FDA social science research – A year in review

Feature ArticlesFeature Articles | 22 December 2022 | Citation

The social science research team at the US Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) engages in extensive research into prescription drug materials for direct-to-consumer purposes and aimed at healthcare providers. Much research has been completed, and much is ongoing. This article provides a summary of the research that was published in 2022.
 
Background
The FDA social science research team fulfills an important role at the OPDP.1,2 The team’s specific analyses and interpretations of human behavior help provide the basis for how people understand and interpret prescription drug promotion. The team is in the OPDP’s Division of Promotion Policy, Research, and Operations and is comprised of four social science analysts and a team leader, all of whom have PhDs and an extensive background in social science research.
  
The results of the team’s research are used to inform guidance and policy development, and at times, FDA rulemaking or in response to a congressional mandate. The team’s research also provides the basis for its advice to internal FDA stakeholders on matters such as labeling, advisory comment letters, and compliance and enforcement actions. Ultimately, the team’s research supports the FDA’s mission of protecting public health.
 
To that end, the research focuses on:1
 
  • Investigating issues relevant to healthcare professional and patient/consumer usage of medical product information,
  • Considering the audience’s perception and comprehension of medical product information, and
  • Assessing the accuracy and effectiveness of the informational messages.
 
The research focuses on advertising features and the target population and the impact both have on the understanding of a drug’s risks and benefits in promotion, as well as research quality. Those respective components can be described as follows:1
 
  • Advertising features – Components of the advertisement such as content and layout, quantitative information, promotional messages, description of disease state, and graphics
  • Target population Audience to whom the advertisement is communicated and for whom the variables would include literacy, education, and age
  • Research quality Helping to maximize the quality of data obtained through analytical methodology development and sampling and response issues
 
The social science team’s research has been extensive, with 74 projects completed between 1999 and 2021.1,3 Although most of the research was conducted in the area of advertising features, much also covered more than one topic area (Figure).
 

 
 
Research methods1
The team uses various research methodologies to meet its research goals, depending on the research question and topic area under investigation.
 
  • Qualitative research – This often precedes quantitative research and is typically conducted in a small number of study participants to ascertain why people think, respond, or feel a certain way. Examples of qualitative research might include:
  • Cognitive interviews, whereby study participants verbalize their thought processes related to study materials. This methodology helps researchers determine whether concepts are interpreted as the study intended;
  • Focus groups, whereby a small group of people are gathered to discuss a given topic; and
  • One-on-one interviews, also for gathering information on a given topic.
 
  • Quantitative research – This is often conducted after qualitative research has been concluded and includes a larger number of study participants. Surveys can provide insight into respondents’ attitudes and perceptions, which could allow for correlations to be made. More in-depth, hypothesis-testing research using the experimental method would involve randomization of study participants to different test conditions in a controlled environment.
  • Literature reviews – These are comprehensive evaluations of previously published research on a topic.
  • Content analyses – These would include assessments of promotional materials in use in the public domain.
 
The following is a summary of the OPDP social science research team’s research that was published in 2022.
 
CSL online prescription drug promotions
In response to the increase over the last two decades in the use of the internet and social media for drug promotion, the research team has assessed the impact of character space limitations (CSLs) in prescription drug promotion.
 
In 2014, the FDA issued a draft guidance to help industry meet fair balance requirements in an environment associated with CSLs.4 The guidance advises companies that if an advertisement on such a platform contains benefit claims, it should also contain risk information, regardless of CSL constraints. In addition, the guidance advises companies to provide a link-out to a more complete discussion of the product’s risks.
 
The team assessed whether substantive risk information included in a CSL communication was effective in communicating the risks or whether the link to the risk information would be sufficient. It conducted four experimental studies and varied whether substantive risk information appeared in the CSL communication.5 The researchers found that consumers’ recognition of substantive risk information was likely improved when risk was included in a CSL communication. However, they noted that if consumers were reading the CSL communication specifically for information about the medication and the communication contained substantive risk information, then they may have been less likely to click a link for additional risk information.
 
Bottom line – Inclusion of risk information in the body of a CSL communication likely improves risk recognition by consumers.
 
Interactive advertising literature review

An interactive advertisement directly engages consumers by using two-way communication to get them to engage with the ad rather than passively watching it. As consumers’ screen time has increased steadily in recent decades, the research team wanted to examine the impact that interactive ads have on prescription drug promotion.

The team conducted a scoping systematic literature review of research published from January 1997 to February 2021 to summarize research findings related to interactive advertising, and the impact on consumer recall and comprehension of product claims and risks.6 The types of interactive ads specifically evaluated in the research included websites, banner and pop-up ads, search engine ads, interactive TV ads, advergames, product websites, digital magazine ads, and social network site ads.
 
The findings showed that consumers did engage with interactive ads. However, the findings were mixed on whether recall and comprehension were improved with more interactivity with the ads.
 
Bottom line – Additional research is needed to determine whether interactivity with ads improves recall and comprehension of the information contained therein.
 
Physician interviews on FDA-approved labeling
While the information contained in the prescribing information (PI) assists healthcare providers with making informed decisions related to treating patients with a specific medication, the utility of the PI can also be mitigated by how cumbersome it can be. The requirements of the 2006 Physician Labeling Rule streamlined much of the format in newer PIs.7 However, it is not clear how useful the information in the PI is to healthcare providers.
 
To assess this question, the social science research team conducted interviews with 70 physicians – 35 primary care physicians and 35 specialists from varying therapeutic areas. Fictitious PI examples were employed to explore physician use, perceptions, preferences, understanding of content, and formatting in the PI. The research specifically addressed topics related to the resources physicians use to find information about prescription drugs; physicians’ interpretation of specific language in labeling; and the presentation of information on risks, drug interactions, and overdosage in labeling.8
 
The research findings suggested that healthcare providers may want more clarity in the Indications and Usage and the Dosage and Administration sections of the label. Responses from interviewees suggested physicians want to see the indicated age group, even for medical conditions that are highly associated with a particular age group (e.g., adults), in the Indications and Usage section of the label. The responses also suggested physicians want to see uniformity in the Dosage and Administration section of the label about administration of the drug in regard to food (e.g., whether it should be taken with or without food). An additional finding was that a lengthy list of drug interactions in the Drug Interactions section of the PI might be misinterpreted by physicians as a comprehensive list.8
 
Bottom line – Physicians may want to see more clarity in the Indications and Usage and Dosage and Administration sections of the PI.
 
Risk information amount and location in direct-to-consumer print ads
FDA regulations, specifically Section 502(n) of the US Federal Food, Drug, and Cosmetic Act, require that print ads for prescription drugs must provide a true statement of information in brief summary describing side effects, contraindications, and effectiveness.9 To satisfy this requirement, ads typically display risk information both as important safety information (ISI) in the main part of the ad and on a separate brief summary page. The ISI is often lengthy, and the brief summary is often repetitive of the ISI content.
 
The research team tested advertisements for two fictitious drugs in ads that included long and short versions of ISI that either included or excluded a brief summary.10 Assessments were evaluated with respect to attention to the advertisement, the ISI, and the brief summary. Consumer attention was measured through self-reports and eye-tracking. Risk retention and risk perceptions were also assessed.
 
The researchers found that participants spent more time fixating on the ad when they saw a long ISI or if there was a brief summary. Participants also spent more time fixating on the ISI when it was long, although the fixations on the brief summary did not differ. Self-reported attention did not vary by length of ISI or presence of the brief summary.
 
The findings also suggested that neither the ISI length nor the presence of a brief summary affected the  risk perception of a product. This finding differed from a previously held assumption that the longer a risk section, the riskier consumers would perceive the drug to be.11
 
With respect to risk retention, ads with a long ISI or a brief summary received more view time from study participants. There was some improvement in risk retention. A combined long ISI and brief summary did not affect attention to, or recall of, risk information.
 
Bottom line – A long ISI and a brief summary may fulfill similar functions when it comes to risk perception and retention.
 
Impact on future policy
Regulatory professionals in industry expect the FDA to implement guidance documents or policy changes quickly based on findings from the research team’s studies. However, the research results are more commonly an initial step into new territory. Additional research is often needed or warranted before the agency can implement policy, which according to Kathryn J. Aikin, PhD, the research team leader, “is typically the result of multiple sources of information.”12  
 
Abbreviations
CSL, character space limitation; FDA, [US] Food and Drug Administration; ISI, important safety information; OPDP, Office of Prescription Drug Promotion; PI, prescribing information.
 
About the author
Amy Toscano, PharmD, RAC, is a senior director in commercial regulatory affairs at Myovant Sciences,  with more than seven years’ experience in the pharmaceutical industry and more than 10 years at the FDA’s Office of Prescription Drug Promotion. Toscano has a bachelor’s degree in accounting and a doctor of pharmacy degree, both from Rutgers University. She can be contacted at amy.toscano@myovant.com
 
Disclaimer The opinions and positions expressed in this article are those of the author and are not, and should not be attributed, to her employer.
 
Citation Toscano A. FDA social science research – A year in review. Regulatory Focus. Published online 22 December 2022.
 
References
All references accessed and/or verified on 19 December 2022.
 
  1. Food and Drug Administration. The social science research team in the Office of Prescription Drug Promotion (OPDP): Rigorous research in service of public health. Not dated. https://www.fda.gov/media/154014/download
  2. OPDP’s Social Science Research Program: Aiming to understand how health care providers and patients interpret prescription drug promotion. Current as of 22 February 2022. https://www.fda.gov/drugs/news-events-human-drugs/opdps-social-science-research-program-aiming-understand-how-health-care-providers-and-patients
  3. Food and Drug Administration. Completed research projects – Office of Prescription Drug Promotion (OPDP) Research webpage. Current as of 19 September 2022.  https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/completed-research-projects-office-prescription-drug-promotion-opdp-research
  4. Food and Drug Administration. Internet/social media platforms with character space limitations — Presenting risk and benefit information for prescription drugs and medical devices [draft guidance]. Dated June 2014. https://www.fda.gov/media/88551/download 
  5. Sullivan HW, et al. Character-space-limited online prescription drug communications:  Four experimental studies. Res Social Adm Pharm. 2022;18(12):4092-4099.  https://www.sciencedirect.com/science/article/pii/S1551741122002637?via%3Dihub
  6. Giombi K, et al. The impact of interactive advertising on consumer engagement, recall, and understanding: A scoping systematic review for informing regulatory science. PLoS ONE. 2002;17(2):e0263339. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8812936/
  7. Department of Health and Human Services, Food and Drug Administration, CDER, CBER. Labeling for human prescription drug and biological products – Implementing the PLR content and format requirements [guidance]. Dated February 2013. https://www.fda.gov/files/drugs/published/Labeling-for-Human-Prescription-Drug-and-Biological-Products---Implementing-the-PLR-Content-and-Format-Requirements.pdf
  8. Sullivan HW, et al.  Physicians’ use of and preferences for FDA-approved prescribing information. Res Social Adm Pharm. 70 2022;18(6):3017-3037. Published 18 June 2022. https://pubmed.ncbi.nlm.nih.gov/34364803/
  9. Federal Food, Drug and Cosmetic Act. 21 US Code 352(n). https://www.govinfo.gov/content/pkg/USCODE-2020-title21/pdf/USCODE-2020-title21-chap9-subchapV-partA-sec352.pdf
  10. Aikin KJ,  et al. Attention to risk information in direct-to-consumer prescription drug print ads: An eye-tracking study. Pharmacoepidemiol Drug Saf. 2022;1-sss9.  https://onlinelibrary.wiley.com/doi/epdf/10.1002/pds.5511 
  11. Davis JJ. Riskier than we think? The relationship between risk statement completeness and perceptions of direct to consumer advertised prescription drugs. J Heal Commun. 2000;5(4):349-369.
  12. Snyder Bulik B.  Surprise: A short list of TV-ad drug risks is easier to recall, FDA study finds. Fierce Pharma. Published 15 August 2017. https://www.fiercepharma.com/marketing/fda-study-finds-shorter-risks-list-pharma-tv-ads-lead-to-better-recall-by-consumers
 
 

 

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