After months of anticipation, the manufacturer of a controversial drug for premature births has agreed to withdraw its treatment, capping an unusual battle with the U.S. Food and Drug Administration over its authority to have medicines removed from the market.
The drug in question, called Makena, was approved more than a decade ago and quickly generated a firestorm over its cost. More recently, though, its effectiveness was thrown into doubt after results of a required follow-up clinical trial failed to verify a benefit. But the company that sells the treatment, Covis Pharma, fought a request by the FDA to withdraw the drug.
The refusal prompted a hearing last October that was seen as a test of the ability of the FDA to have a drug withdrawn when clinical evidence indicates it is not effective for a use that was initially approved. Another key issue that was highlighted by the hearing was the extent to which the FDA is able to enforce the terms of a controversial agency program to accelerate approval of certain drugs.
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