FDA pushes to remove pregnancy drug, company pushes back

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.

About 10% of U.S. births come too early — before 37 weeks, raising the risk of serious health problems and even death in infants. Complicating the Makena debate is support from the leading U.S. obstetrics group to keep the decade-old drug available while more research is done.

“The need for an effective treatment for preterm birth is great,” the American College of Obstetricians and Gynecologists says. “Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition.”

But the FDA says existing data shows weekly injections of the drug don't help prevent a repeat preterm birth.

“Based on the evidence shown today, Makena is not shown to be effective,” said FDA’s drug chief, Dr. Patrizia Cavazzoni, in opening remarks Monday. “Its benefit and risk...