Texas judge suspends FDA approval of abortion pill but gives HHS time to appeal

A federal judge in Texas has made the unprecedented decision to suspend the FDA’s approval of the abortion drug mifepristone but delayed installing the ruling to give the Biden administration time to appeal. 

The ruling siding with anti-abortion groups could have wide-reaching implications on medication-assisted abortions as mifepristone has exploded in use since the Supreme Court’s decision last year to strike down Roe v. Wade. 

However, a federal judge in Washington state issued another ruling that the FDA has to keep the drug on the shelves in 12 liberal states that called for expanding access to mifepristone. 

Federal Judge Matthew Kacsmaryk sided with the anti-abortion group Alliance for Hippocratic Medicine that the drug’s approval back in 2000 was rushed and that the agency has ignored petitions for judicial review. 

Kacsmaryk said the agency’s prior responses to petitions in 2016 and 2021 are inadequate as the agency slow-walked its response to a petition filed in 2002. 

The ruling does give the Department of Health and Human Services (HHS) time to file for emergency relief with the Fifth Circuit Court of Appeals. HHS has not announced its next course of action.

The FDA has said in court filings that the lawsuit was challenging a regulatory action long after its limitations period had expired.