Republican senators request FDA review generic mifepristone approval over safety concerns

US Senator for Alabama - US Senator for Alabama website
US Senator for Alabama - US Senator for Alabama website
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A group of 53 Republican senators, led by U.S. Senators Katie Britt (R-Ala.) and Lindsey Graham (R-S.C.), has called on the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to reconsider the recent approval of a generic version of mifepristone, a medication used in chemical abortions.

In a letter addressed to HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Martin Makary, the senators referenced recent statements from both agencies about concerns regarding data on abortion pill safety and their plans to review scientific evidence. The senators stated, “We commend your recent statements acknowledging the data discrepancies surrounding abortion pill safety and your commitment to reviewing the science. We are also encouraged by HHS’s recent announcement that it will review prior Risk Evaluation and Mitigation Strategies (REMS) approvals given the recent studies raising concerns about the drug’s safety. Given this commitment, however, we are deeply concerned about the FDA’s approval of a new generic version of mifepristone. While we recognize the FDA’s statutory responsibility in evaluating drug applications, the timing of this approval appears inconsistent with the comprehensive safety reassessment your agencies have prioritized. Out of respect for this important review, and with full confidence in your dedication to protecting women’s health, states’ rights, and unborn life, we urge you to take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market.”

The letter further noted concerns about how access to abortion pills could affect state laws following changes brought by Dobbs v. Jackson Women’s Health Organization: “Unrestricted access to abortion pills is systematically undermining states’ rights and violating pro-life state laws. Every month, thousands of abortion drugs are shipped into states that have otherwise limited access to abortion after Dobbs, degrading pro-life laws at the state level across the country.”

Senators joining Britt and Graham include Senate Majority Leader John Thune (R-S.D.), as well as Senators Jim Banks (R-Ind.), John Barrasso (R-Wyo.), Marsha Blackburn (R-Tenn.), John Boozman (R-Ark.), Ted Budd (R-N.C.), Shelley Moore Capito (R-W.Va.), Bill Cassidy (R-La.), John Cornyn (R-Texas), Tom Cotton (R-Ark.), Kevin Cramer (R-N.D.), Mike Crapo (R-Idaho), Ted Cruz (R-Texas), John Curtis (R-Utah), Steve Daines (R-Mont.), Joni Ernst (R-Iowa), Deb Fischer (R-Neb.), Chuck Grassley (R-Iowa), Bill Hagerty (R-Tenn.), Josh Hawley (R-Mo.), John Hoeven (N.D.-N.D.), Jon Husted (R-Ohio), Cindy Hyde-Smith (R-Miss.), Ron Johnson (R-Wis.), Jim Justice (R-W.Va.), John Kennedy (R-La.), James Lankford (R-Okla.), Mike Lee (R-Utah), Cynthia Lummis (R-Wyo.), Roger Marshall (R-Kan.), Mitch McConnell (R-Ky.), Dave McCormick (R-Pa.), Ashley Moody (R-Fla.), Jerry Moran (R-Kan.) Bernie Moreno (R-Ohio), Markwayne Mullin (R-Okla.) Rand Paul (R-Ky.) Pete Ricketts (R-Neb.) Jim Risch (R-Idaho) Mike Rounds (S.D.-S.D.) Eric Schmitt (Mo.-Mo.) Rick Scott (Fla.-Fla.) Tim Scott (S.C.-S.C.) Tim Sheehy (Mont.-Mont.) Dan Sullivan (Ala.-Ala.) Thom Tillis (N.C.-N.C.) Tommy Tuberville (Ala.-Ala.) Roger Wicker (Miss.-Miss.) Todd Young (Ind.-Ind.).

Senator Britt has previously introduced legislation such as the Born-Alive Abortion Survivors Protection Act aimed at requiring care for newborns who survive attempted abortions. She has also received recognition from advocacy groups for her work on related issues.

The full text of the letter sent by these senators can be accessed online.



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