Enforcement officials to address pharmaceutical industry

DHHS OIG to Draft Model Compliance Guidance for the Pharmaceutical Industry

It should be no surprise that government enforcement officials are targeting the pharmaceutical industry. Moreover, the US Department of Health & Human Services (DHHS) Inspector General is considering a Federal Register Notice to implement a corporate compliance program specifically for the pharmaceutical industry.

On June 11th & 12th, 2001, Lew Morris, Assistant Inspector General for Legal Affairs of the DHHS Office of Inspector General, Michael Loucks, Health Care Fraud Chief for the US Attorney's Office in Boston, and Jim Sheehan, Civil Division Chief of the US Attorney's Office in Philadelphia, will join over 50 other leading faculty members in presentations and discussions related to fraud enforcement initiatives, compliance measures and regulatory developments, at the HCCA's 2nd Annual Pharmaceutical Regulatory and Compliance Summit at the Hyatt Regency Crystal City, Arlington, Virginia (minutes from DC's Reagan National Airport).

Other highlights of the Summit include a qui tam panel featuring relator Zachary Bentley from Venacare, a roundtable of pharmaceutical industry compliance officers, and a pre-conference symposium dedicated to privacy issues in the pharmaceutical industry.

The Summit is sponsored by the Health Care Compliance Association (HCCA), a nonprofit association representing over 2,000 of the nation's leading healthcare compliance officers. It's held in association with the Food & Drug Law Institute (FDLI), a nonprofit organization which provides a neutral forum for the critical examination of laws, regulations and policies applicable to drugs, medical devices and other healthcare technologies.

The Summit will feature representatives from the major governmental agencies that are charged with the regulation of pharmaceuticals and biotech, plus the nation's leading private-sector experts in the field, including:

• Anthony O. Boswell, Esq. Corporate Compliance Officer & General Counsel, Laidlaw, Inc.

• Charles M. Brock, Esq. Chief Ethics & Compliance Officer, Abbott Laboratories

• Richard J. Kenny, Jr., Esq. Asst General Counsel, AstraZeneca Pharmaceuticals, LP

• Keith Korenchuk, Esq. Partner, Davis Wright Tremaine & Chairperson for the Global Alliance for eCommerce Law

• Richard P. Kusserow President, Strategic Management Systems, Inc. & Former Inspector General, US DHHS

• Douglas M. Lankler, Esq. Corporate Counsel, Compliance, Pfizer Inc.

• Michael K. Loucks, Esq. Health Care Fraud Chief, US Attorney's Office, District of Massachusetts

• Roger W. Louis, Esq. Chief Compliance Officer, Genzyme Corp

• John Markus, Esq. Sr VP, Fresenius Medical Care North America

• David V. Marshall, Esq. Partner, Davis Wright Tremaine & Former Asst US Attorney

• Vickie McCormick, Esq. Integrity Officer, United Health Group

• Lewis Morris, Esq. Asst Inspector General for Legal Affairs, OIG, US DHHS

• Leslie A. Platt, Esq. Principal & Leader, Health Sciences Research Compliance Group, Ernst & Young, LLP

• Arjun Rajaratnam , Esq. Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline

• Mary E. Riordan, Esq. Sr Counsel, Office of Counsel to the Inspector General, US DHHS

• James Sheehan, Esq. Asst US Attorney, US Attorney's Office, Eastern Dist. of Pennsylvania

• Arvin P. Shroff, Ph.D. Arvin Shroff Associates & Former Deputy Director, Office of Enforcement, FDA

• Roy Snell, Chief Executive Officer, Health Care Compliance Association

• Professor Malcolm K. Sparrow, Ph.D. Lecturer in Public Policy, John F. Kennedy School of Govt, Harvard University

• Robert L. Steinmeier Corporate 21 CFR Part II Program Director, Abbott Laboratories

• David L. Stone General Manager Validation Services, Glemser Technologies Corp

• David Waterbury, Esq. Sr Counsel, Washington State Attorney General's Office, Medicare Fraud Control Unit

• Victoria Wesseler President, Ethics & Compliance Strategies

Over 50 national experts in regulation and compliance in the pharmaceutical field, will analyze and discuss regulatory trends and responsive compliance strategies, through a variety of plenary and 20 concurrent sessions.

The Summit will also feature a pre-conference symposium on Sunday, June 10, on the issue of privacy and data security in pharmaceutical manufacturing and distribution, with a special emphasis on HIPAA requirements and compliance strategies.

For sponsor, exhibitor and registration information, please go to the Summit website at www.pharmaregulation.com or contact Timothy Bower at 800-546-3750 phone, or by email at: timothy.bower@rmpinc.com.

Source: RMP Inc.

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