The Food and Drug Administration quietly approved a new abortion pill this week, just as Health and Human Services Secretary Robert F. Kennedy has been telling Republican officials that the department is conducting a safety review of the medication.
It’s a move that is certain to create an even bigger divide between the Trump administration and anti-abortion leaders, who largely criticized Trump during the 2024 presidential race for distancing himself from the issue. Many still supported him in November because they opposed Kamala Harris’ advocacy for abortion rights.
On Tuesday, the FDA officially approved a new generic mifepristone manufactured by a company called Evita Solutions LLC. The manufacturer’s website states that “all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.” Evita Solutions LLC did not immediately respond to NOTUS’ requests for comment.
The FDA has “concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval,” the agency wrote to Evita Solutions LLC.
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In a statement to NOTUS, HHS Communications Director Andrew Nixon said “the FDA does not endorse any drug product and directs prescribers to follow all labeling.”
“The FDA has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” he continued.
Nixon added that the agency is still “conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”
But one key GOP ally on Thursday still railed against the FDA’s decision.
“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, who had been leading Congress’ calls to HHS to review mifepristone, said on X.
Less than two weeks before the FDA approved the new mifepristone, Kennedy sent a letter to Republican attorneys general, writing that “HHS is committed to studying the adverse consequences reported in relation to mifepristone.”
“To that end, HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” Kennedy continued. (Mifepristone is considered safe and effective by leading medical organizations.)
Anti-abortion leaders have long urged the FDA to rescind its decades-old approval of mifepristone. However, the calls intensified under the Trump administration, with even more dark money flowing into the groups leading the charge, as NOTUS first reported in July.
Republicans and anti-abortion groups have been citing a report by the conservative Ethics and Public Policy Center, which found that nearly 11% of women experienced serious adverse effects after taking mifepristone. The paper is not peer-reviewed, and some anti-abortion leaders have reportedly said that it is “not a study in the traditional sense” and “not conclusive proof of anything.”
Danco Laboratories and GenBioPro manufacture the name-brand and generic versions of mifepristone, respectively. They did not respond to NOTUS’ requests for comment on a new version hitting the market.
Anti-abortion organizations quickly criticized the administration’s decision.
“This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable,” Marjorie Dannenfelser, the president of Susan B. Anthony Pro-Life America, said in a statement. “The prompt completion of the review is made more urgent given this approval to flood the market with a cheap abortion drug.”
Tony Perkins, president of the conservative Family Research Council, said on X that in approving a new abortion pill, “the federal government is undermining states and the intent of the Dobbs decision.”
Kristan Hawkins, president of Students for Life America, called the approval “a true failure.”
“This is a stain on the Trump presidency and another sign that the deep state at the FDA must go,” she added.
Meanwhile, a spokesperson for Planned Parenthood celebrated the decision.
“Over two decades of research and evidence shows mifepristone is extremely safe and effective. This newly approved generic mifepristone will provide another option for people in a time when access is being restricted for political reasons,” the spokesperson told NOTUS.
The FDA’s new mifepristone approval comes as a legal case looking to restrict access to abortion pills is slowly moving through the federal courts. The Trump administration, which inherited the case from the Biden administration, is defending mifepristone on procedural grounds.
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