FDA Revisits Off-Label Communication in Draft Guidance for Medical Product Labeling

In response to requests from drug manufacturers that they be able to communicate supplementary data and information about a product’s “off-label” uses in promotional materials, the FDA issued draft guidance addressing questions about how to appropriately communicate this type of information while remaining consistent with a product’s approved label.

Previously, the FDA stated that it does not consider this supplementary information to be consistent with labeling guidelines; once the agency approves or clears a medical product, it requires that the label indicate conditions for use of the product and directions and information on how to use the product safely and effectively under those specific conditions. If a manufacturer makes claims about a product that have not been evaluated by the FDA, it is considered misbranding and the company may face repercussions.

The FDA’s current draft guidance makes several suggestions for appropriate off-label communication, including:

  • disclosing why the additional data are contextually relevant (including study type, objectives, product dosage/use regimen, control cohort, patient population, and more)
  • divulging limitations related to the study design and methodology
  • accurately characterizing and contextualizing relevant information about the product (including unfavorable or inconsistent findings)

The guidance is open for public comment until April 19, 2017. Visit federalregister.gov for more information.

Sources: U.S. Food and Drug Administration press release, January 18, 2017; Reuters, January 18, 2017.