion and teleMAB, family planning, pregnancy and postpartum issues, and privacy around reproductive health information. Click here to access our new Reproductive Health page.
Since the Supreme Court overturned the constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization earlier this year, demand for medication abortion (MAB) through the Food and Drug Administration (FDA)-approved drug mifepristone—the first of two pills taken in the MAB regimen—has exponentially increased.1 In recent weeks, two efforts were launched to thwart access to MAB by challenging FDA’s regulation of these drugs. In one effort, a lawsuit has been filed to challenge FDA’s approval of mifepristone. In another, anti-abortion groups petitioned FDA to impose new restrictions on mifepristone’s use on a theory of harm to the environment. These strategies are novel in their approaches and illustrate the ongoing efforts to find ways to limit the availability of MAB.
Alliance for Hippocratic Medicine, et al. v. FDA
On November 18, 2022, a group of physician organizations, including the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical & Dental Associations, and several individual OB-GYNs, filed a lawsuit in the U.S. District Court for the Northern District of Texas asking the court to revoke FDA’s original approval of mifepristone from 2000. The lawsuit brings several claims challenging various aspects of FDA’s approval decision and subsequent oversight of mifepristone, spanning the more than 20 years of mifepristone’s marketing in the United States.
Among other things, the plaintiffs assert that FDA exceeded its authority when it approved mifepristone via FDA’s accelerated approval pathway under 21 C.F.R. Part 314 Subpart H. Specifically, plaintiffs claim that pregnancy is not an illness, nor is it “serious or life-threatening,” and that FDA therefore violated its regulations by approving the drug under Subpart H, which applies to drugs that treat “serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.”
Additionally, plaintiffs challenge FDA’s decision to allow the use of mifepristone for up to ten weeks’ gestation (originally, the FDA-approved use was for up to seven weeks’ gestation), FDA’s waiver of requirements under the Pediatric Research Equity Act (PREA) and FDA’s 2019 approval of a generic version of mifepristone.
Students for Life Citizen Petition
On November 15, 2022, an organization called Students for Life, a pro-life advocacy organization for college students, submitted a citizen petition to FDA requesting that the agency modify the post-market safety requirements (or the “Risk Evaluation and Mitigation Strategy”) for mifepristone to require prescribers to include a medical waste bag and “Catch-Kit” (a device similar to a sharps disposal container that is used to collect medical waste) with all mifepristone prescriptions. The organization asserts that at-home abortion using mifepristone creates an environmental hazard when the fetal tissue remains and remnants of the medication are flushed down the toilet and enter waterways and groundwater. As a result, according to Students for Life, the tissue and traces of the medication can “impact animals, causing teratologic repercussions or congenital anomalies like birth defects to animals.”
Students for Life argues that FDA did not conduct adequate environmental studies to evaluate mifepristone’s “effect on the water supply or pollution for the people or animals who consume that water.” However, as noted in the approval documents, FDA did consider the environmental impacts of mifepristone and concluded “that the product can be manufactured, used, and disposed of without any expected adverse environmental effects.” The petition argues there is now evidence of environmental harm that warrants a determination by FDA that fetal tissue resulting from mifepristone is medical waste, requiring the use of medical waste bags and “Catch-Kits” to safely dispose of the tissue.
Students for Life plans to sue FDA if the agency rejects or ignores their citizen petition. Additionally, the group is pursuing federal legislation to force FDA to implement this medical waste requirement.
Conclusion
In the wake of Dobbs, it is unclear how courts will respond to the many questions relating to FDA’s 2000 approval of MAB raised in Alliance for Hippocratic Medicine, et al. v. FDA. Similarly, if Students for Life files a lawsuit related to their petition, courts will be in a position of weighing complicated questions relating to key FDA authorities with respect to drug review and approvals in the United States. It will be critical for all stakeholders to watch as these cases proceed given the important implications not only for MAB but also for all FDA-regulated products.
1 See Abigail. R. A. Aiken, et al., Requests for Self-managed Medication Abortion Provided Using Online Telemedicine in 30 US States Before and After the Dobbs v Jackson Women’s Health Organization Decision, 328 JAMA 1768, 1768-69 (2022) (finding exponential growth in daily MAB orders from an average of 82.6 daily orders prior to Dobbs to 213.7 daily orders from 30 U.S. states since Dobbs).