Government Accountability Office finds flaws in FDA's methods

According to a new 42-page report published by investigators from the Government Accountability Office (GAO), there are significant flaws in the way the FDA tracks drugs after they come to market.

One of the primary issues the GAO found was that drug applications frequently use expedited programs such as fast track designation and breakthrough therapy designation.

From Oct. 1, 2006, to Dec. 31, 2014, approximately one quarter of all drug applications approved by the FDA’s Center for Drug Evaluation and Research (CDER) used at least one expedited program, according to the GAO. Oncology was the product area that most commonly used the expedited programs.

As the New York Times noted in its own coverage of the report, there are both critics and supporters of these expedited programs. The GAO concluded that when programs are used to reduce the time it takes for a drug to be approved, it “further increases the importance of the agency’s postmarket safety oversight,” and the FDA has fallen short with its postmarket reporting.

“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,” the GAO wrote in its report. “Tracked safety issues are potential safety issues that FDA determines are significant and that it tracks using an internal database. Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER of data in its database revealed problems with the completeness, timeliness, and accuracy of the data.”

Rep. Rosa DeLauro (D-Conn.), of the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, commissioned the GAO report. HHS was given time to review and comment on the GAO’s findings, and the full HHS response is included in the report.

The report can be read in full on the GAO’s website.