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© Hogan & Hartson LLP. All rights reserved. Pharmaceutical Compliance Forum Clinical Trials Case Study Stephen J. Immelt Thursday, November 8, 2007
© Hogan & Hartson LLP. All rights reserved. 2 FDA FDA as enforcer Form 483 process and expectations Timing False statement potential Warning letter potential Living with the record Broad regulatory powers beyond the particular trial
© Hogan & Hartson LLP. All rights reserved. 3 State Law Enforcement Highly unusual Could be promoted in connection with personal injury actions Subject to local considerations
© Hogan & Hartson LLP. All rights reserved. 4 OIG/DOJ Not classic false claims act situation, but can be motivated to find a hook Aggressive theories could focus on the approval process Numerous points of exposure for false statements Involvement of federal funding at investigator level Subject injury a material, aggravating factor
© Hogan & Hartson LLP. All rights reserved. 5 University Process Typical response for situations involving potential reputational harm No clear process or guidelines Participation or not? Risks Benefits? IRB issues
© Hogan & Hartson LLP. All rights reserved. 6 Congressional Action Intense interest in research related topics Process Privilege Working with staff Dealing with hearings
© Hogan & Hartson LLP. All rights reserved. 7 SEC/FCPA Growing interest in health care arena Heavy government presence in the delivery of health care in many countries creates broad potential exposure Importance of financial controls and oversight Heightened ambivalence about clinical research
© Hogan & Hartson LLP. All rights reserved. 8 Personal Injury Litigation Variety of exposures beyond direct injury Central importance of the study documents – not only consent but also investigator agreement and protocol Importance of rigorous oversight Access issues
© Hogan & Hartson LLP. All rights reserved. 9 Managing the Big Picture Importance of understanding the full range of issues Importance of regulatory process Importance of speed Impact of press scrutiny Dealing with what went wrong
© Hogan & Hartson LLP. All rights reserved. 10 Baltimore Beijing Berlin Boulder Brussels Caracas Colorado Springs Denver Geneva Hong Kong London Los Angeles Miami Moscow Munich New York Northern Virginia Paris Shanghai Tokyo Warsaw Washington, DC For more information on Hogan & Hartson, please visit us at
© Hogan & Hartson LLP. All rights reserved. How We Get to Where We Want to Be – Managing GCP Inspections Pre-Approval Robert F. Church, Partner Hogan &
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