March 14, 2018 – The FDA has “prioritized a robust social and behavioral science research program” to help the agency understand “how consumers respond to prescription drug promotion,” according to FDA Commissioner Scott Gottlieb, M.D. This Office of Prescription Drug Promotion (OPDP) research “has provided key information to inform our policies related to the proper regulation of prescription drug advertising,” he said in a March 12 statement.

“Although OPDP has been producing significant research for several years, this notice from Commissioner Gottlieb is a significant endorsement of the program and an implied promise that marketing priorities will be evidence-based,” said Coalition for Healthcare Communication Executive Director John Kamp. “Gottlieb is clearly positioning the FDA to be on firmer ground against First Amendment challenges.”

Recent research on how drug risks are presented in TV ads suggested “that a more targeted presentation of risks may lead to better retention of the potential side effects that consumers should weigh as they consider their treatment decisions,” Gottlieb continued, noting that the agency has been looking into new guidelines to streamline that disclosure in TV ads, “to better emphasize potential side effects that are severe, serious and actionable.”

Kamp remarked that the research “clearly points to the need for new disclosure guidelines.” Further, “it seems reasonable to expect that the Commission will be announcing such guidelines soon,” he said.

In the March 12 press release, the FDA states that it “has consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to the agency’s mission,” with a focus on three topic areas:

• Advertising features, including content and format;
• Target populations; and
• Research quality.

The OPDP now offers an update on the status of drug promotion research projects on its Website, broken down into three categories: (1) completed research projects; (2) research pending review and publication; and (3) research in progress.

The FDA has completed 27 studies since 2004; see below for the study names and status of research projects completed in the past several years:

• Disclosure Regarding Additional Risks in DTC Prescription Drug TV Ads (completed in 2017)
• Comparative Price Information in DTC and Professional Prescription Drug Advertisements (completed in 2017)
• Prescriber’s Knowledge and Skills for Interpreting Research Results: A Systematic Review (completed in 2017)
• Web and Mobile Technology DTC Content Analyses (completed in 2017)
• Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing (completed in 2016)
• Examination of Online DTC Drug Promotion (completed in 2016)
• Effect of Promotional Offers on Consumer Perceptions of Product Risks and Benefits (completed in 2016)
• Prescription Drug Promotion from 2001-2004 (completed 2016)

Four research programs are pending peer review and publication:

• Clinical Trial Data in Professional Prescription Drug Promotion
• Experimental Study of DTC Advertising Directed at Adolescents
• Impact of Ad exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads
• Major Statement Content Analysis

The FDA has 13 research projects (announced during the period of 2014 to 2017) that currently are in progress:

• Animation in DTC Advertising
• Character-Space-Limited Online Prescription Drug Communications
• Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Advertising
• Data Display Disclosures in Professional and Consumer Prescription Drug Promotion
• General Population Survey on Prescription Drug Promotion
• Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion
• Hearing, Aging and DTC Television Ads
• Market Claims in DTC Prescription Drug Print Ads
• Quantitative Information in DTC Television Advertisements
• Risk Information Amount and Location in DTC Print Ads
• Risk and Benefit Perception Scale Development
• Superimposed Text in DTC Promotion
• Utilization of Adequate Provision Among Low to Non-Internet Users

At a recent Drug Information Association Advertising and Promotion Regulatory Affairs Conference, OPDP Senior Social Science Analyst and Research Team Lead Kathryn J. Aiken told attendees that they could expect this additional research from OPDP in the future:

• Interpretation of Claims in Scientific Publications vs. Promotional Pieces
• Disease Awareness and Product Promotion in DTC TV Ad Contexts
• Healthcare Professional Survey of Prescription Drug Promotion
• Focus Groups Examining Accelerated Approval Information
• Experimental Study of an Accelerated Approval Disclosure
• Healthcare Professional Interviews: Risk Processing for Newly Promoted Drugs