Nearly all Republicans in the Senate on Thursday called on the Food and Drug Administration (FDA) to “reevaluate” a newly approved drug generic version of the abortifacient drug mifepristone should remain on the market.
The letter from 51 of 53 Republican senators to Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary adds to that Pressures facing the Trump administration by conservatives to restrict access to medication abortion.
Senators Susan Collins (Maine) and Lisa Murkowski (Alaska) were the only two Republicans who did not sign the letter.
The senators praised the agency’s recent commitment to conduct a safety review of mifepristone, one of two drugs used in a medication abortion.
However, they questioned why authorities would approve another generic version of the drug when testing was already underway.
“While we recognize FDA’s legal responsibility in evaluating drug applications, the timing of this approval appears inconsistent with the comprehensive reassessment of safety that your agencies have prioritized,” the lawmakers wrote.
Administration officials have defended the approval as a legal requirement and should not be construed as an endorsement of the drug.
FDA approvals should be based on scientific evidence and independent of political bias. They are conducted by scientists and other experts and involve technical and often lengthy discussions with the drug sponsor.
However, the senators suggested that the FDA should suspend approval pending the outcome of the safety review.
“Out of respect for this important review and with full confidence in your commitment to protecting women’s health, states’ rights, and unborn life, we urge you to take decisive action to reassess whether this generic version of mifepristone is appropriate for market entry,” they wrote.
They called on authorities to suspend distribution of mifepristone and all generic versions and reinstate the in-person delivery requirement, which the Biden administration rolled back during the COVID-19 pandemic.
Removing the in-person restriction will allow doctors to prescribe mifepristone through telemedicine visits and then ship the drug to patients, even if they live in states with near-total abortion bans.
Republicans argued that HHS does not need to wait until the review is complete to act.
“Your agencies have all the information they need to end previous Democratic administrations’ abortion regulations while a comprehensive review is conducted,” they wrote.
President Trump repeatedly promised during the campaign last year that he would leave abortion policy to the states, but Republican lawmakers and anti-abortion advocates have increased the pressure following the approval of generic mifepristone.
