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Better Tracking Needed, Report Says

The US Food and Drug Administration isn't tracking drugs that are on the market as well it should, according to a new report from the Government Accountability Office. This, the New York Times adds, raises questions about the agency's effectiveness.

"We are shortcutting an important part of the approval process in the hope that we get the information later, but now we're finding out that's not happening," Diana Zuckerman, president of the nonprofit consumer research group National Center for Health Research, tells the Times.

As the report, which was commissioned by Rep. Rosa DeLauro (D-Conn.), notes, the FDA's data on "post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult."

DeLauro asked for the review to gauge how well FDA uncovers issues with drugs when more and more are being approved through an expedited process. According to the GAO report, about a quarter of drug applications approved between October 1, 2006 and December 31, 2014 relied on at least one expedited program.

Many of the safety issues the agency did identify weren't being tracked in its computer database, the Times adds. As the GAO report notes, that's likely because of the time-consuming nature of entering such issues into the database.

In addition, Stat News notes that the report criticizes the agency for not posting quarterly reports that identify potential safety issues that it has uncovered, as it is supposed to.

FDA spokesperson Christopher Kelly says the agency is working to enter the information about post-market safety issues into its tracking system as well as to update its quarterly reports, Stat News adds.