GAO finds postmarket data lacking for expedited approvals

In a report released Thursday, the U.S. Government Accountability Office concluded that FDA "lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight." Rep. Rosa DeLauro (D-Conn.) had asked GAO to provide information on FDA's use of the agency's expedited approval pathway and how the agency monitors post-approval safety of expedited and non-expedited drugs.

The report covers drugs approved from Oct. 1, 2006, through Dec. 31, 2014, and focused on four expedited approval pathways: Fast Track, breakthrough therapy, Priority Review and accelerated approval. ...