Yellowhammer Times

U.S. Senator Tommy Tuberville (R-AL) and a group of Republican senators have called on the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to reconsider the approval of a generic version of mifepristone, a drug commonly used for chemical abortions.

In a letter addressed to HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Martin Makary, the senators praised recent statements from both officials that questioned data related to abortion pill safety and expressed support for reviewing existing scientific evidence.

“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 was signed by Senator Tuberville along with more than 40 other Republican lawmakers from various states.

The senators raised concerns about mail-order access to abortion drugs following changes under previous administrations that allowed these medications to be obtained without direct medical supervision or verification of recipient identity or intent. They argued that such policies could lead to misuse by abusers or minors.

According to their letter, “Under current FDA regulations, these drugs can be obtained via mail order without meaningful consultation with a medical professional and without any confirmation of who is purchasing them or for what purpose. These policies have enabled abortion pills to be obtained by abusers, traffickers, and even minors.”

They also cited research suggesting an increased risk of complications associated with mifepristone use since 2016 when reporting requirements were changed: “evidence shows that the risk of serious medical complications after taking mifepristone is at least twenty-two times higher than reported on the drug label.” The senators referenced studies involving over 865,000 medically-induced abortions between 2017 and 2023 which found growing rates of adverse events in real-world settings compared with clinical trials.

The lawmakers argued that expanded access undermines state laws restricting abortion post-Dobbs decision by enabling distribution into states where such procedures are limited.

Senator Tuberville serves on several Senate committees including Armed Services; Agriculture; Veterans’ Affairs; Health, Education, Labor & Pensions; and Aging.