July 22, 2019 – Social science research conducted at the FDA’s Office of Prescription Drug Promotion (OPDP) is designed to investigate issues relevant to healthcare professional and consumer use of medical product information, to consider the audience’s perception and comprehension of that information, and to assess the accuracy and effectiveness of promotional messaging, according to Kathryn Aikin, Ph.D., senior social science analyst and research team lead at OPDP.

Speaking at the recent Coalition for Healthcare Communication Rising Leaders Conference on Healthcare Policy, held in Washington, D.C., Aikin said that social science research can help to: identify goals, identify barriers to achieving goals, identify potential solutions, and then test and verify the effectiveness of those solutions.

“OPDP has a fairly broad research agenda,” she noted. Studies are “developed by the team and come from a variety of sources, including FDA staff, OPDP staff, and external forces.” The OPDP research team focuses on drug advertising features, target populations and the quality of the research supporting promotional claims, with a particular emphasis on the presentation of risks and benefits, she told Rising Leaders attendees.

“We are specifically interested in topics involving risk presentation because these topics have the potential to negatively affect public health,” Aikin said. “We are also concerned about the presentation of benefit. We don’t want consumers to be misled by potentially false hopes. At the end of the day, we want consumers to have accurate and truthful information about the efficacy and risks of products to help them make the best decisions.”

This research agenda is underscored by the OPDP enforcement actions: the majority of the very few Warning Letters and Untitled Letters issued by OPDP during the past several years have alleged violations related to the presentation or omission of risk information.

Aikin shared a slide showing the breakdown of the topics of 45 research studies conducted between 1998 and 2018; the majority of the studies were related to promotional content, followed closely by format and target population.

She also listed the various research methods used by OPDP:

• Cognitive interviews
• Pretesting
• Literature reviews
• Content analysis
• Interviews and focus groups
• Surveys
• Experiments

The potential outcomes of OPDP research studies include: (1) publication; (2) guidance documents; (3) rulemaking; and (4) other regulatory actions. Aikin explained that although they may choose to publish qualitative research results, “we are more likely to use our qualitative research to inform our future quantitative research rather than use it to inform guidance and rulemaking or other regulatory action,” which are generally driven by quantitative research findings.

To date, OPDP has completed 33 research studies, has five studies pending peer review and publication, and has 12 studies in progress. The agency is currently accepting comments through July 29 on one of those studies – covering disease awareness and prescription drug promotion on television. For a full list of OPDP’s research roster, click here.

Aikin also shared some of the study results on risk information, quantitative efficacy information and social media. For example, she discussed the study of the addition of a serious risk to the display page of an ad and the addition of frequency and duration information about side effects in the brief summary, stating that these additions did not negatively affect the understanding of the risk information as a whole, including the most serious warnings and precautions.

“We found consumers use the information in the brief summary in ways that we didn’t expect,” Aikin stated. “They spend less time reading than we expected, but we did find [these additions] did affect comprehension of information.” For additional examples of study results, go to the Coalition’s Resources page to view Aikin’s presentation slides.

Aikin told Rising Leaders attendees that OPDP “is always interested to see other research – and you are welcome to share your research with us.” When asked by an attendee whether OPDP is doing research to measure public health outcomes, Aikin responded that her group’s research is primarily designed around comprehension of information. “Measuring an actual public health outcome is quite challenging given the resources that we have,” she said.

She also contended that direct-to-consumer advertising has changed over the past several decades. “DTC ads have changed a lot over the last 20 years. There is a difference in tone, pacing and content … and there seems to be quite a bit of [creative] latitude there” today, she said.

Responding to an audience question about whether OPDP is still considering a move toward a “less is more” approach to risk disclosures in certain ads, Aikin said that she could not speak specifically about “less is more,” but would say that OPDP has done a number of studies on disclosures as well as a study on the content of the major statement in DTC ads. “OPDP found that presenting just those risks that are serious and actionable, as opposed to a longer risk statement, is equally effective and helps communicate better.”