Pfizer Corporate Integrity Agreement 2018

“These agreements provide the definitive conclusion of important legal issues and help us focus more on what we do best – the discovery, development and delivery of innovative drugs to treat patients facing some of the world`s most debilitating diseases,” said Amy W. Schulman, Pfizer`s senior vice president and general counsel. “We regret some of the steps we have taken in the past, but we are proud of the steps we have taken to strengthen our internal controls and to lead new procedures to not only comply with government and federal laws, but also to meet the high standards that patients, physicians and the public expect from a world leader committed to healing and improving health. The integrity of the company is a top priority for Pfizer, and we will continue to take appropriate steps to further improve our compliance practices and strengthen public confidence in our business. “Today`s agreement demonstrates the FBI`s commitment to ensuring that patients receive health care and that the government pays, which is not affected by bribes,” said Harold H. Shaw, special agent in the batch, the FBI`s Boston division. “What Pfizer is accused of in this case – concealing charitable contributions to increasing corporate profits – undermines the fundamental trust that patients extend to the health care system and threatens the financial integrity of the Medicare program.” As part of the DOJ scheme, Pfizer entered into a corporate integrity agreement (CIA) with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). The CIA introduces some new measures and asks Pfizer to implement a compliance program for companies for a period of five years. On Thursday, May 24, 2018, Pfizer, Inc., agreed to pay $23.85 million to resolve allegations that it was using a foundation as a channel to pay for Medicare supplements that take pfizer drugs. The largest U.S. drug producer has also entered into a five-year enterprise integrity agreement with the U.S.

Department of Health and Human Services` Office of Inspector General. Pfizer has also entered into a Business Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). Among other things, the five-year CIA requires Pfizer to implement measures to ensure that agreements and interactions with third-party patient assistance programs comply with the law. In addition, the CIA requires audits through an independent monitoring organization, compliance certifications of executives and board members, and the implementation of a risk assessment and mitigation process. Pfizer`s existing compliance program includes a Chief Compliance Officer, a Corporate Compliance Committee, a Code of Conduct, comprehensive compliance training, policies and procedures for the appropriate promotion of Pfizer products, audits and controls, a compliance hotline, and extensive procedures to review and address potential issues related to non-compliance with pfizer guidelines or applicable legal requirements. According to the CIA, Pfizer will create an independent auditing body (IRO) that will help the company evaluate and evaluate its advertising and product business functions. In a statement, FBI Special Agent Harold Shaw said the alleged institution “violates the fundamental trust that extends patients to the health care system and threatens the financial integrity of the Medicare program.” Medicare patients are not allowed to participate in co-sponsor coupon programs that sponsor the companies themselves. “Our Corporate Integrity Agreement promotes independence between Pfizer and all patient assistance programs for which it can donate,” said Gregory E. Demske, Chief Inspector General of the U.S. Department of Health.

“In the absence of true independence, as we saw in this case, pharmaceutical companies can use patient assistance programs as tips for inappropriate payments that harm Medicare.