In a new test of abortion rights, four medical organizations and four doctors filed suit last week in a Texas federal district court challenging the FDA's long-standing approval for use in the United States of the chemical abortion drugs mifepristone and misoprostol. The 113-page complaint (full text) in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, (ND TX, filed 11/18/2022), alleges in part:
3. To date, the FDA’s review, approval, and deregulation of chemical abortion drugs has spanned three decades, correlated with four U.S. presidential elections, and encompassed six discrete agency actions...
7. The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an “illness” and argue that these dangerous drugs provide a “meaningful therapeutic benefit” over existing treatments.
8. But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion....
9. What’s more, the FDA needed to disavow science and the law because the FDA never studied the safety of the drugs under the labeled conditions of use....
10, Since then, the FDA has not followed the science, reversed course, or fixed its mistakes,,,
22... [A]ll of the FDA’s actions on chemical abortion drugs—the 2000 approval, the 2016 major changes, the 2019 generic drug approval, and the two 2021 actions to eliminate the in-person dispensing requirement—failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail, express company, or common carrier.,,,
ADF issued a press release announcing the filing of the lawsuit.
