Do communications about drug delivery systems fall within the “refill reminder” exception to marketing?

Answer:

Yes.  Where an individual is prescribed a self-administered drug or biologic, such as insulin, communications regarding all aspects of a drug delivery system, such as an insulin pump, fall within the refill reminder exception at paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501, provided any financial remuneration received in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.

Created 9/19/13