The US Food and Drug Administration (FDA) recently invited public comment on a proposed study of the impact on consumer perceptions of product risks and benefits of coupons embedded in direct-to-consumer (DTC) print advertisements for prescription and over-the-counter (OTC) drugs. For the Federal Register notice click here. Importantly, the request for comments acknowledges that the FDA has no authority to regulate prescription drug prices under the Federal Food, Drug, and Cosmetic Act and stipulates that the agency will limit its analysis to the issue of consumer perceptions.

The proposed study will examine what impact the presence of coupons in DTC full-product and reminder advertisements may have on consumers’ perceptions of product risks and benefits and their overall impression of the advertised product. The study will focus on advertisements for an insomnia drug and look for subtle differences in perception based on promotion types. Participants will be asked to read one randomly selected print advertisement for a new drug and then answer questions about their evaluation of the information presented in the advertisement. These questions will probe perceptions about the product, including perceived riskiness of the drug, likelihood of benefits and behavioral intent (talking to doctor, product purchase, etc.).

The FDA plans to test three types of advertisements along with five types of promotions.  The types of advertisements are: (1) a full-product advertisement for a prescription drug; (2) a reminder advertisement for a prescription drug; and (3) an advertisement for an over-the-counter drug. The OTC drug advertisement is being included to see if prior research related to consumer package goods can be replicated. The promotion types are: (1) free trial offer; (2) “buy one, get one free;” (3) money-off prescription purchase cost; (4) “money back guarantee;” and (5) a “no promotion” condition. The FDA notes that all of these promotional variations, except for “buy one, get one free,” have been used in drug advertisements. The FDA is requesting comment on other promotional types that could be tested.

The notice of proposed information collection specifically requests comments on the following topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The deadline for submission of comments is February 13, 2009. If you need additional information or would like assistance with comment preparation, please contact:

Larri Short
short.larri@arentfox.com
202-775-5786

Samuel Cohen
cohen.samuel@arentfox.com
202-857-6322