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

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

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

4. 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. 5 Drug Marketing False or misleading labeling and advertising “Misleading” includes material omissions Promoting unapproved uses Inadequate brief summary Lacking in fair balance

6. 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. 7 Drug Marketing Unapproved new drugs Reporting clinical trial results Press releases Securities filings Describing narrow indications

8. 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. 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. 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. 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. 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. 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. 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. 15 Drug Marketing FDA enforcement Untitled letters or warning letters Stop using the material Corrective communications Penalties for FDCA violations

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

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

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

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

20. 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. 21 Drug Marketing Issues of practical application First Amendment Direct-to-consumer promotion Internet

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