1. FDA Update on Advertising and Promotion of Prescription Drugs Thomas Abrams, R.Ph., M.B.A. Division of Drug Marketing, Advertising, and Communications Food and Drug Administration January 30, 2006

2. Topics Policy Updates Enforcement Updates 2006 and beyond

3. DDMAC’s Mission To protect the public health by assuring prescription drug promotion is truthful, balanced, and accurately communicated

4. Policy Updates Direct-to-Consumer Promotion (DTC) Risk Information Guidance Development

5. Direct-to-Consumer Promotion Increasing interest Concerns about DTC PhRMA and Industry Actions FDA Actions

6. FDA Actions and DTC Research on DTC conducted Sept 2003 – Public Meeting held on DTC research Feb 2004 – 3 draft guidances issued Nov 2004 – DTC Research Final Report Nov 2005 – DTC Part 15 Meeting held

7. Risk Information Most common violation cited in DDMAC’s letters Important to public health American public entitled to balanced picture

8. Risk Information Industry – make efforts to better present risk info – include serious and common risks cannot omit risk from promotion FDA – working on draft guidance for risk info presentation – taking necessary and appropriate enforcement actions

9. Guidance Development Presentation of Risk Information Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (Brief Summary) Help-seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firm (Help-seeking)

10. Enforcement Analysis 15 Warning Letters in 2005 vs 4-5 WLs average of previous years Stopped and corrected misleading promotion Actions needed to achieve compliance

11. Types of Violations - Most Common Inadequate Risk Information - 82% Misleading Effectiveness Claims - 43% Misleading Comparative Claims - 43%

12. Targeted Audience Healthcare Professional Directed - 60% Consumer Directed - 30% Both HCP and Consumer Directed - 10%

13. Violations concerning Risk Information Nipent Warning Letter Survanta Warning Letter

14. Nipent Warning Letter Booth panel and handout Overstatement of safety and efficacy Failed to present any risk information Boxed Warnings about severe renal, liver, pulmonary, and CNS toxicities Untitled letter in 1997 – risk Untitled letter in 2001 – misleading claims

15. Nipent Warning Letter Overstatement of Safety – Nipent is selectively cytotoxic to the leukemic population, exhibiting little or no effect on stem cells – Unsubstantiated and contradicts PI (use of drug is associated with multiple hematologic cytopenias) Omission of risk information

17. Survanta Warning Letter Direct mailer to healthcare professionals Effectiveness claims – Large, colorful, bolded headers – colorful charts – bullet points Risk information – small font in two lines at very bottom of page 3 of 4-page promotional piece – below the references and footnotes

20. Misleading Effectiveness Claims Quadramet Warning Letter

21. DTC radio ad, patient testimonial video, and website Overstatement of effectiveness Omission and minimization of risk information – Bone marrow suppression – Radioactivity in excreted urine

22. Quadramet Warning Letter Quadramet doesn’t make you lose your hair, it targets the cancer and that is what so great about it. It knows where to go. I think it is amazing. Quadramet travels to the site of bone reformation due to metastatic bone cancer to provide relief with a single injection. After the Quadramet shot started to take effect, she was back to her old self, she wasn’t drowsy. And I am surprised that she didn’t sit here and cook a big meal for you guys.

23. Misleading Comparative Claims Lumigan Warning Letter Remodulin Warning Letter

24. Lumigan Warning Letter Sales aid Unsubstantiated superiority claims – Weight of evidence proves LUMIGAN produces lowest mean IOP. For example…vs beta-blockers … vs travoprost… vs latanoprost… vs dual therapy – Lumigan produces lowest mean IOP…vs dual therapy 14% to 27% greater mean IOP reduction than Cosopt

26. Remodulin Warning Letter Journal ad and FAQ booklet Misleading comparative claims to Flolan – Answer to “How is Remodulin different than Flolan” highlights advantages of Remodulin’s method of administration (subcutaneous vs. central infusion) – “Can I Switch From Flolan to Remodulin?” “Yes in fact there were published results … where patients were successfully switched from Flolan to Remodulin.” Both presentations fail to reveal material facts -- that Flolan has a proven effect on walking distance and survival in indicated patient population while Remodulin has not demonstrated these benefits

27. Promotion of Unapproved Uses Cubicin Warning Letter

28. Journal advertisement and website Broadens the indication – treatment of all infections caused by Staph aureus PI states it is not indicated for pneumonia – In Phase 3 studies of community-acquired pneumonia, death rate was higher

29. Correctives Same audience and similar vehicle Correct misleading messages Examples – print ad, DHCP letter

31. Plans for 2006 - DTC Part 15 Analysis and Follow Up PhRMA Guiding Principles – Increase in number of submissions of proposals Advisory comments Guidance Development

32. Plans for 2006 –Guidance Development and Voluntary Compliance Guidance Development – Presentation of Risk Information – Help-Seeking Communications – Brief Summary research Voluntary Compliance – Guidance – Advisory Comments – Outreach

33. Plans for 2006 - Enforcement Continue close monitoring and oversight of prescription drug promotion Take appropriate actions to ensure compliance Continue efforts to encourage voluntary compliance

34. DDMAC Information Phone numbers: – Phone - (301) 796-1200 – Fax - (301) 796-9877 and (301) 796-9878 Web addresses: – www.fda.gov/cder/ddmac – Warning and untitled letters : Posted on www.fda.gov/cder/warn – Guidances: Posted on www.fda.gov/cder/guidance