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
DDMAC’s Mission: To protect the public health by assuring prescription drug promotion is truthful, balanced, and accurately communicated
Functions of DDMAC
Ensure compliance with FFD&C Act Not false Not misleading Balance between risks and benefits
Voluntary Compliance Enforcement Action
Voluntary Compliance
Guidance documents Comments when requested Clarifications of issues and
questions
“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
Advertising
Advertising -- published journals, magazines, and other periodicals, newspapers, broadcast through media such as television, radio, and telephone communications
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
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.
Types of Promotion
Help seeking (“see your doctor,” disease oriented) -- these are NOT drug ads
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
Types of Promotion Product claim
claims or representations trigger requirements for accuracy and balance
risk disclosure requirement
Enforcement
Surveillance Disseminated materials submitted
to FDA Post-marketing reporting
requirements (Form 2253) Conference attendance Complaints Surveillance including websites, TV
ads, and journal ads
Enforcement Options
Untitled letters Warning Letters Injunctions/consent decrees Seizures
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
Examples (con’t)
Reminder ads with product representations
Overstated claims re: likelihood of benefit, especially for products with relatively low efficacy
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
Effexor (cont.)
“…how’re you feeling these days? Okay? Not bad? Come on, is that where you want to be?...”
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
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
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…”
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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