FDA approves another generic abortion pill, prompting outrage from conservatives

WASHINGTON (AP) β€” Federal officials have approved another generic version of theΒ abortion pill mifepristone, a regulatory formality that quickly triggered pushback fromΒ anti-abortion groupsΒ and politicians aligned with the Trump administration.

Drugmaker Evita Solutions announced on its website that theΒ Food and Drug AdministrationΒ signed off on its low-cost form of theΒ pill, which is approved to end pregnancies through 10 weeks.

Students for Life Action, which opposes abortion, in a statement Thursday called the approval β€œa 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 in a post on X, stating, β€œI have lost confidence in the leadership at FDA.”

A spokesperson for the agency said the FDA β€œhas very limited discretion in deciding whether to approve a generic drug,” and added that FDA officials do not β€œendorse any product.”

The criticism comes as Republican President Donald Trump’s top health officials, including Health SecretaryΒ 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 letter to Republican attorneys general last month, Kennedy and FDA CommissionerΒ Dr. Marty MakaryΒ pledged to conduct a full review of the drug’s safety.

Under Makary and Kennedy, the FDA has repeatedlyΒ delayed decisions on vaccines, ultimatelyΒ narrowing the terms of approvalΒ for this year’s COVID-19 shots. That type of political intervention was previously highly unusual at the FDA, where career scientists typically make such decisions.

The FDA approved the original version of mifepristone in 2000 and gradually eased access over time. That included approving the first generic pill, from drugmaker GenBioPro, in 2019.

In 2021, the FDA under Democratic President Joe BidenΒ permitted online prescribingΒ 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 used in the original medication.

β€œThis is exactly how our system is supposed to work, and it has worked this way for decades,” said Mini Timmaraju of Reproductive Freedom for All. β€œCareer scientists and civil servants at the FDA did their jobs.”

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.

On its website, Evita states that it β€œbelieves that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.”

The company said in an email that the drug is expected to launch in January of next year.

Approval of a second generic is unlikely to affectΒ access to the pill, which is typically taken with another drug, misoprostol. The combination accounts for roughly two-thirds of all U.S. abortions. Mifepristone dilates the cervix and blocks the hormone progesterone, while misoprostol causes the uterus to cramp and contract.

Access to mifepristone isΒ restrictedΒ across large sections of the country because of state laws that ban abortion β€” including medication abortion β€” or impose separate restrictions on the drug’s use. Those laws are subject to a number ofΒ ongoing lawsuitsΒ that are winding their way throughΒ the legal system.

Restrictions on the pill are not supported by most major medical societies, including the American Medical Association.