DTC Drug Advertising: FDA to Launch First Public Survey Since 2002

Regulatory NewsRegulatory News | 26 February 2016 |  By 

Direct-to-consumer (DTC) advertising for pharmaceuticals has been a hot topic recently as federal and state officials have questioned their utility, particularly as the US and New Zealand are the only two countries in the world that have them. Now, the US Food and Drug Administration (FDA) is looking to survey patients about their experiences with DTC drug ads.

The survey will question respondents about their knowledge of FDA's authority over prescription drug advertising, their exposure to DTC advertising, their beliefs and attitudes about DTC advertising and the influence of DTC advertising on searching for further information and patient-physician interactions.

The results of the National Direct-to-Consumer Advertising Survey, which FDA estimates will reach about 1,765 respondents, will be compared to the 2002 survey.

“Numerous changes have affected the DTC landscape since 2002, including declines in print readership, the rise in online prescription drug promotion, and self-imposed industry guidelines for DTC advertising. These changes may have affected consumers' exposure to different kinds of DTC advertising and its influence on their attitudes and behaviors,” FDA said.

At the end of the 20-minute online survey, respondents will be randomly assigned to view one of two ads for fictional prescription drugs intended to treat high cholesterol and asked questions about FDA's authority regarding specific claims within the ad.

The survey is meant to build on previous research by recruiting a wider range of respondents, weighting the data to make it nationally representative and asking more questions about DTC promotion, including online ads.

“The survey will include a debriefing to inform respondents that the advertised drug was fictitious. We will also measure other potentially important characteristics such as demographics, insurance coverage, and prescription drug use. The survey is available upon request,” FDA said in Friday's Federal Register.

The agency also noted that it plans to recruit for the survey, which it says will be representative of the US population, by “using two $1 bills ($2 total per sampled respondent) mailed in advance with the initial invitation letter as a gesture to encourage response and maintain data quality. Offering a small token of value to participants establishes a latent social contract and subsequent reciprocity.”

FDA will contact those receiving the mailing a second time and conduct an experiment to test whether a short statement mentioning the previously paid incentive increases survey response. Half the sample will see language that reminds them they received a cash incentive in the previous letter; the remaining half will be reminded they received a letter but will not be specifically reminded about the incentive.

Over the years, FDA has studied how consumers understand pharmaceutical advertising in a variety of ways.

The new survey also comes as Rep. Rosa DeLauro (D-CT) has recently introduced a bill that would prohibit all DTC ads for the first three years after a new drug is approved. Physicians at the American Medical Association (AMA) in November also called for a ban on DTC ads for pharmaceuticals.

Federal Register


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy