Off-label promotion on Waxman’s oversight agenda
Executive Summary
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)