In the Press
March 16, 2023

Abortion Pill Ruling Looms Over FDA's Drug Approval Process (Axios)

A federal judge in Texas is poised to rule "as soon as possible" on whether to suspend the FDA's approval of a widely-used abortion pill and potentially reverse the agency's authority on drug regulation for the first time. Legal experts fear that if District Judge Matthew Kacsmaryk orders the FDA to temporarily withdraw its approval of mifepristone, others will challenge FDA-approved treatments that they disagree with. "There’s no precedent or basis for the judge to simply 'undo' an approval from the bench," said Susan Lee, a Life Sciences partner who specializes in the FDA's regulation of drugs and biologics, to Axios. "A judge’s appropriate role can be to consider whether the FDA appropriately exercised its legal authorities and followed its own regulations when making decisions, but it would be concerning if Judge Kacsmaryk were to come to a decision suggesting that his ruling can supersede the authorities that have been granted to FDA by law."