Problems continue with FDA postmarketing review processes

Pharmaceutical CommercePharmaceutical Commerce - January/February 2016

Industry is doing better at filing studies, but the agency is falling behind reviews, says GAO

One week, FDA gets to brag on its rising number of drug approvals, and its success in using fast-track and other protocols to expedite review and approval of new drugs; the next week, it gets hammered by the Government Accountability Office (GAO) for its inability to manage the delivery of post-marketing studies, which are frequently a condition of granting the expedited approval.

The just-released report, FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement, concludes, among other things, 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.” GAO looked at two of the four mechanisms FDA has for expediting approvals (the fast track designation and the breakthrough therapy designation) for applications reviewed between October 2006 and through the end of 2014. Various data and studies are supposed to be filed in the FDA Document Archiving, Reporting, and Regulatory Tracking System (DARRTS), and then to be reviewed by FDA personnel. GAO (and FDA’s own internal reviews) found that of some 1,400 postmarket studies that have been provided to FDA, only half have received a formal review and analysis. There are also problems with properly reporting safety issues; and FDA’s inability to monitor the overall progress of postmarket reviews resulting in its inability to file required quarterly reports to Congress.

Unlike past years (2006, 2009 and at other times), when reviews of FDA showed that drug sponsors were not meeting deadlines for filing postmarket studies, this GAO report points to FDA’s problems in conducting internal reviews of the filed information. The DARRTS system is unwieldy (and is supposed to be replaced in the next few years); and there are problems with the accuracy of filed data. For its part, FDA says that it uses other reporting mechanisms besides DARRTS, but concedes, in multiple instances, that it lacks the resources to perform the timely reviews. Not all expedited approvals require postmarket studies, and some of these studies address relatively minor issues besides overall drug safety. Even so, FDA concurred with GAO’s overall findings, and said that improvements are under way.

The GAO report was requested by Rep. Rosa DeLauro (D-CT), ranking member of an Appropriations Committee subcommittee, who noted that since only two four expedited review processes were studied by GAO, the report might be an underestimate of FDA’s oversight issues. “If FDA is shifting more of the safety risk to consumers by allowing fewer and shorter clinical trials on expedited drugs, adequate tracking of drug safety issues and review of post market studies are absolutely vital,” she said in a statement.

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