Republican senators call on FDA to reconsider generic abortion pill approval

Senator Lindsey Graham, US Senator for South Carolina - Official U.S. Senate headshot
Senator Lindsey Graham, US Senator for South Carolina - Official U.S. Senate headshot
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A group of 51 Republican Senators, led by U.S. Senator Lindsey Graham of South Carolina, has sent a letter to the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and Food and Drug Administration (FDA) Commissioner Dr. Martin Makary. The letter addresses recent statements by the agencies regarding discrepancies in data on abortion pill safety and their intention to review scientific evidence related to the issue.

In their letter, the Senators praised HHS and FDA for acknowledging concerns about abortion pill safety and for committing to further scientific review. They expressed specific concern over the FDA’s recent approval of a generic version of mifepristone, a drug commonly used for chemical abortions.

“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,” wrote the Senators.

The letter also addressed concerns over how access to abortion pills could impact state laws following changes in federal abortion policy after 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,” they continued.

The letter was signed by Republican Senators from across the country, including Jim Banks (Indiana), John Barrasso (Wyoming), Marsha Blackburn (Tennessee), John Boozman (Arkansas), Katie Britt (Alabama), Ted Budd (North Carolina), Shelley Moore Capito (West Virginia), Bill Cassidy (Louisiana), John Cornyn (Texas), Tom Cotton (Arkansas), Kevin Cramer (North Dakota), Mike Crapo (Idaho), Ted Cruz (Texas), John Curtis (Utah), Steve Daines (Montana), Joni Ernst (Iowa), Deb Fischer (Nebraska), Charles Grassley (Iowa), Bill Hagerty (Tennessee), Josh Hawley (Missouri), John Hoeven (North Dakota), Jon Husted (Ohio), Cindy Hyde-Smith (Mississippi), Ron Johnson (Wisconsin), Jim Justice (West Virginia), John Kennedy (Louisiana), James Lankford (Oklahoma), Mike Lee (Utah), Cynthia Lummis (Wyoming), Roger Marshall (Kansas), Mitch McConnell (Kentucky), David McCormick (Pennsylvania), Ashley Moody (Florida), Jerry Moran (Kansas), Bernie Moreno (Ohio), Markwayne Mullin (Oklahoma), Rand Paul (Kentucky), Pete Ricketts (Nebraska), James Risch (Idaho), Mike Rounds (South Dakota), Eric Schmitt (Missouri), Rick Scott (Florida), Tim Scott(South Carolina ), Tim Sheehy(Montana ), Dan Sullivan(Alaska ), John Thune(South Dakota ), Thom Tillis(North Carolina ), Tommy Tuberville(Alabama ), Roger Wicker(Mississippi ) and Todd Young(Indiana ).

The full text of the letter is available online.



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