WASHINGTON, DC (January 14, 2016) Congresswoman Rosa DeLauro (CT-03) today announced the findings of a report she commissioned by the U.S. Government Accountability Office that examined the U.S. Food and Drug Administration’s expedited drug approval process and review of postmarket drug safety.

“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,” said Congresswoman Rosa DeLauro (CT-03). “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.”

“FDA acknowledges that drugs approved through expedited pathways can pose additional risks for patients, yet this new GAO report clearly highlights that FDA is not doing its due diligence in tracking drug safety issues and post market studies that are critical in ensuring  patient safety,” continued DeLauro. “Today, if FDA wants to know if there are problems with a drug, there is no reliable or readily accessible data for them to conduct a comprehensive overview and make informed decisions. This system is a severe safety risk for American consumers and I urge Dr. Robert Califf, President Obama’s nominee for Commissioner of the FDA, to find a solution going forward once he is confirmed.”

Once FDA approves a drug for marketing, whether using an expedited program or not, the agency is required to monitor the drug’s safety and progress in completing postmarket studies. Currently, FDA has four expedited programs that facilitate and expedite the review of new drugs that have the potential to address an unmet medical need. Approximately one quarter of drugs that FDA approved for the U.S. market from October 1, 2006, to December 31, 2014, used at least one expedited pathway and some applications utilized more than one expedited pathway.

The GAO report highlighted the following issues with FDA’s oversight of drug safety:

  • FDA’s data on tracked safety issues were incomplete.
  • FDA’s postmarket study data were outdated and contained inaccuracies.
  • Tracked safety issue and postmarket study data were not readily accessible to FDA staff for analysis.
  • Lack of complete, timely, and accurate data has resulted in FDA not publishing required reports in a timely manner.
  • Lack of reliable and accessible data restricts FDA’s ability to conduct systematic oversight of postmarket safety.
  • FDA lacks comprehensive plans to address the problems with its tracked safety issue and postmarket study data.

 

The GAO’s findings also note that this is not a new issue for the agency – reports dating back to 2006 have found similar issues. The findings by GAO are likely an underestimate of FDA’s oversight issues given that GAO only evaluated 2 of FDA’s 4 expedited pathways.

Congresswoman DeLauro commissioned the report following the release of another GAO report in October 2015 that found that medical devices approved by the FDA are making it onto the market without rigorous study or oversight. The latest report from GAO provides a clear analysis for the FDA to develop and implement comprehensive improvements to its drug safety oversight process.

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