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Current Trends in Enforcement

Current Trends in Enforcement. Richard Kingham Covington & Burling June 8, 2004. Current Trends Affecting International Companies. US Foreign Corrupt Practices Act Foreign regulation of financial relationships with the medical profession International safety reporting

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Current Trends in Enforcement

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  1. Current Trends in Enforcement Richard Kingham Covington & Burling June 8, 2004

  2. Current Trends Affecting International Companies • US Foreign Corrupt Practices Act • Foreign regulation of financial relationships with the medical profession • International safety reporting • Good clinical practice • Off-label promotion

  3. Foreign Corrupt Practices Act • Charitable contributions • Sponsoring government doctors to attend conferences • When is a foreign doctor a government official for FCPA purposes? • Abuse of post-marketing studies

  4. FCPA rule of reason analysis • Sound medical or scientific basis • No quid pro quo • Avoid appearance of improper purpose • Other factors

  5. Financial relationships with doctors • Investigator-initiated studies • Effect of EC Clinical Trials Directive • Grants • Advisory boards • Hospitality, travel expenses, etc.

  6. International Safety Reporting • Increasingly harmonized requirements • Increased emphasis on inspections and enforcement • Effect of FDA proposal • Nonclinical studies

  7. Good Clinical Practice • EC Clinical Trials Directive • Who is the sponsor? • When does ICH GCP apply? • Inspections and enforcement

  8. Off-Label Promotion • Increased focus in US • First Amendment and FDAMA • Recent high-profile cases • Possible implications for Europe • Code enforcement proceedings • Private litigation

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