A Food and Drug Administration advisory panel recommended that a controversial treatment for preventing premature births should be withdrawn from the market after reviewing a clinical trial that indicated the medicine, called Makena, is not effective.
The agency is not required to follow the recommendations of its panels, but the 9-to-7 vote calls into question the future of a medication that has been the standard of care across the U.S. since it was approved eight years ago. At the time, the FDA required a followup study as a condition of endorsing the medicine under its accelerated approval process.
As noted previously, the findings in the latest study have catapulted Makena back into the headlines nearly a decade after it became one of the earliest examples of price gouging by a drug maker, an episode that also saw the FDA become ensnared in controversy over the cost of a medicine. The follow-up study, which is called Prolong, was published last week in the American Journal of Perinatology.
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