• FDA Will Use Fake DTC Ads to Test Consumer Reactions
  • September 4, 2008
  • Law Firm: Manatt, Phelps & Phillips, LLP - Los Angeles Office
  • The Food and Drug Administration plans to use ads for a fake blood-pressure medicine to test whether images distract consumer attention from safety warnings.

    The FDA says it will conduct an online survey of 2,400 consumers ages 40 and older seeking their reactions to the simulated ads, according to an August 5 notice on the agency’s web site. The study must first be approved by the Office of Management and Budget.

    Companies spend $30 billion a year in the United States on direct-to-consumer (“DTC”) drug marketing, triple the amount of a decade ago, according to a recent study in the New England Journal of Medicine. Each year, the FDA warns dozens of companies about ads and marketing materials the agency considers misleading. Invariably, the drug companies who receive warning letters comply by pulling or revising the complained-of spots. The study is aimed at determining what factors or techniques in ads contribute to misperceptions.

    A standing complaint of consumer groups is that drug spots unfairly underplay risk factors.

    The FDA plans to develop a number of spots for the fake high blood pressure drug employing various images and text while a narrator reads the risk information. Some of the visuals will highlight the drug’s benefits to determine if such visuals distract consumer attention away from safety warnings.

    The agency first suggested the study last August as a survey of 1,020 consumers in shopping malls. It then made extensive modifications to the study’s methodology as a result of comments it received, including changing the mode of surveying and the type of questions asked.