• Product Promotion Buzzword Refresher
  • July 23, 2012 | Author: Julie Klish Tibbets
  • Law Firm: Alston & Bird LLP - Washington Office
  • Given the volume of marketing materials routing to regulatory affairs professionals on the materials review committees of drug and medical device companies each year, a periodic refresher on buzzwords that the U.S. Food and Drug Administration (FDA) has found to be problematic in the past can help preserve the sharp focus of your critical eye and reduce the risk of a regulatory action. While the list of buzzwords has not changed much over the last several years, it is a good exercise to revisit this list often as you review your company's promotional materials:

    • New, now approved, introducing (use of these terms beyond the first six months following approval, clearance or introduction is not appropriate)

    • Drug/device of choice, gold standard, standard of care, next-generation (these terms, unless substantiated, can misleadingly imply superior efficacy in a product class)

    • Novel, breakthrough, only, unique (these terms also can imply product superiority or greater efficacy than demonstrated to FDA; be careful of claims that use these terms to inappropriately link the mechanism of action (MOA) to clinical efficacy)

    • Rapid (this term can misleadingly represent that the product works faster than it is approved or cleared to work)

    • Potent (this can misleadingly represent greater product efficacy than demonstrated to FDA or superiority in a product class)

    • Preferred (product preference claims can be implied superiority claims and FDA has said that patient preference claims require support from well-designed and controlled head-to-head studies using well-developed instruments)

    • Convenient, easy, simple (these terms can minimize the product directions and recommendations for use and administration, as well as minimize the risks associated with product use)

    • Well-tolerated (this term should not be used for a boxed warning product or in combination with an adverse event spread; according to FDA, doing so would be misleading)

    Use of any of the above terms in a promotional material requires thoughtful consideration of claim substantiation and the manner in which the term is being presented. Remember that the appropriate use of any term in product promotion is a fact-specific inquiry that requires the careful attention of a regulatory reviewer.