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4 Int'l. In-House Counsel J. 1 (2010-2011)

handle is hein.journals/iihcj4 and id is 1 raw text is: International In-house Counsel Journal Vol. 4, No. 13, Autumn 2010, 1 The Impact of the Fraud and Abuse Laws on Pharmaceutical Advertising and Marketing Compliance: A Manufacturer's Perspective LESLIE GLADSTONE RESTAINO General Counsel, Validus Pharmaceuticals, USA DAVID RESTAINO Partner, Fox Rothschild LLP, USA The intersection between the health care fraud and abuse laws and pharmaceutical marketing practices in the U.S. raises interesting compliance issues for pharmaceutical manufacturers, particularly in light of the newly enacted federal health care reform legislation.1 The legislation includes significant anti-fraud measures as well as additional funding to fight fraud and abuse.2 Such increased scrutiny on pharmaceutical promotional practices requires manufacturers to pay close attention to and comply with the heath care laws, regulations and guidelines. Compliance is the only clear path to minimizing exposure to potential liability. 1. Anti-Kickback and False Claim Laws Under the federal health care program anti-kickback law3, it is illegal for any individual to offer to pay to induce a person to: 1. refer an individual to a person for any item or service for which payment may be made under a federal health care program'; 2. purchase or order such an item or service; or 3. arrange for or recommend purchasing or ordering such an item or service. Illegal payments include, directly or indirectly, kickbacks, bribes, rebates, cash or in kind remuneration. A person need not have actual knowledge of the anti-kickback statue or a specific intent to violate the anti-kickback statute. 1 The health care reform legislation consists of H.R. 3590, the Patient Protection and Affordable Care Act, and H.R. 4872, the Health Care and Education Reconciliation Act of 2010. 2 An additional $10 MM/year for 2011-2020 and an additional $200 MM/year for 2011-2016 (H.R. 3590, Sec. 6402 and Sec. 1304, respectively). 3 42 U.S.C. §1320a-7b. 4 A federal health care program is a health benefit program funded in whole or in part by the federal government and includes Medicare, Medicaid, and the VA health network, among others. ISSN 1754-0607 print/ISSN 1754-0607 online International In-house Counsel Journal