Off-Label Promotion Probes May Focus On Companies’ R&D Plans
While federal prosecutors investigating allegations of "off-label" drug promotions focus on sales and marketing material, they also scrutinize a company's R&D plans
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FDA has unveiled the much-anticipated labeling change for GlaxoSmithKline's type 2 diabetes therapy Avandia, but is deeming the information about rosiglitzone's cardiovascular risk "inconclusive" and is asking the sponsor to undertake a long-term outcomes study to address outstanding safety questions
Issues surrounding off-label dissemination may be clarified through regulations required by the FDA Amendments Act of 2007
Bristol-Myers Squibb enters into a corporate integrity agreement with the Office of Inspector General as part of a settlement to resolve a variety of civil allegations Sept. 28. Bringing to end a lengthy investigation into Bristol's pricing, sales and marketing practices, the firm and Department of Justice finalize a settlement of $499 million; as anticipated, Bristol will pay over $317 million to the federal government and over $181 million to Medicaid-participating states with previously reserved funds (1"The Pink Sheet" Jan. 1, 2007, p. 13). DoJ alleges that Bristol: illegally paid health care providers to encourage them to purchase Bristol's products; knowingly promoted "off-label" uses of the atypical antipsychotic Abilify (aripiprazole); helped set fraudulent inflated prices; and knowingly misreported its best price for the antidepressant Serzone (nefazodone)...