On the recordSeptember 20, 2005
the Scientific Advisory Committee system at the Food and Drug Administration is meant to provide the Agency with unbiased, independent, professional advice on the safety and efficacy of drugs, devices, biologics, food, and veterinary medicine. To protect the objectivity and the integrity of advisory committees, members have long been subject to a number of conflict of interest laws and regulations. Unfortunately, the Food and Drug Administration has routinely granted waivers to scientists with financial ties to the manufacture of the products under consideration or their competitors. These waivers can compromise the integrity of this important advisory process. Let me give one example. The February 2005 advisory panel considering whether painkillers, Celebrex, Bextra, and Vioxx, could safely be marketed to the public included 10 scientists who were granted conflict of interest waivers. Ten of the thirty-two members--that is 31 percent--consulted for or received research support from Pfizer, which makes Celebrex and Bextra; and Merck, which makes Vioxx; or Novartis, which is seeking approval for a similar painkiller. Had the votes of those 10 scientists been excluded, the panel would have favored withdrawing Bextra from the market and blocking the return of Vioxx.…
Source
govinfo.gov




