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U.S. Department of Health and Human Services

About FDA

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OPDP Complaints


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 356H.
Please include in the submission:
  • Cover letter identifying the drug, manufacturer, promotional materials and violations
    • Include "Complaint" in the subject line of the cover letter
    • Include contact name, title, address, phone, fax, and email of the person that OPDP should contact about issues related to the submission
  • Promotional materials
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 a "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.