Tom Abrams, Director of the Office of Prescription Drug Promotion, discusses FDA’s Bad Ad Program
This summer, FDA’s Office of Prescription Drug Promotion (OPDP) recognizes 10 years of the Bad Ad Program, designed to educate healthcare providers (HCPs) about how they can support our mission to protect public health by helping to ensure prescription drug promotion is truthful, balanced, and accurately communicated.
This mission is accomplished through comprehensive surveillance, compliance, and education programs, and by fostering better communication of labeling and promotional information to both HCPs and consumers.
Specifically, by raising awareness about false or misleading prescription drug promotion and providing an easy process for reporting it, the Bad Ad Program helps OPDP gain valuable assistance from HCPs in fulfilling its mission.
Continuing Education Credits Available through the Bad Ad Program
Here’s a reminder that our Bad Ad program offers a course with continuing education credits for physicians, physician assistants, nurses, nurse practitioners, pharmacists, and pharmacy technicians. HCP trainees can also take the course for a certificate of completion. It’s a free, hour-long e-learning course. Find out more at www.fda.gov/BadAd.
We have also developed real-life case studies to help HCPs and HCP trainees learn how to recognize and report potentially false or misleading prescription drug promotion.
When the Bad Ad Program began 10 years ago, we hoped to decrease the number of false or misleading promotional messages by educating HCPs on how to identify and report them. We’re encouraged by program results.
By July 2020, HCPs had submitted nearly 2,000 reports of potentially false or misleading promotion to the Bad Ad program, all of which have been, or are being, thoroughly reviewed and investigated. In those cases where the promotion met the criteria needed for further FDA action, OPDP moved forward with a risk-based compliance strategy to put a stop to the promotion. Even in cases where the report may not have led to a compliance action, it still served as valuable information to focus our ongoing surveillance activities.
Prescription Drug Promotion
Prescription drug promotion can provide valuable information about drug therapies. It must be truthful, balanced, and not misleading, because HCPs may consider this information when making treatment decisions for their patients.
In 2017, the pharmaceutical industry spent more than $24 billion on prescription drug promotion, with more than $18.5 billion allotted for marketing to HCPs. Prescription drug promotion is used in a wide variety of advertising and marketing sources. In fact, in 2019, OPDP received more than 110,000 unique pieces of prescription drug promotional materials for review including:
- TV and radio advertisements
- Written or printed prescription drug promotional materials
- Internet-based promotion, including social media
OPDP’s authority to regulate these prescription drug promotional materials stems from the Federal Food Drug and Cosmetic Act. Prescription drug promotion must:
- Not be false or misleading
- Have balance between efficacy and risk information
- Reveal material facts about the product being promoted, including facts about consequences that may result from use of the drug
We ask HCPs to be aware of these requirements when presented with advertising and promotion of prescription drugs that could affect treatment decisions for their patients.
Common Drug Promotion Issues
The following is a list of common issues to be aware of when you are exposed to prescription drug promotion. If you come across these promotional issues, please let us know by reporting them to the Bad Ad program.
- Omitting or downplaying of risk
- Overstating the drug’s benefits
- Failing to present a “fair balance” of risk and benefit information
- Omitting material facts about the drug
- Making claims that are not appropriately supported
- Misrepresenting data from studies
- Misleading drug comparisons
- Misbranding an investigational drug
Continue to Contribute to the Bad Ad Program by Recognizing and Reporting, Here’s How
When you come across an instance of potentially false or misleading drug promotion, you can help put a stop to it by reporting it.
- Email: BadAd@fda.gov
- Call toll-free: 855-RX-BADAD or 855-792-2323
Bad Ad Program
5901-B Ammendale Road
Beltsville, MD 20705-1266
Remember, you can submit a report anonymously, but we do encourage HCPs to include contact information so that we can follow up, if necessary, for more information. When you report a complaint, we ask that you be as detailed as possible by describing the promotion, including the name of the drug, and when you saw it. We also ask that you report in as timely a manner as possible.
Help us ensure prescription drug promotion is truthful, balanced, and accurately communicated. Let’s continue to work together to minimize and deter Bad Ads. Thanks to those who have reported and continue to report for making this program successful!
Tom Abrams is the Director of the Office of Prescription Drug Promotion (OPDP) in FDA's Center for Drug Evaluation and Research. OPDP’s mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. Prior to joining FDA, Mr. Abrams worked in pharmaceutical sales and marketing for Merck and Company. Mr. Abrams received his BS degree in pharmacy from the School of Pharmacy, Rutgers University and his MBA degree from Rutgers School of Business.