What types of communications fall within the “refill reminder” exception to marketing?

Answer:

The refill reminder exception to the definition of “marketing” encompasses refill reminders and other communications about a drug or biologic that is currently being prescribed for the individual. See paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501. In addition to refill reminders about currently prescribed drugs, the exception encompasses communications about generic equivalents of a drug being prescribed, adherence communications encouraging individuals to take prescribed medicines as directed, and communications about prescriptions that have lapsed within the last 90 calendar days. Also, where an individual is prescribed a self-administered drug, communications regarding all aspects of a drug delivery system fall within the refill reminder exception. Thus, these types of communications are permitted without an individual’s authorization, provided any financial remuneration received from the pharmaceutical manufacturer in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.

Created 9/19/13