NCHR Comments on the FDA’s Experimental Study of Risk Information Amount and Location in Direct-To-Consumer Print Ads

Thank you for the opportunity to express our views on the FDA’s experimental study of risk information amount and location in direct-to-consumer print ads. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

It is vital that direct-to-consumer ads contain appropriate information on associated risks and side effects as well as benefits. It is particularly important that the information is easy to read, easy to understand, is of appropriate text size, and is in plain sight.  Since a large proportion of people taking prescription drugs are over 50, the size and visibility of the text is especially important.

We urge the following changes:

  1. The exclusion criteria need to be changed, in order to ensure a large number of participants are over 40 years of age. According to The Vision Council Research, more than 75% of Americans use some type of vision correction.[i] By eliminating all individuals with prescription glasses or hard contact lenses, the FDA would eliminate too many consumers.  It is not clear from the description if reading glasses would also be disqualifying; if so, that would eliminate many individuals over 40.
  2. It is essential that the experiments be conducted on a population that is diverse in terms of gender, age, and race/ethnicity. There is no information in the study proposal to ensure diversity or to ensure that the study participants represent the likely population for whom the ads are intended.
  3. The questionnaires will include an open-ended question to study risk recall, but does not determine if the consumer understands it. That is also important.

Thank you for the opportunity to comment on this study.  As noted above, revisions to the study design are needed to ensure that the consumers being studied are representative of those for whom medication ads are intended.

For questions or more information, please contact Dr.Varuna Srinivasan, MBBS MPH at vs@center4research.org or at (202) 223-4000.

[i] The Vision Council Research. US Optical Overview and Outlook. https://www.thevisioncouncil.org. December 2015.