Federal regulators approved another generic version of the abortion drug mifepristone, a regulatory process that quickly sparked a backlash from anti-abortion groups and politicians aligned with the Trump administration.
Pharmaceutical company Evita Solutions announced on its website the Food and Drug Administration's approval of a low-cost pill approved to terminate pregnancies up to 10 weeks.
Students Against Abortion-For Life Action said in a statement Thursday that the approval is “a stain on President Trump and another sign that the FDA deep state must be abolished.”
Missouri Republican Sen. Josh Hawley also criticized the move, saying in a post about X that he had “lost faith in FDA leadership.”
An agency spokesperson said the FDA “has very limited discretion in deciding whether to approve generic drugs,” adding that FDA officials “do not endorse any products.”
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The criticism comes as Republican President Donald 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 been repeatedly deemed safe and effective by FDA scientists.
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President Kennedy and FDA Commissioner Dr. Marty McCulley pledged in a letter to the Republican attorney general last month to conduct a thorough investigation into the drug's safety.
Under Mr. McCulley and Mr. Kennedy, the FDA repeatedly delayed decisions on vaccines, ultimately narrowing the conditions for approval of COVID-19 shots this year. This kind of political interference has been highly unusual at the FDA, where career scientists typically make such decisions.
The FDA approved the original version of mifepristone in 2000 and gradually made it more accessible over time. This includes drug company GenBioPro's first generic drug approval in 2019.
In 2021, under Democratic President Joe Biden, the FDA allowed online prescribing and mail-order sales of the drug, greatly expanding access. Abortion opponents have continued to fight the change ever since.
Generic drug approval is typically a mechanistic process at the FDA, with multiple counterfeit products typically approved after the original drug's patent has expired. In most cases, generic drug manufacturers only need to demonstrate that their drug matches the ingredients and formulation used in the original drug.
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“This is exactly how our system is supposed to work and has worked this way for decades,” said Mini Thimaraju of Reproductive Freedom for All. “Career scientists and public servants at the FDA did their job.”
The FDA typically approves such applications within 10 months. However, Evita Solutions applied to market mifepristone four years ago, according to filings posted on the FDA's website.
“We believe everyone should have access to safe, affordable, high-quality, effective and compassionate abortion care,” Evita says on its website.
The drug is expected to be available next January, the company said in an email.
Approval of a second generic drug is unlikely to affect access to the pill, which is typically taken in conjunction with another drug, misoprostol. This combination accounts for approximately two-thirds of all abortions in the United States. Mifepristone dilates the cervix and blocks the hormone progesterone, while misoprostol causes uterine spasms and contractions.
Access to mifepristone is restricted in much of the country by state laws that prohibit abortion, including medication abortion, or impose separate restrictions on the drug's use. These laws are the subject of many ongoing lawsuits that are winding their way through the legal system.
Pill restrictions are not supported by most major medical societies, including the American Medical Association.
According to the government's website, the combination of drugs used for abortion in Canada is called mifedymiso, which includes tablets of mifepristone and misoprostol.
In Canada, provinces and territories allow only doctors and nurses to prescribe mifedymiso, with the exception of Quebec, where midwives are also allowed to prescribe mifedymiso.
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