The agency’s decision has drawn conservative criticism.
The FDA signed off on a second generic option for the abortion pill mifepristone on Tuesday, hours before most of the federal government shut down and despite Republican opposition to the drug.
Evita Solutions applied to make another generic mifepristone on Oct. 1, 2021, according to the FDA’s Sept. 30 approval letter. The agency typically aims to approve abbreviated new drug applications — those submitted for generics — within 10 months, but the process can take longer depending on how many questions or concerns reviewers have.
There’s also precedent for the FDA to take time on mifepristone decisions — GenBioPro, the first generic maker for the drug, first applied for approval in 2009 and fielded a rejection in 2018 before getting approval the following year during the first Trump administration.
Tuesday’s approval prompted backlash from conservatives like Sen. Josh Hawley (R-Mo.), who called it “shocking” in an X post Thursday when the decision surfaced.
“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,” he said. “I have lost confidence in the leadership at FDA.”
Hawley threatened to withhold his support for FDA Commissioner Marty Makary’s nomination earlier this year if he didn’t fire his top lawyer over her work defending the Biden administration’s mifepristone regulations. Hilary Perkins had also worked on the Trump DOJ’s 2020 defense of the FDA’s pandemic-era enforcement of the drug’s in-person dispensing requirement as a career attorney.
Students for Life of America and Students for Life Action President Kristan Hawkins called the approval “a true failure.”
“This is a stain on the Trump Presidency and another sign that the deep state at the FDA must go,” she said in a statement.
In a statement, HHS spokesperson Andrew Nixon said the agency “has very limited discretion in deciding whether to approve a generic drug,” and that by law the department must approve a generic drug application if the manufacturer demonstrates it’s identical to the branded product.
HHS is studying reported adverse events from the drug to ensure the FDA’s risk-mitigation program for mifepristone “is sufficient to protect women from unstated risks,” he said. “The FDA does not endorse any drug product and directs prescribers to follow all labeling.”
The drug was first approved under the brand name Mifeprex in 2000. Mifepristone is taken in combination with misoprostol through 10 weeks of gestation to end a pregnancy, and medication abortions account for about two-thirds of the procedures in the U.S.
Evita Solutions didn’t respond to a request for comment. The company aims to “normalize abortion care” and make it “accessible to all,” according to its website.
Abortion advocates applauded the approval.
“Despite ongoing attempts by anti-abortion activists to spread fear and misinformation, the FDA continues to do its job of following the science, ensuring safety, and expanding access to essential health care,” Kirsten Moore, director of the EMAA Project, which supports expanding medication abortion access, said in a statement.