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Forest Celexa, Lexapro Off-Label Promotion, Kickbacks Alleged In DoJ Suit

Executive Summary

Forest waged an extensive campaign to get doctors to prescribe its antidepressants Lexapro and Celexa for off-label use in children, while concealing data that Celexa was no more effective than placebo in pediatric patients, and carried an increased risk of suicide attempts, the Department of Justice claims in a 1complaint filed against the company

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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)

Bextra Settlement Coming Soon: Industry Should Brace For Impact

Pfizer's pending $2.3 billion settlement of an investigation into the promotion of Bextra (valdecoxib) sets a new record for a pharma company's liability in a health care fraud case, and begs the question of how big the political liability facing the industry will be as the latest wave of marketing cases reaches settlement

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