The Food and Drug Administration (FDA) announced an opportunity for the public to comment on the Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements (ads). Specifically, this study is designed to test different ways of presenting benefit and risk information in the brief summary in DTC print ads.
Comments must be submitted by November 1, 2010. They can be submitted electronically or can be sent to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket No. FDA–2010–N–0417.
Background
Section 502(n) of the Federal Food, Drug, and Cosmetic Act specifies that ads for prescription drugs and biological products must provide a true statement of information ‘‘in brief summary’’ about the advertised product’s ‘‘side effects, contraindications, and effectiveness.’’
In addition, the prescription drug advertising regulations specify that the information about risks must include each specific side effect and contraindication from the advertised drug’s FDA-approved labeling, including the Warnings, Precautions, Adverse Reactions, and other relevant sections.
The FDA noted that some of the current approaches to fulfilling the brief summary requirement, while adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer directed promotion. This difficulty has caused FDA concern regarding the adequacy of the brief summary in DTC print advertisements for prescription drugs.
Consequently, since the regulations do not specify how to address each risk, drug ad sponsors can use discretion in fulfilling the brief summary requirement. The FDA noted that this frequently results in sponsors using print in small type, stating verbatim, the risk related sections of the approved product labeling (also called the package insert, professional labeling, prescribing information, and direction circular).
FDA is concerned about this practice because while adequate to fulfill the brief summary requirement for print advertisements, this labeling is written for health professionals, using medical terminology, and may not be the most ideal.
As a result, the notice asserts that there may be other ways to fulfill this requirement that improve consumers’ ability to find and comprehend the information in this important document. Specifically, the FDA suggests that both information content and the format in which it is presented will impact comprehension.
Accordingly, the FDA explained that the current study will add to previous research by systematically examining these different elements to determine whether and how to add qualitative and quantitative benefit and risk information to the brief summary. Upon completion, FDA said that the results will inform the agency of the usefulness and parameters of various format and content options for the brief summary.
Study for Comments
The study will be conducted in two concurrent parts; one examining variations on the benefit information presented in DTC print advertisements and the other examining variations on the risk information presented in DTC print advertisements.
The factors studied will be the type of information (i.e., the addition of quantitative and qualitative information in a box format) and the level of efficacy or risk.
FDA will vary the level of efficacy and risk such that the largest effect is noticeably different from the placebo, whereas the smallest effect is minimally different from the placebo.
In carrying out the study, FDA will test a product for the treatment of high prevalence medical condition and modeled on an actual drug used to treat that condition. Participants will be consumers who have been diagnosed with the medical condition of interest. They will be randomly assigned to read one ad version.
After reading the ad, participants will answer a series of questions about the drug. FDA will then test how the information type affects perceived efficacy, perceived risk, behavioral intention, and accurate understanding of the benefit and risk information. They will do so by conducting interviews to last no more than 20 minutes.
A total of 11,750 participants will be involved in the study, which will be a one-time (rather than annual) collection of information. FDA estimates the burden of this collection to be approximately 4,000 hours to complete the study.
With respect to the following collection of information, FDA invites comments on these 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.
Comments can be submitted electronically, and are due by November 1, 2010.
For more information contact:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–3792,
Elizabeth.Berbakos@fda.hhs.gov.