Fact Check: Was the FDA 'required' to approve the new generic abortion pill?

By Madison Evans - Posted at LiveAction:

Published October 17, 2025

At the end of September, the FDA approved another generic manufacturer's abortion pill — and in the outrage that followed, Health and Human Services Secretary Robert F. Kennedy, Jr. (RFK) claimed the FDA was required by law to approve it. He stated on X, “@US_FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.”

But is this claim accurate?

Key Takeaways:
  • When the FDA approved another company's generic abortion pill, HHS Secretary Robert F. Kennedy Jr. claimed the FDA was required by law to do so.
  • The FDA has failed to follow certain time-limit guidelines for drug approval, and they did so in this case as well, with the abortion drug under review for four years instead of the required 180-day limit.
  • There are avenues for the denial of a drug application, including for reasons of safety and efficacy.