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FDA’s Fake Drug Ads
FDA is requesting permission from OMB to conduct a survey on Direct To Consumer (DTC) pharmaceutical advertising. Specifically, the agency is seeking to determine whether "competing, compelling visual information about potential drug benefits interferes with viewers’ processing and comprehension of risk information...." In developing the study, the agency "will create a variety of ads for a new (fictitious) brand of high blood pressure medication."

The agency claims that "the study will provide useful it considers whether it is appropriate to develop guidance to help improve how broadcast ads present a prescription drug’s risks and benefits." A Consumers Union official stated that the agency was "responding to criticism of many of us that the risk information is underplayed."

The FDA study would be an ambitious attempt to measure complex cognitive processes. While there is the potential to learn about how consumers process advertising information, any biases or other shortcomings in the study design or execution could produce misleading results. To help prevent any preconceptions about DTC from being translated into the study’s conclusions, it is essential that FDA adhere to the Data Quality Act and Paperwork Reduction Act, including statistical guidance documents.

Since it is the FDA’s intent to use the study in developing policies for the pharmaceutical industry, the study’s results should be designated as "influential information." In addition to being subjected to peer review, FDA should release the study data, and accompanying analysis, in draft form for public comment.

See Federal Register notice

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