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FDA nominee still must answer tough questions about drug safety plans

Thursday, March 17, 2005

FDA nominee still must answer tough questions about drug safety plans

(Washington, D.C.) – The nominee to head the nation’s Food and Drug Administration should commit to a truly independent Office of Drug Safety, making drug study results public and full funding to support agency efforts to aggressively monitor drug safety, Consumers Union said today.
The Senate Health committee today questioned nominee Lester Crawford on his plans to improve prescription drug safety if he is approved as FDA commissioner. Crawford, who has served as deputy or acting FDA commissioner for nearly three of the past four years, was asked by several committee members to submit written answers to their questions about drug safety issues.
“Dr. Crawford should be doing all he can to assure the American public that he will take the meaningful steps needed to ensure drug safety and improve transparency in the agency,” said Jeannine Kenney, senior policy analyst with Consumers Union, the nonprofit publisher of Consumer Reports.
“If Dr. Crawford is truly committed to protecting the American public, he will vigorously support, not dodge, efforts to ensure the FDA has the tools and the authority to get the job done,” Kenney said. “The Senate should pursue these answers.”
Consumers Union, Consumer Federation of America and U.S. PIRG are supporting legislation (the Fair Access to Clinical Trials Act co-sponsored by Sens. Grassley and Dodd) that would require drug companies to make results of all their clinical drug trials public so doctors, researchers and consumers have access to information about potentially harmful side effects.
The groups also support an Independent Office of Drug Safety to aggressively monitor drug safety and act swiftly when issues are raised. Right now, drug safety reviewers have no independent authority, and are overseen by the same FDA office that is responsible for new drug approval. The groups say this is an inherent conflict of interest.

Contact: Susan Herold, 202-462-6262