In the Press
April 6, 2023

Analysis: Texas Abortion Pill Ruling Could Disrupt U.S. Drug Oversight (Reuters)

A federal judge in Texas could soon order the U.S. Food and Drug Administration to withdraw its approval of abortion pill mifepristone, a move that if allowed to stand could severely undermine the agency, health policy and legal experts said. "This case potentially has very significant consequences for both products that are already on the market, as well as new products," said Susan Lee, a Life Sciences and FDA partner. "The potential implications are so much broader than just what could happen to mifepristone." The possibility of its approvals being overruled would likely see the FDA become more cautious, Lee said to Reuters. The increased scrutiny would make it more difficult and time-consuming to get products approved, and possibly more expensive to develop. "There's going to be so much uncertainty about what would happen even if you were to achieve approval in the first place," said Lee. "There could be a downstream impact on pricing."