Drug maker Bristol-Myers Squibb Company (BMS) will pay $2.1 million – the largest fine allowed by law – for failing to inform the Federal Trade Commission of agreements reached with Apotex, Inc., regarding potential generic competition to its blockbuster drug Plavix. BMS’s conduct violated a 2003 FTC Order and the Medicare Modernization Act, which requires that certain drug company agreements be accurately reported to both the Commission and the U.S. Department of Justice (DOJ). The complaint alleges that BMS failed to disclose that, as part of a patent settlement in which Apotex agreed not to launch its generic version of Plavix for several years, 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.
The Commission’s complaint and Order announced today stem from a 2003 FTC Order settling charges that BMS had entered into agreements with potential generic drug manufacturers to delay their entry into the market, in exchange for payments from BMS. The 2003 Order required BMS to submit certain future drug settlement agreements to the FTC for review. The Medicare Modernization Act also requires that certain drug agreements be filed with both the FTC and the DOJ.
The Commission’s complaint and Order announced today stem from a 2003 FTC Order settling charges that BMS had entered into agreements with potential generic drug manufacturers to delay their entry into the market, in exchange for payments from BMS. The 2003 Order required BMS to submit certain future drug settlement agreements to the FTC for review. The Medicare Modernization Act also requires that certain drug agreements be filed with both the FTC and the DOJ.
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