Report Reveals Gaps in FDA Oversight of Drug Safety

Government Watchdog Reports Gaps in FDA Drug Safety Oversight

Posted on behalf of Jeff Pitman on February 1, 2016 in Dangerous Drugs
Updated on February 24, 2022

A new report released by the Government Accountability Office (GAO) reveals disturbing gaps in the the Food and Drug Administrations (FDA) tracking of drug safety issues, putting patients across the nation at risk.

The January 2016 report details numerous flaws in the system used by the FDA to track safety issues that have been identified in medications already on the market. The database was found to be plagued by incomplete records, as well as inaccurate and outdated information.

Poor Follow-up on Drug Safety Issues

The FDA has made great strides in approving new drugs quickly and efficiently. In 2015, the agency approved 45 first generation medications, the highest total in 19 years. More than half of the new medications approved last year were fast-tracked to get them approved for market sooner.

The FDA typically requests or requires follow-up studies after a drugs release. However, the GAO report discovered that the FDA is behind in reviewing those studies.

Of the 1,400 studies requested or required by the FDA between 2008 and late 2013, more than half did not receive timely review.

Follow-up studies are critical in helping experts identify potential safety issues that may not emerge until patients begin taking a medication. When these studies are not reviewed, safety issues go unnoticed, putting patients at greater safety risk.

The FDA also revealed that a majority of potential drug safety issues that have been identified have not been input into the tracking system.

The agency placed the blame for the poor tracking on the heavy workload of its review staff who it says prioritizes identifying safety issues over administrative tracking.

If you have been harmed by a medication prescribed to you, you may be entitled to compensation. The drug injury attorneys at Pitman, Kalkhoff, Sicula & Dentice, S.C. will work diligently to recover funds on your behalf.

Call 877-877-2228 or complete our online form today to request a free consultation.

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