Sign Brief that Spotlights Risks to Women, Girls in FDA Disregard of the Law

WASHINGTON – U.S. Senators Jim Risch (R-Idaho) and Cindy Hyde-Smith (R-Miss.) today led 12 Senators in signing an amicus brief supporting a lawsuit challenging the Food and Drug Administration’s approval and deregulation of chemical abortion drugs.

The brief, authored by Americans United for Life, has been filed in the case of Alliance for Hippocratic Medicine v. FDA , which is pending before the Northern District of Texas.  The brief spotlights how the FDA’s actions have disregarded the law and put the lives and health of women and girls in danger.  It follows a Jan. 26 letter to the FDA that every member of the Idaho delegation signed.

“Human life is invaluable, yet the Biden administration is looking for more and more ways to promote abortion,” said Senator Risch. “This administration is enabling and encouraging chemical abortions, which are dangerous. The FDA has a responsibility to protect women, girls, and the unborn, and it should be held accountable for failure to prevent these harmful drugs from becoming readily available.”

“The FDA’s reckless decisions to approve and deregulate chemical abortion drugs put the profits and political agenda of the abortion industry over the law and abundant evidence that abortion drugs present harm to women, girls, and their unborn babies,” Senator Hyde-Smith said.  “These facts provide a clear legal basis to hold the FDA accountable for abdicating its responsibility to protect the American people from these dangerous drugs and for overstepping its authority under the law.”

The lawmakers’ brief supports the medical associations and pro-life doctors who filed the lawsuit based on the FDA wrongfully disregarding the risks and dangers associated with chemical abortion drugs as it approved and progressively eased restrictions on the pregnancy-ending drugs to make them more widely available.

The amicus brief makes three primary arguments that demonstrate how the FDA exceeded its authority by subverting the law and public policy with its approval and deregulation of harmful chemical abortion drugs.  The brief contends the FDA endangered the health of women and girls when it:

• Failed to adhere to the drug approval process in the Federal Food, Drug, and Cosmetic Act (FFDCA) – “By subverting the FFDCA’s patent safeguards, the FDA is playing a dangerous game with the health and safety of women and girls, which is why the FDA’s approval and deregulation of chemical abortion pills should be preliminarily enjoined.”
• Unlawfully waived the pediatric study requirement under the Pediatric Research Equity Act – “Contrary to the FDA’s assertion, adolescent patients seeking chemical abortions face unique challenges that place them in dissimilar conditions to adult women, and waiving the pediatric rule jeopardizes the health and safety of adolescent patients…  Notably, the FDA authorized chemical abortion drugs without knowing the drugs’ impact on adolescent development, especially its effect on girls’ immune systems.”
• Violated federal law by permitting mail-order chemical abortion pills – “Federal law bars the use of the United States Postal Service and private carriers from mailing abortion-inducing drugs, including the chemical abortion regimen of mifepristone and misoprostol…  By contravening federal law to allow telemedicine and mail order chemical abortion pills, the FDA is endangering women’s health and safety.”

In addition to Hyde-Smith and Risch, U.S. Senators Roger Wicker (R-Miss.), Tommy Tuberville (R-Ala.), James Lankford (R-Okla.), Marco Rubio (R-Fla.), Steve Daines (R-Mont.), John Thune (R-S.D.), Mike Braun (R-Ind.), Kevin Cramer (R-N.D.), Markwayne Mullin (R-Okla.), John Hoeven (R-N.D.), and Roger Marshall, M.D. (R-Kan.) signed the brief.

SBA Pro-Life America, Catholic Vote, Students for Life Action, Family Policy Alliance, U.S. Conference of Catholic Bishops support the lawmakers’ amicus brief.

Documents associated with the amicus brief filing:

• Unopposed Motion of 67 Members of Congress for Leave to File a Brief as Amici Curiae in Support of Plaintiffs’ Motion for a Preliminary Injunction
• Brief Amici Curiae of 67 Members of Congress in Support of Plaintiffs’ Motion for a Preliminary Injunction
• Appendix to Brief Amici Curiae of 67 Members of Congress in Support of Plaintiffs’ Motion for a Preliminary Injunction

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