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Pharmaceuticals / Postmarket Safety

FDA Lacks Reliable Postmarket Data for Expedited Drugs, GAO Report Finds

Jan. 22, 2016

While the FDA is speeding many drugs to the market, the agency lacks reliable, accessible data needed to conduct systematic oversight and meet postmarket safety reporting responsibilities, says a GAO report released last week.

The government watchdog conducted the study to provide information about the FDA’s expedited programs and its postmarket monitoring of expedited and nonexpedited drugs.

CDER’s internal evaluation of data uncovered problems with its completeness, timeliness and accuracy of postmarketing data, despite internal controls.

For example, about one-fourth of the drug applications CDER approved from Oct. 1, 2006, to Dec. 31, 2014, used at least one expedited pathway. For the 444 approved drug applications that used one or more of those expedited programs, CDER found 144 potential safety issues had not been formally tracked using the Document Archiving, Reporting, and Regulatory Tracking System database.

Of those 444 applications, 408 used the priority review designation, and 93 used the fast track designation. Fifty applications were approved through accelerated approval pathway, while 17 used breakthrough therapy designations.

FDA staff prioritized identifying and addressing potential safety issues over administrative tracking, according to the report commissioned by Rep. Rosa DeLauro (D-Conn.), the ranking member of the Subcommittee on Labor, Health and Human Services, Education and Related Agencies.

The report also disclosed inaccuracies in much of the postmarket study data. For example, more than one-third of the roughly 1,400 studies from March 2008 to September 2013 had their progress report updated or corrected during CDER’s evaluation.

Moreover, staff cannot readily access tracked safety issues and postmarket study data for analysis, the report says. The DARRTS database “cannot be queried to determine characteristics of tracked safety issues, such as the therapeutic area of the drug associated with a safety issue, the population affected, or what regulatory actions, if any, FDA took in response to a tracked safety issue,” it reads. According to the report, such information must be manually reviewed.

The GAO recommends that the agency develop specific plans with goals and time frames to ensure the correctness of the database on tracked safety issues and postmarket studies. It also calls on the FDA to work with stakeholders to identify additional improvements.

Although the agency has taken steps to address these issues, “it lacks comprehensive plans for doing so,” the report says.

Read the report here: www.fdanews.com/01-14-16-GAOPostmarketDataReport.pdf.