The anti-abortion movement’s patience with the Food and Drug Administration (FDA) is wearing thin following the agency’s recent approval of a second generic version of mifepristone, one of two drugs taken for a medication abortion.
President Trump repeatedly pledged during the campaign last year that he would leave abortion policy to the states, but anti-abortion advocates and lawmakers have been pushing him to go further and sharply restrict the availability of mifepristone.
So far, that hasn’t happened.
A letter sent to a group of GOP state attorneys general in September confirmed that the FDA was reviewing evidence about the safety of mifepristone to investigate how it can be safely dispensed.
“This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary wrote in the letter, sent Sept. 19.
The disclosure garnered some cautious optimism from the right, as lawmakers and activists said they hoped the FDA would soon act to roll back regulatory changes that made mifepristone easier to access.
But then came the news that Evita Solutions would soon become the third company in the U.S. approved to manufacture and sell mifepristone.
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA,” Sen. Josh Hawley (R-Mo.) wrote on social platform X.
When asked about mifepristone during his confirmation hearing, Makary said he would “take a solid, hard look at the data and to meet with the professional career scientists who have reviewed the data at the FDA and to build an expert coalition to review the ongoing data, which is required to be collected.”
In a letter sent Friday to Makary, Hawley asked for specific information about the drug’s approval process and demanded the commissioner explain his personal role in granting the approval.
“This decision appears to ignore the science while advancing a highly questionable ideological agenda,” Hawley wrote.
He noted that since any potential safety changes will now come after the generic’s approval, it could be exempt from them.
“This would render your safety review toothless and irrelevant,” Hawley wrote.
Separately, a group of House conservatives called on Kennedy to fire the division leaders responsible for greenlighting the drug as part of any shutdown-related layoffs.
“It is clear that rogue actors within the FDA are working to undermine both the sanctity of life and the Administration’s commitment to protecting it,” the lawmakers, led by Rep. Mark Harris (R-N.C.), wrote. “For this reason, we respectfully urge that you consider the director of the Office of Generic Drugs, the director of the Center for Drug Evaluation and Research, and other bureaucrats responsible for this reckless decision as part of your reduction-in-force evaluations.”
Administration officials have defended the decision as one they were legally required to make.
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.
“It’s not an endorsement of this drug by any means. They are just simply following the law,” White House press secretary Karoline Leavitt said Friday. “By law, the secretary of the Department of Health and Human Services must approve a generic drug application if the application demonstrates the drug is the ‘same’ as the brand-name drug.”
To date, the White House has primarily attacked low-hanging fruit on abortion.
The administration slashed funds for family planning grants and rolled back a Biden-era policy on emergency access to abortion, but it has not yet taken major steps to curtail access.
Sixteen states have near-total bans on abortion. Yet abortion is still an option for people who live there because of the availability of abortion medication. Physicians operating in states where abortion is protected are prescribing mifepristone via telehealth and then sending the pills in the mail.
The effort has sparked legal challenges over the “shield laws” that protect those physicians from prosecution in states that outlaw abortion.
Anti-abortion groups want the FDA to, at a minimum, immediately reinstate stricter regulations that prohibit mifepristone from being sent in the mail. The Biden administration rolled those back during the COVID-19 pandemic.
“President Trump believes states have the right to pass and enforce pro-life protections. Yet every day this right is being trampled upon by the abortion industry,” leading anti-abortion group Susan B. Anthony Pro-Life America said in a statement.
Kelsey Pritchard, director of state public affairs for the group, said there’s no reason the FDA needs to wait. The safety review should be a priority, she said, but the administration needs to roll back the loosened prescribing requirements without it.
“We need FDA to change course. Quickly,” Pritchard said.
Pritchard said approving a second generic mifepristone doesn’t align with the administration’s stated priorities.
“This is not MAGA, this is not MAHA” she said. “It doesn’t make America healthy again.”
Kristi Hamrick, a spokesperson for Students for Life of America, said she “understands the sentiment” of lawmakers calling for change at the FDA.
“We will need more than assurances on social media that a real and honest review is underway,” Hamrick told The Hill in a text message.
“We are looking for concrete discussions and signs that on this issue, the work is getting done. The Trump administration has taken a ground-up evaluation of all kinds of things in government in hand. And that needs to include chemical abortion pills,” Hamrick said.
Students for Life was part of a coalition of anti-abortion advocates, state lawmakers, physicians and religious leaders that urged the FDA on Friday to reverse the latest approval and remove mifepristone from the market.
“This approval directly contradicts Secretary Kennedy’s recent public assurances that the safety of abortion drugs was in question and would receive thorough review,” they wrote.
