Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with the Trump administration.
Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form of the pill, which is approved to end pregnancies through 10 weeks. Evita Solutions is the second company to have an approved generic version of mifepristone. The first was from pharmaceutical company GenBioPro, approved in 2019.
The move prompted backlash from some conservatives.
Republican Sen. Josh Hawley of Missouri criticized the move in a post on X, stating: “I have lost confidence in the leadership at FDA.”
“Anyone who tries to say their hands are tied has not been paying attention,” Students for Life of America and Students for Life Action President Kristan Hawkins told CBS News. “These drugs are dangerous, and this is a stain on the entire administration.”
Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, said in a statement Thursday, “This reckless decision by the F.D.A. to expand the availability of abortion drugs is unconscionable.”
The criticism comes as President Trump’s top health officials, including Health Secretary Robert F. Kennedy Jr., face growing pressure from abortion opponents to reevaluate mifepristone, which was approved 25 years ago and has repeatedly been deemed safe and effective by FDA scientists.
In a statement, HHS spokesperson Andrew Nixon told CBS News that the agency “has very limited discretion in deciding whether to approve a generic drug” and that “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.”
In a letter to Republican attorneys general last month, Kennedy and FDA Commissioner Dr. Marty Makary pledged to conduct a full review of the drug’s safety.
In their letter, Kennedy and Makary wrote, “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.”
CBS News medical contributor Dr. Celine Gounder said last month that the FDA is unlikely to withdraw approval, a rare move that would likely trigger lawsuits, but depending on the safety review, it could restrict access by limiting telehealth or mail delivery, or by narrowing who can prescribe the drug.
On the campaign trail last year, Mr. Trump told CBS News’ Caitlin Huey-Burns that he would not prevent access to mifepristone.
In 2021, the FDA under Democratic President Joe Biden permitted online prescribing and mail-order delivery of the drug, greatly expanding access. Abortion opponents have been fighting the change ever since.
Approval of generic drugs is typically a rote process at the FDA, with multiple copycat versions usually approved after the patent on the original drug expires. In most cases, generic drugmakers only need to show that their drug matches the ingredients and formula developed by the original drugmaker.
The FDA typically approves such applications within 10 months. But filing documents posted to the FDA’s website show that Evita Solutions filed its application to market mifepristone four years ago.
The company did not immediately respond to The Associated Press’ requests for comment.
On its website, Evita states that it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.”
Approval of a second generic is unlikely to affect access to the pill, which is typically taken with another drug, misoprostol. The majority of women who terminate pregnancies do so through medication abortions. Mifepristone dilates the cervix and blocks the hormone progesterone, while misoprostol causes the uterus to cramp and contract.
“This is exactly how our system is supposed to work, and it has worked this way for decades,” Mini Timmaraju, president and CEO of Reproductive Freedom for All, said in a statement. “The only reason this routine approval is making headlines is because anti-abortion politicians have turned health care into a political battlefield.”
Access to mifepristone is restricted across large sections of the country because of state laws that ban abortion — including medication abortion — or impose separate restrictions on the drug’s use. Those laws are subject to a number of ongoing lawsuits that are winding their way through the legal system.
Restrictions on the pill are not supported by most major medical societies, including the American Medical Association.
