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The Food and Drug Administration released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees, and the waivers that allow them to participate in specific meetings.
The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing. “When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” she said.
The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations. For highly technical subjects, the FDA often must choose from a small pool of potential advisers, and these people frequently have conflicts of interest, she said.
Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the process has been controversial. Federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site.
The draft guidance can be viewed at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf
The Food and Drug Administration released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees, and the waivers that allow them to participate in specific meetings.
The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing. “When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” she said.
The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations. For highly technical subjects, the FDA often must choose from a small pool of potential advisers, and these people frequently have conflicts of interest, she said.
Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the process has been controversial. Federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site.
The draft guidance can be viewed at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf
The Food and Drug Administration released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees, and the waivers that allow them to participate in specific meetings.
The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing. “When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict,” she said.
The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations. For highly technical subjects, the FDA often must choose from a small pool of potential advisers, and these people frequently have conflicts of interest, she said.
Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the process has been controversial. Federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site.
The draft guidance can be viewed at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM209201.pdf