PRESS RELEASE: National Pharma Congress Audioconference: Off Label Promotion - Compliance Issues and Practices

Thursday, October 2, 2003
  • 1:00 pm - 2:45 pm (Eastern)
  • 12:00 pm - 1:45 pm (Central)
  • 11:00 am - 12:45 pm (Mountain)
  • 10:00 am - 11:45 am (Pacific)
  • Sponsored by the Pharmaceutical Compliance Forum
Contact: Paul Tunnecliff
800-684-4549 phone

WASHINGTON DC USA -- HEALTHCARE UPDATE NEWS SERVICE(TM) -- SEPTEMBER 25, 2003: The Pharma Congress 2003, November 12 - 14, 2003, in Washington, DC,, announced today the scheduling of a national audioconference on Off Label Promotion: Compliance Issues and Practices on Thursday, October 2, 2003, from 1:00 pm - 2:45 pm (Eastern).


The Audioconference agenda is set forth in Eastern Daylight Time below:
  • 1:00 pm Welcoming Remarks and Introduction of Faculty
    Anthony L. Farino
  • 1:05 pm Government Perspective on Off Label Promotion
    Virginia Gibson
  • 1:20 pm Legal Issues Around Off Label Promotion, including Overlapping Issues between FDA and the False Claims Act
    Paul Kalb
  • 1:35 pm Off Label Promotion: Managing Regulatory Issues - Insights from an In house Lawyer
    Michael Misocky
  • 1:50 pm Off Label Promotion: Assessing and Managing Risk in the Context of an Effective Compliance Program
    Lori Queisser
  • 2:05 pm Questions and Answers
  • 2:45 pm Adjournment
  • Virginia Gibson, Esq., Assistant U.S. Attorney, Chief, Civil Division, Eastern District of Pennsylvania, Philadelphia, PA
  • Paul Kalb, JD, MD, Partner, Sidley Austin Brown & Wood, Washington, DC
  • Michael Misocky, R.Ph., JD, Director, PPD Regulatory Affairs, Advertising and Promotion, Abbott Laboratories, Abbott Park, IL
  • Lori Queisser, Chief Compliance Officer, Eli Lilly and Company, Indianapolis, IN
  • Anthony L. Farino, Partner, PricewaterhouseCoopers, Chicago, IL (Moderator)
  • To set forth the latest FDA policies on off-label promotion and how to comply
  • To assess the risks and benefits associated with off-label promotion
  • To analyze FDA regulations for disseminating Information during the approval process
  • To examine the limits of off-label speech and distribution of peer-reviewed articles
  • To balance First Amendment communication rights and FDA regulatory limitations
  • To understand potential liability under the False Claims Act and other statutes for off-label violations
  • To suggest approaches to sales force training regarding off-label communication

The Audioconference is sponsored by the Pharmaceutical Compliance Forum (PCF). PCF was founded in early-1999 by compliance professionals from the pharmaceutical industry, to promote effective corporate compliance programs. The organization is open to others in the industry, and has more than doubled its membership since it was founded. The members meet twice a year, for one to two days, focusing on open and informal sharing of compliance information, best practices and current developments in the field.


Only Pharma Audioconferences offer 11 types of continuing education credit that can be applied for and approved online. The Following Extensive CEs: AAPC; ACCME; ACHE; ACMPE; ACPE; AHIMA; ANCC; CISSP/SSCP; HIMSS, HCCB; MCLE; and NASBA.


Please save the date for the upcoming Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, November 12 - 14, 2003, in Washington, DC,, featuring the following keynote faculty:

  • Thomas Abrams, Director, Div of Drug Advertising, Marketing & Communications, US Food & Drug Administration, Rockville MD
  • Arthur L. Caplan, Ph.D., Director, Center for Bioethics, University of Pennsylvania, Fellow, American Association for the Advancement of Science, the Hastings Center, the College of Physicians of Philadelphia, and the New York Academy of Medicine, Philadelphia, PA
  • Dara Corrigan, Acting Principal Deputy Inspector General, Office of Inspector General, Department of health and Human Services, Washington, DC
  • Raymond Gilmartin, Chairman, President & CEO, Merck & Co., Inc., Whitehouse Station NJ
  • Senator Chuck Grassley (R/IA) (Invited), United States Senate, Chairman, Senate Finance Committee, Washington, DC
  • John Guthrie, Esq., Director, Medicaid Fraud Control Unit, Office of Attorney General, Columbus, OH
  • Peter Keisler, Esq. (Invited), Assistant Attorney General, Civil Division, United States Department of Justice, Washington, DC
  • Thomas B. Leary, Esq., Commissioner, US Federal Trade Commission, Washington DC
  • Michael Loucks, Esq., Chief of the Health Care Fraud Unit, Asst U.S. Attorney, US Attorney's Office for the District of Massachusetts, Boston, MA
  • Mark B. McClellan MD, Ph.D., Commissioner, US Food & Drug Administration, Rockville MD
  • Dennis Nally, Chairman & Sr Partner, PricewaterhouseCoopers, New York, NY
  • Janet Rehnquist, Esq., Partner, Venable LLP, Former Inspector General, Department of Health & Human Services, Washington, DC
  • Thomas Scully, Administrator, US Center for Medicare & Medicaid Services, Department of Health & Human Services, Washington DC
  • James Sheehan, Esq., Chief of the Civil Div, Asst U.S. Attorney, US Attorney's Office for the Eastern District of Pennsylvania, Philadelphia PA
  • The Honorable Tommy Thompson (Invited), Secretary, Department of Health and Human Services, Washington, DC
  • Janet Woodcock MD, Director, Center for Drug Evaluation & Research, US Food & Drug Administration, Rockville MD

The Audioconference Registration Fee is $345 per Site. No limit to number of attendees per site.

You can register online at:

Alternatively, you can download and print the Audioconference Registration Form from the website:

The completed form can be faxed to 760-418-8084 or sent to:
    PharmaAudioconference Office
    7790 Barberry Ave
    Yucca Valley CA USA 92284

Please email your request to: