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Promotion and Marketing of Prescription Drugs

Promotion and Marketing of Prescription Drugs. Lesley R. Frank, Ph.D., J.D. FDA-DDMAC September 23, 2004. What is DDMAC?. FDA’s Division of Drug Marketing, Advertising, and Communications

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Promotion and Marketing of Prescription Drugs

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  1. Promotion and Marketing of Prescription Drugs Lesley R. Frank, Ph.D., J.D. FDA-DDMAC September 23, 2004

  2. What is DDMAC? • FDA’s Division of Drug Marketing, Advertising, and Communications • DDMAC’s Mission: To protect the public health by assuring prescription drug promotion is truthful, balanced, and accurately communicated

  3. Functions of DDMAC • Ensure compliance with FFD&C Act • Not false • Not misleading • Balance between risks and benefits • Voluntary Compliance • Enforcement Action

  4. Voluntary Compliance • Guidance documents • Comments when requested • Clarifications of issues and questions

  5. “Promotional” Labeling • Brochures, booklets, mailing pieces, file cards, bulletins, calendars, price lists, catalogs, letters, videos, slides, exhibits, and similar pieces of printed, audio, or visual matter descriptive of a prescription drug

  6. Advertising • Advertising -- published journals, magazines, and other periodicals, newspapers, broadcast through media such as television, radio, and telephone communications

  7. Standards for Labeling and Advertising • May recommend and suggest the drug ONLY for those uses contained in the approved product labeling • May not be false, lacking in fair balance, or otherwise misleading • Prescription drugs are unique -- the law requires disclosures of the consequences of using the drug

  8. What’s False or Misleading • Better or more effective than indicated • Safer (fewer side effects, lower severity, incidence) • Comparative claims (better/safer than other products) w/o substantial evidence • Misleading presentation of data, risk relative to benefit, etc.

  9. Types of Promotion • Help seeking (“see your doctor,” disease oriented) -- these are NOT drug ads

  10. Types of Promotion • Reminder -- regulations specifically exempt from disclosure requirements; includes name of product, but no representations beyond dosage form and packaging, price information • not for products with especially serious (“boxed”) warnings

  11. Types of Promotion • Product claim • claims or representations trigger requirements for accuracy and balance • risk disclosure requirement

  12. Enforcement

  13. Surveillance • Disseminated materials submitted to FDA • Post-marketing reporting requirements (Form 2253) • Conference attendance • Complaints • Surveillance including websites, TV ads, and journal ads

  14. Enforcement Options • Untitled letters • Warning Letters • Injunctions/consent decrees • Seizures

  15. Examples of Violations • Minimization or ineffective communication of important risk information • Promotion of unapproved uses or drugs • Unsubstantiated claims of efficacy or safety • Unsubstantiated comparative claims

  16. Examples (con’t) • Reminder ads with product representations • Overstated claims re: likelihood of benefit, especially for products with relatively low efficacy

  17. Effexor XR/Effexor Untitled Letter • Professional and DTC promotion • Professional pieces claimed that drug is more effective than SSRIs • Cited meta-analysis is not substantial evidence

  18. Effexor (cont.) • “…how’re you feeling these days? Okay? Not bad? Come on, is that where you want to be?...”

  19. Effexor (cont.) • DTC radio ad omitted common adverse events (e.g., sexual side effects, dry mouth) • Ad broadened indication • Failed to distinguish between normal periodic feelings of low interest/low energy and major depressive disorder

  20. Taxotere Warning Letter • DTC print ads • Overstated survival benefits: Headline: “The next move may be the key to survival” • Proven survival differences were at best several months and were only observed in specific populations • Other drugs with proven survival benefits • Unsupported outcomes claims • Stay involved in important aspects of your life

  21. Taxotere WL (cont.) • Omission of risk information • Boxed warning information on risk of life-threatening infections, severe allergic reactions, and severe fluid retention • Certain common side effects • Minimization of risk • Risk information lacked visual prominence • Began “Like all anticancer agents, there are side effects…”

  22. DDMAC Information • Web address: • http://www.fda.gov/cder/ddmac • Warning and untitled letters : Posted on www.fda.gov/cder/warn • Phone numbers: • (301) 827-2831 or (301) 827-2828 • Fax number: • (301) 594-6771

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