The DDMAC Research Team is an integral part of the Division’s science, enforcement, and policy program. DDMAC has an active research program designed to investigate applied and theoretical issues in the communication of risk and benefit information in direct-to-consumer (DTC) and professional promotional prescription drug materials. This research program utilizes a number of different research methodologies, including survey and experimental research as well as qualitative research for development purposes. DDMAC’s research supports FDA’s goal of science-based policy while maintaining its commitment to protect the public health. Several past or ongoing research projects are listed below:
Experimental Research:
- Evaluation of Format and Content in the Brief Summary in Print Ads
(Expected completion date: 2008)
The brief summary is a page of risk information required to be included in any piece of print prescription drug advertising. It was traditionally a verbatim copy of the prescribing information designed for physicians in medical terminology. FDA is interested in improving the communication of risk information in this format. The current series of three studies investigates 1) how people use the brief summary in its current form, 2) what are the best types of information to include, and 3) what are the strengths and weaknesses of some alternative ways to present the information.
For more information about these studies, please see:
Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer
(DTC) Print Advertisements for Prescription Drugs: Study 1
Experimental Evaluation of Variations in Content and Format of the Brief Summary
in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs
- Effect of Distraction on Information Processing in DTC Television Ads
(Expected completion date: 2009)
DTC television ads tend to attract much attention because they are so widely disseminated. Critics of DTC speculate that visual images of emotionally pleasant scenes during the presentation of risk information detract from the comprehension of that risk information. The current study is designed to investigate the role of visual and tonal distraction as well as the potential mitigating role superimposed text may play.
For more information about this study, please see:
Agency Information Collection Activities; Proposed Collection; Comment
Request; Experimental Evaluation of the Impact of Distraction on Consumer
Understanding of Risk and Benefit Information in Direct-to-Consumer
Prescription Drug Broadcast Advertisements
- Communication of Effectiveness Information in DTC Print Ads
(Expected completion date: 2011)
This study will investigate the communication of effectiveness information on the main advertising page of print advertisements. By varying the presentation of this information, we will determine which manipulations bring consumers closer or farther away from an independent physician assessment of the effectiveness of the drug product in actual practice. This multi-phase study is in early development.
- Addition of Toll-Free Statement in Television DTC Ads
(Expected completion date: Fall 2009)
As part of FDAAA, we will examine the addition of a statement in television ads that directs individuals to a phone number and website to which they can report side effects. We will examine the role of placement, duration, and prominence in the understanding of the risk information, the benefit information, and the comprehension of the toll-free statement itself.
- Assessing Understanding of Risk and Benefit Information in Television and Print DTC Ads with the Addition of Quantitative Information
(Expected completion date: 2012)
In this study, under early development, we will examine the communication of complicated efficacy information. Specifically, we will examine whether quantitative information can be successfully added to television and print advertisements to maximize the audience's understanding of the risk and benefit information in the piece. This three part study may involve simple efficacy claims, risk reduction claims, and composite endpoint information.
Survey Research:
Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs
(Completion date: November 19, 2004).
Two surveys of consumers were undertaken in 1999 and 2002 and a physician survey took place in 2002 to evaluate attitudes toward DTC broadcast ads in general and the impact these ads have on doctor-patient interactions. Much more information can be found here:
Patient and Physician Attitudes and Behaviors Associated With Direct-to-Concumer (DTC) Promotion of Prescription Drugs - Summary of FDA Survey Research Results
Qualitative Research:
- Reactions to Common Terminology Used in DTC Ads
(Completion date: July, 2007)
Four focus groups with consumers were designed to explore common phrases that often appear in DTC advertising, such as “individual results may vary” and “generally well-tolerated.” The groups were conducted in an effort to understand how consumers respond to and talk about a number of different phrases and concepts. The research was also designed to assess whether further quantitative research would be conducted on this topic. At this time, no quantitative research is planned. Given resource issues within the Division, no quantitative research on this topic is planned at this time.
- Influences on Physician Prescribing Behaviors
(Completion date: August, 2004)
Four focus groups of physicians were held to explore what the most important influences were on their prescribing practices. The majority of physicians in these groups indicated that financial considerations, such as formulary and sampling, were preeminent, as well as discussions with colleagues. Few physicians reported being influenced by promotion in any form, including detailing, professional journal advertising, or DTC advertising. These groups were designed to explore avenues for further quantitative research on this topic. Given resource issues within the Division, no quantitative research on this topic is planned at this time.
In addition to research conducted by and for DDMAC, DDMAC researchers consult with other divisions within FDA and with external groups. The following are two examples of recent work for other organizations:
- Gender Differences in the Processing of Drug Label Information
(Completion date: July, 2006)
As consultants to the Office of Women’s Health and the Office of Drug Safety (now the Office of Surveillance and Epidemiology), a series of studies was planned to examine gender differences in the comprehension and use of materials that accompany prescription drug prescriptions from the pharmacy as well as FDA-approved materials. A series of focus groups was conducted in the summer of 2006, revealing that there were few differences in the processing of information or the use of the information. Given resource issues in the lead divisions, this project was terminated after the qualitative phase and no quantitative research is planned.
- Toll-Free Statement Wording Research
(Completed: October 2008)
In 2006, the Best Pharmaceuticals for Children Act mandated that a statement be included on packaging for prescription and over-the-counter products that gave consumers a contact number for FDA to report serious side effects. DDMAC was consulted to conduct a study to determine the best wording for this statement. A series of focus groups with consumers was held in the winter of 2007 which led to the selection of nine possible statements for quantitative testing. Experimental research was then conducted to evaluate these statements. Analyses showed that all statements were generally clear and understandable with the exception of one statement. Participants were able to distinguish between serious and minor side effects and reported that they would call their healthcare provider for medical emergencies rather than FDA. Overall, few individuals reported that they would call the FDA to report side effects.
The full report can be found at Regulations.gov. (Click on the PDF icon.)
The DDMAC Research Team also provides technical assistance to external groups who consult with DDMAC on the design and implementation of studies concerning the communication of information in promotional forums. These groups include pharmaceutical companies, non-profit organizations, and academic researchers.
DDMAC Research Team:
Kathryn Aikin, Ph.D.
Amie O’Donoghue, Ph.D
Helen Sullivan, Ph.D. MPH
CONTACT US: DTCP@fda.hhs.gov
