Promotion and Marketing of
Prescription Drugs
Lesley R. Frank, Ph.D., J.D.
FDA-DDMAC
September 23, 2004
What is DDMAC?
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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
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Ensure compliance with FFD&C Act
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Not false
Not misleading
Balance between risks and benefits
Voluntary Compliance
Enforcement Action
Voluntary Compliance
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Guidance documents
Comments when requested
Clarifications of issues and questions
“Promotional” Labeling
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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
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Advertising -- published journals,
magazines, and other periodicals,
newspapers, broadcast through media
such as television, radio, and telephone
communications
Standards for Labeling and
Advertising
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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
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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
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Help seeking (“see your doctor,” disease
oriented) -- these are NOT drug ads
Types of Promotion
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Reminder -- regulations specifically
exempt from disclosure requirements;
includes name of product, but no
representations beyond dosage form
and packaging, price information
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not for products with especially serious
(“boxed”) warnings
Types of Promotion
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Product claim
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claims or representations trigger
requirements for accuracy and balance
risk disclosure requirement
Enforcement
Surveillance
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Disseminated materials submitted to
FDA
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Post-marketing reporting requirements
(Form 2253)
Conference attendance
Complaints
Surveillance including websites, TV ads,
and journal ads
Enforcement Options
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Untitled letters
Warning Letters
Injunctions/consent decrees
Seizures
Examples of Violations
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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)
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Reminder ads with product
representations
Overstated claims re: likelihood of
benefit, especially for products with
relatively low efficacy
Effexor XR/Effexor Untitled Letter
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Professional and DTC promotion
Professional pieces claimed that drug is
more effective than SSRIs
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Cited meta-analysis is not substantial
evidence
Effexor (cont.)
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“…how’re you feeling these days?
Okay? Not bad? Come on, is that
where you want to be?...”
Effexor (cont.)
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DTC radio ad omitted common adverse
events (e.g., sexual side effects, dry
mouth)
Ad broadened indication
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Failed to distinguish between normal
periodic feelings of low interest/low energy
and major depressive disorder
Taxotere Warning Letter
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DTC print ads
Overstated survival benefits: Headline: “The
next move may be the key to survival”
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Proven survival differences were at best several
months and were only observed in specific
populations
Other drugs with proven survival benefits
Unsupported outcomes claims
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Stay involved in important aspects of your life
Taxotere WL (cont.)
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Omission of risk information
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Boxed warning information on risk of lifethreatening infections, severe allergic reactions,
and severe fluid retention
Certain common side effects
Minimization of risk
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Risk information lacked visual prominence
Began “Like all anticancer agents, there are side
effects…”
DDMAC Information
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Web address:
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Phone numbers:
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http://www.fda.gov/cder/ddmac
Warning and untitled letters : Posted on
www.fda.gov/cder/warn
(301) 827-2831 or (301) 827-2828
Fax number:
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(301) 594-6771