Waxman Asks FDA To Explain How Its Regulatory Priorities Aid Public Health
Executive Summary
Rep. Henry Waxman, D-Calif., is challenging FDA's priorities for writing rules and guidances, saying the agency appears to be more interested in loosening marketing restrictions and reducing product liability for drug and device makers than in protecting public health
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Off-label promotion on Waxman’s oversight agenda
Both drug companies and federal officials are slated to feel the heat as the House Energy and Commerce Committee examines off-label marketing of drugs during the 111 Congress. The item is on the committee's oversight agenda, which was proposed by Chairman Henry Waxman, D-Calif., and approved by the panel Feb. 10. The agenda includes a review of FDA, CMS and Justice Department efforts to investigate and prosecute manufacturers that violate federal standards, as well as a look at drug makers' activities. FDA's January issuance of final guidance on off-label reprints was panned by Waxman as "a long-coveted parting gift" to industry from the Bush Administration (1"The Pink Sheet," Feb. 2, 2009, p. 41). In his previous job as chairman of the Oversight and Government Reform Committee, Waxman had sought an explanation from FDA as to why the reprint policy was considered a priority (2"The Pink Sheet," Sept. 22, 2008, p. 28)
Off-label promotion on Waxman’s oversight agenda
Both drug companies and federal officials are slated to feel the heat as the House Energy and Commerce Committee examines off-label marketing of drugs during the 111 Congress. The item is on the committee's oversight agenda, which was proposed by Chairman Henry Waxman, D-Calif., and approved by the panel Feb. 10. The agenda includes a review of FDA, CMS and Justice Department efforts to investigate and prosecute manufacturers that violate federal standards, as well as a look at drug makers' activities. FDA's January issuance of final guidance on off-label reprints was panned by Waxman as "a long-coveted parting gift" to industry from the Bush Administration (1"The Pink Sheet," Feb. 2, 2009, p. 41). In his previous job as chairman of the Oversight and Government Reform Committee, Waxman had sought an explanation from FDA as to why the reprint policy was considered a priority (2"The Pink Sheet," Sept. 22, 2008, p. 28)
Reprinting FDAMA Approach: Waxman Urges FDA Review Of Off-Label Articles
Rep. Henry Waxman, D-Calif., is pushing FDA to require companies to submit reprints of journal articles on off-label use before providing them to practitioners, should the agency go forward with guidance permitting off-label promotion