Sen. Grassley Suggests 9/11-Like Commission On Drug Safety
This article was originally published in The Pink Sheet Daily
Executive Summary
Senate Finance Committee Chair Grassley says an independent commission of experts could provide recommendations to the executive branch and Congress. "It seems the time has come for a comprehensive review of drug safety," he says.
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Senate Finance Committee Chair Chuck Grassley (R-Iowa) suggested that a 9/11-like commission could provide recommendations to strengthen drug safety. "An independent commission of experts - along the lines of the 9/11 commission - could provide valuable recommendations for both the executive and legislative branches about changes that could enhance drug safety in the Unites States," Grassley said Dec. 17. "It seems the time has come for a comprehensive review of drug safety and of how federal government agencies oversee drug research and approve, license and regulate drugs." "By having scientific experts scrutinize what's happened and make well-informed recommendations, both the executive branch and Congress could make reforms and strengthen public confidence in prescription drugs and agencies that regulate those drugs," he added. Grassley has been active in FDA oversight during 2004. The Finance chair plans to introduce legislation to restructure FDA's drug safety review function (1 (Also see "Sen. Grassley Plans Legislation On Independence Of FDA Drug Safety Office" - Pink Sheet, 23 Nov, 2004.)). He also announced his intent to develop legislation to establish a clinical trial registry (2 (Also see "Senate Finance Considering Clinical Trials Registry Legislation" - Pink Sheet, 12 Dec, 2004.)). This year has "revealed serious problems involving children and antidepressants, painkillers like Vioxx , Bextra and Celebrex , the flu vaccine and the AIDS drug nevirapine," Grassley said. The same day, Pfizer announced that Celebrex demonstrated an increase in cardiovascular risk compared to placebo in a cancer trial (see 3 (Also see "Pfizer Celebrex Polyp Trial Shows Increase In Cardiovascular Events" - Pink Sheet, 17 Dec, 2004.)). "Right now we have a situation where the public is left wondering when the next shoe might drop when it comes to drug safety," Grassley noted. - Andrew Shelton |