In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. Food and Drug Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market.
For the first time, the FDA has explained in copious detail why agency officials believe the medication, which is called Makena, should be removed. The briefing documents, which were released in advance of the three-day session, also pushed back considerably against arguments made by Covis Pharma, the manufacturer, for continuing to make its drug available to American women.
The hearing, which starts on Oct. 17, will be closely watched for different reasons. For one, it represents a rare instance in which such a session has been called to review FDA efforts to withdraw a medicine, or at least revoke an approved use. This will also put on display 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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