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 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


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

 


Additional Resources

Return to OPDP Homepage

 

 
Back to Top