The US Food and Drug Administration has approved a new generic version of mifepristone, a drug central to most medication abortions in the country. The decision, quietly issued earlier this week, enables Evita Solutions to produce the pill, joining an existing generic already on the market. Abortion rights advocates praised the approval as a victory for evidence-based medicine, while anti-abortion groups denounced it as a betrayal.
Read: Trump Vows To Send National Guard Into ‘All US Cities’ Amid Crime Surge
Evita Solutions Approval
The FDA’s decision allows Evita Solutions to manufacture its generic version of mifepristone, first approved as a brand-name drug in 2000. Mifepristone, typically used with misoprostol, is the most common medication method for terminating pregnancies in the United States. By approving another supplier, the agency has expanded access despite intense political and legal battles over abortion since the Supreme Court overturned Roe v Wade in 2022.
Also read: Louisiana Leaders Divide Over National Guard Deployment to Fight Crime
Fierce Political Backlash
The approval drew immediate criticism from anti-abortion politicians and advocacy groups. “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,” Republican senator Josh Hawley wrote on X. Kristan Hawkins, president of Students for Life of America, called the approval “a true failure,” adding, “This is a stain on the Trump presidency.”
Also read: Citizens Panic as ICE Buys Secret Tool to Track Americans’ Daily Movements
Safety Review Questioned
Last month, Health Secretary Robert F Kennedy Jr announced his department would review mifepristone’s safety. Anti-abortion groups pushed for the review, seizing on an April paper by the conservative Ethics and Public Policy Center. The study claimed that nearly 11% of women suffered sepsis or other severe complications within 45 days of using mifepristone, though the report was neither peer-reviewed nor published in a medical journal.
Also read: 300 ICE Agents Storm Chicago Complex in Venezuelan Gang Crackdown
Experts Challenge Claims
Medical experts have strongly disputed the claims made in the center’s paper. Researchers found that the study included flawed data, such as counting ectopic pregnancies as complications even though mifepristone does not cause or worsen them. In contrast, more than 100 studies conducted over three decades and in multiple countries consistently show that mifepristone is both safe and effective for abortion care.
Also read: US Shutdown Weakens Cyber Defenses As Thousands Of Experts Exit
Supporters Applaud Decision
Abortion rights advocates celebrated the FDA’s move, emphasizing that it reinforced scientific evidence. “By expanding generic options, the agency is reinforcing mifepristone’s impeccable safety record,” said Kiki Freedman, co-founder and CEO of Hey Jane, a telemedicine abortion provider. She stressed the importance of defending medical evidence in the face of politically motivated efforts to restrict care.
Also read: Migrant Families Torn Apart Again As Trump Revives Separation Policy
FDA’s Legal Obligation
The Department of Health and Human Services declined to comment further, but a spokesperson told the New York Times that “the FDA has minimal discretion in deciding whether to approve a generic drug.” By law, the agency must approve applications that demonstrate a generic is identical to its brand-name counterpart. This legal framework has limited the administration’s ability to block new approvals even under political pressure.