Pharmaceutical Compliance Forum Clinical Trials Case Study Stephen

FDA • FDA as enforcer • Form 483 process and expectations • Timing •

State Law Enforcement • Highly unusual • Could be promoted in connection with personal

OIG/DOJ • Not classic false claims act situation, but can be motivated to find

University Process • Typical response for situations involving potential reputational harm • No clear

Congressional Action • Intense interest in research related topics • Process • Privilege •

SEC/FCPA • Growing interest in health care arena • Heavy government presence in the

Personal Injury Litigation • Variety of exposures beyond direct injury • Central importance of

Managing the Big Picture • Importance of understanding the full range of issues •

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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. 2

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. 4

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. 5

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. 7

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 • Access of rigorous oversight issues © Hogan & Hartson LLP. All rights reserved. 8

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. 9

For more information on Hogan & Hartson, please visit us at www. hhlaw. com 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 © Hogan & Hartson LLP. All rights reserved. 10

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