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Capitol Health Call
July 9, 2008

Clash Over Drug Approvals

JAMA. 2008;300(2):160. doi:10.1001/jama.300.2.160-a

Sen Chuck Grassley (R, Iowa) strongly defended himself from an accusation that his investigation into the Food and Drug Administration (FDA) drug approval process will delay getting effective medicines to market, thereby possibly resulting in thousands of preventable cancer deaths.

Mark Thornton, MD, PhD, MPH, a former medical officer in the FDA's Office of Oncology Products, said in a May 29 Wall Street Journal opinion piece that accelerated approval of new drugs based on research using surrogate end points has dramatically increased the pace of cancer clinical trials and that Grassley's investigation will impede this process. Grassley said that using surrogate end points is a valid way for the FDA to approve drugs, but that the agency failed to follow up on companies' promises to conduct postmarketing studies to determine if their products provide a clinical benefit.

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