FDA pushes to remove pregnancy drug, company pushes back
The maker of a drug intended to reduce premature births is making a last-ditch effort to keep its medication on the market, even as health regulators insist that it doesn’t work
WASHINGTON (AP) — 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.
The hearing will resemble a courtroom trial, with FDA staff and company scientists presenting arguments for and against the drug Makena, followed by a vote Wednesday by a panel of outside experts. FDA leaders will ultimately make the final decision whether to order a withdrawal.
