INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, Robert Dean, MBA, Director, and Michael Sauers, Deputy Director, of Division II in the FDA’s Office of Prescription Drug Promotion discuss the FDA’s Bad Ad program.
The Office of Prescription Drug Promotion (OPDP) is located in the FDA’s Center for Drug Evaluation and Research. OPDP’s mission is to protect the public health by ensuring prescription drug information is truthful, balanced, and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both health-care professionals and consumers.
Origins of the Bad Ad Program
What is the FDA’s Bad Ad program, and when was it launched?
Mr. Dean: In May 2010, the FDA launched the Bad Ad program. This educational program was designed to raise awareness among physicians and other health-care professionals about untruthful or misleading prescription drug promotion. The program has since had a significant impact on protecting the public health and has been expanded recently to offer new ways to increase awareness of untruthful or misleading prescription drug promotion.
Affiliated CME
The Bad Ad program recently launched a Continuing Medical Education (CME) course. Can you tell us more about it?
Mr. Sauers: In October 2013, the Bad Ad program launched an e-learning course in partnership with Medscape. It’s a free, hour-long course that offers CME credit for physicians and Continuing Education (CE) credit for other health-care professionals like nurses, nurse practitioners, pharmacists, and physician assistants.
We encourage all health-care professionals to take this course. It’s easy to use and consists of seven modules. For example, one module goes into the psychology of promotion and talks about the sales techniques that many pharmaceutical representatives use. There’s also a brief test at the end of the course where you watch video snippets and try to spot misleading promotion.
The course is available at www.fda.gov/BadAd. Again, it’s free and only about an hour long. We really want to make it easy for health-care professionals to learn about untruthful and misleading drug promotion.
Program Goals and Impact
Why did the FDA create the Bad Ad program? And how does the CME course relate to that?
Mr. Dean: The first goal of the program is to raise awareness among physicians and other health-care professionals of misleading promotion. The second goal is to streamline the process for those health-care professionals who choose to engage with us to help stop misleading promotion.
Through various activities such as conference exhibits, grand rounds presentations and educational outreach, we believe we are slowly but surely raising awareness, not only from a regulatory perspective of what is false or misleading, but also of what health-care professionals can do to help stop misleading messages from reaching their colleagues and patients. By offering a direct line of communication between health-care professionals and FDA regulatory reviewers (badad@fda.gov), they can be sure that their concerns will be addressed by the appropriate FDA staff.
What has been the impact of the Bad Ad program?
Mr. Sauers: It’s had a significant impact. In the year after the program launched, the FDA received more than triple the number of complaints over the past annual average, with most complaints coming from health-care professionals. For example, we received 37 complaints regarding a misleading TV advertisement for a product called EpiPen. Three days after the first complaints arrived in the FDA’s Bad Ad e-mail inbox, the manufacturer voluntarily withdrew the ad at the FDA’s request and soon issued a correction.
Obviously, the more health-care professionals who know about the Bad Ad program, the more impact the program can potentially have. We’re trying to raise professional awareness of the program; that’s one of the reasons for offering the CME course online and free of charge.
What do you want health-care professionals to take away from the Bad Ad program and CME course?
Mr. Dean: The takeaway for physicians and other health-care professionals is that while promotion can serve as a valuable means of education, it can also potentially be misleading. And as a concerned health-care professional, there is an avenue for you to help improve the quality of prescription drug information available to you, your colleagues, and your patients.
Role of Students
What about all of the future health-care professionals who are still in school?
Mr. Sauers: Students hoping to become health-care professionals are actively engaged in forming clinical practice habits that may last throughout their careers, so reaching them now could have a strong impact on how they view prescription drug promotion. Because students will soon be providing care to patients and prescribing the innovative medicines marketed by the pharmaceutical industry, increasing their awareness about misleading drug advertising and promotion will have a lasting public health impact.
To help them become more discerning about promotional information, we’ve developed several case studies based on FDA Warning Letters and Untitled Letters issued to drug companies. The case studies, which represent common problems with promotion, can be downloaded from the Bad Ad website at www.fda.gov/badad.
We’re also encouraging medical, pharmacy, physician assistant, nursing, and other health-care professional schools to incorporate these cases into their coursework. The cases expose students to a range of promotional materials including a website, a journal ad, and a television ad, and touch upon numerous promotional practices that don’t comply with FDA regulations.
Through the case studies, students will have an opportunity to evaluate and discuss these real-life examples of misleading drug promotion. The case studies are designed to be used in tandem with the CME/CE course; however, in lieu of continuing education credit, students will receive a certificate of completion for viewing the course.
Common Issues
What would you say are the most common types of issues that the FDA encounters with prescription drug promotion?
Mr. Dean: We encounter a wide range of issues while reviewing prescription drug promotion. However, the most common issues that we typically identify include:
Overstating the efficacy of a drug. One example would be if a sales representative says, “Drug X delivers results in as little as 3 days,” and you learn later that clinical trials showed results in 12 weeks.
Omitting or minimizing the risks of the product. A presentation about a prescription drug that describes a drug’s benefits but not its risks is a common example of this violation.
Making comparisons between drugs when there has been no adequate and well-controlled head-to-head study demonstrating a difference.
Office of Prescription Drug Promotion
You have told us about the Bad Ad program, but can you tell us about your office?
Mr. Dean: Here at the FDA, OPDP is charged with protecting the public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated. OPDP resides within the Center for Drug Evaluation and Research (CDER), which reviews and approves new prescription drugs. Because we are housed in CDER, we are responsible for prescription drug promotion only, while other FDA Centers handle things like dietary supplements, devices, and biologics.
OPDP’s traditional regulatory activities for monitoring prescription drug promotion rely primarily on review of industry promotional pieces submitted to the FDA, complaints filed by the pharmaceutical industry, and field surveillance at large medical conventions. While these efforts are effective, we realized that in order to increase effectiveness, we needed a way to raise awareness among health-care professionals about misleading promotion.
As a former pharmaceutical sales representative, I was well aware of prescription drug marketing practices and wanted to develop a program that partnered with health-care professionals to ensure that prescription drug promotion is truthful, accurate, and balanced. As a result, I created the Bad Ad program with Mike Sauers who is also a former sales representative.
Additional information about OPDP and prescription drug advertising and promotion can be found at www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/drugmarketingadvertisingandcommunications/default.htm.
Are health-care professionals able to communicate with your office if they have questions or if they identify misleading promotion?
Mr. Sauers: We’ve created a dedicated toll-free number and e-mail address to allow health-care professionals to communicate their concerns to us, or to report potentially misleading prescription drug promotion that either they or their patients have encountered. Call us toll free at 855-RX-BADAD or e-mail BadAd@fda.gov. ■
Disclosure: Mr. Dean and Mr. Sauers reported no potential conflicts of interest.
