Americans United for Life (AUL) filed a friend-of-the-court brief on behalf of 94 Members of the United States Congress in Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, the case that has challenged the Food and Drug Administration’s (FDA) approval and deregulation of chemical abortion drugs. Senator Cindy Hyde-Smith (MS) and Representative August Pfluger (TX–11) led the brief, and signatories included 18 Senators and 76 Members of the House of Representatives, representing 34 States.

After making its way up and down the courts, with the United States Supreme Court recently blocking any changes to the approval status of chemical abortion drugs while this litigation is ongoing, the case has returned to the Fifth Circuit Court of Appeals. The Fifth Circuit has the opportunity to protect patient safety by affirming the District Court’s suspension of the FDA’s 2000 approval of chemical abortion drugs. As our brief highlights, the FDA subverted federal laws—including patient safeguards—when approving and deregulating chemical abortion drugs. Consequently, these unlawful actions jeopardized patient health and safety. The brief presents three arguments to the Fifth Circuit:

  1. The FDA’s failure to adhere to the Federal Food, Drug, and Cosmetic Act’s drug approval process has created grave risks to the health and safety of women and girls;
  2. The FDA endangers pregnant adolescents seeking chemical abortion drugs by unlawfully subverting the pediatric study requirement;
  3. The FDA has created serious hazards for women’s health and safety by permitting mail-order chemical abortion drugs in violation of federal laws.

“The FDA did not act within its congressionally authorized power when approving and deregulating chemical abortion drugs,” explains Steven H. Aden, AUL Chief Legal Officer & General Counsel. “Unfortunately, this means the FDA subverted critical safeguards for patient health and safety, which has endangered women and girls seeking these drugs. We urge the Fifth Circuit to affirm the suspension of these dangerous drugs, which is in the public interest of patient welfare.”

“This case showcases the grave impact deregulating chemical abortion drugs has on patient health and safety, especially because of the inherent risks of coercion and abuse within abortion decisions,” highlights Danielle Pimentel, AUL Policy Counsel. “The FDA has loosened patient safeguards, including critical protections for in-person medical examinations. This exacerbates the serious risks of intimate partner violence and reproductive control and enables abusers to control women and girls. The Fifth Circuit should uphold the District Court’s suspension of chemical abortion drugs to protect the welfare of women and girls.”

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