83 FR 39441 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Disclosures in Professional and Consumer Prescription Drug Promotion
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 154 (August 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 154 (August 9, 2018)
| Page Range | 39441-39448 | |
| FR Document | 2018-17045 |
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)] [Notices] [Pages 39441-39448] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17045] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0558] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Disclosures in Professional and Consumer Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 (PRA). DATES: Fax written comments on the collection of information by September 10, 2018. ADDRESSES: 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 oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-NEW and title ``Disclosures in Professional and Consumer Prescription Drug Promotion.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Disclosures in Professional and Consumer Prescription Drug Promotion OMB Control Number 0910-NEW I. 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 (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 regulates prescription drug advertising and promotional labeling directed to healthcare professionals (HCPs) and consumers (section 502(a) and (n), respectively, of the FD&C Act (21 U.S.C. 352(a) and (n))). In the course of promoting their products, pharmaceutical sponsors (sponsors) may present a variety of information including the indication, details about the administration of the product, efficacy information, and clinical trial data. To present often complicated information concisely, sponsors may not include relevant information in the body of the text or visual display of the claim. Additionally, sponsors may not always present limitations to the claim in the main body of the text or display. In these cases, sponsors typically include disclosures of information somewhere in the promotional piece. There is limited published research on disclosures in prescription drug promotion, either directed to consumers or to HCPs. The use of disclosures is one method of communicating information to HCPs and consumers about scientific and clinical data, the limitations of that data, and practical utility of that information. These disclosures may influence HCP and consumer comprehension and decision making, and may affect how and what treatment HCPs prescribe for their patients. Previous research on the effectiveness of disclosures has been conducted primarily in the dietary supplement arena (Refs. 1-4). Thus, the proposed research will examine the effectiveness of clear and conspicuous disclosures in prescription drug promotion directed to both populations. The purpose of our study is to determine how useful disclosures regarding prescription drug information are when presented prominently and adjacent to claims.\1\ Specifically, are HCPs and consumers able to use disclosures to effectively frame information in efficacy claims in prescription drug promotion? --------------------------------------------------------------------------- \1\ The Federal Trade Commission (FTC), which regulates the advertising of non-prescription drug products as well as other non- FDA regulated products (e.g., package goods, cars, etc.) issued a specific position on disclosures (Ref. 5) for the advertising it regulates. Specifically, FTC explains that disclosures must be ``clear and conspicuous''; in other words, in understandable language, located near the claim to be further clarified, and not hidden or minimized by small font or other distractions. --------------------------------------------------------------------------- To address this research question, we have designed a set of studies that cover both consumers and HCPs, as well as three presentations addressing different [[Page 39442]] types of information: Scope of treatment, ease of use, and statistical significance (see table 1). The scope of treatment information to be tested can be thought of as disease-awareness information; that is, a broader discussion of a medical condition that includes disease characteristics beyond what the promoted drug has been shown to treat. The disclosure for this condition will focus on the disease characteristics that the product has been shown to treat. The ease of use information to be tested is a simple claim of easy drug administration, followed by a disclosure that includes material information about drug administration. Finally, the statistical significance information to be tested includes a presentation of efficacy analyses, followed by a disclosure revealing that the results of the presented analyses were not statistically significant, and thus must be viewed with considerable caution. We selected these types of information because they are commonly seen in promotional material. Each participant will view three different professionally developed mock promotional print pieces for different prescription drug products that mimic currently available promotion. For each of the three promotional pieces, they will be randomized to see an ad with a weak disclosure, a strong disclosure, or no disclosure. We will manipulate the strength of disclosure by including additional concluding information (strong) or not (weak) in the disclosure statement. In all cases, disclosures will be adjacent to claims and written in font clear enough to be detected. Table 12--Identical Study Designs for Samples of HCPs and Consumers ---------------------------------------------------------------------------------------------------------------- Level of disclosure Type of claim -------------------------------------------------- Control Weak Strong ---------------------------------------------------------------------------------------------------------------- Study A: HCPs ---------------------------------------------------------------------------------------------------------------- Scope of Treatment................... Evidence Only.......... Evidence + Conclusion.. No Disclosure Ease of Use.......................... Evidence Only.......... Evidence + Conclusion.. No Disclosure Statistical Significance............. Evidence Only.......... Evidence + Conclusion.. No Disclosure ---------------------------------------------------------------------------------------------------------------- Study B: Consumers ---------------------------------------------------------------------------------------------------------------- Scope of Treatment................... Evidence Only.......... Evidence + Conclusion.. No Disclosure Ease of Use.......................... Evidence Only.......... Evidence + Conclusion.. No Disclosure Statistical Significance............. Evidence Only.......... Evidence + Conclusion.. No Disclosure ---------------------------------------------------------------------------------------------------------------- We will analyze the results of the scope of treatment disclosures, the ease of use disclosures, and the statistical significance disclosures independently of each other, even though each participant will see one of each. The claims and disclosures are different enough that practice effects should be moderated, but we will counterbalance the order of ads shown to minimize potential bias. Because promotional pieces intended for HCPs and consumers have different levels of complexity and medical depth, and because the amount of knowledge expected between the two groups differs, the studies will use separate mock promotional pieces and ask slightly different comprehension questions of each group. We will maintain as much similarity across groups as possible for descriptive comparisons. Both consumers and HCPs will be recruited from internet panels. Because promotional pieces will represent three different medical conditions, we will obtain a general population sample of consumers and a HCP sample of primary care physicians. We will exclude individuals who are employees of the U.S. Department of Health and Human Services or who work in pharmaceutical, advertising, or marketing settings because their knowledge and experiences may not reflect those of the typical healthcare provider or consumer. Eligible participants who agree to participate voluntarily in this survey will view mock promotional pieces and answer questions about their comprehension of the main messages in the promotion, perceptions of the product, attention to disclosures and intention to ask a HCP about it (consumers) or to prescribe the product (HCPs). Questionnaires are available upon request. Pretests will be conducted before conducting the main studies to ensure the mock promotional pieces are realistic and that the questionnaire flows well and questions are reasonable. We will supplement the findings of the pretests with two small eye-tracking studies. Researchers use eye-tracking technology to capture viewing behavior that is independent of self-report. The technology measures where and for how long participants glanced at or examined particular parts of a display. It has been used in studies of consumer print advertising (Refs. 6-8) and internet promotion (Refs. 9 and 10). To our knowledge, there is little or no published research using eye-tracking technology with HCPs. We will use these small eye-tracking studies to determine what parts of each promotional piece consumers and HCPs actually viewed. Specifically, we will be able to determine whether they looked at the disclosure statement at all, and we can obtain a rough idea of how long they looked at it. This data will complement the self-reported items on the questionnaire. Moreover, we will use this data, as well as the pretest data, to improve the main studies. For this part of the study, 20 consumers and 20 HCPs will view the promotional pieces. In the Federal Register of June 14, 2017 (82 FR 27268), FDA published a 60-day notice requesting public comment on the proposed collection of information. Four comments were received. Responses to those comments follow. For brevity, some public comments are paraphrased and therefore may not reflect the exact language used by the commenter. We assure commenters that the entirety of their comments was considered even if not fully captured by our paraphrasing in this document. The following acronyms are used here: DTC = direct-to- consumer; HCP = healthcare professional; FDA and ``The Agency'' = Food and Drug Administration; OPDP = FDA's Office of Prescription Drug Promotion. The first public comment responder (regulations.gov tracking number lkl-8y39-rtyb) included 25 individual [[Page 39443]] comments, to which we have responded. Comment 1a (summarized): FDA is conducting too much research without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health. The Agency should publish a comprehensive list of its prescription drug advertising and promotion studies from the past 5 years and articulate a clear vision for its research priorities for the near future. Response 1a: OPDP's mission is to protect the public health by helping to ensure that prescription drug information is truthful, balanced, and accurately communicated, so that patients and healthcare providers can make informed decisions about treatment options. OPDP's research program supports this mission by generating scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that we believe are most central to our mission, focusing in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits; focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience; and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. Because we recognize the strength of data and the confidence in the robust nature of the findings is improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage, which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website includes links to the latest Federal Register notices and peer-reviewed publications produced by our office. The website maintains information on studies we have conducted, dating back to a survey of DTC attitudes and behaviors conducted in 1999. Comment 1b (The commenter provided a summary of the comments followed by a more detailed description of the same comments. For brevity, the summary of comments has been omitted and only the specific comments [1b through 1y] are provided below. The commenter's full comments may be accessed at regulations.gov via tracking number lkl- 8y39-rtb) (verbatim): It is not clear from this description whether the study will yield useful information to evaluate whether disclosures provide appropriate contextual information in certain communications, whether such disclosures can be made more effective, and where the disclosures are necessary to ensure communications are truthful and non-misleading. The Agency should provide significantly more detail regarding the design of the study, the proposed disclosures, the mock promotional pieces, and the information it seeks to collect. Response 1b: We have provided the purpose of the study, the design, the population of interest, and have provided the questionnaire to numerous individuals upon request. These materials have proven sufficient for others to comment publicly, and for academic experts to peer-review the study successfully. We do not make draft stimuli public during this time because of concerns that this may contaminate our participant pool and compromise the research. Comment 1c (summarized): After pretesting, the Agency should make available revised questionnaires, data collection methodologies, and stimuli. Response 1c: In this current notice, we provide the revised design as based on academic peer reviewers, cognitive interviewing, and public comments. The revised questionnaire is also available upon request. Our full stimuli are under development during the PRA process. We do not make draft stimuli public during this time because of concerns that this may contaminate our participant pool and compromise the research. Individuals are welcome to inquire about the progress of the study and any changes from the pretests will be communicated at that time. Comment 1d (summarized): FDA should base mock promotional stimuli on realistic promotional pieces. Response 1d: We have done this. Our stimuli are modified from actual promotional pieces in the marketplace to disguise the original product. Comment 1e (summarized): It is unclear whether such disclosures will contain relevant information ordinarily provided in promotional materials. Response 1e: The goal of our research is to obtain answers to questions about prescription drug promotion that will inform the Agency and stakeholders. Thus, we strive in all of our studies to make our mock promotional pieces as realistic as possible. That includes any disclosures that we may include in testing. Also, please see response to comment 1d. Comment 1f (verbatim): FDA seems to have an overly broad conception of the need for disclosures for ``scope of treatment'' communications. In the Notice, FDA describes this type of communication as ``a disease- awareness claim; that is, a broader discussion of a medical condition that may include disease characteristics beyond what the promoted drug has been shown to treat.'' Where a disease awareness communication discusses a disease in a manner beyond what the promoted drug has been shown to treat, but does so in a balanced manner without implying any particular treatment benefits from the associated drug, it should be viewed as providing helpful general background information on the disease, and not as making an off-label claim for the drug. In those circumstances, there should be no need for any disclosure about the limits of use of the drug. FDA should clarify its understanding of ``scope of treatment'' claims and make its proposed claims and disclosures available for public comment. Response 1f: Previous research has demonstrated that presenting study participants with information about the consequences of a disease, particularly when the information was integrated into one print ad with information about a particular drug, resulted in false beliefs that the advertised drug prevented those consequences.\2\ The ``scope of treatment'' claims that are included in this research are embedded in mock promotional materials, juxtaposed with specific efficacy information about the mock drug products. As such, they will likely imply ``particular treatment benefits from the associated drug.'' This research will help us to evaluate the usefulness of a disclosure in relation to this type of information when it is found in promotional pieces. Also, please see response to comment 1c. --------------------------------------------------------------------------- \2\ Aikin, K.J., H.W. Sullivan, and K.R. Betts, (2016). ``Disease information in direct-to-consumer prescription drug print ads.'' Journal of Health Communication, 21(2), pp. 228-239. --------------------------------------------------------------------------- [[Page 39444]] Comment 1g (verbatim): FDA states that the ``ease of use'' claim ``is a simple claim of easy drug administration that omits specific important details that contribute to a more difficult drug administration than suggested.'' This statement appears to imply that all ease of use claims are misleading, where the Agency perhaps intends to clarify that validated and non-misleading ``ease of use'' claims may require a disclosure or more context. FDA should clarify its understanding of ``ease of use'' claims, and, in testing, ensure it does not test overly misleading base claims for ``ease of use'' that would be difficult to contextualize with a disclosure statement and hence would bias the results of its study. Such claims should be made available for public comment. Response 1g: FDA did not intend to imply that all ease of use claims are misleading or that all ease of use claims would necessarily require a disclosure. FDA agrees that some ease of use statements require a disclosure or more context and intends to evaluate one such example with this research. We have revised the description of the study in this notice to clarify. Also, please see response to comment 1c. Comment 1h (verbatim): FDA states that the ``statistical significance'' claim ``will be one in which the disclosure reveals that the presented analyses were not statistically significant, and thus must be viewed with considerable caution.'' It is not clear what content FDA intends to test for this type of claim. We encourage FDA to clarify how it intends to present ``not statistically significant'' analyses for testing in order to ensure such claims are presented with appropriate contextual information. Such claims should be made available for public comment. Response 1h: Please see responses to comment 1c, 1d, and 1e. Comment 1i (summarized): The Agency should clarify what distinctions will be made between HCP and consumer pieces. Response 1i: As our mock promotional pieces have been adapted from existing materials in the public domain, the materials directed to HCPs and to consumers vary in similar ways to what can currently be seen in the public domain. For example, materials directed to HCPs tend to have more data, more technical medical language, and more text in general. Consumer pieces are generally written in plainer language and generally do not include as much data and statistical information. Our pieces are highly realistic as they were developed from actual promotional pieces. Comment 1j (verbatim): The Agency proposes that consumer and HCP subjects will be recruited from internet panels, indicating that the study will be conducted using an electronic format. Because the proposed research topic is not dependent on an electronic medium, FDA should consider testing non-electronic media as well, including printed promotional pieces. Response 1j: Although our study will be conducted via the internet, we will show participants mock print materials in .pdf format. Comment 1k (verbatim): The Agency proposes to use eye-tracking studies to complement the self-reported items on the questionnaire and to improve the main studies. [The commenter] encourages the Agency to use this technology in conjunction with other inputs (for example, qualitative research) to understand why subjects are looking at a portion of the proposed materials, rather than to draw conclusions that such portions were viewed. Additionally, an explanation of the use of eye-tracking technology should also be included during the subject enrollment process. Response 1k: FDA plans to collect and analyze eye-tracking (physical measures of attention) data in conjunction with other measures, including cognitive interviews. To avoid the potential for priming effects, the eye-tracking component of the study will not be explained to recruited individuals before they report for their in- person sessions. However, participants will be made aware of the eye- tracking component during the informed consent process. Comment 1l (summarized): The commenter recommends increasing the sample size of the eye-tracking components to ensure more robust data. Response 1l: Our primary method of analysis of the eye-tracking data will be examination of gaze plots coupled with self-report data provided by participants. Thus, eye-tracking results will be examined on an individual, rather than aggregate, level. Furthermore, the eye- tracking studies included in this research are intended as qualitative, formative studies; they will be used to inform any necessary changes to the stimuli before the main studies. Formative eye-tracking studies such as these are often executed with sample sizes as small as five participants.\3\ In our experience, a sample of 20 participants in each population ensures that we will collect fully useable data from a minimum of 15 participants in each population. Used as an observation tool, eye-tracking complements the other data collected to increase discoverability of specific events and confidence in our qualitative findings. --------------------------------------------------------------------------- \3\ Pernice, K. and J. Nielsen, (2009). ``How to Conduct Eyetracking Studies.'' https://media.nngroup.com/media/reports/free/How_to_Conduct_Eyetracking_Studies.pdf. --------------------------------------------------------------------------- Comment 1m (summarized): The commenter recommends limiting the participant sample to disease sufferers rather than a general population sample. Response 1m: We carefully consider the type of sample to use in each of our studies. In the current study, the population of sufferers for the conditions addressed by our stimuli (i.e., chronic obstructive pulmonary disease (COPD), chronic iron overload, and high blood pressure) are varied. Because we are showing participants more than one ad, we chose not to select diagnosed populations or specialists. Comment 1n (summarized): FDA should recruit a demographically and geographically diverse sample. Response 1n: We agree and we plan to recruit individuals with a range of gender, race, ethnicity, and, as much as possible within an internet sample, socioeconomic status. For the consumer sample, we aim for a sample with 60 percent of people who have some college or less. An advantage of sampling via internet panel is that we have access to individuals in all parts of the United States. Comment 1o (verbatim): FDA should capture whether subjects comprehend certain information disclosed in the mock promotional pieces, even if the subject does not recall information on the specifics. Currently, open-ended and recall questions (e.g., Consumer Questionnaire Q2-Q3; HCP Questionnaire Q2-Q3) ask test subjects to identify certain information regarding the featured drug products (what a mock drug product is specifically ``used for'' or ``not approved for''). It is not clear why such an open-ended format or questions are necessary for the research purpose of the study, as subjects could recognize a limit to the efficacy being presented even if they do not follow or recall all of the details of a disclosure. Response 1o: We do intend to capture what information has been observed in the mock promotional pieces, and we do this through the open-ended and recall questions. It is common practice to include open- ended and closed-ended questions in one research study, as they tend to complement each other. Open-ended questions allow responses that have not been prompted by particulars, which is not the case with closed- ended questions. Closed-ended questions [[Page 39445]] provide a more efficient way of obtaining information. Comment 1p (summarized): FDA should ensure that terms used in the consumer pieces are consumer-friendly. Response 1p: We agree and always review our mock consumer pieces for lay language. The terms mentioned by the commenter (e.g., chronic iron overload, COPD, lung function, scientific evidence, effectiveness, statistically significant) will be used in the HCP materials. However, we also strive to make our materials as realistic as possible, and in this case, we have modified existing DTC pieces for consumers. If they used a term (e.g., COPD), and OPDP reviewers agreed that this is common and acceptable, we maintained it in our mock pieces. Comment 1q (summarized): FDA should consider changing the sliding scale format of Q4. Response 1q: We carefully develop each question of our questionnaires, taking into account language and response options. No cognitive interview participant reported confusion with this sliding scale question. Without scientific justification for changing the response format of this question, we will maintain the current format. Comment 1r (verbatim): In a study setting, subjects may be prone to pay attention to more or all of the information presented throughout the study, including claims designed to be intentionally misleading. As a result, subjects are more likely to be biased based on the strength or weakness of the claims and disclosures presented. The Agency should address what efforts it will take to avoid response bias by presenting these varying degrees of disclosures. Response 1r: The study is designed so that participant will be randomly assigned to condition. Moreover, the only aspect of the participants' experiences that will be varied in the study will be the manipulations that we have described. Any individual differences in attention or ability or potential biases should be spread across experimental conditions. Thus, if we find differences between and among conditions, we can be reasonably sure that the manipulations caused the differences. We have not found in the past that our participants spend an inordinate amount of time viewing stimuli, but we will be careful to place the research in context when we interpret the data. Comment 1s (verbatim): The Consent Text introduction should not state that the survey is being conducted ``on behalf of the U.S. Food and Drug Administration.'' This statement could potentially influence subjects' responses to study questions. Instead, this information might be provided at the conclusion of the study. Response 1s: In previous studies, we took this same view and typically used ``Department of Health and Human Services.'' We will incorporate this change. Comment 1t (verbatim): Questions regarding statements in ads (Consumer Questionnaire Q10, Q20, Q30; HCP Questionnaire Q12, Q22, Q33) should be the first questions presented following the subjects' viewing of a promotional piece. A subject will likely recall the statements that appeared in the promotional piece most accurately immediately after reviewing the piece and before answering other questions that could influence their selection of answers. Response 1t: As with all other aspects of study design, we carefully develop questionnaires with order effects in mind. Therefore, we chose to include questions regarding perception of efficacy or ease of use, information seeking, and behavioral intention first because it is important that participant responses to these items be based solely on the information presented in the ads. The questions referenced by the commenter also include incorrect recall items, which could potentially bias responses to later questions if the order was changed. Additionally, repeated exposures to the correct recall items in the above-referenced questions could have a reinforcing effect that could confound results. Comment 1u (verbatim): In the Consumer Questionnaire, an ``FDA employee'' category, similar to S7 and S8, should be added to the Screener Survey. These individuals should also be terminated from the study. Response 1u: We will revise question S8 to read, ``Do you work for a pharmaceutical company, an advertising agency, a market research company, or the U.S. Department of Health and Human Services?'' to capture these individuals, as suggested. Comment 1v (verbatim): In the Consumer Questionnaire, Q8-Q9 should be presented prior to Q6-Q7 in order to prevent bias in favor of non- HCP sources. Similarly, Q19 should appear before Q18, and Q28 should appear before Q27. Response 1v: We will reorder the questionnaire as the commenter suggested. Comment 1w (summarized): We recommend that Q8-Q9, Q19, and Q28 be expanded to more fully evaluate the role of the prescriber in aiding consumers' understanding of disclaimers in promotional materials. Response 1w: HCPs are often a very important source of information about prescription drugs. However, when prescription drugs are promoted directly to consumers, they may be more likely to look for information on their own before taking steps to consult their HCPs. We have taken this into account in this study by examining the responses of both consumers and HCPs. Comment 1x (verbatim): In the HCP Questionnaire, Q5, Q7, and Q29 should be omitted. Comparative efficacy is highly dependent on the particular HCP subject's experience outside the experiment setting; this question thus may lead to highly variable results. Further, how the drug featured in the mock promotional communication compares to other prescription medications has no relevance to FDA's stated study goals. Questions regarding comparative efficacy should thus be omitted from the proposed HCP Questionnaire. Response 1x: Comparative efficacy questions are another way to assess how HCPs respond to prescription drug promotion. Any subjective experiences outside the experiment setting should fall out because HCPs will be randomly assigned to conditions. The questions are relevant to our study because HCPs make comparative decisions each time they make a prescribing decision. Comment 1y (verbatim): In the HCP Questionnaire, Q34 does not appear to provide appropriate programming instructions for the scenario in which Q33_A=01 and Q33_D=01. FDA should confirm that Q33 may be asked if subjects select both Q33_A and Q33_D, and provide that this question may be repeated for both responses. The variable label text for Q34 should also be rewritten as follows: ``How much did the statement [disclosure] influence your assessment of the scientific evidence for [D]esyflux?'' Response 1y: Q33 asks whether participants have seen any of the listed statements. Q34 is asked for each of Q33_A and Q33_D when they respond affirmatively to that statement in Q33. Thus, participants who chose option 01 for both items will see two separate questions. We will make the suggested changes to Q34. The second public comment responder (regulations.gov tracking number lkl-8y11-169c) included four individual comments, to which we have responded. Comment 2a (summarized): FDA should give consideration to the representativeness of online study [[Page 39446]] volunteers to the general public who will view print ads. Response 2a: This is an excellent point and one to which we have given much thought. As with all research, there is a tradeoff of efficiencies when it comes to collecting information from volunteers. Recruiting from internet panels is a relatively economical way to achieve large sample sizes from all across the United States, making it possible to achieve geographic and urban/rural diversity in a way that was not previously possible. However, it is true that members of lower socioeconomic classes do not have the same access to computers and the internet, and therefore our sample may be skewed toward individuals who have higher education and/or income. We have attempted to mitigate this issue by aiming for recruitment of 60 percent of individuals with some or no college and 40 percent of individuals with a college degree or more. While it is important to note that random assignment of respondents to experimental conditions provides us the ability to make causal claims about our findings, we do note that truncating the population from which we sample is a limitation of the study and will describe this in any publication or presentation that results from the data. Comment 2b (verbatim): We suggest that the study include electronic advertisements in addition to print advertisements to account for and reflect changes in consumer consumption of media, including the increase of electronic promotion and advertising of products by sponsors. Response 2b: We agree that more information and promotion is moving to electronic presentations, including the internet, mobile applications, and other communication formats. However, the questions we ask in this current study are fundamental questions that should not differ based on presentation format. Moreover, our print ads are similar to what might be shown on a website, which is a prominent electronic format. We have other studies ongoing that are examining other electronic presentation modes (e.g., 82 FR 32842, July 18, 2017). Comment 2c (summarized): If the three levels of disclosure are to be strong, weak, and none, we recommend considering the following levels of disclosure:Additional concluding information makes it strong Less additional information makes it weak No additional information makes it none Response 2c: Thank you for clearly investing time and energy in responding to this study design. The suggested levels of disclosure are effectively the same as what we have included in our study design. The weak disclosure provides some additional information, while the strong disclosure provides both the additional information and an explicit conclusion based on the information. Comment 2d (summarized): FDA should keep in mind that stronger disclosures may be longer, therefore eye-tracking time may reflect length, not necessarily effectiveness. Response 2d: The commenter is correct in that a longer block of text will generally result in a longer gaze fixation. We have taken steps to keep the stronger disclosures as close as possible in length to the weaker disclosures. However, as noted previously, eye-tracking outcomes will be analyzed qualitatively. Our primary interest is whether the disclosure was attended to--the length of attention is of less interest in this case. The third public comment responder (regulations.gov tracking number lkl-8y16-bf58) included five individual comments, to which we have responded. Comment 3a (summarized): The commenter assumes that stimuli will conform to FDA regulations and requirements in non-study aspects and will not overdramatize claims versus disclosures. Response 3a: All stimuli will conform to FDA regulations, as reviewed by OPDP reviewers. Additionally, we have designed the materials to fall within realistic parameters, thus the claims and disclosures are representative of what we may see in the marketplace. Comment 3b (summarized): The commenter includes a section titled ``Comments on the Brief Summary and Provision of Risk Information in Advertising'' wherein FDA is encouraged to continue to consider the purpose and practical limits of advertising. Response 3b: FDA agrees that a consideration of the purpose and practical limits of prescription drug promotion will guide the development of research projects. Otherwise, the comment appears to fall outside the scope of this particular proposed research. Comment 3c (summarized): Add ``Don't Know'' options for questions about perceived effectiveness in the consumer questionnaire. Response 3c: Questions about perceived effectiveness by definition involve subjective rather than objective assessments of effectiveness. Participants have the option to skip these questions if they wish. Comment 3d (verbatim): We suggest also including questions to capture whether respondents have a general understanding that there are limitations to the data and information being presented, even if they do not recall specific information and disclosure statements. Response 3d: This is a good suggestion, but it is important to phrase such questions appropriately. For example, simply asking participants if they believe the data is thorough and complete or that the data has limitations is not likely to yield useful information. However, there are several validated skepticism scales that approach this idea of trusting the validity of presented information. Although these items are not tied to data specifically, they will provide some information for us about how much individuals rely on the data. We have added two questions near the end of the survey to address this issue. Comment 3e (summarized): The commenter recommends deleting ``. . . from a source other than your healthcare provider'' from questions 6 and 7. Response 3e: Because we ask about seeking information from a HCP in other questions, we will retain this distinction in Q6 and Q7 for clarity. The fourth public comment responder (regulations.gov tracking number lkl-8y38-n0p8) included eight individual comments, to which we have responded. Comment 4a (summarized): The commenter is supportive of the research. Response 4a: Thank you for your support. Comment 4b (summarized): The commenter suggests carefully selecting medical conditions to ensure a range of therapeutic areas. Specifically, they suggest one life-threatening condition (e.g., cardiovascular conditions leading to stroke), one chronic condition (e.g., atopic dermatitis), and one non-life-threatening and non-chronic condition (e.g., urinary tract infection). Response 4b: FDA believes this proposed range of medical conditions is a great way to choose therapeutic categories. For the current study, however, we limited ourselves to medical conditions that have existing promotional pieces that include a variety of limitations that can be feasibly explained in a disclosure. We will keep the commenter's approach in mind and apply it in future research when possible. Comment 4c (summarized): The commenter suggests selecting a diversity [[Page 39447]] of participants, including gender, race, ethnicity, socioeconomic status, etc., to better represent the population at large. Also, FDA should consider inclusion and exclusion criteria for HCPs and consumers carefully. Response 4c: We agree that these characteristics are important and strive to obtain representativeness across a variety of personal demographics. Although we will aim to recruit a diverse group of participants with sufficient variation on demographic characteristics such as gender, race, age, and education, we note that this study features random assignment to condition, whereby these demographic characteristics should have an equal chance of occurring. In terms of HCPs, we will include them if they are primary care physicians, and will work to recruit a sample with sufficient diversity on demographic characteristics as noted above. Comment 4d (verbatim): It is critical that FDA evaluates the merits of unbiased introduction by not presenting a promotional piece to HCPs with specialty in the same therapeutic category. Response 4d: For this study, we will be recruiting only primary care physicians and not specialists. Thus, while any given participant may have experience treating one or more of the conditions represented by our stimuli, none should have specialties in the respective therapeutic categories. Comment 4e (summarized): The commenter encourages the use of a health literacy competency tool such as a readability calculator to ensure consumers can understand the language. Response 4e: We agree that the plain language communication of information is critical for the best public health outcomes. Nevertheless, our aim in this study is to test promotional materials that are available in the public domain. Although we have disguised the products and campaigns in our mock stimuli, all pieces are derived directly from promotion in the marketplace. We feel this is important to ensure that our study is relevant. Comment 4f (summarized): The commenter recommends recruiting through hospitals, doctor offices, and clinics rather than via the internet. The commenter suggests that this will expand on the pool of participants, help minimize potential bias, and ensure the entire population of the United States is represented as not everyone has access to or uses the internet. Response 4f: Please see our response to comment 2a. Comment 4g (summarized): The commenter recommends conducting subgroup analyses, such as with older adults. Response 4g: We will examine covariates including age, race, and education level to determine whether these variables have any effect on our findings. This study is not designed to conduct between-subgroup analyses. If we detect relevant trends, such subgroup analyses may become good candidates for future studies. Comment 4h (verbatim): [The commenter] recommends that the FDA communicate the actions they will take based on the study results and analysis. We also encourage FDA to provide further communication about when FDA will publish the study results, how the study results will be applied, and how this will impact the work of FDA. Response 4h: Please see our response to comment 1a. FDA estimates the burden of this collection of information as follows: Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response \2\ ---------------------------------------------------------------------------------------------------------------- Consumers ---------------------------------------------------------------------------------------------------------------- Pretest Screener.............. 833 1 833 0.03 (2 minutes) 25 Pretest....................... 500 1 500 0.33 (20 165 minutes). Eye-Tracking Screener......... 80 1 80 0.08 (5 minutes) 7 Eye-Tracking Study............ 20 1 20 1............... 20 Main Study Screener........... 2,500 1 2,500 0.03 (2 minutes) 75 Main Study.................... 1,500 1 1,500 0.33 (20 495 minutes). ---------------------------------------------------------------------------------------------------------------- HCPs ---------------------------------------------------------------------------------------------------------------- Pretest Screener.............. 735 1 735 0.03 (2 minutes) 22 Pretest....................... 500 1 500 0.33 (20 165 minutes). Eye-Tracking Screener......... 80 1 80 0.08 (5 minutes) 7 Eye-Tracking Study............ 20 1 20 1............... 20 Main Study Screener........... 2,206 1 2,206 0.03 (2 minutes) 67 Main Study.................... 1,500 1 1,500 0.33 (20 495 minutes). --------------------------------------------------------------------------------- Total..................... .............. .............. .............. ................ 1,563 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Rounded to the next full hour. II. References The following references are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Dodge, T. and A. Kaufman. ``What Makes Consumers Think Dietary Supplements Are Safe and Effective? The Role of Disclaimers and FDA Approval.'' Health Psychology, 26(4), 513-517. (2007). 2. Dodge, T., D. Litt, and A. Kaufman. ``Influence of the Dietary Supplement Health and Education Act on Consumer Beliefs About the Safety and Effectiveness of Dietary Supplements.'' Journal of Health Communication: International Perspectives. 16(3), 230-244. (2011). [[Page 39448]] 3. Mason, M.J., D.L. Scammon, and X. Feng. ``The Impact of Warnings, Disclaimers and Product Experience on Consumers' Perceptions of Dietary Supplements.'' Journal of Consumer Affairs, 41(1), 74-99. (2007). 4. France, K.R. and P.F. Bone. ``Policy Makers' Paradigms and Evidence from Consumer Interpretations of Dietary Supplement Labels.'' Journal of Consumer Affairs, 39(1), 27-51. (2005). 5. FTC. ``Full Disclosure.'' Accessed at: https://www.ftc.gov/news-events/blogs/business-blog/2014/09/full-disclosure (September 23, 2014) Last accessed on June 22, 2018. 6. Higgins, E., M. Leinenger, and K. Rayner. ``Eye Movements When Viewing Advertisements.'' Frontiers in Psychology, 5, 210. (2014). 7. Pieters, R., M. Wedel, and R. Batra. ``The Stopping Power of Advertising: Measures and Effects of Visual Complexity.'' Journal of Marketing, 74(5), 48-60. (2010). 8. Thomsen, S. and K. Fulton. ``Adolescents' Attention to Responsibility Messages in Magazine Alcohol Advertisements: An Eye- Tracking Approach.'' Journal of Adolescent Health, 41, 27-34. (2007). 9. Simola, J., J. Kuisma, A. [Ouml][ouml]rni, L. Uusitalo, et al. ``The Impact of Salient Advertisements on Reading and Attention on Web pages.'' Journal of Experimental Psychology: Applied, 17(2), 174-190. (2011). 10. Wedel, M. and R. Pieters. ``A Review of Eye-Tracking Research in Marketing.'' In Review of Marketing Research, vol. 4 (pp. 123-147), N. K. Malhotra (Ed.). Armonk, New York: M. E. Sharpe. (2008). Dated: August 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17045 Filed 8-8-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39441
meetings and other committee DEPARTMENT OF HEALTH AND FDA to conduct research relating to
management activities, for both the HUMAN SERVICES drugs and other FDA regulated products
Centers for Disease Control and in carrying out the provisions of the
Prevention and the Agency for Toxic Food and Drug Administration FD&C Act.
Substances and Disease Registry. FDA regulates prescription drug
[Docket No. FDA–2017–N–0558]
advertising and promotional labeling
Sherri A. Berger, directed to healthcare professionals
Agency Information Collection
Chief Operating Officer, Centers for Disease (HCPs) and consumers (section 502(a)
Control and Prevention. Activities; Submission for Office of
Management and Budget Review; and (n), respectively, of the FD&C Act
[FR Doc. 2018–17042 Filed 8–8–18; 8:45 am] (21 U.S.C. 352(a) and (n))). In the course
Comment Request; Disclosures in
BILLING CODE 4163–18–P
Professional and Consumer of promoting their products,
Prescription Drug Promotion pharmaceutical sponsors (sponsors) may
present a variety of information
DEPARTMENT OF HEALTH AND AGENCY: Food and Drug Administration, including the indication, details about
HUMAN SERVICES HHS. the administration of the product,
ACTION: Notice. efficacy information, and clinical trial
Centers for Disease Control and data. To present often complicated
Prevention SUMMARY: The Food and Drug information concisely, sponsors may not
Administration (FDA) is announcing include relevant information in the
Notice of Closed Meeting that a proposed collection of body of the text or visual display of the
information has been submitted to the claim. Additionally, sponsors may not
In accordance with Section 10(a)(2) of
Office of Management and Budget always present limitations to the claim
the Federal Advisory Committee Act
(OMB) for review and clearance under in the main body of the text or display.
(Pub. L. 92–463), the Centers for Disease
the Paperwork Reduction Act of 1995 In these cases, sponsors typically
Control and Prevention (CDC)
(PRA). include disclosures of information
announces the following meeting.
The meeting will be closed to the DATES: Fax written comments on the somewhere in the promotional piece.
collection of information by September There is limited published research
public in accordance with provisions set
10, 2018. on disclosures in prescription drug
forth in Section 552b(c) (4) and (6), Title
ADDRESSES: To ensure that comments on promotion, either directed to consumers
5 U.S.C., and the Determination of the or to HCPs. The use of disclosures is one
Director, Management Analysis and the information collection are received,
OMB recommends that written method of communicating information
Services Office, CDC, pursuant to Public to HCPs and consumers about scientific
Law 92–463. comments be faxed to the Office of
Information and Regulatory Affairs, and clinical data, the limitations of that
Name of Committee: Safety and data, and practical utility of that
Occupational Health Study Section OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_ information. These disclosures may
(SOHSS), National Institute for influence HCP and consumer
Occupational Safety and Health submission@omb.eop.gov. All
comments should be identified with the comprehension and decision making,
(NIOSH). and may affect how and what treatment
OMB control number 0910–NEW and
Dates: October 16–October 18, 2018. title ‘‘Disclosures in Professional and HCPs prescribe for their patients.
Time: 8:00 a.m.–5:00 p.m., EDT. Consumer Prescription Drug Previous research on the effectiveness of
Promotion.’’ Also include the FDA disclosures has been conducted
Place: Embassy Suites, 1900 Diagonal
primarily in the dietary supplement
Road, Alexandria, VA 22314. docket number found in brackets in the
arena (Refs. 1–4). Thus, the proposed
Agenda: The meeting will convene to heading of this document.
research will examine the effectiveness
address matters related to the conduct of FOR FURTHER INFORMATION CONTACT: Ila
of clear and conspicuous disclosures in
Study Section business and for the S. Mizrachi, Office of Operations, Food prescription drug promotion directed to
study section to consider safety and and Drug Administration, Three White both populations. The purpose of our
occupational health-related grant Flint North, 10A–12M, 11601 study is to determine how useful
applications. Landsdown St., North Bethesda, MD disclosures regarding prescription drug
For Further Information Contact: Nina 20852, 301–796–7726, PRAStaff@ information are when presented
Turner, Ph.D., Scientific Review Officer, fda.hhs.gov. prominently and adjacent to claims.1
NIOSH, 1095 Willowdale Road, SUPPLEMENTARY INFORMATION: In Specifically, are HCPs and consumers
Morgantown, WV 26506, (304) 285– compliance with 44 U.S.C. 3507, FDA able to use disclosures to effectively
5976; nturner@cdc.gov. has submitted the following proposed frame information in efficacy claims in
The Director, Management Analysis collection of information to OMB for prescription drug promotion?
and Services Office, has been delegated review and clearance. To address this research question, we
the authority to sign Federal Register have designed a set of studies that cover
Disclosures in Professional and both consumers and HCPs, as well as
notices pertaining to announcements of Consumer Prescription Drug Promotion
meetings and other committee three presentations addressing different
management activities, for both the OMB Control Number 0910–NEW
1 The Federal Trade Commission (FTC), which
Centers for Disease Control and I. Background regulates the advertising of non-prescription drug
sradovich on DSK3GMQ082PROD with NOTICES
Prevention and the Agency for Toxic products as well as other non-FDA regulated
Substances and Disease Registry. Section 1701(a)(4) of the Public products (e.g., package goods, cars, etc.) issued a
Health Service Act (42 U.S.C. specific position on disclosures (Ref. 5) for the
Sherri Berger, 300u(a)(4)) authorizes FDA to conduct advertising it regulates. Specifically, FTC explains
Chief Operating Officer, Centers for Disease research relating to health information. that disclosures must be ‘‘clear and conspicuous’’;
Control and Prevention. in other words, in understandable language, located
Section 1003(d)(2)(C) of the Federal near the claim to be further clarified, and not
[FR Doc. 2018–17043 Filed 8–8–18; 8:45 am] Food, Drug, and Cosmetic Act (FD&C hidden or minimized by small font or other
BILLING CODE 4163–18–P Act) (21 U.S.C. 393(d)(2)(C)) authorizes distractions.
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comments, to which we have reviewed publications produced by our Comment 1e (summarized): It is
responded. office. The website maintains unclear whether such disclosures will
Comment 1a (summarized): FDA is information on studies we have contain relevant information ordinarily
conducting too much research without conducted, dating back to a survey of provided in promotional materials.
articulating a clear, overarching research DTC attitudes and behaviors conducted Response 1e: The goal of our research
agenda or adequate rationales on how in 1999. is to obtain answers to questions about
the proposed research related to the goal Comment 1b (The commenter prescription drug promotion that will
of further protecting public health. The provided a summary of the comments inform the Agency and stakeholders.
Agency should publish a followed by a more detailed description Thus, we strive in all of our studies to
comprehensive list of its prescription of the same comments. For brevity, the make our mock promotional pieces as
drug advertising and promotion studies summary of comments has been omitted realistic as possible. That includes any
from the past 5 years and articulate a and only the specific comments [1b disclosures that we may include in
clear vision for its research priorities for through 1y] are provided below. The testing. Also, please see response to
the near future. commenter’s full comments may be comment 1d.
Response 1a: OPDP’s mission is to accessed at regulations.gov via tracking
protect the public health by helping to number lkl-8y39-rtb) (verbatim): It is not Comment 1f (verbatim): FDA seems to
ensure that prescription drug clear from this description whether the have an overly broad conception of the
information is truthful, balanced, and study will yield useful information to need for disclosures for ‘‘scope of
accurately communicated, so that evaluate whether disclosures provide treatment’’ communications. In the
patients and healthcare providers can appropriate contextual information in Notice, FDA describes this type of
make informed decisions about certain communications, whether such communication as ‘‘a disease-awareness
treatment options. OPDP’s research disclosures can be made more effective, claim; that is, a broader discussion of a
program supports this mission by and where the disclosures are necessary medical condition that may include
generating scientific evidence to help to ensure communications are truthful disease characteristics beyond what the
ensure that our policies related to and non-misleading. The Agency should promoted drug has been shown to
prescription drug promotion will have provide significantly more detail treat.’’ Where a disease awareness
the greatest benefit to public health. regarding the design of the study, the communication discusses a disease in a
Toward that end, we have consistently proposed disclosures, the mock manner beyond what the promoted drug
conducted research to evaluate the promotional pieces, and the information has been shown to treat, but does so in
aspects of prescription drug promotion it seeks to collect. a balanced manner without implying
that we believe are most central to our Response 1b: We have provided the any particular treatment benefits from
mission, focusing in particular on three purpose of the study, the design, the the associated drug, it should be viewed
main topic areas: Advertising features, population of interest, and have as providing helpful general background
including content and format; target provided the questionnaire to numerous information on the disease, and not as
populations; and research quality. individuals upon request. These making an off-label claim for the drug.
Through the evaluation of advertising materials have proven sufficient for In those circumstances, there should be
features we assess how elements such as others to comment publicly, and for no need for any disclosure about the
graphics, format, and disease and academic experts to peer-review the limits of use of the drug. FDA should
product characteristics impact the study successfully. We do not make clarify its understanding of ‘‘scope of
communication and understanding of draft stimuli public during this time treatment’’ claims and make its
prescription drug risks and benefits; because of concerns that this may proposed claims and disclosures
focusing on target populations allows us contaminate our participant pool and available for public comment.
to evaluate how understanding of compromise the research. Response 1f: Previous research has
prescription drug risks and benefits may Comment 1c (summarized): After demonstrated that presenting study
vary as a function of audience; and our pretesting, the Agency should make participants with information about the
focus on research quality aims at available revised questionnaires, data consequences of a disease, particularly
maximizing the quality of research data collection methodologies, and stimuli. when the information was integrated
through analytical methodology Response 1c: In this current notice, into one print ad with information about
development and investigation of we provide the revised design as based a particular drug, resulted in false
sampling and response issues. on academic peer reviewers, cognitive beliefs that the advertised drug
Because we recognize the strength of interviewing, and public comments. The prevented those consequences.2 The
data and the confidence in the robust revised questionnaire is also available ‘‘scope of treatment’’ claims that are
nature of the findings is improved upon request. Our full stimuli are under included in this research are embedded
through the results of multiple development during the PRA process. in mock promotional materials,
converging studies, we continue to We do not make draft stimuli public juxtaposed with specific efficacy
develop evidence to inform our during this time because of concerns information about the mock drug
thinking. We evaluate the results from that this may contaminate our products. As such, they will likely
our studies within the broader context participant pool and compromise the imply ‘‘particular treatment benefits
of research and findings from other research. Individuals are welcome to from the associated drug.’’ This research
sources, and this larger body of inquire about the progress of the study will help us to evaluate the usefulness
knowledge collectively informs our and any changes from the pretests will of a disclosure in relation to this type
policies as well as our research program.
sradovich on DSK3GMQ082PROD with NOTICES
be communicated at that time. of information when it is found in
Our research is documented on our Comment 1d (summarized): FDA promotional pieces. Also, please see
homepage, which can be found at: should base mock promotional stimuli response to comment 1c.
https://www.fda.gov/aboutfda/ on realistic promotional pieces.
centersoffices/officeofmedicalproducts Response 1d: We have done this. Our 2 Aikin, K.J., H.W. Sullivan, and K.R. Betts,
andtobacco/cder/ucm090276.htm. The stimuli are modified from actual (2016). ‘‘Disease information in direct-to-consumer
website includes links to the latest promotional pieces in the marketplace prescription drug print ads.’’ Journal of Health
Federal Register notices and peer- to disguise the original product. Communication, 21(2), pp. 228–239.
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Comment 1g (verbatim): FDA states Comment 1j (verbatim): The Agency population ensures that we will collect
that the ‘‘ease of use’’ claim ‘‘is a simple proposes that consumer and HCP fully useable data from a minimum of
claim of easy drug administration that subjects will be recruited from internet 15 participants in each population.
omits specific important details that panels, indicating that the study will be Used as an observation tool, eye-
contribute to a more difficult drug conducted using an electronic format. tracking complements the other data
administration than suggested.’’ This Because the proposed research topic is collected to increase discoverability of
statement appears to imply that all ease not dependent on an electronic specific events and confidence in our
of use claims are misleading, where the medium, FDA should consider testing qualitative findings.
Agency perhaps intends to clarify that non-electronic media as well, including Comment 1m (summarized): The
validated and non-misleading ‘‘ease of printed promotional pieces. commenter recommends limiting the
use’’ claims may require a disclosure or Response 1j: Although our study will participant sample to disease sufferers
more context. FDA should clarify its be conducted via the internet, we will rather than a general population sample.
understanding of ‘‘ease of use’’ claims, show participants mock print materials Response 1m: We carefully consider
and, in testing, ensure it does not test in .pdf format. the type of sample to use in each of our
overly misleading base claims for ‘‘ease Comment 1k (verbatim): The Agency studies. In the current study, the
of use’’ that would be difficult to proposes to use eye-tracking studies to population of sufferers for the
contextualize with a disclosure complement the self-reported items on conditions addressed by our stimuli
statement and hence would bias the the questionnaire and to improve the (i.e., chronic obstructive pulmonary
results of its study. Such claims should main studies. [The commenter] disease (COPD), chronic iron overload,
be made available for public comment. encourages the Agency to use this and high blood pressure) are varied.
Response 1g: FDA did not intend to technology in conjunction with other Because we are showing participants
imply that all ease of use claims are inputs (for example, qualitative more than one ad, we chose not to select
misleading or that all ease of use claims research) to understand why subjects diagnosed populations or specialists.
would necessarily require a disclosure. are looking at a portion of the proposed Comment 1n (summarized): FDA
FDA agrees that some ease of use materials, rather than to draw should recruit a demographically and
statements require a disclosure or more conclusions that such portions were geographically diverse sample.
context and intends to evaluate one viewed. Additionally, an explanation of Response 1n: We agree and we plan
such example with this research. We the use of eye-tracking technology to recruit individuals with a range of
have revised the description of the should also be included during the gender, race, ethnicity, and, as much as
study in this notice to clarify. Also, subject enrollment process. possible within an internet sample,
please see response to comment 1c. Response 1k: FDA plans to collect and socioeconomic status. For the consumer
Comment 1h (verbatim): FDA states analyze eye-tracking (physical measures sample, we aim for a sample with 60
that the ‘‘statistical significance’’ claim of attention) data in conjunction with percent of people who have some
‘‘will be one in which the disclosure other measures, including cognitive college or less. An advantage of
reveals that the presented analyses were interviews. To avoid the potential for sampling via internet panel is that we
not statistically significant, and thus priming effects, the eye-tracking have access to individuals in all parts of
must be viewed with considerable component of the study will not be the United States.
caution.’’ It is not clear what content explained to recruited individuals Comment 1o (verbatim): FDA should
FDA intends to test for this type of before they report for their in-person capture whether subjects comprehend
claim. We encourage FDA to clarify how sessions. However, participants will be certain information disclosed in the
it intends to present ‘‘not statistically made aware of the eye-tracking mock promotional pieces, even if the
significant’’ analyses for testing in order component during the informed consent subject does not recall information on
to ensure such claims are presented process. the specifics. Currently, open-ended and
with appropriate contextual Comment 1l (summarized): The recall questions (e.g., Consumer
information. Such claims should be commenter recommends increasing the Questionnaire Q2–Q3; HCP
made available for public comment. sample size of the eye-tracking Questionnaire Q2–Q3) ask test subjects
Response 1h: Please see responses to components to ensure more robust data. to identify certain information regarding
comment 1c, 1d, and 1e. Response 1l: Our primary method of the featured drug products (what a mock
Comment 1i (summarized): The analysis of the eye-tracking data will be drug product is specifically ‘‘used for’’
Agency should clarify what distinctions examination of gaze plots coupled with or ‘‘not approved for’’). It is not clear
will be made between HCP and self-report data provided by why such an open-ended format or
consumer pieces. participants. Thus, eye-tracking results questions are necessary for the research
Response 1i: As our mock will be examined on an individual, purpose of the study, as subjects could
promotional pieces have been adapted rather than aggregate, level. recognize a limit to the efficacy being
from existing materials in the public Furthermore, the eye-tracking studies presented even if they do not follow or
domain, the materials directed to HCPs included in this research are intended recall all of the details of a disclosure.
and to consumers vary in similar ways as qualitative, formative studies; they Response 1o: We do intend to capture
to what can currently be seen in the will be used to inform any necessary what information has been observed in
public domain. For example, materials changes to the stimuli before the main the mock promotional pieces, and we do
directed to HCPs tend to have more studies. Formative eye-tracking studies this through the open-ended and recall
data, more technical medical language, such as these are often executed with questions. It is common practice to
sradovich on DSK3GMQ082PROD with NOTICES
and more text in general. Consumer sample sizes as small as five include open-ended and closed-ended
pieces are generally written in plainer participants.3 In our experience, a questions in one research study, as they
language and generally do not include sample of 20 participants in each tend to complement each other. Open-
as much data and statistical 3 Pernice, K. and J. Nielsen, (2009). ‘‘How to
ended questions allow responses that
information. Our pieces are highly Conduct Eyetracking Studies.’’ https://
have not been prompted by particulars,
realistic as they were developed from media.nngroup.com/media/reports/free/How_to_ which is not the case with closed-ended
actual promotional pieces. Conduct_Eyetracking_Studies.pdf. questions. Closed-ended questions
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provide a more efficient way of Administration.’’ This statement could consumers’ understanding of
obtaining information. potentially influence subjects’ responses disclaimers in promotional materials.
Comment 1p (summarized): FDA to study questions. Instead, this Response 1w: HCPs are often a very
should ensure that terms used in the information might be provided at the important source of information about
consumer pieces are consumer-friendly. conclusion of the study. prescription drugs. However, when
Response 1p: We agree and always Response 1s: In previous studies, we prescription drugs are promoted directly
review our mock consumer pieces for took this same view and typically used to consumers, they may be more likely
lay language. The terms mentioned by ‘‘Department of Health and Human to look for information on their own
the commenter (e.g., chronic iron Services.’’ We will incorporate this before taking steps to consult their
overload, COPD, lung function, change. HCPs. We have taken this into account
scientific evidence, effectiveness, Comment 1t (verbatim): Questions in this study by examining the
statistically significant) will be used in regarding statements in ads (Consumer responses of both consumers and HCPs.
the HCP materials. However, we also Questionnaire Q10, Q20, Q30; HCP Comment 1x (verbatim): In the HCP
strive to make our materials as realistic Questionnaire Q12, Q22, Q33) should be Questionnaire, Q5, Q7, and Q29 should
as possible, and in this case, we have the first questions presented following be omitted. Comparative efficacy is
modified existing DTC pieces for the subjects’ viewing of a promotional highly dependent on the particular HCP
consumers. If they used a term (e.g., piece. A subject will likely recall the subject’s experience outside the
COPD), and OPDP reviewers agreed that statements that appeared in the experiment setting; this question thus
this is common and acceptable, we promotional piece most accurately may lead to highly variable results.
maintained it in our mock pieces. immediately after reviewing the piece Further, how the drug featured in the
Comment 1q (summarized): FDA and before answering other questions mock promotional communication
should consider changing the sliding that could influence their selection of compares to other prescription
scale format of Q4. answers.
Response 1q: We carefully develop medications has no relevance to FDA’s
Response 1t: As with all other aspects
each question of our questionnaires, stated study goals. Questions regarding
of study design, we carefully develop
taking into account language and comparative efficacy should thus be
questionnaires with order effects in
response options. No cognitive omitted from the proposed HCP
mind. Therefore, we chose to include
interview participant reported Questionnaire.
questions regarding perception of
confusion with this sliding scale Response 1x: Comparative efficacy
efficacy or ease of use, information
question. Without scientific justification questions are another way to assess how
seeking, and behavioral intention first
for changing the response format of this HCPs respond to prescription drug
because it is important that participant
question, we will maintain the current promotion. Any subjective experiences
responses to these items be based solely
format. outside the experiment setting should
on the information presented in the ads.
Comment 1r (verbatim): In a study fall out because HCPs will be randomly
The questions referenced by the
setting, subjects may be prone to pay assigned to conditions. The questions
commenter also include incorrect recall
attention to more or all of the are relevant to our study because HCPs
items, which could potentially bias
information presented throughout the make comparative decisions each time
responses to later questions if the order
study, including claims designed to be they make a prescribing decision.
was changed. Additionally, repeated
intentionally misleading. As a result, Comment 1y (verbatim): In the HCP
exposures to the correct recall items in
subjects are more likely to be biased Questionnaire, Q34 does not appear to
the above-referenced questions could
based on the strength or weakness of the provide appropriate programming
have a reinforcing effect that could
claims and disclosures presented. The instructions for the scenario in which
confound results.
Agency should address what efforts it Comment 1u (verbatim): In the Q33_A=01 and Q33_D=01. FDA should
will take to avoid response bias by Consumer Questionnaire, an ‘‘FDA confirm that Q33 may be asked if
presenting these varying degrees of employee’’ category, similar to S7 and subjects select both Q33_A and Q33_D,
disclosures. S8, should be added to the Screener and provide that this question may be
Response 1r: The study is designed so Survey. These individuals should also repeated for both responses. The
that participant will be randomly be terminated from the study. variable label text for Q34 should also
assigned to condition. Moreover, the Response 1u: We will revise question be rewritten as follows: ‘‘How much did
only aspect of the participants’ S8 to read, ‘‘Do you work for a the statement [disclosure] influence
experiences that will be varied in the pharmaceutical company, an advertising your assessment of the scientific
study will be the manipulations that we agency, a market research company, or evidence for [D]esyflux?’’
have described. Any individual the U.S. Department of Health and Response 1y: Q33 asks whether
differences in attention or ability or Human Services?’’ to capture these participants have seen any of the listed
potential biases should be spread across individuals, as suggested. statements. Q34 is asked for each of
experimental conditions. Thus, if we Comment 1v (verbatim): In the Q33_A and Q33_D when they respond
find differences between and among Consumer Questionnaire, Q8–Q9 should affirmatively to that statement in Q33.
conditions, we can be reasonably sure be presented prior to Q6–Q7 in order to Thus, participants who chose option 01
that the manipulations caused the prevent bias in favor of non-HCP for both items will see two separate
differences. We have not found in the sources. Similarly, Q19 should appear questions. We will make the suggested
past that our participants spend an before Q18, and Q28 should appear changes to Q34.
The second public comment
sradovich on DSK3GMQ082PROD with NOTICES
inordinate amount of time viewing before Q27.
stimuli, but we will be careful to place Response 1v: We will reorder the responder (regulations.gov tracking
the research in context when we questionnaire as the commenter number lkl–8y11–169c) included four
interpret the data. suggested. individual comments, to which we have
Comment 1s (verbatim): The Consent Comment 1w (summarized): We responded.
Text introduction should not state that recommend that Q8–Q9, Q19, and Q28 Comment 2a (summarized): FDA
the survey is being conducted ‘‘on be expanded to more fully evaluate the should give consideration to the
behalf of the U.S. Food and Drug role of the prescriber in aiding representativeness of online study
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![Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39447
of participants, including gender, race, physicians and not specialists. Thus, represented as not everyone has access
ethnicity, socioeconomic status, etc., to while any given participant may have to or uses the internet.
better represent the population at large. experience treating one or more of the Response 4f: Please see our response
Also, FDA should consider inclusion conditions represented by our stimuli, to comment 2a.
and exclusion criteria for HCPs and none should have specialties in the
consumers carefully. Comment 4g (summarized): The
respective therapeutic categories.
Response 4c: We agree that these commenter recommends conducting
Comment 4e (summarized): The subgroup analyses, such as with older
characteristics are important and strive commenter encourages the use of a
to obtain representativeness across a adults.
health literacy competency tool such as
variety of personal demographics. a readability calculator to ensure Response 4g: We will examine
Although we will aim to recruit a consumers can understand the language. covariates including age, race, and
diverse group of participants with education level to determine whether
Response 4e: We agree that the plain these variables have any effect on our
sufficient variation on demographic
characteristics such as gender, race, age, language communication of information findings. This study is not designed to
and education, we note that this study is critical for the best public health conduct between-subgroup analyses. If
features random assignment to outcomes. Nevertheless, our aim in this we detect relevant trends, such
condition, whereby these demographic study is to test promotional materials subgroup analyses may become good
characteristics should have an equal that are available in the public domain. candidates for future studies.
chance of occurring. In terms of HCPs, Although we have disguised the
products and campaigns in our mock Comment 4h (verbatim): [The
we will include them if they are primary commenter] recommends that the FDA
care physicians, and will work to recruit stimuli, all pieces are derived directly
from promotion in the marketplace. We communicate the actions they will take
a sample with sufficient diversity on based on the study results and analysis.
demographic characteristics as noted feel this is important to ensure that our
study is relevant. We also encourage FDA to provide
above. further communication about when
Comment 4d (verbatim): It is critical Comment 4f (summarized): The
FDA will publish the study results, how
that FDA evaluates the merits of commenter recommends recruiting
the study results will be applied, and
unbiased introduction by not presenting through hospitals, doctor offices, and
how this will impact the work of FDA.
a promotional piece to HCPs with clinics rather than via the internet. The
specialty in the same therapeutic commenter suggests that this will Response 4h: Please see our response
category. expand on the pool of participants, help to comment 1a.
Response 4d: For this study, we will minimize potential bias, and ensure the FDA estimates the burden of this
be recruiting only primary care entire population of the United States is collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual
Activity responses per Average burden per response Total hours 2
respondents responses
respondent
Consumers
Pretest Screener ............................... 833 1 833 0.03 (2 minutes) ............................... 25
Pretest ............................................... 500 1 500 0.33 (20 minutes) ............................. 165
Eye-Tracking Screener ..................... 80 1 80 0.08 (5 minutes) ............................... 7
Eye-Tracking Study ........................... 20 1 20 1 ....................................................... 20
Main Study Screener ........................ 2,500 1 2,500 0.03 (2 minutes) ............................... 75
Main Study ........................................ 1,500 1 1,500 0.33 (20 minutes) ............................. 495
HCPs
Pretest Screener ............................... 735 1 735 0.03 (2 minutes) ............................... 22
Pretest ............................................... 500 1 500 0.33 (20 minutes) ............................. 165
Eye-Tracking Screener ..................... 80 1 80 0.08 (5 minutes) ............................... 7
Eye-Tracking Study ........................... 20 1 20 1 ....................................................... 20
Main Study Screener ........................ 2,206 1 2,206 0.03 (2 minutes) ............................... 67
Main Study ........................................ 1,500 1 1,500 0.33 (20 minutes) ............................. 495
Total ........................................... ........................ ........................ ........................ ........................................................... 1,563
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the next full hour.
II. References available electronically at https:// Disclaimers and FDA Approval.’’ Health
www.regulations.gov. FDA has verified Psychology, 26(4), 513–517. (2007).
The following references are on
sradovich on DSK3GMQ082PROD with NOTICES
the website addresses, as of the date this 2. Dodge, T., D. Litt, and A. Kaufman.
display in the Dockets Management ‘‘Influence of the Dietary Supplement
document publishes in the Federal
Staff (HFA–305), Food and Drug Health and Education Act on Consumer
Register, but websites are subject to
Administration, 5630 Fishers Lane, Rm. Beliefs About the Safety and
1061, Rockville, MD 20852 and are change over time.
Effectiveness of Dietary Supplements.’’
available for viewing by interested 1. Dodge, T. and A. Kaufman. ‘‘What Makes Journal of Health Communication:
persons between 9 a.m. and 4 p.m., Consumers Think Dietary Supplements International Perspectives. 16(3), 230–
Monday through Friday; they are also Are Safe and Effective? The Role of 244. (2011).
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![39448 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
3. Mason, M.J., D.L. Scammon, and X. Feng. Substances.’’ This guidance has been identified, as confidential, if submitted
‘‘The Impact of Warnings, Disclaimers developed to provide manufacturers as detailed in ‘‘Instructions.’’
and Product Experience on Consumers’ with recommendations for submission Instructions: All submissions received
Perceptions of Dietary Supplements.’’ must include the Docket No. FDA–
Journal of Consumer Affairs, 41(1), 74–
of new drug applications (NDAs),
99. (2007). investigational new drug applications 2018–D–2614 for ‘‘Dissolution Testing
4. France, K.R. and P.F. Bone. ‘‘Policy (INDs), or abbreviated new drug and Acceptance Criteria for Immediate-
Makers’ Paradigms and Evidence from applications (ANDAs), as appropriate, Release Solid Oral Dosage Form Drug
Consumer Interpretations of Dietary for orally administered immediate- Products Containing High Solubility
Supplement Labels.’’ Journal of release (IR) drug products that contain Drug Substances.’’ Received comments
Consumer Affairs, 39(1), 27–51. (2005). highly soluble drug substances. The will be placed in the docket and, except
5. FTC. ‘‘Full Disclosure.’’ Accessed at: guidance is intended to describe when for those submitted as ‘‘Confidential
https://www.ftc.gov/news-events/blogs/ Submissions,’’ publicly viewable at
business-blog/2014/09/full-disclosure a standard release test and criteria may
be used in lieu of extensive method https://www.regulations.gov or at the
(September 23, 2014) Last accessed on
June 22, 2018. development and acceptance criteria- Dockets Management Staff between 9
6. Higgins, E., M. Leinenger, and K. Rayner. setting exercises. a.m. and 4 p.m., Monday through
‘‘Eye Movements When Viewing DATES: The announcement of the
Friday.
Advertisements.’’ Frontiers in • Confidential Submissions—To
guidance is published in the Federal
Psychology, 5, 210. (2014). submit a comment with confidential
Register on August 9, 2018.
7. Pieters, R., M. Wedel, and R. Batra. ‘‘The information that you do not wish to be
Stopping Power of Advertising: ADDRESSES: You may submit either made publicly available, submit your
Measures and Effects of Visual electronic or written comments on comments only as a written/paper
Complexity.’’ Journal of Marketing, Agency guidances at any time as submission. You should submit two
74(5), 48–60. (2010). follows:
8. Thomsen, S. and K. Fulton. ‘‘Adolescents’
copies total. One copy will include the
Attention to Responsibility Messages in Electronic Submissions information you claim to be confidential
Magazine Alcohol Advertisements: An with a heading or cover note that states
Eye-Tracking Approach.’’ Journal of
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Adolescent Health, 41, 27–34. (2007). following way: CONFIDENTIAL INFORMATION.’’ The
9. Simola, J., J. Kuisma, A. Öörni, L. Uusitalo, • Federal eRulemaking Portal: Agency will review this copy, including
et al. ‘‘The Impact of Salient https://www.regulations.gov. Follow the the claimed confidential information, in
Advertisements on Reading and instructions for submitting comments. its consideration of comments. The
Attention on Web pages.’’ Journal of Comments submitted electronically, second copy, which will have the
Experimental Psychology: Applied, including attachments, to https://
17(2), 174–190. (2011).
claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
10. Wedel, M. and R. Pieters. ‘‘A Review of
Eye-Tracking Research in Marketing.’’ In
the docket unchanged. Because your for public viewing and posted on
Review of Marketing Research, vol. 4 (pp. comment will be made public, you are https://www.regulations.gov. Submit
123–147), N. K. Malhotra (Ed.). Armonk, solely responsible for ensuring that your both copies to the Dockets Management
New York: M. E. Sharpe. (2008). comment does not include any Staff. If you do not wish your name and
Dated: August 3, 2018. confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Leslie Kux,
such as medical information, your or information on the cover sheet and not
Associate Commissioner for Policy.
anyone else’s Social Security number, or in the body of your comments and you
[FR Doc. 2018–17045 Filed 8–8–18; 8:45 am] confidential business information, such must identify this information as
BILLING CODE 4164–01–P as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
information, or other information that except in accordance with 21 CFR 10.20
DEPARTMENT OF HEALTH AND identifies you in the body of your and other applicable disclosure law. For
HUMAN SERVICES comments, that information will be more information about FDA’s posting
Food and Drug Administration posted on https://www.regulations.gov. of comments to public dockets, see 80
• If you want to submit a comment FR 56469, September 18, 2015, or access
[Docket No. FDA–2018–D–2614] with confidential information that you the information at: https://www.gpo.gov/
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
Dissolution Testing and Acceptance public, submit the comment as a 23389.pdf.
Criteria for Immediate-Release Solid written/paper submission and in the Docket: For access to the docket to
Oral Dosage Form Drug Products manner detailed (see ‘‘Written/Paper read background documents or the
Containing High Solubility Drug Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Substances; Guidance for Industry; received, go to https://
Availability Written/Paper Submissions
www.regulations.gov and insert the
AGENCY: Food and Drug Administration, Submit written/paper submissions as docket number, found in brackets in the
HHS. follows: heading of this document, into the
ACTION: Notice of availability. • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets and/or go to the Dockets Management
SUMMARY: The Food and Drug Management Staff (HFA–305), Food and
sradovich on DSK3GMQ082PROD with NOTICES
Staff, 5630 Fishers Lane, Rm. 1061,
Administration (FDA or Agency) is Drug Administration, 5630 Fishers Rockville, MD 20852.
announcing the availability of a final Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any
guidance for industry entitled • For written/paper comments guidance at any time (see 21 CFR
‘‘Dissolution Testing and Acceptance submitted to the Dockets Management 10.115(g)(5)).
Criteria for Immediate-Release Solid Staff, FDA will post your comment, as Submit written requests for single
Oral Dosage Form Drug Products well as any attachments, except for copies of this guidance to the Division
Containing High Solubility Drug information submitted, marked and of Drug Information, Center for Drug
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Document Created: 2018-08-09 01:11:28
Document Modified: 2018-08-09 01:11:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Dates | Fax written comments on the collection of information by September 10, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 39441 |
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