In May 2010, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) launched the Bad Ad program. This program was designed to raise awareness among health care professionals (HCPs) and HCP students about untruthful or misleading prescription drug promotion and provide them with an easy way to report it to FDA. Since the program has launched, FDA has released annual reports about its progress.
As part of this program, FDA announced that OPDP is launching an e-learning CME/CE course and case studies. In announcing the program, OPDP Director Tom Abrams noted that his office wants to make sure “the information your doctor or prescriber receives is truthful and not misleading, because they may use it when deciding what medicines to prescribe to you, their patient.”
The e-learning course is a one-hour, self-paced training to help HCPs and HCP students learn how to identify prescription drug promotion that may be misleading or raise other regulatory issues and report it to FDA. Medscape has created the course, which is ACCME accredited, and there is no cost for participation.
“The goal of this activity is to educate healthcare professionals and students about the role they can play in helping the FDA ensure that prescription drug advertising and promotion is truthful and not misleading.” The faculty on this committee include various employees from FDA’s OPDP, as well as Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER).
Specifically, the course can be taken for CME/CE credit and is made up of seven (7) modules, including modules on
- The Bad Ad Program,
- Principals of Persuasion,
- FDA Oversight of Prescription Drug Promotion and Marketing,
- Common Drug Promotion Issues, and
- Reporting Potential Drug Promotion Issues
While anyone can take the course, the target audience is all current and future HCPs, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists—all of which can receive CE credit for the program.
Upon completion of this activity, participants will be able to:
- Identify the role that FDA, OPDP and HCPs play in regulating prescription drug promotion and advertising
- Describe the most common regulatory issues raised by prescription drug promotion
- Recognize false or misleading prescription drug promotion
Additionally, OPDP developed several case studies based on recent enforcement letters. HCP schools can incorporate these case studies into their curriculum to raise awareness about misleading prescription drug promotion. Abrams noted that “because students are actively engaged in forming clinical practice habits that may last throughout their careers, reaching them now with Bad Ad information could have a strong impact on how they view prescription drug promotion.”
The cases cover a range of promotional materials and touch upon numerous prescription drug promotion issues. Each case includes a facilitator’s guide with questions and a detailed answer key. The case studies are based on FDA Warning and Untitled letters issued to drug companies.
Abrams encouraged medical, pharmacy, nursing and other health care related schools to incorporate these cases into their coursework. The cases cover a range of promotional materials including a website, journal ad, and TV ad, and touch upon numerous promotional practices that don’t comply with our regulations. Through the case studies, students will have an opportunity to evaluate and discuss these real-life examples of misleading drug promotion.
The e-learning course and case studies will provide a solid fundamental understanding of common regulatory issues with prescription drug promotion to the nation’s current and future HCPs.
OPDP believes that these new resources will continue to raise awareness about misleading prescription drug promotion and the role that HCPs can play in reporting these issues to FDA.