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Back Senators’ Call to Fill Agency Slot; Investigate Concerns About Drug Safety

Wednesday, Dec. 22, 2004
Janell Mayo Duncan, CU, (202) 462-6262 x. 1115 or Rob Schneider (914) 378-2208
Travis Plunkett, CFA, (202) 387-6121
Ed Mierzwinski, USPIRG (202) 546-9707

In Wake of Vioxx, Consumer Groups Call for Strong, Independent Head of FDA; Support Investigation to Root Out Agency Problems
Back Senators’ call to fill agency slot; investigate concerns about drug safety

(Washington, D.C.) – In the wake of Vioxx and other safety problems related to prescription drugs, consumer groups today called for a strong, independent leader to direct the Food and Drug Administration, citing the fact the agency has been without a Senate-confirmed head for almost two-thirds of the current administration’s tenure.
Consumers Union, Consumer Federation of America and U.S Public Interest Research Group support a call by Sen. Bingaman (D-NM) today asking President Bush to act soon as possible to find a new leader of the FDA. Since Jan 2001, the agency has been run by a deputy or acting commissioner for all but 16 months.
“Consumers’ safety has suffered because there has not been a strong, independent leader of the agency to ensure the safety of prescription drugs,” said Janell Mayo Duncan, Legislative and Regulatory Counsel for Consumers Union. “We need a leader who will not be beholden to the interests of the pharmaceutical industry, and who puts drug safety and efficacy first.”
The groups also commend Sen. Charles E. Grassley (R-IA) for his leadership on this issue, and his request in June for a GAO investigation of the FDA Office of New Drug Approval and Office of Drug Safety to determine what systemic failures at FDA may have allowed certain prescription medicines to be approved and marketed despite potential serious safety risks. A hearing sponsored last month by Grassley’s Finance Committee included testimony from an FDA employee who said the agency as currently configured “is incapable of protecting America against another Vioxx.” The employee also named five more drugs that may have safety issues. Dr. Graham’s concerns have been confirmed by the results of a recently released 2002 survey conducted by the HHS Inspector General’s Office of FDA scientists indicating that almost one fifth of those surveyed said they had been pressured to approve a drug despite concerns about safety, effectiveness or quality.
“We need a thorough examination of what is wrong at the FDA and to put in place the appropriate measures to ensure the medicines on the market are safe and effective,” said Travis Plunkett, legislative director of CFA.”
The groups also support the creation of a vigorous and independent office of drug safety, and legislation that would require a mandatory, public clinical drug trial registry, so all drug trial safety would be accessible to physicians, researchers and consumers, and would make adverse safety information more difficult to hide.
To view the letters from the groups to Senators Bingaman and Grassley, click on Senator’s name.
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