Do communications about new formulations of a currently prescribed medicine fall within the “refill reminder” exception to marketing?
No, only communications about drugs or biologics currently prescribed to the individual fall within the refill reminder exception at paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501. However, covered entities may communicate in a general manner to individuals regarding the availability of a drug with, for example, a different dosing schedule or form, without triggering the marketing requirements. For example, a pharmacy could send an adherence communication to an individual that also informs the individual about the availability of a product with a more convenient dosing schedule or in a liquid instead of pill format, without naming the particular medication. Alternatively, communications about specific new formulations of a drug may fall within the treatment exception to marketing at paragraph (2)(ii)(A) of the definition, provided the covered entity does not receive financial remuneration in exchange for making the communication. In addition, such communications may be made in a face-to-face encounter with the individual, without authorization, even if financial remuneration is received in exchange for making the communication.