The Bad Ad Program
FDA's Bad Ad Program is an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion. The program’s goal is to raise awareness among healthcare providers including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and trainees about potentially false or misleading prescription drug promotion while also providing them with an easy way to report it to the Agency. The program is run by the Agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research.
Oversight of Prescription Drug Promotion
Prescription drug promotion must:
- Not be false or misleading
- Have a 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
What types of promotion does OPDP regulate?
OPDP regulates prescription drug promotion made by or on behalf of the drug’s manufacturer, packer, or distributor, including:
- TV and radio advertisements
- Written or printed prescription drug promotional materials
- Internet based promotion including social media
- Speaker program presentations
- Sales representative presentations
OPDP does not regulate promotion of:
- Over-the-Counter Drugs
- Certain Biological Products
- Medical Devices
- Foods
- Drugs for Animals
- Compounded Drugs
- Cosmetics
- Dietary Supplements
* If your report is not related to prescription drug promotion, please see the table below for the appropriate points of contact.
Common Drug Promotion Issues:
- 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
- Making misleading drug comparisons
- Misbranding an investigational drug
Reporting:
To report potentially false or misleading prescription drug promotion:
- Email: BadAd@fda.gov
- Call toll-free 855-RX-BADAD or 855-792-2323
- Write:
Bad Ad Program
FDA/CDER/OPDP
5901-B Ammendale Rd
Beltsville, MD 20705-1266
While the following information is NOT required, it is greatly appreciated and facilitates OPDP’s review of the report:
- Name of the prescription drug product (brand name or established name and generic if possible)
- Reason for the report – please provide as much detail as possible
- Links to and/or images of the potentially misleading prescription drug promotion
- Your contact information (or if you prefer to be anonymous, please state that)
- Any other information you think may be relevant
Please see the FAQs section below for additional information regarding submitting a report to the Bad Ad Program.
If your report is related to any of the following items, please email the following points of contact:
| Type of Product | Point of Contact |
|---|---|
| General Inquiries | CDER Division of Drug Information |
| Non-prescription Drug Products | Office of Compliance (OC) General Complaint Box |
| Certain Biological Products | Center for Biologics Evaluation and Research (CBER) Advertising and Promotional Labeling Branch (APLB) |
| Medical Devices | Center for Devices and Radiological Health (CDRH) |
| Food and Cosmetics | Center for Food Safety and Applied Nutrition (Food and Cosmetics) |
| Drugs for Animals | Center of Veterinary Medicine (CVM) |
| Compounded Drugs | Office of Compliance (OC) Compounding |
| Dietary Supplements | Office of Dietary Supplement Programs |
| Tobacco Products | Center for Tobacco Products (CTP) |
Bad Ad Course and Educational Case Studies:
Although healthcare providers are frequently exposed to prescription drug promotion, they often have not received education on recognizing false or misleading prescription drug promotion. As part of FDA's Bad Ad Program, OPDP has an online course and has developed real-life case studies to help bridge this gap for healthcare providers and trainees.
The course is a one-hour, self-paced training to help healthcare providers and trainees learn how to recognize and report potentially false or misleading prescription drug promotion to the FDA. It includes modules regarding the Bad Ad Program, the Science of Influence, FDA Oversight of Prescription Drug Promotion, Common Prescription Drug Promotion Issues, Real-Life Scenarios, and Reporting Potential Drug Promotion Issues.
The real-life case studies that OPDP has developed are based on actual Warning and Untitled Letters issued by OPDP to companies regarding alleged false or misleading prescription drug promotion. They are designed to be able to be used in a teaching setting. The case studies include the alleged violative promotional material, the Warning or Untitled Letter that was issued, the prescribing information, and a facilitator guide that can be used by an instructor to lead a discussion in a group setting.
Webinars
FDA encourages all healthcare providers to learn more about the Bad Ad Program because it may inform their review of information that they come across in prescription drug promotion. To help facilitate knowledge about the Bad Ad Program, FDA is seeking opportunities to work with professional organizations to help provide their members with information regarding the Bad Ad Program and more broadly prescription drug promotion through webinars. To learn more please contact us at BadAd@fda.gov
Frequently Asked Questions
1. Is the program only for healthcare providers?
Anyone can submit a report to FDA. However, the Bad Ad Program itself is focused primarily on healthcare providers since the majority of prescription drug promotion is directed towards healthcare providers. FDA does have a website designed to help educate consumers about false or misleading direct-to-consumer (DTC) promotion.
2. Can I report anonymously?
Yes, anonymous reports often alert OPDP to potential problems. However, reports accompanied by names and contact information are helpful in cases in which OPDP needs to follow-up for more information.
3. Will OPDP be able to stop the false or misleading promotion?
In many cases, yes, especially if the appropriate evidence is provided (e.g., a copy of the promotional material).
4. What will happen to my report once I have contacted OPDP?
The information you provide will be sent to the OPDP reviewer responsible for this class of drugs. The reviewer will evaluate it and determine if it may serve as the basis for a potential compliance action or as valuable information for our ongoing surveillance activities.
5. How do I learn more?
To learn more about OPDP in-service training for large medical group/hospitals or to speak directly with an OPDP reviewer, call 301-796-1200.
6. Will I hear from OPDP about the outcome of my report?
The Agency does not comment on ongoing investigations.
You can find OPDP’s compliance letters on the FDA Warning Letters and FDA Untitled Letters webpages.
Additional Resources
- "Q&A with FDA” Podcast with Dr. Catherine Gray
- FDA's Bad Ad Infographic (Spanish language version)
- FDA's Bad Ad Quiz
- Division of Drug Information Home Study Webinar: FDA’s Bad Ad Program
- FDA's Bad Ad Article: FDA’s ‘Bad Ad’ Program Encourages HCPs to Report False or Misleading Prescription Drug Promotion (Spanish language version)
- OPDP Compliance Actions: Warning Letters and Notice of Violation Letters to Pharmaceutical Companies