U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Surveillance: Post Drug-Approval Activities
  5. Office of Prescription Drug Promotion
  6. The Bad Ad Program
  1. Office of Prescription Drug Promotion

The Bad Ad Program

 

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.

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

Please see the FAQs section below for additional information regarding submitting a report to the Bad Ad Program.

Bad Ad CE 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 continuing education (CE) and has developed real-life case studies to help bridge this gap for healthcare providers and trainees. 

The CE 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 CE course is accredited for physicians, physician assistants, nurse practitioners, nurses, pharmacists, and pharmacy technicians. It can also be taken by others for a certificate of completion.

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.


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

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

Frequently Asked Questions

  1. Is the program only for healthcare providers?
    Anyone can submit a complaint 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 complaints often alert OPDP to potential problems.  However, complaints 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 complaint 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.

Return to OPDP Homepage

Back to Top