The Food and Drug Administration (FDA) approved a second generic version of the abortion drug mifepristone shortly before the federal government shut down and in the face of Republican condemnation of the medication. The company that makes mifepristone, Evita Solutions, applied to make another generic form of the drug in 2021, per the FDA’s Sept. 30 approval letter.
The agency typically makes its decision within 10 months, but the approval can take longer while concerns and questions from officials are investigated, as reported by Politico.
Download the SAN app today to stay up-to-date with Unbiased. Straight Facts™.
Point phone camera here
Conservative backlash
The FDA’s sign-off Tuesday of the new generic drug drew backlash from conservative groups and Republicans like Sen. Josh Hawley of Missouri.
“[The] 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,” Hawley wrote on X Thursday. “I have lost confidence in the leadership at [the] FDA.”
Hawley then warned he would not support FDA Commissioner Marty Makary’s nomination earlier this year if the agency failed to fire his top attorney over her alleged efforts to preserve the Biden administration’s mifepristone regulations. The lawyer in question, Hilary Perkins, had also led work on behalf of President Donald Trump’s Department of Justice’s 2020 support of the FDA’s requirement for the drug to be dispensed in person.
Anti-abortion groups were also quick to condemn the FDA’s approval.
“This is a stain on the Trump presidency and another sign that the deep state at the FDA must go,” said Kristan Hawkins, president of Students for Life of America and Students for Life Action, in a statement.
Reproductive rights groups commend move
Reproductive rights advocates, meanwhile, celebrated the decision.
“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 removing barriers to abortion drugs, said in a statement.
HHS responds
A spokesperson for the Department of Health and Human Services (HHS), Andrew Nixon, told The Washington Post that the FDA “has very limited discretion in deciding whether to approve a generic drug.”
He noted that under U.S. law, an application is required to be approved if it shows that the generic drug is identical to the brand-name version, adding that generic applications are not mandated to prove safety or effectiveness. He said that HHS is “conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”
“The FDA does not endorse any drug product and directs prescribers to follow all labeling,” Nixon added.
