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News and Press: Policy News

GAO Report Hammers FDA for Lax Oversight on Speedily Approved Drugs

Monday, January 25, 2016   (0 Comments)
Posted by: Kate Oesterle
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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the Government Accountability Office found a wealth of problems with the FDA's safety tracking, including incomplete, outdated and inaccurate data.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.


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