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

WASHINGTON, D.C. – U.S. Senator Cindy Hyde-Smith (R-Miss.) and U.S. Representative August Pfluger (R-Texas-11) today led 13 Senators and 54 Representatives 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 led by Hyde-Smith that was signed by 77 Senators and Members of Congress.

“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 Biden Administration’s decision to allow dangerous life-ending chemical abortion drugs to be ordered online or purchased in a store without proper medical consultation or oversight is blatantly putting politics over the safety of women.  It is unacceptable to see the politicization of the Food and Drug Administration, which is tasked with ensuring products are safe for Americans.  I am proud to join Senator Hyde-Smith and other leaders in Congress in standing up against this dangerous decision,” Representative Pfluger said.

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, 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.), James Risch (R-Idaho), John Hoeven (R-N.D.), and Roger Marshall, M.D. (R-Kan.) signed the brief.

In addition to Pfluger, the brief was also signed by U.S. Representatives Robert Aderholt (Ala.–04). Mark Alford (Mo.–04), Jodey Arrington (Texas–19), Brian Babin (Texas–36), Jim Banks (Ind.–03), Cliff Bentz (Ore.–02), Andy Biggs (Ariz.–05), Lauren Boebert (Colo.–03), Mike Bost (Ill.–12), Michael Burgess (Texas–26), Jerry Carl (Ala.–01), Earl L. “Buddy” Carter (Ga.–01), Ben Cline (Va.–06), Michael Cloud (Texas–27), Andrew Clyde (Ga.–09), Warren Davidson (Ohio–08), Jeff Duncan (S.C.-03), Jake Ellzey (Texas–06), Ron Estes (Kan.–04), Mike Ezell (Miss.–04), Randy Feenstra (Iowa–04), Virginia Foxx (N.C.–05), Russ Fulcher (Idaho-01), Tony Gonzales (Texas–23), Bob Good (Va.–05), Michael Guest (Miss.–03), Andy Harris, M.D. (Md.–01), Diana Harshbarger (Tenn.–01), Kevin Hern (Okla.–01), Ronny Jackson (Texas–13), Bill Johnson (Ohio-06), Mike Johnson (La.–04), Trent Kelly (Miss.–01), Doug LaMalfa (Calif.–01), Doug Lamborn (Colo.–05), Debbie Lesko (Ariz.–08), Lisa McClain (Mich.–09), Mary Miller (Ill.–15), John Moolenaar (Mich.–02), Alex X. Mooney (W.Va.–02), Nathaniel Moran (Texas–01), Andy Ogles (Tenn.–05), David Rouzer (N.C.–07), Keith Self (Texas–03), Pete Sessions (Texas–17), Adrian Smith (Neb.–03), Chris Smith (N.J.–04), Claudia Tenney (N.Y.–24), Randy Weber (Texas–14), Daniel Webster (Fla.–11), Brad R. Wenstrup, D.P.M. (Ohio-02), Roger Williams (Texas–25), and Joe Wilson (S.C.–02).

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:

Statements from members of the Mississippi congressional delegation:

“Deregulating chemical abortion pills not only exceeds FDA’s mandate, but also goes against the agency’s mission of protecting health and safety,” Senator Wicker said.  “It is a brazenly political move that puts women in danger of experiencing severe complications without proper care or medical supervision.”

“The FDA is responsible for assuring public safety and health of the products under its jurisdiction.  The decision to approve the use of chemical abortions is a failure of its overarching mission and has placed the lives of women in jeopardy,” Congressman Guest said.  “The FDA’s actions have completely undermined the law, and our amicus brief makes a solid legal claim that is founded on our duty as government officials to protect the women whose health the FDA has seemingly disregarded.”

“The decision by the FDA to approve and deregulate dangerous abortion drugs contradicts their mission,” said Congressman Ezell. “I’m grateful to Senator Hyde-Smith and Congressman Pfluger for leading this effort, and I’m proud to join them in standing up for the unborn.”