Episode 61 – Drug Pricing: New OIG Guidance Reaffirms the Seven Elements of an Effective Compliance Program

In November, the Department of Health and Human Services’ Office of the Inspector General (OIG) issued new compliance program guidance that affirms OIG’s long-standing focus on the seven elements of an effective compliance program, first published in 2003. In this episode of Connected With Latham, partner Chris Schott and associate Danny Machado are joined by guest Lynn Robson of United Therapeutics. They discuss how the OIG’s compliance framework is relevant to drug manufacturers, how past enforcement actions can inform implementation of a compliance program, and how an effective compliance program can be beneficial in the enforcement context.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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In each episode of Connected With Latham, we discuss ideas, developments, and trends shaping the global economy.