Regulatory Focus™ > News Articles > FDA Lacks Reliable, Accessible Postmarket Data on Drugs, GAO Says

FDA Lacks Reliable, Accessible Postmarket Data on Drugs, GAO Says

Posted 14 January 2016 | By Zachary Brennan 

FDA Lacks Reliable, Accessible Postmarket Data on Drugs, GAO Says

The US Food and Drug Administration (FDA) does not have reliable, readily accessible data on safety issues and postmarket studies for drugs approved through expedited review pathways, the Government Accountability Office said in a report released Thursday.

The report dug into FDA’s Center for Drug Evaluation and Research (CDER) data, which received about 1,000 requests for fast track designation and breakthrough therapy designation (the other two expedited programs for reviewing new drugs are accelerated approval and priority review) and were most commonly for oncology drugs.

Of the more than 770 requests for fast track designation since FY 2007, FDA granted about two-thirds of these requests, and of the more than 220 requests for breakthrough therapy designation, since that pathway was established in July 2012, the agency denied more than half of these requests.

However, GAO found that evaluations of data conducted by CDER to track safety events revealed problems with the completeness, timeliness and accuracy of the data.

More specifically, GAO said CDER indicated that a vast number of potential safety issues were not being tracked in its database, known as the Document Archiving, Reporting and Regulatory Tracking System (DARRTS). Of those likely meeting criteria for tracked safety issues, CDER identified 144 issues that had not been formally tracked in DARRTS.

In addition, GAO found that over half of reviews of sponsors’ submissions associated with about 1,400 postmarket studies FDA requested or required from March 2008 to September 2013 were delayed or overdue.

“These problems, as well as problems with the way data are recorded that impair their accessibility, have prevented FDA from publishing statutorily required reports on certain potential safety issues and postmarket studies in a timely manner, and have restricted the agency’s ability to perform systematic oversight of postmarket drug safety,” GAO said.

In addition, the office found that FDA is not planning 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 approved under FDA’s standard pathway.

As of October 2015, FDA had not published required annual reports with data on postmarket studies for FY 2013 and 2014.

“FDA officials told us that they had decided to delay publication of the reports primarily due to CDER’s internal evaluation of the postmarket study data and subsequent efforts to address the data problems that were identified,” the report said.

Rep. Rosa DeLauro (D-CT), who commissioned the GAO report, said in a statement Thursday: "The GAO report confirms my greatest fear, that FDA lacks fundamental resources and leadership in ensuring that drugs brought quickly to market are truly safe and effective."

In its defense, FDA said it would like to clarify three points related to a draft version of the report.

First, the agency says that all drugs must meet the same statutory standards for safety and effectiveness, regardless of their expedited status. Second, drugs authorized through expedited pathways do not necessarily require different postmarket studies than other drugs approved through standard pathways, and finally, FDA says it’s working to address “challenges related to administrative tracking of its postmarket safety work.”

GAO Report


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