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Special Concerns Relating To Promotional Labeling And Advertising For Medical Devices

Special Concerns Relating To Promotional Labeling And Advertising For Medical Devices. Thomas O. Henteleff Stacy L. Ehrlich Kleinfeld, Kaplan and Becker, LLP May 3, 2005. Level Playing Field Issues. Inherent Problems of Maintaining Different Regulatory Standards FDA vs. FTC

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Special Concerns Relating To Promotional Labeling And Advertising For Medical Devices

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  1. Special Concerns Relating To Promotional Labeling And Advertising For Medical Devices

  2. Thomas O. HenteleffStacy L. Ehrlich Kleinfeld, Kaplan and Becker, LLPMay 3, 2005

  3. LevelPlayingFieldIssues • Inherent Problems of Maintaining • Different Regulatory Standards • FDA vs. FTC • Drugs vs. Devices • FDA Staff with Different Educational Backgrounds and Training

  4. Level PlayingFieldIssues • Inherent Problems of Maintaining (Cont.) • FDA Staff with Different Workload • Limited Financial and Manpower Resources • Lack of Appreciation of Relevant Facts Due to Confidentiality and Open Investigation File Considerations

  5. Level Playing Field Issues • Procedures to Address • Internal Guidance Documents • Industry Guidance Documents • FDA Staff Training Programs • FDA Evaluation and Monitoring Procedures

  6. Level Playing Field Issues • Procedures to Address (Cont.) • Administrative Procedures • Request for Internal Agency Review • CDRH Ombudsman • Office of Chief Mediator and Ombudsman • Citizens’ Petitions • Petitions for Reconsideration

  7. Level Playing Field Issues • Procedures to Address (Cont.) • Other Procedures • Cease and Desist Letters • Trade Complaints Filed With Government • NAD Complaint • Lanham Act Litigation

  8. Level Playing Field Issues • Procedures to Address (Continued) • Other Procedures (Continued) • Litigation to Enforce Agency Action to Treat Similar Situations in a Similar Manner • Allergan v. Shalala • Bracco Diagnostics v. Shalala • U.S. v. An Article of Device . . . Diapulse

  9. Internet Issues • Scope • Advantages • Privacy • Convenience • Potential Cost Savings

  10. Internet Issues • Risks • Broad Coverage/Low-Cost • Health Risks • Economic Risks

  11. Internet Issues • Jurisdiction • Labeling or Advertising • Restricted vs. Rx and OTC Devices • FDA vs. FTC • Does It Make A Difference? • Joint Prohibition Against False and Misleading Representations • Adequate Substantiation • Clearance Limitations • Remedies

  12. Internet Issues • Legitimate Prescriptions • Online Questionnaires • Current Prescriptions • Legitimate Source • Fairness to Contact Lens Consumer Act

  13. Internet Issues • Self-Policing • Certification • Monitoring • Consumer Education • Enforcement • Operation Cure-All • Cyber Warning Letters

  14. Internet Issues • Electronic Labeling • Advantages • Section 206 MDUFMA • Provisions • Scope

  15. Market Integrity Issues • Unapproved Products/Uses • False or Misleading Claims • Counterfeit • Importation • Black Market • Gray Market • Kickback

  16. Questions? Stacy Ehrlich Kleinfeld, Kaplan and Becker (202) 223-5120 sehrlich@kkblaw.com

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