Pharmaceutical Promotion Compliance: Avoiding the Common Mistakes

April 4, 2016
Pharmaceutical Compliance Monitor

Types : Bylined Articles

There are certain key questions to keep in mind when creating promotional materials for prescription drugs and reviewing these materials for regulatory compliance:

  • Is the content truthful and not misleading?
  • Does the content present a full and balanced disclosure of risks and material facts?
  • Are the product claims being made in the promotional material explicitly included within the indication approved by the FDA?
  • Are the product claims supported by substantial evidence?

If you cannot respond with a resounding “yes” to each of these questions, the promotional materials may violate FDA regulations and guidance and could earn you an FDA warning letter, an FDA finding that the prescription drug is misbranded and/or an FDA enforcement action.

Over the years, the FDA, specifically the Office of Prescription Drug Promotion (“OPDP”), has through guidance and letters, continued to flesh out what the agency defines as truthful, balanced, substantiated claims that fall within the product indications-or at least provided real life examples of prescription drug claims that violate agency standards. The following discussion addresses some of the most frequent violations found by the FDA in promotional claims – as set forth in recent OPDP letters.


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