Appendix C

APPENDIX C

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0417]

Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the FEDERAL REGISTER concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements (ads). This study is designed to test different ways of presenting benefit and risk information in the brief summary in DTC print ads.

DATES: Submit either electronic or written comments on the collection of information by [insert date 60 days after date of publication in the FEDERAL REGISTER].

ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information 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 the docket number found in brackets in the heading of this document.

FOR FURTHER 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.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. "Collection of information" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the FEDERAL REGISTER concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

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.

Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements --New

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.” The prescription drug advertising regulations (§ 202.1(e)(3)(iii) (21 CFR 202.1(e)(3)(iii))) 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. 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.

In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements for prescription drugs. Because the regulations do not specify how to address each risk, sponsors can use discretion in fulfilling the brief summary requirement under § 202.1(e)(3)(iii). Frequently, sponsors print in small type, verbatim, the risk-related sections of the approved product labeling (also called the package insert, professional labeling, prescribing information, and direction circular). This labeling is written for health professionals, using medical terminology. While adequate to fulfill the brief summary requirement for print advertisements, this method may not be the most ideal. Research has shown that while many consumers will make the effort to read the brief summary in prescription drug print advertisements if they are especially interested in the drug, as a general rule consumers typically read little or none of the brief summary information.¹ Health practitioners themselves have indicated they often have difficulty finding information they actively seek in package inserts (see 65 FR 80733 at 81082, December 22, 2000, for a discussion of studies supporting the use of a highlights section in physician labeling). There may be other ways to fulfill this requirement that improve consumers’ ability to find and comprehend the information in this important document.

There is evidence suggesting that both information content and the format in which it is presented will impact comprehension. For instance, research with the format of over-the-counter (OTC) drug labels,² the nutrition facts label,³ and other information formats⁴ demonstrates that information presented with section headings, graphics (such as bullets), and other design elements is more easily read than information presented in paragraph format.

Research conducted by FDA and others has examined the content and format of the brief summary specifically. For instance, FDA conducted a series of relevant studies (OMB control numbers 0910-0591 and 0910-0611). Schwartz, Woloshin, and Welch have compared one format for adding quantitative and qualitative benefit and risk information to the brief summary.⁵ Specifically, Schwartz et al. designed a prescription drug facts box similar in format to the Nutrition Facts panel and OTC Drug Facts panel. The box contains a number of elements, including qualitative and quantitative (both absolute frequency and absolute difference) information about benefits and risks. This study showed that consumers who were provided efficacy information in a prescription drug facts box were more likely to correctly choose the product with the higher efficacy than consumers who saw the brief summary using medical language from the Prescribing Information PI. However, it is unclear which elements of the drug facts box are necessary to improve consumer understanding. For instance, it is not known whether simply adding efficacy rate information to a consumer-friendly brief summary would be sufficient to enable consumers to understand a product’s efficacy, or whether qualitative summations are necessary as well.

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. The results of this study will inform FDA of the usefulness and parameters of various format and content options for the brief summary.

Design Overview: This 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. We 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. These factors will be combined in a factorial design as follows:

Table 1. --Proposed Design (4 x 5 + 2)
	Efficacy Level
Information Type	Smallest Effect	Smaller Effect	Mid-size Effect	Larger Effect	Largest Effect
Absolute Frequency	81% vs. 82%	61% vs. 82%	41% vs. 82%	21% vs. 82%	1% vs. 82%
Absolute Frequency + Qualitative Label	Fewer 81% vs. 82%	Fewer 61% vs. 82%	Fewer 41% vs. 82%	Fewer 21% vs. 82%	Fewer 1% vs. 82%
Absolute Difference + Qualitative Label	Fewer (1%)	Fewer (21%)	Fewer (41%)	Fewer (61%)	Fewer (81%)
Absolute Frequency + Absolute Difference + Qualitative Label	Fewer (1%) 81% vs. 82%	Fewer (21%) 61% vs. 82%	Fewer (41%) 41% vs. 82%	Fewer (61%) 21% vs. 82%	Fewer (81%) 1% vs. 82%
Note. Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22 cells) will also be used to test risk information (for a total of 44 cells). The specific numbers in the table are placeholders only. Qualitative label example: “fewer people taking drug X had disease/symptom Y.”

The test product will be 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. We will test how the information type affects perceived efficacy, perceived risk, behavioral intention, and accurate understanding of the benefit and risk information.

Interviews are expected to last no more than 20 minutes. A total of 11,750 participants will be involved in the study. This will be a one-time (rather than annual) collection of information.

FDA estimates the burden of this collection of information as follows:

Table 2.--Estimated Annual Reporting Burden1
Activity	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Pretest	750	1	750	20 minutes	250
Main Study	11,000	1	11,000	20 minutes	3,667
Total					3,917
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: August 25, 2010.

1 Aikin, K.J., Swasy, J.L. and Braman, A.C. (2004). Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey Research Results, Final Report. Available at http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/UCM152860.pdf. Last accessed August 12, 2010.

2 Aikin, K.J. (1998). Consumer Comprehension and Preference for Variations in the Proposed Over-The-Counter Drug Labeling Format, Final Report; Vigilante, W.J. & Wogalter, M.S. (1997). The preferred order of over-the-counter (OTC) pharmaceutical label components. Drug Information Journal, 31, 973-988.

3 Levy, A.S., Fein, S.B. & Schucker, R.E. (1992). More effective nutrition label formats are not necessarily more preferred. Journal of the American Dietetic Association, 92(10), 1230-1234.

4 Lorch, R. & Lorch, E. (1995). Effects of organizational signals on text-processing strategies. Journal of Educational Psychology, 87(4), 537-544; Lorch, R. & Lorch, E. (1996). Effects of organizational signals on free recall of expository text. Journal of Educational Psychology, 88(1), 38-48; Lorch, R., Lorch, E. & Inman, W. (1993). Effects of signaling topic structure on text recall. Journal of Educational Psychology, 85(2), 281-290.

5 Schwartz, L.M., Woloshin, S., & Welch, H.G. (2009). Using a drug facts box to communicate drug benefits and harms: Two randomized trials. Annals of Internal Medicine, 150(8). Available online at http://www.annals.org/cgi/content/full/0000605-200904210-00106v1. Last accessed August 12, 2010.