DirecttoConsumer Advertising Legal and Regulatory Limitations

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Direct-to-Consumer AdvertisingLegal and
Regulatory Limitations
Pam Weagraff Founder and Principal
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Overview

• Why do we care?
• Memory Lane and the Advent of Direct to Consumer
  Advertising (DTC)
• FDA Guidance on Direct to Consumer Advertising
• Lessons Learned . . . .

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Why do we care?

• Fundamental Issue for Advertising in Med Tech
  Industry Today
• Activity afoot in pharmaceutical industry
• Industry discussion of submitting all advertising
  to FDA
• Reaction of consumers to DTC
• FDA attention to DTC

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Memory Lane . . . Basic Constitutional Authority

• First Amendment -- Congress shall make no law
  abridging the freedom of speech

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Basic Statutory Authority

• 201 Definition of Labeling
• All labels and other written, printed, or graphic
  matter (1) upon any article or any of its
  containers or wrappers, or (2) accompanying such
  article
• representations made or suggested by statement,
  word, design, device, or any combination thereof,
  or the extent to which the labeling or
  advertising fails to reveal material facts
  material
• 301 Prohibited Acts and PenaltiesThe
  adulteration or misbranding of any food, drug,
  device, or cosmetic in interstate commerce.

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Basic Statutory Authority502 (21 U.S.C. 352)

• A drug or device shall be deemed to be
• misbranded(a) If its labeling is false or
  misleading in any particular.
• FDA looks to the intended use of a product

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Basic Regulatory Authority 21 CFR 801.4
Intended Use

• Held responsible for the intended uses for
  which company promotes product
• Objective intent of the persons legally
  responsible for the labeling
• Determined by such persons expressions or may be
  shown by the circumstances surrounding the
  distribution of the article
• May be shown by labeling claims, advertising
  matter, or oral or written statements by such
  persons or their representatives

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Basic Regulatory Authority 21 CFR 801.6
Misbranding

• Labeling or advertising that is false, misleading
  or lacking in fair balance
• Labeling that lacks adequate directions for use
• Failure to include brief statement in restricted
  device and drug advertising

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Advent of DTC 1

• 1983 - First DTC Ad for pain reliever Rufen
  kicks off 22 year transformation of
  pharmaceutical marketing
• 1989 12 M in DTC advertising compared to 4 B in
  2004
• Ads fuel breakthrough medicines into blockbusters
• Too late to put the genie back in the bottle . .
  . David Kessler, former FDA Commissioner

1 San Francisco Chronicle Susan Todd, May 22,
2005
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DTC Gains Momentum 1

• Push to Pull Marketing Strategy sales reps /
  physicians replaced by consumer demands for drugs
  by name, e.g., Claritan
• FDA Treatment of Television Commercials
• Up until 1997, guidelines same as print ads which
  were 30 to 40 years old, required to show lengthy
  information and potential risks, led to
  reminder ads
• TV ads exempted from lengthy information brief
  information requirement

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The Revolution Continues

• Advantage Increased publics awareness and
  thereby involvement in healthcare
• Disadvantage
• Consumers potentially taking too many drugs and
  or those heavily advertised
• Communicate in sound bites versus scientific
  facts
• Catalyst for Change hyper-advertised Cox II pain
  medicines and erectile dysfunction drugs
• Proposed legislation to limit DTC until drug on
  the market for two years
• PHARMA code of conduct for DTC

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Consumer-Directed Advertising of Restricted
Devices 2/10/04

• Brief Statement Requirement per 21 U.S.C. 352
  (r)(2) . . . intended uses of the device and
  relevant warnings, precautions, side effects and
  contraindications

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Consumer-Directed Advertising of Restricted
Devices 2/10/04

• FDAs Presumption about Advertising
  consumer-friendly language
• Not false or misleading
• Balanced presentation of effectiveness and risk
  information
• Thorough major statement including most important
  warnings, precautions, side effects and
  contraindications
• All information relevant to devices indication,
  including brief intended use statement, and any
  limitations

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Brief Statement - Disclosure

• Operating toll-free number with choice of . . .
• Receiving labeling information via mail
• Having labeling read, i.e., recorded messages
• Reference to a mechanism to provide labeling to
  consumers with restricted access to technology,
  i.e., additional information via print
  advertisements which appear concurrently and as
  broadly distributed
• Internet web page (URL) address
• Healthcare practitioners as source of additional
  information
• Note also applies to telephone advertisements

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Lessons Learned . . . ?

• Warning Letters to Pharma
• Promotional materials are false and misleading .
  . . disseminated in ads and labeling pieces
  directly to consumers . . . claims are broader
  than what FDA approved
• Labeling piece is false and misleading because
  it makes unsubstantiated effectiveness claims,
  for and omits material facts about . . .
• Patient video is misleading because it
  overstates the efficacy of XYZ, minimizes
  safety risks and makes unsubstantiated
  superiority claims . . .

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Thank you for your attention!
Pam Weagraff Founder and Principal
Contact InformationPhone 978-664-4655e-mail
pjweagraff_at_aceleraconsulting .com www.aceleracons
ulting.com