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New Report Identifies Gaps in FDA’s Drug Safety Oversight


Posted On behalf of Pfeifer Morgan & Stesiak on Jan 28, 2016 in Product Injury

FDA drug safety trackingThe Government Accountability Office has found multiple shortcomings in the system utilized by the Food and Drug Administration to track drug safety issues. A new report shows that the FDA is failing to effectively track drug issues, putting consumers at risk.

Drug Safety Tracking Database Missing Information

The FDA is tasked with tracking information regarding safety issues of medications on the market; the GAO report has found that the database used to keep this safety information is not up to par, housing incomplete records as well as inaccurate and outdated data.

The Department of Health and Human Services, overseer of the FDA, notes that the tracking system can be difficult to update. The FDA claims that administrative tracking was less of a priority compared to finding and assessing drug safety issues.

Follow-Up Studies Not Completed

The FDA has made great strides in their efficiency and speed of approving new drugs; 45 first generation drugs were released in 2015, the highest in 19 years. The agency often requests or requires follow-up studies from drug manufacturers after the release of a medication, which are essential for uncovering potential safety issues that can only be found once patients begin treatment with new medications.

The GAO report notes that of the 1,400 follow-up studies that the FDA asked for or required from 2008 to fall 2013, they were behind schedule in reviewing over half.

In the case of high-priority medications receiving expedited reviews to speed up their release, the FDA failed to properly track follow-up studies of these critical medications.

If you have experienced severe side effects or harm after taking a dangerous drug, you may be able to recover compensation for your injuries. Contact the product liability attorneys at Pfeifer, Morgan & Stesiak today for a free consultation. We are dedicated to pursuing justice for you.

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