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 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.
Report: Contact Information
Phone: 855-RX-BADAD or 855-792-2323
E-Mail: BadAd@fda.gov
Write: FDA/CDER/OPDP
5901-B Ammendale Rd
Beltsville, MD 20705-1266
Fax: 301-847-8444
OPDP's Mission
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.
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