Federal regulators have approved a second generic version of the abortion pill mifepristone, a routine step that quickly drew backlash from anti-abortion groups and some Republican lawmakers.
Drugmaker Evita Solutions announced on its website that the Food and Drug Administration (FDA) had cleared its low-cost version of the pill, which is approved to end pregnancies up to 10 weeks.
Students for Life Action, a group opposed to abortion, blasted the decision. In a statement Thursday, it called the approval a stain on the Trump presidency and another sign that the “deep state” at the FDA must go. Republican Sen. Josh Hawley of Missouri also criticized the move, writing on X: “I have lost confidence in the leadership at FDA.”
The criticism highlights the political pressure facing the Trump administration from abortion opponents. Some conservatives have urged officials to revisit the drug’s safety, despite repeated findings by FDA scientists that mifepristone is safe and effective.
In a letter to Republican attorneys general last month, Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary pledged to conduct a full review of the drug.
Mifepristone was first approved in 2000 and has been gradually made more accessible. The FDA authorized the first generic version, manufactured by GenBioPro, in 2019. Two years later, under Democratic President Joe Biden, the agency permitted telehealth prescribing and mail-order delivery of the drug—a policy shift that dramatically expanded access. Abortion opponents have been challenging that decision in court ever since.
In August, Costco Wholesale cited low demand and announced it would not sell mifepristone in its U.S. pharmacy stores.
Generic approvals are usually considered routine. After the patent on the original drug expires, multiple drugmakers often enter the market with cheaper versions. To receive approval, companies must demonstrate that their product is chemically identical to the original. In most cases, such reviews are completed within 10 months.
However, Evita Solutions’ application took far longer. According to FDA filings, the company submitted its request four years ago. The FDA did not explain the delay. Evita did not immediately respond to requests for comment.
On its website, the privately held company states that it believes all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.
Approval of Evita’s pill is not expected to significantly alter access to mifepristone. The medication is typically prescribed with misoprostol, a second drug that causes the uterus to contract and empty. Together, the two drugs account for roughly two-thirds of U.S. abortions.
Mifepristone works by blocking the hormone progesterone and softening the cervix to prepare the body for expulsion. Still, access to the regimen remains sharply limited in many states. Abortion bans—including bans on medication abortion—have been enacted across large parts of the country. Other states have passed restrictions specific to mifepristone. Those measures remain tied up in ongoing legal challenges.
Major medical groups, including the American Medical Association, oppose restrictions on the pill, saying they are not supported by scientific evidence.
This is a breaking news article. Updates to follow.
This article includes reporting by the Associated Press.
https://www.newsweek.com/donald-trump-generic-abortion-pills-drug-mifepristone-fda-10820710
