Key Takeaways

• The Food and Drug Administration's (FDA) approval of the abortion drug mifepristone has been at the center of two conflicting court decisions, one from the Northern District of Texas and another from the Eastern District of Washington. The Texas decision blocks prescribing and dispensing of mifepristone nationwide, while the Washington decision enjoins the FDA from altering the status quo related to mifepristone. This discrepancy is likely to escalate to the Supreme Court of the United States for review.
• The Texas case was brought by several organizations and individual doctors who argue that the FDA's approval of the drug in 2000 violated Subpart H and that its pre-2021 actions were arbitrary and capricious. The court found that the plaintiffs' arguments have a substantial likelihood of success on the merits and thus stayed the FDA's 2000 approval of mifepristone and all subsequent challenged actions related to that approval.
• The American Medical Association, Pfizer, and dozens of other biotech and pharmaceutical company leaders have expressed support for the FDA's approval of mifepristone, arguing that the Texas decision ignores decades of scientific evidence and legal precedent. Meanwhile, the governor of California has taken action to ensure access to the drug, purchasing an emergency stockpile of misoprostol in the wake of the Texas decision.

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision blocks prescribing and dispensing of mifespristone nationwide, while the Washington decision enjoins the FDA from altering the status quo related to mifepristone. The discrepancy is likely to escalate to the Supreme Court of the United States for review.

In response to the Texas decision, the American Medical Association issued a press release stating that the decision “flies in the face of science” and “threatens to upend access to a safe and effective drug.” Similarly, Pfizer and dozens of other biotech and pharmaceutical company leaders signed an open letter in support of the FDA’s approval, indicating that the Texas decision ignores decades of scientific evidence and legal precedent. The governor of California announced that California purchased an emergency stockpile of misoprostol in the wake of the Texas decision.

Background

The FDA first approved Mifeprex in 2000 and approved a generic version of Mifeprex, mifepristone tablets, 200 mg, in 2019. In 2021, the FDA suspended the in-person dispensing requirement in response to the COVID-19 pandemic. On Jan. 3, the FDA modified the Mifepristone Risk Evaluation and Mitigation Strategies (REMS) Program, allowing more retail pharmacies to dispense abortion pills upon completion of a certification process.

Texas Case

The plaintiffs in the Texas case – Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical and Dental Associations, as well as three individual doctors – argue that the FDA’s 2021 actions violate the Comstock Act and the Administrative Procedure Act (APA).[1] They further argue that the FDA’s approval of the drug in 2000 violated Subpart H and that its pre-2021 actions were arbitrary and capricious. The court found that the plaintiffs’ arguments have a substantial likelihood of success on the merits and thus stayed the FDA’s 2000 approval of mifepristone and all subsequent challenged actions related to that approval. The full opinion can be read here.

Washington Case

The plaintiffs in the Washington case, a coalition of attorneys general from 17 states and the District of Columbia, sought to block the FDA from removing mifepristone from the market. The Washington court issued a status quo preliminary injunction preventing the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.” The “Plaintiff States” are identified as Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, and the District of Columbia. The full opinion can be read here.

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