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 Different Regulatory Standards FDA vs. FTC FDA vs. FTC Drugs vs. Devices Drugs vs. Devices FDA Staff with Different Educational Backgrounds and Training FDA Staff with Different Educational Backgrounds and Training

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

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

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

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

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

Internet Issues Scope Scope Advantages Advantages Privacy Privacy Convenience Convenience Potential Cost Savings Potential Cost Savings

Internet Issues Risks Risks Broad Coverage/Low-Cost Broad Coverage/Low-Cost Health Risks Health Risks Economic Risks Economic Risks

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

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

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

Internet Issues Electronic Labeling Electronic Labeling Advantages Advantages Section 206 MDUFMA Section 206 MDUFMA Provisions Provisions Scope Scope

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

Questions? Stacy Ehrlich Kleinfeld, Kaplan and Becker (202)