Direct-to-Consumer Advertising of Genetic Tests - PowerPoint

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 Advertising of Genetic Tests

                                                    Sarah Botha
                               Division of Advertising Practices
                                    Federal Trade Commission

The opinions expressed are my own and not necessarily those of the FTC
    DTC Advertising of Genetic
    Tests and the FTC
 FTC’s jurisdiction over DTC advertising of
  genetic tests
 FTC’s method for evaluating promotional
  claims for health-related products
 Tools the FTC uses to prevent consumer
 FTC’s role with respect to genetic testing
    FTC Legal Framework and
    Approach to Regulation
 Primarily a law enforcement agency
 No pre-market approval process
 No regulatory distinction between product
 No regulatory distinction between
  health/disease/structure function claims
  Advertising and the FTC

“The dissemination or the causing to be
disseminated of any false advertisement
. . . shall be an unfair or deceptive act or
practice . . . under section 5 [of the FTC
Act, 15 U.S.C. § 45].”

                           15 U.S.C. § 52(b)
   Health Products and the FTC

“It shall be unlawful for any person,
partnership, or corporation to disseminate,
or cause to be disseminated, any false
advertisement . . . by any means . . . for
the purpose of inducing . . . directly or
indirectly, the purchase . . . of food, drugs,
devices, services, or cosmetics.”

                             15 U.S.C. § 52(a)
     Advertiser’s Responsibilities
 An advertiser is responsible for all objective
  claims – express and implied – that are
  conveyed to reasonable consumers
    “[A]n otherwise false advertisement is not rendered
     acceptable merely because one possible
     interpretation of it is not untrue.” (In re National
     Commission on Egg Nutrition et al., 1976)

 Ads must be truthful and not misleading
    An ad may be literally truthful and yet still be
     deceptive to consumers
    An ad may be deceptive by omission
    Advertiser’s Responsibilities
 All objective claims must be substantiated at the
  time they are made

 Any disclaimer that is necessary to prevent an
  ad from being deceptive must be “clear and
  conspicuous” and must effectively convey the
  correct net impression to consumers
 Must have a reasonable basis for any objective
 At least the level claimed in the ad
 Depends on a variety of factors, including nature
  of the claim - “soft, radiant skin” vs. “proven
  protection against skin cancer”
  Substantiation for Scientific

Health- or safety-related claims must be
substantiated with competent and
reliable scientific evidence at the time
that the claims are made.
     Not all clinical studies are the
     same – the best studies:
 Test the relevant clinical endpoints
 Are tested on a representative human
 Test the finished product itself, not individual
 Test the same dosages and delivery method
 Are double-blinded, randomized, and placebo-
 Are statistically significant and have clinically
  meaningful results
 Are published in peer-reviewed journals
      Clinical studies must be
      examined in context
   Can’t evaluate studies in isolation
   Consider all relevant evidence
   Reconcile inconsistent/conflicting results
   Claim may need to be qualified
   Don’t make claim if weight of evidence
     What Are Our Priorities?
 Products that claim to treat or cure serious
 Products that potentially pose significant safety
  concerns to consumers
 Products that are deceptively marketed to or for
  children and adolescents
 Claims with the potential to cause widespread or
  severe consumer injury
 Referrals from the NAD and other self-regulatory
     FTC Tools for Combating
 Monitoring of DTC advertising claims for
  genetic testing and enforcement actions
  where appropriate
 Consumer education
   July 2006: FTC-FDA-CDC joint consumer fact sheet
    titled, “At-Home Genetic Tests: A Healthy Dose of
    Skepticism May Be the Best Prescription”
   FTC Participation on SACGHS

 Serve as an Ex Officio member on the
  Secretary’s Advisory Committee on
  Genetics, Health, and Society (SACGHS)

   Sarah Botha