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Bristol-Myers Squibb will pay a $2.1 million civil penalty—the largest allowed by law—for failing to inform the Federal Trade Commission (FTC) about its efforts to delay generic competition for its blockbuster blood-thinning drug Plavix. FTC says the fine stems from charges that BMS entered into agreements with Canadian drugmaker Apotex to delay the launch of a generic form of Plavix in the U.S. for several years, in exchange for payments from BMS. The complaint alleges that BMS “also orally stated, among other things, that it would not compete with Apotex during the first 180 days after Apotex did market its new generic drug.” FTC says the arrangement violated the reporting requirements of the Medicare Modernization Act of 2003, which mandates that unwritten understandings be described in writing and provided to the commission along with written agreements. “Firms submitting required filings with FTC have an absolute obligation to be forthright and complete,” says David P. Wales, acting director of FTC’s Bureau of Competition. “Filing firms must understand that they can’t reach oral understandings and simply omit them from their required filings.” In May 2007, BMS paid $1 million to settle criminal charges that it lied to the Department of Justice about its Plavix agreement with Apotex.
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