Truthful Prescription Drug Advertising and Promotion
FDA's Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.
The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research. The program's goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency: e-mail BadAd@fda.gov or call 855-RX-BADAD.
Bad Ad CME/CE course and Educational Case Studies:
Content on this Page
"What To Do About Misleading Drug Ads" Video (Medscape Today)
Bad Ad Program Year End Reports
Please see the Bad Ad program's year end reports which provide a summary of the program's activities during that year.
Prescription drug advertising must:
- Be accurate
- Balance the risk and benefit information
- Be consistent with the prescribing information approved by FDA
- Only include information that is supported by strong evidence
What types of promotion does OPDP regulate?
- TV and radio advertisements
- All written or printed prescription drug promotional materials
- Speaker program presentations
- Sales representative presentations
OPDP does not regulate promotion of:
- Over-the-Counter Drugs
- Dietary Supplements
- Medical Devices
- Omitting or downplaying of risk
- Overstating the effectiveness
Promoting Uses Not Addressed in Approved Labeling
- Misleading drug comparisons
Example of Omission of Risk
You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.
This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.
Example of Uses Not Addressed in Approved Labeling
You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.
This presentation would be illegal because it promotes an unapproved use.
Example of Overstating the Effectiveness
“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”
This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.
1. Can I report anonymously?
Yes, anonymous complaints often alert FDA to potential problems. However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.
2. Will OPDP be able to stop the misleading promotion?
In many cases, yes, especially if the appropriate evidence is provided. Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.
3. What will happen to my complaint once I have contacted OPDP?
The information you provide will be sent to the Regulatory Review Officer in OPDP responsible for this class of drugs. The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.
4. How do I learn more?
To learn more about OPDP in-service training for large medical group/hospitals call 301-796-1200.
Phone: 855-RX-BADAD or 855-792-2323
5901-B Ammendale Rd
Beltsville, MD 20705-1266
Fax: 301-847-8444 or 301-847-8445
OPDP is responsible for ensuring truthful advertising and promotion of prescription drugs.
Our mission is to…
- Protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.
- Guard against false and misleading advertising and promotion through comprehensive surveillance, enforcement, and educational programs.
Key Points of the Bad Ad Program Dear Colleague Letter (Bad Ad Program)(PDF - 34KB) ‘Bad Ad Program’ to Help Health Care Providers Detect, Report Misleading Drug Ads[ARCHIVED]
Bad Ad Program: FDA Aims to Keep Drug Promotion Truthful
Commissioner's Letter regarding the launch of Bad Ad CME/CE course and educational case studies(PDF - 575KB)