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This article was originally published in SRA
Executive Summary
Bristol-Myers Squibb to plead guilty to lying to US government about Plavix deal
Bristol-Myers Squibb to plead guilty to lying to US government about Plavix deal
Bristol-Myers Squibb (BMS) has agreed to plead guilty to lying to the US federal government about its agreement with a competitor regarding generic copies of its anticoagulant drug, Plavix (clopidogrel)1.
The US Department of Justice announced on 30 May 2007 that the company had agreed to a guilty plea and a $1 million criminal fine for entering into an agreement with Canada-based Apotex Inc not to compete for generic sales of Plavix. This agreement violated the terms of a separate consent decree to which BMS was subject, requiring the company to submit any proposed patent settlements to the Federal Trade Commission for review and approval.
Filing this information with the US District Court is the next procedural step in completing the agreement to resolve the federal antitrust investigation, a BMS spokeswoman told RAJ Pharma. The company hopes to enter its plea in court as soon as possible.
The Department of Justice launched its investigation of the agreement between BMS, its marketing partner, Sanofi-Aventis, and Apotex in July 20062. BMS and Sanofi-Aventis are accused of asking Apotex to delay the launch of its generic version of Plavix. In exchange, BMS is said to have agreed not to launch its own generic Plavix to compete with the Canada-based company's product.
References
1. Department of Justice press release, 30 May 2007, www.usdoj.gov/atr/public/press_releases/2007/223634.htm
2. The Regulatory Affairs Journal - Pharma, 2006, 17(8), 557