• Leading federal prosecutors explain off-label threats facing pharma
• Senior pharma counsel outline proactive compliance measures http://www.biomedical-market-news.com/

ALEXANDRIA VA USA -- HEALTHCARE UPDATE NEWS SERVICE^TM - NOVEMBER 10, 2003: "Off-label promotion is an area that will get increasing scrutiny from prosecutors around the country," warns Michael Loucks, Chief of the Health Care Fraud Unit, Asst US Attorney, in Boston. Loucks and other federal prosecutors explain how much of this attention is being driven by expanded use of the False Claims Act under new fraud theories, in the latest issue of Rx Compliance Report, Oct. 31, 2003.

While traditional FDA concerns in this area continue to loom large, the scope of investigations is expanding considerably, says Virginia Gibson, Asst US Attorney, Chief, Civil Div, Eastern District of Pennsylvania. "The issue that really concerns us today is more the promotion and marketing of pharmaceutical products," she asserts.

The October Special Issue on Off-Label Promotion includes detailed analysis by Loucks, Gibson, and others into what the government is now looking for in its investigations in this area.

• Leading defense counsel Paul Kalb outlines emerging fraud theories for off-label promotion
• In-house counsel at Abbott offers detailed advice on managing risk associated with off-label promotion
• Advertising expert John Kamp explains how allegations in a California plaintiff's case would make journal article company sponsored commercial speech

• Senior Wyeth counsel outlines keys to effective internal policy development
• Veteran outside counsel Leigh-Ann Patterson and Dina Michels explain what every in-house counsel needs to know about HIPAA's restrictions on promotional activities
• U.S. Sentencing Commission proposes tighter compliance guidelines

HHS Acting Principal Deputy Inspector General Dara Corrigan, FDA Commissioner Mark McClellan, Centers for Medicare and Medicaid Services Administrator Tom Scully, and a host of others, update industry leaders at the Fourth Annual Pharmaceutical Regulatory Compliance Congress and Best Practices Forum, Nov. 12-14, 2003, in Washington DC, www.PharmaCongress.com.

ABOUT RX COMPLIANCE REPORT:

Rx Compliance Report is the only news source devoted exclusively to the government's expanding crackdown on pharmaceutical sales and marketing. The HHS OIG recently reported "a ton" of open investigations into pharmaceutical sales and marketing that it says will take years to resolve. Every month, Rx Compliance Report reports on these investigations and offers practical firsthand advice from industry executives, government officials and outside experts on how to respond to this menacing trend, through effective compliance programs, sales force training, monitoring and auditing.

Rx Compliance Report focuses on the non-FDA entities now leading these fraud and abuse investigations. These include the US Dept of Justice, HHS Office of Inspector General, state Attorneys General, state Medicaid Fraud Control Units, and the Federal Trade Commission.

Rx Compliance Report's subscribers include legal, regulatory, and compliance executives from nearly every major pharmaceutical company, as well as emerging pharma and biotech companies, national law firms, ad agencies and industry consultants.

Each month, it provides up-to-date information and practical advice in these key areas:

• Compliance program development
• Sales force training
• Monitoring and auditing
• Drug pricing (Best price, AWP, Medicaid drug rebates)
• False Claims Act strategic defenses
• Sarbanes-Oxley
• HIPAA
• Off-label promotion
• Sample accountability/PDMA
• Continuing medical education
• Direct-to-consumer advertising
• Internet promotion