Almost every Senate Republican on Thursday urged the Food and Drug Administration (FDA) to “reevaluate” whether a newly approved generic version of the abortion drug mifepristone should stay on the market.
The letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary from 51 of 53 Republican senators adds to the pressure the Trump administration is facing from conservatives to restrict access to medication abortion.
Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska) were the only two Republicans who did not sign the letter.
The senators commended the agency’s recent commitment to conduct a safety review of mifepristone, one of two drugs taken for a medication abortion.
But they questioned why the agencies would approve another generic version of the drug if the review was already underway.
“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,” the lawmakers wrote.
Administration officials have defended the approval as one they were legally required to make and should not be construed as an endorsement of the drug.
FDA approvals are meant to be rooted in science and independent of political bias. They are conducted by scientists and other experts and involve technical and often lengthy discussions with the drug’s sponsor.
But the senators suggested the FDA should suspend the approval pending the outcome of the safety review.
“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,” they wrote.
They called on the agencies to suspend distribution of mifepristone and all generic versions, as well as to reinstate an in-person dispensing requirement that the Biden administration rolled back during the COVID-19 pandemic.
Removing the in-person restriction has allowed doctors to prescribe mifepristone through telehealth visits and then mail the drug to patients, even if they live in states with near-total abortion bans.
The Republicans argued the HHS doesn’t need to wait until the review is finished to act.
“Your agencies have all the information they need to bring an end to previous Democrat administrations’ abortion drug regulations while a comprehensive review is conducted,” they wrote.
President Trump repeatedly pledged during the campaign last year that he would leave abortion policy to the states, but GOP lawmakers and anti-abortion advocates have been ramping up the pressure following the approval of generic mifepristone.
