- Covis Pharma Group, the company that makes Makena, the only drug aimed at preventing preterm birth, announced on Tuesday that it was voluntarily pulling the medication off the market after advisers for the Food and Drug Administration concluded that the treatment did not help pregnant women at all.
- Makena had been cited by critics as a flawed example of the F.D.A.’s accelerated drug approval program because the agency’s original green light for sale was based on indications that the drug would be effective.
- The drug’s removal means that many women who have had an early birth will have no evidence-backed therapy to use during another pregnancy.
- Congressional efforts to alter the accelerated approval process culminated last year with minor changes, including the speeding up of follow-up studies to confirm whether a drug benefits patients.
- The F.D.A. should seek even more authority to improve the program, said Dr. Michael Carome, director of health research at Public Citizen, a consumer advocacy group.
Preterm Birth Drug Withdrawn After 12 Years
The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women.
By Christina Jewett
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