About FDA

OPDP Complaints

Please note that complaints about prescription drug promotion are not accepted in eCTD, and they should only be submitted as paper hard copies. *

Please submit complaints regarding professional and consumer materials separately.  A duplicate copy of the submission should be provided. Please do not include Form FDA 2253 or Form FDA 356h.

Please include the following:

  • Correspondence stating that it is a complaint. Please include the drug, manufacturer, and specific regulatory concerns in the correspondence. In addition, the correspondence should include the contact name, title, address, phone, fax, and email of the person that the Agency should contact about issues related to the submission.
  • Supporting information or documentation, if available.
Complaints should be sent to the FDA Central Document Room at the following address:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion
5901-B Ammendale Road
Beltsville, MD 20705-1266
To help avoid misdirection of your complaint, OPDP suggests applying an "OPDP" sticker [example sticker (PDF)] or other prominent directional notation to the exterior of packages.  If it is not possible to add this notation to the exterior of the package, OPDP recommends adding a prominent directional notation (e.g., sticker, rubber stamp, etc.) to the cover letter itself.
*If applicable, an electronic copy of a TV or radio ad in an acceptable file format (e.g. a CD containing a .wmv or .wma file) may be included with a complaint.
Healthcare providers may also submit complaints through the Bad Ad Program.

Page Last Updated: 06/03/2015
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