FDA Update on Advertising and Promotion of Prescription Drugs

1. FDA Update on Advertising and Promotion of Prescription Drugs Thomas Abrams Division of Drug Marketing, Advertising, and Communications Food and Drug Administration February 22, 2006

2. Topics • Policy Updates • Enforcement Updates • 2006 and beyond

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

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

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promotion make efforts to better present risk info FDA taking necessary and appropriate enforcement actions working on draft guidance for risk info presentation

6. 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)

7. 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

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

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

10. Violations concerning Risk Information • Nipent Warning Letter • Survanta Warning Letter

11. 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 information • Untitled letter in 2001 – misleading claims

12. 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

14. 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

17. Misleading Effectiveness Claims • Quadramet Warning Letter

18. Quadramet Warning Letter • DTC radio ad, patient testimonial video, and website • Overstatement of effectiveness • Omission and minimization of risk information • Bone marrow suppression • Radioactivity in excreted urine

19. 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.

20. Misleading Comparative Claims • Lumigan Warning Letter • Remodulin Warning Letter

21. 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

23. 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

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

29. 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

30. 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

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