Life Science Compliance Update

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March 15, 2016

FDA National Direct to Consumer Advertising Survey – Again

If at first you don't succeed try, try again. That seems to be the theme of a recent announcement by the Food and Drug Administration (FDA) on the proposed collection of consumer attitudes towards Direct to Consumer Advertising (DTC).

Under the Paperwork Reduction Act, federal agencies are required to publish notice in the Federal Register of any proposed collection of information and to allow sixty days for public comment in response. This most recent notice by the FDA solicits comments on research entitled, "National Direct-to-Consumer Advertising Survey." The objective of the research is to survey the American population about their experiences with, and attitudes toward, direct-to-consumer (DTC) prescription drug advertising.

The FDA last surveyed patients about their experiences with and attitudes toward DTC advertising in 2002, and as numerous changes have been made that affect the DTC landscape, the FDA is interested to see whether the changes have had an influence on consumer attitudes and behaviors. Some of the changes include: declines in print readership, the rise in online prescription drug promotion, and self-imposed industry guidelines for DTC advertising.

The survey is expected to contain questions about "respondents' knowledge of FDA's authority with respect to prescription drug advertising, their exposure to DTC advertising, their beliefs and attitudes about DTC advertising, and the influence of DTC advertising on further information search and patient-physician interactions." At the end of the survey, participants will be asked to view one of two ads for fictional prescription drugs intended to treat high cholesterol and will be asked questions about the FDA's authority regarding specific claims found within the ad.

The general purpose of the survey is to build on previous research through a wider range of respondents (approximately 1,765, enticed to respond with 2 $1 bills found in a pre-survey invitation envelope), weighting the data to make it more representative, and asking more questions about DTC promotion. The FDA believes that offering a small token of value to the participates will establish a "latent social contract and subsequent reciprocity."

This survey comes after Representative Rosa DeLauro introduced a bill that, if passed, would prohibit all DTC ads for the first three years after a new drug is approved. Physicians at the American Medical Association (AMA) have also called for a ban on DTC ads for pharmaceuticals.

For those who are interested, information and study summaries of previous FDA surveys about advertising, including DTC advertising, can be found here.

The FDA is asking for comments, in either electronic or written format, to be submitted by close of business on April 29, 2016.

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