Conservative lawmakers and anti-abortion groups said they felt betrayed by the Food and Drug Administration’s (FDA) approval of a second generic version of the drug.
Now, nearly every Republican senator sent a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary saying the agency should “reevaluate” whether that newly approved drug should stay on the market because of safety concerns.
Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska) were the only two Republicans who did not sign the letter.
Additionally, the lawmakers called on the administration to suspend the distribution of mifepristone and all generic versions as an “imminent hazard,” and reinstate a requirement that the drug must be prescribed in person, which would effectively end all telehealth and mail orders.
The Biden administration removed the in-person restriction during the COVID-19 pandemic, allowing 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 senators commended the agency’s recent commitment to conduct a safety review of mifepristone, but said the agency did not need to wait for the results 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.
While lawmakers want the administration to take executive action on mifepristone, there are also legal cases that could restrict access to the drug. Louisiana this week sued FDA over the telehealth changes, and a years-long case brought by red state attorneys general was recently transferred to Missouri instead of dismissed, keeping it alive and giving it a better chance of being heard.
Trump 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. They said the HHS secretary must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,
While FDA reviews are meant to be non-political and scientific, there are ways to draw out the process by demanding more data from the sponsor. FDA reviewed the first generic version of mifepristone for 10 years before approving it.
FDA received the application for the second generic version, made by Evita Solutions, in October 2021.
