In Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, (ND TX, April 7, 2023), a Texas federal district court held that plaintiffs have a substantial likelihood of success on their claim that the FDA's 2021 action allowing the abortion drug mifepristone to be distributed by mail violates the Comstock Act and thus was also in violation of the Administrative Procedure Act. The court also concluded that the FDA's approval in 2000 of doctors prescribing mifepristone violated the agency's rules for approval of new drugs. The FDA rules (Subpart H) relied upon to approve the drug apply to "new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments...." The court said in part:
[T]o satisfy Subpart H, FDA deemed pregnancy a “serious or life-threatening illness[]” and concluded that mifepristone “provide[d] [a] meaningful therapeutic benefit to patients over existing treatments.” See 21 C.F.R. §§ 314.500; 314.560. FDA was wrong on both counts....
Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life. Defendants even admit pregnancy is not an “illness.”...
FDA also exceeded its authority under the second requirement of Subpart H. In addition to treating a serious or life-threatening illness, chemical abortion drugs must also provide a “meaningful therapeutic benefit” to patients over surgical abortion... [T]his cannot be the case because chemical abortion drugs do not treat “serious or life-threatening illnesses” — a prerequisite to reaching the second requirement.... Similarly, chemical abortion drugs cannot be “therapeutic” because the word relates to the treatment or curing of disease.
The court stayed the FDA's approval of mifepristone, but stayed the effectiveness of its order for 7 days so the government can appeal to the U.S. 5th Circuit Court of Appeals for emergency relief. President Joe Biden issued a statement (full text) criticizing the court's decision and reporting that the Justice Department has already filed an appeal. Vice President Kamala Harris also issued a statement (full text) criticizing the decision.
Meanwhile, in State of Washington v. U.S. Food & Drug Administration, (ED WA, April 7, 2023), a Washington federal district court issued a preliminary injunction barring the FDA from "altering the status quo and rights as it relates to the availability of Mifepristone" in the 17 states and District of Columbia that are plaintiffs in the case. Plaintiffs are challenging certain requirements for prescribing mifepristone added in 2023.
Seattle Times reports on the decisions.
