Drugs

FDA Failing in Expedited Drug Safety Oversight: GAO

A Government Accountability Office report examining FDA’s expedited drug approval process in terms of postmarket drug safety found that “FDA lacks fundamental resources and leadership in ensuring that drugs brought to market quickly are truly safe and effective,” says Rep. Rosa DeLauro (D-CT), who requested the report. “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.”

DeLauro says the agency acknowledges that drugs approved through expedited pathways can pose additional patient risks, and is not doing its due diligence in tracking drug safety issues and post-market studies that are critical in ensuring patient safety. “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,” DeLauro says. “This system is a severe safety risk for American consumers and I urge Dr. Robert Califf … to find a solution going forward once he is confirmed.”

GAO, DeLauro says, highlighted these issues with FDA drug safety oversight:
data on tracked safety issues are incomplete; postmarket study data were outdated and contained inaccuracies; tracked safety issues and postmarket study data were not readily accessible to FDA staff for analysis; lack of complete, accurate, and timely 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; and FDA lacks comprehensive plans to address the problems with its tracked safety issue and postmarket study data.

DeLauro says GAO noted that these are not new issues for the agency and were raised in reports dating back to 2006. She says the current findings likely underestimate the agency’s oversight problems since GAO only looked at two of the four expedited pathways.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome