GAO report hammers FDA for lax oversight on speedily approved drugs

These days, the FDA is approving more and more drugs under its expedited programs, meaning new treatments are getting to patients faster. The problem? The agency isn't doing such a good job of monitoring those meds after they hit the marketplace, according to a government report.

A new study from the Government Accountability Office found a wealth of problems with the FDA's safety tracking, including incomplete, outdated and inaccurate data. Beyond that, more than half of the required submissions from pharma companies between March 2008 and September 2013--related to 1,400 post-market studies--were either delayed or overdue.

The result? "The lack of reliable and accessible data restricts FDA's ability to conduct systematic oversight of post-market safety," the report says.

That's worrying some industry watchers, especially with less data on expedited therapies coming in on the front end. About a quarter of the 1,717 drug applications U.S. regulators approved between October 2006 and the end of 2014 used at least one of four programs designed to speed up FDA green lights, such as the agency's priority review tag.

Rep. Rosa DeLauro (D-CT)

"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," Rep. Rosa DeLauro (D-CT), who asked for the study, told Bloomberg. "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."

In a response seen by Bloomberg, the FDA said it's been working to improve its tracking and assessment abilities, stressing that treatments approved through expedited programs have to meet the same safety and effectiveness standards as other drugs.

Meanwhile, some pharma companies have benefitted from the FDA's backlog since it began mandating post-marketing safety studies in 2007. In July 2013, Johns Hopkins University researchers took a look at the FDA's follow-up on those studies, determining that in 2011, 85% hadn't been completed and more than half hadn't even begun.

That won't last, though, if the FDA takes the GAO's advice. The FDA "should develop plans to correct problems with its post-market safety data and ensure that these data can be easily used for oversight," it wrote, noting that the Department of Health and Human Services (HHS) agreed with its recommendations.

- read the report (PDF)
- see Bloomberg's take

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