FDA panel backs removal of unproven pregnancy drug

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) — A panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn’t work. Wednesday’s recommendation is non-binding, but it clears the way for the Food and Drug Administration to remove the drug from the market. The FDA deemed the drug ineffective and called for its removal in 2020. But manufacturer Covis Pharma has challenged that decision, setting up this week’s public hearing to discuss the drug. The FDA granted Makena accelerated approval in 2011 based on a small study in which it appeared to reduce premature births. But a follow-up study failed to confirm any benefit for women or babies.