FDA Outlines Examples of Communications Consistent with Approved Labeling

The FDA is providing industry with a list of examples of product communications, including promotional materials, consistent with agency-approved labeling.

Sponsors can disclose information on the safety and efficacy profile of a drug, including comparative and pivotal clinical trial data, to provide context consistent with FDA-required labeling. Information on adverse reactions, a drug’s effect in a subpopulation and the long-term safety and efficacy of a product are also considered appropriate disclosures.

The FDA said sponsors cannot convey information about unapproved uses. For example, a drugmaker should not characterize a therapy as a monotherapy if it is only approved for use in combination with another treatment.