A powerful bloc of 17 Republican senators is raising alarm bells and demanding immediate answers from the Food and Drug Administration (FDA) over its recent, quiet approval of a new generic chemical abortion drug.
Sen. Bill Cassidy (R-LA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led the group in a strongly worded letter to FDA Commissioner Marty Makary on Thursday. The senators are seeking clarity on the agency’s September 30 approval of a generic abortion pill from drugmaker Evita Solutions, which they deem “dangerous.”
The lawmakers claim the approval is a failure to protect women and “flies in the face” of President Donald Trump’s dedication to pro-life policies.
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“To be clear: this approval fails to mitigate the risks to women that have been identified and fails to protect women from the coercive use of the drug,” the senators wrote, stressing that the drug’s approval under the existing Risk Evaluation and Mitigation Strategy (REMS) framework is “flawed.”
They are now pressing Makary to provide an update on the agency’s review of the existing abortion drug, mifepristone, and their plans to “reinstate necessary safeguards.”
The letter includes signatures from prominent Republicans like Sens. Tommy Tuberville (R-AL), Rand Paul (R-KY), Josh Hawley (R-MO), Ted Budd (R-NC), and Lindsey Graham (R-SC), among others.
This action comes as a conservative think tank’s study found that one in ten women experience a “serious adverse event” after taking the abortion pill. HHS Secretary Robert F. Kennedy Jr. confirmed in September that the FDA was already launching a review into risks related to mifepristone.
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Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, praised the senators, stating the drugs are “risking the lives of women across America” and that the FDA’s response was to approve “a cheaper version of a drug that ends unborn lives and sends women to the ER.”
When reached for comment, a Health and Human Services (HHS) spokesperson indicated the agency “will respond to the senators directly,” adding that HHS is conducting a study to ensure the current risk mitigation program is “sufficient to protect women from unstated risks.”
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