FDA Approves Second Generic Version of Abortion Drug Mifepristone

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 approval came just hours before the government shutdown began this week. This latest action follows the FDA’s approval of mifepristone’s latest generic form, which has drawn criticism from conservatives and GOP opposition. Mifepristone is an abortion pill that is opposed by anti-abortion groups and many Republicans.

Approval Background and Timeline

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. While the agency typically makes its decision within 10 months, the approval can take longer while concerns and questions from officials are investigated. This decision highlights why this story matters: the FDA's approval of a second generic mifepristone reflects ongoing national debates over abortion access and regulatory processes for reproductive health medications, illustrating deep political and ideological divisions.

Political and 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. He further stated, “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, Hilary Perkins, over her alleged efforts to preserve the Biden administration’s mifepristone regulations. 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.

Support from Reproductive Rights Advocates

Reproductive rights advocates, meanwhile, celebrated the decision. Kirsten Moore, director of the EMAA Project, which supports removing barriers to abortion drugs, said in a statement: “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.”

Regulatory Procedures and HHS Stance

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.” Furthermore, Nixon added, “The FDA does not endorse any drug product and directs prescribers to follow all labeling.”

Summary of Stakeholder Positions