The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by July 20, 2012.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
firstname.lastname@example.org. All comments should be identified with the OMB control number 0910-new and title, “Experimental Study: Experimental Study: Disease Information in Branded Promotional Material.” Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7651, email@example.com.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Experimental Study: Disease Information in Branded Promotional Material—(OMB Control Number 0910-New)
I. Regulatory Background
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(c) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(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 (Ref. 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.
Rationale: 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 act) and FDA regulations.”(Ref. 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 (Ref. 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 (Ref. 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 outcome information to branded promotional materials on consumer perceptions and understanding. This information will be examined in the context of direct-to-consumer prescription drug print advertisements. We hope to more readily generalize our findings by exploring the issues raised in this document in three medical conditions varying in severity and symptomatology: Chronic obstructive pulmonary disease (COPD), lymphoma, and anemia.
We plan to examine two variables in this study: the type of disease information (possible disease outcomes, versus non-outcome information, versus no information) 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.” A third group will see drug product information only (no disease information). 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. We are exploring a number of different options for implementing these two variables. For example: alternating paragraphs of product and disease information, disease information on one page and product information on another page, use of different colors and fonts for disease and product information, and different visuals for disease and product information. Final format variations will be determined through pretesting. The pretests are designed only to make sure the particulars of the main study are implemented in the best way possible. The results of the pretests will not increase the burden on respondents in the main study, nor will the main study design change as a result of the pretests.
This study 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.
The design is described in Table 1:
Table 1—Study Design
|Medical condition||Disease information plus||Format of disease and product information|
|Integrated||Separated||Control (no disease info)|
Data will be collected using an Internet protocol. Participants will be recruited from a general population sample to control for prior knowledge about disease outcomes. Because the task presumes basic reading abilities, all selected participants must speak and read English fluently. Participants must be 18 years or older. We will use ANOVAs and regressions to test hypotheses. Interviews are expected to last no more than 20 minutes. A total of 4,650 participants will be involved in the study. This will be a one-time (rather than annual) collection of information.
In the Federal Register of August 16, 2011 (76 FR 50737), FDA published a 60-day notice for public comment on the proposed collection of information. FDA received one public submission. In the following section, we outline the observations and suggestions raised in the submission and provide our responses.
(Comment 1) One statement suggested we add a multiple choice question to obtain a baseline of how consumers research information about their disease in other forms and if they are actively engaged in health care decisions.
(Response) We agree this question is interesting, but feel it is outside the scope of the current study. The purpose of the study is to examine how disease outcome and product information contained within the same piece influences perceptions of product benefit.
(Comment 2) One comment stated that the inclusion of the MedWatch reporting statement discloses the prescription status of the product and suggested rewording the question about the type of product being tested.
(Response) We have reworded the question, removing the choice options “household cleaner” and “herbal supplement” and added a “don't know” option.
(Comment 3) Two statements said that open-ended questions would result in subjective data interpretation and suggested either replacing them with closed-ended questions or deleting. These statements also suggested that procedures for coding, categorizing and analyzing verbatim responses be established in advance, and that comparable questions about both benefits and risks be included.
(Response) We have established baseline codes for the open-ended questions and included parallel questions to assess perceptions of benefits and risks (see draft questionnaire). Other codes will be established through pretesting. We will have two independent raters for coding and we will calculate inter-rater reliability. Disagreements between coders will be resolved through discussion. In addition, our open-ended questions are accompanied by closed-ended questions.
(Comment 4) One comment stated that those previously diagnosed with the medical condition may respond differently than the newly diagnosed.
(Response) We agree that length of diagnosis could impact responses to information. We are recruiting a general population sample and plan to use medical condition as a covariate. We have added a question to assess time since diagnosis among those who self-identify as having the condition of interest.
(Comment 5) The submission suggested deleting items: (1) Attitudes about the product; (2) multiple items measuring the same construct (risk, benefit); and (3) perceptions of the risk/benefit tradeoff.
(Response) We have addressed these suggestions in the following ways. We have deleted the questions measuring product attitudes. We believe that two questions measuring risk and benefits are necessary to assess the reliability (Ref. 5) of each construct and so have kept both questions. With regard to the final point, we agree that the risk/benefit ratio is different for each patient, but we also think that the perceived risk/benefit ratio for a product is influenced by the information presented in the ad. It is relevant here in that the risk/benefit assessment may be influenced by the perception that the disease outcome information is a product characteristic.
(Comment 6) One statement suggested deleting the questions related to behavioral intention, while another statement suggested expanding these questions.
(Response) As these statements are contradictory, we offer our reasoning behind including these questions. In an ideal situation, we would be able to measure actual behaviors that may result from exposure to a particular promotional campaign. Because we cannot do that, we propose to measure participants' intended behavior; that is, the likelihood that they would engage in specific outcome behaviors that may occur as a result of exposure to the product and disease information. This is in concordance with the recommendations of the November 17, 2011, meeting of the Risk Communication Advisory Committee, which suggested behavioral intention as an important variable to measure in research studies on promotion.
(Comment 7) One comment stated that the questions assessing recall included false benefit items but were not balanced with statements to recall true/factual disease awareness information and suggested including true statements from the disease awareness information.
(Response) Our use of the term “false benefit” in the questionnaire notes may have caused confusion. In the draft questionnaire, “false benefit” simply refers to disease characteristics that are not part of the product's indication. The purpose of this question is to first determine which, if any, of the outcome claims are being interpreted by the participant as product benefits. Following this question is an open-ended question intended to measure what it was about the ad that suggested that (see questionnaire). We have revised the questionnaire notes to read “outcome” and “non-outcome” for clarity.
(Comment 8) One statement asked for more detail about the study design and stimuli layout and offered specific suggestions on variables to include in the study: Vary the presentation of the disease information using headers with and without disclaimers, use a control test ad with no headers, use branded colors, non-branded colors, etc. to maximize understanding of whether consumers are able to distinguish between disease information and product claims and whether the format enhances understanding.
(Response) We have included a description of the study design in both the 60-day and 30-day Federal Register notices. We are exploring a number of different options for implementing the layout of the stimuli. For example: Alternating paragraphs of product and disease information, disease information on one page and product information on another page, use of identical or different colors and fonts for disease and product information, and different visuals for disease and product information. Final format variations will be determined through pretesting. This is the first study of this issue and therefore we are focusing on a small number of variations. It is not feasible to include every possible variation. We appreciate the layout suggestions provided.
(Comment 9) One statement addressed the recruitment process, requesting that we disclose how participants will be recruited and recommending mall intercept recruitment because recruiting participants online may not be reflective of the consumer likely to observe print advertising.
(Response) We plan to recruit and conduct the study online to use our resources most efficiently.
(Comment 10) One statement asked for a rationale for our sample size.
(Response) We have provided a rationale for our sample size in the Power Analysis.
(Comment 11) One statement requested details on the assignment to conditions, saying it was unclear if the study will include a sufficiently stratified sample based on language abilities, preexisting knowledge/disease awareness, age, gender, etc.
(Response) Participants will be randomly assigned to conditions. An attempt will be made to have an equal number of males and females in each experimental cell. Approximately 20 percent of participants in each cell will have a high school education or less, with a range of education and race/ethnicity represented in each condition. The following screening criteria will be employed: participants must be age 18 and over, must not work for a pharmaceutical company, an advertising agency, a market research company, or be health care professionals.
(Comment 12) One statement asked that the screener specify if only those previously diagnosed with the condition will be eligible to participate, saying those previously diagnosed with the medical condition may engage differently than those who are recently diagnosed.
(Response) We agree that those who have the medical condition may react differently than those who do not. We plan to use diagnosis as a covariate in our analyses.
The total annual estimated burden imposed by this collection of information is 1,873 hours for this one-time collection.
The response burden chart is listed in table 2.
Table 2—Estimated Annual Reporting Burden 1
|Activity||No. of respondents||No. of responses per
respondent||Total annual responses||Average burden per
response 2||Total hours|
|Sample outgo (pretests and main survey)||27,679|
|Number of screener completes (35%)||9,688||1||9,688||2/60||323|
|Number eligible (80%)||7,750|
|Number of completes, Pretests (60%)||900||1||900||20/60||300|
|Number of completes, Study (60%)||3,750||1||3,750||20/60||1,250|
|Number of pretest/study completes||4,650|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
|2 Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format “[number of minutes per response]/60”.|
The following references have been placed on display in the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)
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 * * *”
2. Draft Guidance for Industry: `Help-Seeking' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms” (pg. 1). Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070068.pdf. Last accessed June 8, 2012.
3. Lee-Wingate, S. and Xie, Y. (2010). Consumer perceptions of product-claim versus help-seeking direct-to-consumer advertising. “International Journal of Pharmaceutical and Healthcare Marketing,” 4(3), 232-246.
4. Burke, R. R., DeSarbo, W. S., Oliver, R. L., and Robertson, T. S. (1988). Deception by implication: An experimental investigation. “Journal of Consumer Research,” 14(4), 483- 494; Harris, R. J. (1977) Comprehension of pragmatic implication in advertising. “Journal of Applied Psychology,” 62, 603-608; Jacoby, J. and Hoyer, W. (1987). “The comprehension and miscomprehension of print communications.” New York: The Advertising Educational Foundation.
5. Guidance for Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071975.pdf. Last accessed November 16, 2011.
6. Transcript available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM283132.pdf. Last accessed January 4, 2012.
Dated: June 14, 2012.
Assistant Commissioner for Policy.
[FR Doc. 2012-14989 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P