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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: 1 Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3 ways to enhance the quality, utility, and clarity of the information to be collected; and 4
ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

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Text Analysis of Proprietary Drug Name Interpretations OMB Control Number 0910NEW
Section 1701a4 of the Public Health Service Act 42 U.S.C.
300ua4 authorizes FDA to conduct research relating to health information.
Section 1003d2C of the Federal Food, Drug, and Cosmetic Act FD&C
Act 21 U.S.C. 393d2C authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.
The Office of Prescription Drug Promotions OPDP mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. OPDPs research program provides 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 are most central to our mission. Our research focuses in particular on three main topic areas: 1 Advertising features, including content and format;
2 target populations; and 3 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
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methodology development and investigation of sampling and response issues. This study will inform all three topic areas.
Because we recognize the strength of data and the confidence in the robust nature of the findings are 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 home page, which can be found at:
https www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/
office-prescription-drug-promotionopdp-research. The website includes links to the latest Federal Register notices and peer-reviewed publications produced by our office.
As part of the prescription drug regulatory review process, sponsors propose proprietary names for their products. These names undergo a proprietary name review that involves the Office of Drug Safety, the relevant medical office, and OPDP. OPDP
reviews names to assess for alignment with the FD&C Act, which provides, among other things, that labeling can misbrand a product if false or misleading representations are made see 21 U.S.C. 321n and 352a. A
proprietary name that appears in labeling could result in such misbranding if it is false or misleading.
OPDP reviews, among other things, whether names: 1 Overstate the efficacy or safety of the drug; 2 suggest drug indications that are not accurate;
3 suggest superiority without substantiation; or 4 are of a fanciful nature that misleadingly implies unique effectiveness or composition. It would be helpful in OPDPs review of promotional implications of proprietary names for data on consumer and prescriber interpretations of proposed proprietary names to be more readily available for consideration. The proposed research will utilize text analysis e.g., topic modeling and sentiment analysis to ascertain how consumer and primary care physician PCP populations interpret prescription drug names, which will assist OPDPs consideration of promotional implications.
This proposed research builds upon and extends OPDP research entitled Empirical Study of Promotional Implications of Proprietary Prescription Drug Names 86 FR 14440. That research involves an experimental
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design intended to assess names that potentially overstate the efficacy of a product. In contrast, the proposed research involves a survey design that comprises primarily open-ended questions intended to generate text for analysis, an approach that is unrestricted in its ability to assess different types of promotional implications e.g., minimization of risk and unsubstantiated superiority, in addition to overstatement of efficacy.
The proposed research will add to the depth and breadth of knowledge we can draw from during the review of proposed proprietary drug names.
The key objectives of the proposed research are as follows:
1. To apply new techniques such as topic modeling and sentiment analysis forms of text analysis to answer OPDPs research questions about consumer and PCP
interpretations of proprietary prescription drug names.
2. To help develop a methodological approach for assessing consumer and prescriber interpretations of drug names, which can potentially be used in the future as a standard assessment tool.

Our methodological approach will involve nationally representative samples. Consumers will be recruited from Ipsos Public Affairs KNOWLEDGEPANEL. PCPs will be recruited using a two-stage approach that will begin with a purchased list of PCPs based on the American Medical Association Physician Masterfile. These members will then be matched to one or more sample provider lists to recruit PCP participants for this study. We propose a sample of 300 consumers and 300 PCPs for the main study. We have designed a within-subjects experiment in which participants will be exposed to multiple drug names to maximize power to find differences with this sample size.
The stimuli will comprise 60
experimental names and 60 control names. Participants will be randomized to 1 of 10 groups so that no one responds to more than 12 names in total. Each participant will see six experimental names and six control names. The experimental names will be names with suspected promotional implications, whereas the control names will not have suspected promotional implications. Names will be viewed in random order. Participants will respond in open-ended text boxes about their perceptions of each drug name.
Supplementary closed-ended questions may also be presented. We will conduct text analysis of the responses and present descriptive results for individual drug names by participant cohort i.e., consumers vs. PCPs, and
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