Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Saturday, April 30, 2016

Public Citizen sues FDA for information on Advisory Panel participants




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Advisory committees furnish expert advice to federal government agencies. The FDA has approximately 50 advisory committees and panels that the agency advice on issues related to FDA-regulated products, such as whether the FDA should approve new medical products, request additional studies, or change a product’s labeling. The FDA posts on its website a roster of the members serving on each advisory committee, frequently accompanied by members’ curricula vitae (CV). The FDA frequently redacts the CVs, however, by blacking out information about the dates of degrees conferred, the names of professional colleagues and mentors, the amounts of grants received from private companies, and the names of unpublished articles. Many of the redactions were unaccompanied by any indication of why, but many were marked to indicate that the FDA believed that the redacted information fell under the Freedom of Information Act (FOIA) exemptions for confidential commercial information and for material the disclosure of which would cause an unwarranted invasion of privacy.

CVs are compiled by individuals specifically for the purpose of sharing information about the individuals’ background. Believing that the redactions based on the FDA’s determination that the information is “confidential” or “private” are thus unjustified under FOIA, and that the information redacted would help the public better to assess the backgrounds, qualifications, and potential biases of advisory committee members, Public Citizen submitted a FOIA request to the FDA in May 2014, in which Public Citizen requested “unredacted” copies of the CVs. As of April 2016, only three of the FDA’s six divisions had responded to the request, and all but one continued to redact information from the CVs.

Public Citizen sued the FDA under FOIA seeking an order compelling the FDA to respond fully to its request, without the redactions that appear to be wholly unjustified. In addition, because FOIA requires agencies to post frequently requested records online and the FDA’s website concedes that advisory committee member CVs are frequently requested, the suit seeks an order requiring the FDA to post unredacted copies of the CVs on its website going forward.

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