The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn’t work.
A Food and Drug Administration meeting that opened Monday comes more than two years after the agency declared the drug ineffective and called for its removal. Drugmaker Covis Pharma has challenged the agency’s conclusion, setting up the highly unusual three-day public hearing.
The meeting underscores the limits of FDA’s authority and the long, onerous process to remove a drug on the rare occasion when a company won’t do so voluntarily at the agency’s request.
