The Center for Drug Evaluation and Research, or CDER, is the FDA's OTC and prescription drug watchdog. Efficacy and safety are the names of its game. But someone has to look after drug market--and that would be the Office of Prescription Drug Promotion (OPDP), probably best-known as the distributor of the dreaded untitled and warning letters that inspire trepidation among pharma marketers.
But the OPDP also has a research budget, and it's racking up studies of consumers and their responses to drug promotions. Currently underway, for example, are studies about DTC ads aimed at adolescents, risk disclosures during commercials and in print--even an eye-tracking study to determine perception and distractions during the mandatory reading of side effects.
But we wondered, just how does OPDP decide what to research? So we asked Tim Irvin, CDER's press officer, along with some other questions in an email interview.
Q: How do you choose what topics to study?
A: OPDP's research team members, in collaboration with research contractors, develop study designs and materials with input from other OPDP stakeholders. OPDP's research is then subject to the Paperwork Reduction Act. There are two public comment periods, 60 days and 30 days, in which the public have the opportunity to provide comments on the proposed data collection. After the 30-day open comment period, OMB evaluates the proposed information collection, [which] can begin after OMB approval is received. After data is collected and analyzed, the research team develops manuscripts for publication in peer-reviewed journals. ... There is no set number of studies to be conducted. We will continue to conduct studies as long as there are issues that will benefit from empirical data.
Q: Who are the ODPD stakeholders that have input into the studies chosen? Are the topics influenced by what's in the news or what patients or physicians are concerned about?
A: OPDP's research projects are driven both by considering which topics will have an impact on public health, in keeping with OPDP's mission, and by topics mandated through legislation. Our studies are developed with two aims in mind: first, to inform policies with regard to the promotion of prescription drug products; and second, to provide valuable information on aspects of prescription drug promotion that can improve the safe and effective use of these products.
Q: Do pharma companies have any input?
A: All interested parties and stakeholders, including pharmaceutical companies, have the opportunity for extensive input during the two public comment periods. We often make minor and major changes to our studies based on feedback from stakeholders, including pharmaceutical companies. Outside of the public comment process, we welcome ideas about possible future studies. Although there is no formal method for this form of feedback, we have an email address [[email protected]] that can be used to suggest ideas.
Q: How long does the average study take from start to finish?
A: The average experimental study with random assignment takes from 3-4 years. This length includes the extensive public comment process, peer review, human subjects review, and OMB approval timeline. … Some less complex studies, such as surveys, take 2-3 years. Other studies that do not require OMB approval, such as content analyses, generally take 1-2 years to complete.
Q: How big is the research team that works on the studies and what kind of backgrounds do they have?
A: The research team currently consists of four individuals who have doctoral degrees in social psychology. In addition, one member also has a Masters of Public Health. They have years of experience in experimental and survey design, data collection, and analysis.
Q: What have been some of the more important findings over the years?
A: All the studies that are conducted are important. Below are three examples illustrating the importance of OPDP's research:
The brief summary study informed the brief summary guidance, [which allows drugmakers to experiment with limited risk disclosures in drug ads; it can be found here].
The literature review and format, quant, and efficacy studies informed the response to HR 3507, [a bill that would have expanded telemedicine use in the government's TRICARE program].
The distraction study (posted in the public docket) informed the response to the Clear, Conspicuous, and Neutral rule. [The eye-tracking study is a follow-up.]
- see OPDP previous and current studies