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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2011-N-0568]
 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 research entitled “Experimental Study: Disease Information in Branded Promotional Material.” The proposed research will explore the nature of including information about a disease and promotional information about a specific drug treatment in the same advertising piece.
 DATES: Submit either electronic or written comments on the collection of information by October 17, 2011.
 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., P150-400B, Rockville, MD 20850, 301-796-3972, 
                        *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: Disease Information in Branded Promotional Material—(OMB Control Number 0910-New) *Regulatory Background:*
                     Section 1701(a)(4) of the Public Health Service 
                    ( print page 50738)
                    Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 903(b)(2)(c) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. FDA regulations require prescription drug advertisements to contain accurate information about the benefits and risks of the drug advertised. Generally, the advertising must not be misleading about the effectiveness of the drug. Specifically, the ad must not contain a representation or suggestion that the drug is better than has been shown by substantial evidence or useful in a broader range of patients.[1]
                    
                     The regulations prohibit sponsors from, for example, disseminating promotional information that may broaden the indications of medications beyond the indication for which they have been approved. This regulation is designed to avoid misleading the audience by overpromising the outcomes of a particular drug and also to maintain a level playing field among competitors. As a public health agency, FDA encourages the communication of accurate health messages about medical conditions and treatments. One way in which broad disease information is communicated to the public is through disease awareness communications: “Disease awareness communications are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device. Help-seeking communications are disease awareness communications directed at consumers. FDA believes that disease awareness communications can provide important health information to consumers and health care practitioners, and can encourage consumers to seek, and health care practitioners to provide, appropriate treatment. This is particularly important for under-diagnosed, under-treated health conditions, such as depression, hyperlipidemia, hypertension, osteoporosis, and diabetes. Unlike drug and device promotional labeling and prescription drug and restricted device advertising, disease awareness communications are not subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA regulations.” [2] Some research has shown that disease awareness advertising is viewed by consumers as more informative and containing less persuasive intent than full product advertising.[3] Sponsors may choose to include disease information in their full product promotions. Such information is designed to educate the patient about his or her disease condition. However, in some cases a full description of the medical condition may include information about specific health outcomes that are not part of a drug's approved indication. The current project is designed to determine if providing such information in branded full product advertisements affects perceptions of the product. When broad disease information accompanies or is included in an ad for a specific drug, consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad by making inferences that go beyond what is explicitly stated in an advertisement.[4]
                    
                     For example, the mention of diabetic retinopathy in an advertisement for a drug that lowers blood glucose may lead consumers to infer that the drug will prevent diabetic retinopathy, even if no direct claim is made. The advertisement may imply broader indications for the promoted drug than are warranted, leading consumers to infer effectiveness of the drug beyond the indication for which it was approved. If consumers are able to distinguish between disease information and product claims in an ad, then they will not be misled by the inclusion of disease information in a branded ad. If consumers are unable to distinguish these two, however, then consumers may be misled into believing that a particular drug is effective against long-term consequences. The current study will explore perceptions that result from including both disease information and promotional information about a specific drug in the same advertising piece. *Design Overview:***
                     We will investigate the effects of adding disease information to branded promotional materials on consumer perceptions and understanding. Disease information will be examined in the context of direct-to-consumer (DTC) prescription drug print advertisements. We hope to more readily generalize our findings by exploring the issues raised above in three medical conditions varying in severity and symptomatology. For example, disease information in a category such as oncology may be viewed differently than a mild skin condition or a non-symptomatic condition such as high cholesterol. We plan to examine two variables in this study: The type of disease information in the piece (information about the disease and its possible outcomes, versus information about the disease without outcomes, versus no information about the disease) and the format of the information (integrated with drug information versus separated). Some participants will see information about the disease that avoids discussion of disease outcomes the drug has not been shown to address, such as, “Diabetes is a disease in which blood sugar can vary uncontrollably, leading to uncomfortable episodes of high or low blood sugar.” Other participants will see disease information that mentions consequences of the disease that go beyond the indication of the advertised product, such as, “Untreated diabetes can lead to blindness, amputation, and, in some cases, death.” We will also examine the way in which the disease information is presented relative to the product claims in the piece by varying the format: Disease information mixed (integrated) with product claims versus disease information apart (separated) from product claims. This study is experimental in method and utilizes random assignment to conditions. Within medical condition, participants will be randomly assigned to see one version of the ad. Participants will be recruited from a general population sample to control for prior knowledge about disease outcomes.
                    ( print page 50739) The preliminary design is included as follows: Table 1—Study Design
Medical condition
Disease outcome 
                             information
Format of disease information
Control
                             (no disease information)Integrated
SeparatedCondition A
No OutcomesOutcomesCondition B
No OutcomesOutcomesCondition C
No OutcomesOutcomes
 FDA estimates the burden of this collection of information as follows: We estimate the response burden to be 20 minutes in the pretests and the study, for a burden of 1,985 hours. This will be a one time (rather than annual) collection of information. The questionnaire is available upon request. The response burden chart is listed as follows: Table 2—Estimated Annual Reporting Burden5
Activity
Number of
                             respondents
Number of 
                             responses per 
                             respondent
Total annual 
                             respondents
Average burden per response
Total hoursScreener
6,750
1
6,750
0.03 (2 min.)
203Pretests
900
1
900
0.33 (20 min.)
297Study
4,500
1
4,500
0.33 (20 min.)
1,485Total




1,985
  Dated: August 11, 2011. Leslie Kux, Acting Assistant Commissioner for Policy.


# Footnotes

1.
    
                         See 21 CFR 202.1(e)(6): “An advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n) of the act, among other reasons if it: (i) Contains a representation or suggestion, not approved or permitted for use in the labeling, that a drug is better, more effective, useful in a broader range of patients (as used in this section, 
                        *patients*
                         means humans and in the case of veterinary drugs, other animals), safer, has fewer, or less incidence of, or less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience (as described in paragraphs (e)(4)(ii)(b) and (c) of this section) whether or not such representations are made by comparison with other drugs or treatments  * * *.” Back to Citation
 2.
    
                         See Draft Guidance for Industry: “ `Help-Seeking' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms” (p. 1), available at 
                        *http://www.fda.gov/​downloads/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​ucm070068.pdf*. Last accessed February 16, 2011. Back to Citation
 3.
    
                         Lee-Wingate, S. and Y. Xie, “Consumer perceptions of product-claim versus help-seeking direct-to-consumer advertising,” 
                        *International Journal of Pharmaceutical and Healthcare Marketing,*
                         4(3), 232-246, 2010. Back to Citation
 4.
    
                         Burke, R.R., W.S. DeSarbo, R.L. Oliver, and T.S. Robertson, “Deception by implication: An experimental investigation,” 
                        *Journal of Consumer Research,*
                         14(4), 483-494, 1988; Harris, R.J., “Comprehension of pragmatic implication in advertising,” 
                        *Journal of Applied Psychology,*
                         62, 603-608, 1977; Jacoby, J., and W. Hoyer, “The comprehension and miscomprehension of print communications,” New York: The Advertising Educational Foundation, 1987. Back to Citation
 5.
    
                         There are no capital costs or operating and maintenance costs associated with this collection of information. Back to Citation


[FR Doc. 2011-20814 Filed 8-15-11; 8:45 am] BILLING CODE 4160-01-P