Update Nov Dec 2013 - (Page 36)

FDLI Activities A Look Back at Advertising and Promotion 2013: Trends and Priorities in Enforcement By Jennifer Kane, Manager, Tobacco/Drugs Portfolio; Editor D uring the September 16th Trends and Priorities in Enforcement session at FDLI's 2013 Advertising and Promotion Conference, the panel discussed lessons from recent settlements involving medical products in the advertising and promotion areas. Moderator Alexis Reisin Miller, Partner, Morgan Lewis & Bockius LLP, reflected on how recent settlements have demonstrated the importance that the review processes extend beyond compliance teams to include all aspects of a company, including legal, R&D, and even manufacturing, in an interdisciplinary effort. Miller also observed the interplay between FDA and the Office of the Inspector General (OIG) within the U.S. Department of Health and Human Services (HHS) in conducting enforcement actions. Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General, OIG, HHS, elaborated on this interplay during her remarks. The rest of the panel offered perspectives from the private bar and industry and included Joy Liu, Partner, Ropes & Gray LLP, Kirke D. Weaver, Managing Counsel, Office of General Counsel, Merck & Co., Inc., and Douglas B. Brown, Partner, Rumberger Kirk & Caldwell. Liu started the session with a review of the past year's settlements. She noted that within the past 12 months, the total dollar amounts for settlements were $1.7 billion compared with a total dollar amount of $5.6 billion in the previous year. She explained that though there were more settlements this year than last, most were for smaller dollar amounts ($50 million and less). Liu reviewed several of the significant cases settled after the December 2012 Caronia decision, including the Par case related to the alleged off-label promotion of the drug Megace ES that settled for $45 million in March 2013 with the extra requirement that the company agree to drop its First Amendment challenge to FDA's off-label promotion regulatory scheme. Another off-label promotion case involving Ista's eye drop Xibrom settled for $33.5 million in May 2013 with 36 Update November/December 2013 a relatively rare felony misbranding charge and a divestiture agreement that permitted Ista, recently purchased by Bausch & Lomb, to transfer all of its assets to Bausch & Lomb by November 2013. Liu also discussed the details of the July 2013 settlement involving Wyeth's Rapamune and the April 2013 complaint filed by the United States against Novartis, which alleges that the company paid kickbacks to doctors in exchange for prescribing its drugs. Riordan described the role of the OIG in coordinating with the Department of Justice to assess criminal and civil liability in recent settlements. She emphasized that the goal of the OIG is to prevent and detect fraud and abuse in healthcare programs and that while the OIG has the authority to exclude direct or indirect healthcare providers from participation in federal healthcare programs, it uses this remedy very judiciously. Riordan cited the divestiture agreement in the Ista case as an example of resolving the mandatory exclusion requirement in a way that would not be disruptive to beneficiaries. Riordian also explained that corporate integrity agreements (CIA) are an alternative to exclusion. Elements essential to a CIA are risk assessment, identification, monitoring and mitigation. In reviewing some recent cases, Riordan observed trends including a detailed description of the facts underlying a criminal plea in charging documents, such as in the Amgen settlement from December 2012. This added detail, she noted, supports the Department of Justice's efforts to share stories with the public and to discourage future bad conduct. Further, affirmative requirements in plea agreements with forward-looking obligations show concern for a company's behavior on an ongoing basis. She also noted that requirements for financial incentives should apply to both sales representatives and executives. For example, sales for off-label purposes should not be counted toward bonuses. Finally, Riordan recommended companies review CIA requirements that do not focus on www.fdli.org http://www.fdli.org

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Update Nov Dec 2013