Do communications about specific adjunctive drugs related to the currently prescribed drug fall within the “refill reminder” exception to marketing?

Answer:

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. An adjunctive drug that may be used in conjunction with a currently prescribed drug to help treat a patient’s underlying condition or address one or more side effects of a currently prescribed drug does not fall within this category. However, covered entities may communicate in a general manner to individuals regarding the availability of adjunctive drugs related to the drug that is currently being prescribed to the individual without triggering the marketing requirements. For example, a pharmacy could send a communication to an individual alerting the individual to possible side effects from her currently prescribed medication, and suggesting the individual go ask her doctor about a medication to treat the side effects if she experiences them, without naming a particular medication. Alternatively, communications about adjunctive drugs 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.

Created 9/19/13