Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
Posted Mar 17 2011 1:30pm
The Prescriber's Role – Recognize and Report
FDA's educational outreach program is 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 Division of Drug Marketing, Advertising, and Communications in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.
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 Unapproved Use
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 off-label 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.Frequently Asked Questions
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 DDMAC be able to stop the misleading promotion?
In many cases, yes, especially if 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 DDMAC?
The information you provide will be sent to the Regulatory Review Officer in DDMAC 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 DDMAC in-service training for large medical group/hospitals or to speak directly with a DDMAC Reviewer, call 301-796-1200.