FDA Approves Second Generic Abortion Pill, Igniting Conservative Backlash

FDA Greenlights Evita Solutions' Generic Mifepristone

The U.S. Food and Drug Administration (FDA) announced on October 2, 2025, the approval of another generic version of the abortion pill mifepristone. This latest approval, granted to Evita Solutions, LLC, a Virginia-based pharmaceutical company, marks the second generic form of the drug to enter the market. The decision, while a standard regulatory procedure for generic medications, has quickly drawn sharp criticism from anti-abortion organizations and conservative political figures across the United States.

The FDA's letter of approval for Evita Solutions' 200 mg oral tablet was dated September 30. Mifepristone is typically used in combination with another drug, misoprostol, for the medical termination of intrauterine pregnancies up to 10 weeks (70 days of gestation). The drug functions by blocking progesterone, a hormone crucial for maintaining pregnancy, while misoprostol induces uterine contractions. The first generic version of mifepristone was approved in 2019 from GenBioPro, with the brand-name drug, Mifeprex, marketed by Danco Laboratories.

Widespread Criticism Amidst Safety Review

The approval has been met with immediate and vocal opposition from anti-abortion advocates and conservative politicians. Republican Senator Josh Hawley of Missouri expressed his disapproval on X, stating, 'I have lost confidence in the leadership at FDA.' Kristan Hawkins, President of Students for Life of America and Students for Life Action, called the approval 'a stain on the entire administration' and asserted that 'These drugs are dangerous.' Marjorie Dannenfelser, President of Susan B. Anthony Pro-Life America, described the FDA's action as a 'reckless decision.' Former Vice President Mike Pence went further, calling the approval 'a complete betrayal of the pro-life movement' and demanding the resignation of HHS Secretary Robert F. Kennedy Jr.

This regulatory action comes at a time when the Trump administration's top health officials, including Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary, have pledged to conduct a 'full review of the drug's safety.' In response to the backlash, an HHS spokesperson, Andrew Nixon, clarified that the agency 'has very limited discretion in deciding whether to approve a generic drug' and that 'by law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug.'

Advocates Emphasize Routine Process and Access

Despite the political controversy, proponents of abortion access highlighted the routine nature of generic drug approvals. Mini Timmaraju, President and CEO of Reproductive Freedom for All, stated, 'This is exactly how our system is supposed to work, and it has worked this way for decades.' She added that the approval is 'making headlines' only 'because anti-abortion politicians have turned health care into a political battlefield.' Evita Solutions itself states on its website that it 'believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care' and seeks 'to normalize abortion care' and 'make care accessible to all.'

Mifepristone is a critical component in nearly two-thirds of all abortions in the U.S. While the generic approval aims to expand access, the drug's availability remains restricted in many states due to existing bans or specific regulations, which are currently subject to ongoing legal challenges. Major medical organizations, including the American Medical Association, do not support these restrictions. The newly approved generic version will adhere to the existing Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program, which outlines specific safety protocols.