FDA Quietly Approves Another Generic Formulation of Abortion Drug Mifepristone

The FDA approved a second generic version of mifepristone on September 30, prompting immediate backlash from anti-abortion advocates and Republican lawmakers who questioned the timing of the decision amid promises of a comprehensive safety review.

The approval occurred just hours before most of the federal government entered a shutdown, according to Politico, underscoring the complex political environment surrounding reproductive health policy during the current administration.

In a letter dated September 30, the FDA informed Evita Solutions that its abbreviated new drug application met necessary requirements, determining the company's 200 mg mifepristone tablets to be "bioequivalent and therapeutically equivalent" to the reference listed drug, Mifeprex, manufactured by Danco Laboratories.

The approval represents a routine regulatory action that has nonetheless become politically charged. "The [FDA] has very limited discretion in deciding whether to approve a generic drug," Health and Human Services (HHS) spokesperson Andrew Nixon emphasized in a statement to Politico, noting that federal law mandates approval when manufacturers demonstrate their product is identical to the branded version.

A Protracted Approval Process

Evita Solutions filed its application on October 1, 2021, according to FDA documents cited by Politico and PBS. While the agency typically aims to approve abbreviated new drug applications within 10 months, the process has been ongoing for almost 4 years, although the protracted timeline is not without precedent in mifepristone approvals. GenBioPro, which manufactures the first generic version, initially applied in 2009, received a rejection in 2018, and finally gained approval in 2019 during the first Trump administration, Politico reported.

Political Fallout and Safety Concerns

The approval drew sharp criticism from Republican officials and anti-abortion groups. Senator Josh Hawley (R-Mo.) called the decision "shocking" in an X post, stating: "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. I have lost confidence in the leadership at FDA," according to Politico.

The controversy is rooted in recent commitments by Trump administration health officials to reevaluate mifepristone's safety profile. Health and Human Services Secretary Robert F Kennedy Jr and FDA Commissioner Marty Makary, MD, MPH, pledged to Republican attorneys general last month to conduct a full safety review, citing "recent studies raising concerns about the safety of mifepristone," The Hill reported.

RFK Jr stated on X that "the Biden administration removed mifepristone's in-person dispensing rule without studying the safety risks. We are filling that gap," he said, and echoed HHS Nixon's statement regarding the federal requirement that generic approval immediately follow a demonstration of parity with the brand-name drug, Reuters reported.

Clinical Context and Safety Data

Mifepristone was first approved by the FDA in 2000 and is used in combination with misoprostol to terminate pregnancies through 10 weeks of gestation. The drug blocks progesterone, the hormone necessary for maintaining the uterine lining during pregnancy, while misoprostol induces uterine contractions to complete the abortion process.

Medication abortions now account for approximately two-thirds of all abortions in the United States.

The FDA has maintained that mifepristone has proven "extremely safe" after decades of use by millions of women in the US and globally, with studies demonstrating that "serious adverse events are exceedingly rare," Reuters reported. Major medical societies, including the American Medical Association, do not support restrictions on the pill, PBS noted.

Nixon's statement indicated that HHS is currently studying reported adverse events to ensure the FDA's Risk Evaluation and Mitigation Strategy program "is sufficient to protect women from unstated risks," adding that "the FDA does not endorse any drug product and directs prescribers to follow all labeling," according to Politico.

Manufacturer and Market Impact

Evita Solutions, a privately held company, describes its mission on its website as working to "normalize abortion care" and make it "accessible to all." The company did not respond to media requests for comment, according to multiple outlets.

The approval is unlikely to significantly impact access to mifepristone, which remains restricted across large portions of the country as a result of state-level abortion bans or specific limitations on medication abortion use. These restrictions are subject to numerous ongoing lawsuits, PBS noted.

The Biden-era's 2021 elimination of the in-person dispensing requirement, permitted online prescribing and mail-order delivery—changes that abortion opponents continue to challenge.

In August, Costco Wholesale announced it would not stock mifepristone in its US pharmacy locations, citing low demand, according to Reuters.