FDA Approves Generic Mifepristone from Evita Solutions, Drawing Congressional Criticism
Key Insights
The FDA approved Evita Solutions (search) as a third manufacturer of generic mifepristone in a September 30 letter, joining GenBioPro (search) and original manufacturer Danco Laboratories (search) in producing the abortion medication.
Senator Josh Hawley criticized the approval, arguing it occurred without completion of a promised comprehensive safety review and expressing concerns about the FDA's regulatory oversight.
The approval comes amid ongoing policy debates over mifepristone access, with current Biden administration policies allowing telehealth prescribing and mail delivery, contrasting with previous Trump-era in-person dispensing requirements.
The Food and Drug Administration has approved Evita Solutions (search) as a third manufacturer of generic mifepristone, the abortion medication originally developed by Danco Laboratories (search). According to Reuters, the FDA granted approval to Evita in a September 30 letter, expanding the company's ability to produce the generic version alongside existing manufacturer GenBioPro (search).
Regulatory Approval and Company Background
Evita Solutions (search) describes its mission as working to "normalize abortion" and make it "accessible to all." The company states on its website that it "believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live."
Mifepristone functions by blocking progesterone, a hormone needed to sustain pregnancy, and is typically followed by misoprostol to complete the abortion process. The drug's approval expands the manufacturing base for this medication amid ongoing policy discussions.
Congressional Response
Senator Josh Hawley, R-Mo., criticized the FDA's decision, arguing that the agency approved the drug without completing a promised comprehensive safety review. "FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother," Hawley wrote on X Thursday afternoon.
In an interview with Fox News Digital, Hawley expressed confusion about the FDA's decision-making process. "I just, I can't figure out what's happening at the FDA. I'm totally baffled by it," Hawley said, noting that the promised safety review has barely begun.
Current Regulatory Framework
Under the Biden administration, the FDA implemented policy changes allowing telehealth prescribing and mail-order delivery of abortion pills for the first time. Previously, the agency required mifepristone to be dispensed in person to screen for complications such as ectopic pregnancy (search).
Hawley advocated for returning to previous regulatory approaches. "What needs to happen is the FDA needs to get in line with the president's policy and put back into place the safety regulations President Trump had. Ditch the Biden approach and go back to President Trump's approach," he said.
Opposition Groups and Advocacy
The approval occurs as abortion drugs face mounting opposition from conservative lawmakers, religious organizations and pro-life groups. Religious groups like Inspire Investing and Alliance Defending Freedom have campaigned against the drug, while the Restoration of America Foundation (ROAF) has pressed lawmakers for accountability.
Last month, ROAF called on the Senate Finance Committee to hold Health and Human Services Secretary Robert F. Kennedy Jr. accountable at a hearing, demanding answers about the removal of safety protocols for mifepristone. In a letter obtained by Fox News Digital, ROAF warned that policy changes leave women more vulnerable and shift costs to taxpayers.
The organization argued that Biden-era changes endanger women by allowing abortion pills to be prescribed via telehealth and sent through the mail, representing a departure from previous in-person dispensing requirements designed to screen for potential complications.