GAO Report Says FDA Needs Better Oversight for Expedited Applications

A recent report by the United States Government Accountability Office to the Ranking Member, Subcommittee on Labor, Health and Human Services, Education and Related Agencies, Committee on Appropriations, House of Representatives reviews expedited drug approvals. GAO evaluated the number of new drugs approved through an expedited review process, and determined that the U.S. Food and Drug Administration (FDA) should improve its methods of postapproval oversight.

Fast track designation and breakthrough therapy designation are two of the FDA’s four expedited drug approval programs (the other two are accelerated approval and priority review). According to the GAO report, roughly 1,000 requests for these programs were submitted to the FDA’s Center for Drug Evaluation and Research (CDER) from October 1, 2006 to December 31, 2014. The FDA approved about two-thirds of the 770 requests for fast track designation since fiscal year 2007. The agency approved less than half of the 220 breakthrough therapy designation requests submitted since the program started in July 2012.

Based on FDA data, GAO found that approximately one quarter of the drug applications approved by CDER from October 1, 2006 to December 31, 2014 used at least one expedited program. According to the report, the most common area to use expedited programs was oncology.

GAO determined 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.” Based on internal federal control standards, the FDA should be recording important safety information in a timely manner that allows staff to act accordingly; this information should also be readily available for external reporting purposes. GAO found issues with completeness, timeliness, and accuracy of CDER data. As a result, the FDA has not be able to publish statutorily required reports on safety issues and postmarket studies in an appropriate time frame. The report states “Although FDA has taken some steps to address the problems with its data, the agency lacks plans that comprehensively outline its efforts and establish related goals and time frames. Additionally, FDA does not have plans to use these data to inform its oversight of its expedited programs, such as determining if drugs that used an expedited program were subsequently associated with tracked safety issues at rates or of types that differed from drugs that used FDA’s standard process.”

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