Philip Katz Crowell & Moring LLP 1001 Pennsylvania Avenue, NW Washington, DC 20004

1. Regulation of Drug MarketingIntroduction to Drug Law and RegulationFDLI WorkshopApril 28-29, 2003Teaneck, New Jersey Philip Katz Crowell & Moring LLP 1001 Pennsylvania Avenue, NW Washington, DC 20004 (202) 624-2660 pkatz@crowell.com

2. Drug Marketing • Advertising • Labeling • Other activities/statements • Sales force • Press releases • Securities filings

3. Drug Marketing • Advertising • Not well defined • Labeling • Label and “all other written, printed or graphic matter . . . accompanying” the drug • “Accompanying” defined broadly

4. Drug Marketing • Misbranded drugs • False or misleading labeling • Labeling lacks required information • Labeling lacks adequate directions for use or adequate warnings • Rx drug advertising lacks brief summary

5. Drug Marketing • False or misleading labeling and advertising • “Misleading” includes material omissions • Promoting unapproved uses • Inadequate brief summary • Lacking in fair balance

6. Drug Marketing • Unapproved new drugs • Defined by intended use • Look to advertising/labeling claims, statements, knowledge of other uses • Includes off-label uses of approved drugs

7. Drug Marketing • Unapproved new drugs • Reporting clinical trial results • Press releases • Securities filings • Describing narrow indications

8. Drug Marketing • Brief summary • True statement of information in brief summary relating to side effects, contraindications, and effectiveness • Exception for reminder ads • Exception for broadcast ads

9. Drug Marketing • Brief summary • Side effects, contraindications broadly defined • Information must be specific • Can’t fix false or misleading statements elsewhere in ad

10. Drug Marketing • Fair balance • Part of “true statement” in brief summary • Balance between information about effectiveness and that regarding side effects, contraindications • Look to scope, depth and detail of information

11. Drug Marketing • Lack of fair balance • Inadequately supported effectiveness or safety claims • Comparative claims not demonstrated by substantial evidence or substantial clinical experience • Selective, unrepresentative use of information

12. Drug Marketing • Reminder advertising • No need for brief summary • No representation or suggestion concerning safety, effectiveness or indications • Price ads only, if drug has boxed warning

13. Drug Marketing • Broadcast advertising • Information relating to major side effects and contraindications in audio or audio and visual parts of presentation • Exempt from brief summary if “adequate provision” made for disseminating approved labeling

14. Drug Marketing • August 1999 guidance on “adequate provision” • Toll-free number for access to labeling • Print ads or brochures • Website address • “See your doctor for more info”

15. Drug Marketing • FDA enforcement • Untitled letters or warning letters • Stop using the material • Corrective communications • Penalties for FDCA violations

16. Drug Marketing • FTC enforcement • OTC drug advertising • Different perspective, process, and results than FDA • Focus on false or misleading representations

17. Drug Marketing • FTC enforcement • Identify the representation • Determine whether it’s true and substantiated

18. Drug Marketing • Identifying the representation • Express and implied claims • Intent irrelevant • Reasonable interpretation by target audience

19. Drug Marketing • Truth and substantiation • Implied presence of substantiation • “Establishment” claims • True + false = false

20. Drug Marketing • Prescription Drug Marketing Act • Drug sample distribution • Written request from licensed practitioner • Requirements re request, receipt, verifying prescribing authority, inventory reconciliation, systems to prevent diversion, record-keeping • Significant penalties for violations

21. Drug Marketing • Issues of practical application • First Amendment • Direct-to-consumer promotion • Internet

22. Regulation of Drug MarketingIntroduction to Drug Law and RegulationFDLI WorkshopApril 28-29, 2003Teaneck, New Jersey Philip Katz Crowell & Moring LLP 1001 Pennsylvania Avenue, NW Washington, DC 20004 (202) 624-2660 pkatz@crowell.com