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Akron Univ. School of Law

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Monday, January 12, 2009

FDA: Scientific Review Process Needs Reform

Last week, the Associated Press reported on a letter from scientists to the Obama transition team alerting them and complaining about mismanagement in a division of the Food and Drug Administration. The AP quotes from the letter, "The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead. The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx. The FDA declined to publicly respond to the letter, but said it is working to address the concerns. In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe. "Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid." A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official. . . .

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