FDA panel backs removal of unproven pregnancy drug
A panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn't work
WASHINGTON (AP) — Federal health advisers have ruled that a drug intended to prevent premature births doesn’t work, clearing the way U.S. regulators to follow through on a long-delayed effort to get it off the market.
The Food and Drug Administration’s advisory panel voted 14-1 that the injectable drug Makena should be removed from the market, despite appeals from the manufacturer to keep it available pending additional research.
The experts essentially agreed with a 2020 FDA decision that deemed the drug ineffective and called for its removal. The manufacturer, Covis Pharma, had challenged that decision, setting up this week’s rare public hearing.
“There’s no strong evidence that the drug is effective,” said Margaret Katz of the University of Southern California. “I would recommend the drug be withdrawn until we can get the data that really shows effectiveness.”
