Corporate Integrity Agreement Pfizer

The CIA is implementing certain new measures and is asking Pfizer to continue maintaining an enterprise compliance program for a period of five years. „Our Corporate Integrity Agreement promotes independence between Pfizer and all patient assistance programs for which pfizer may be donated,“ said Gregory E. Demske, Chief Justice Advisor to the Inspector General of the U.S. Department of Health. „Without true independence, as we saw in this case, pharmaceutical companies can use patient assistance programs as inappropriate payment channels that harm Medicare.“ Under the deal, which is the largest ever reached by a drug manufacturer accused of marketing crime, Pfizer will pay $1.0 billion in civil payments related to a series of drugs and a $1.3 billion fine, which only affects Bextra. The final agreement also terminated previous off-label advertising practices related to certain payments to healthcare professionals involving Zyvox, Geodon and Lyrica, as well as nine other Pfizer medicines, as well as several measures related to Qui Tam. In addition, a subsidiary of Pfizer, Pharmacia & Upjohn Company, Inc., will plead guilty, in criminal proceedings, to violating U.S. Food, Drug and Cosmetics Act in connection with its previous promotion of Bextra. A portion of the civil payments are distributed to 49 states and DC, in accordance with Medicare`s public agreements. Amy W. Schulman, Pfizer`s senior vice president and general counsel, said, „These agreements result in the definitive conclusion of important legal cases and help focus on what we do best – the discovery, development and delivery of innovative medicines to treat patients who face some of the world`s weakest diseases.“ To enter into written agreements describing the extent of the work to be performed, the consultant fees to be paid and the compliance obligations for the consultants. Pfizer`s disclosure of payment information is subject to the confidentiality rules contained in clinical research agreements entered into prior to July 1, 2009 with a physician established in the United States.

Pfizer will not include these confidentiality clauses in new or renewed clinical research agreements entered into after the CIA`s effective date that require payment to a U.S.-based physician. Pfizer Inc. announced today that it has entered into a previously notified tentative agreement in principle with the U.S. Department of Justice (DOJ) to resolve an investigation into previous off-label advertising practices related to Bextra, which Pfizer voluntarily withdrew from the market in 2005. The final agreement also resolves other DOJ investigations into alleged off-label advertising practices involving Zyvox, Geodon and Lyrica, allegations regarding certain payments to healthcare professionals under the latter and nine other Pfizer drugs, and several related measures that Tam. . . .

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