Are pharmaceutical manufacturer-funded communications to patients concerning a prescribed drug considered marketing under the Privacy Rule if they are required by a Risk Evaluation and Mitigation Strategy (REMS)?
No. If the Food and Drug Administration (FDA) determines that a particular drug can only be approved with additional measures, beyond labeling, to mitigate a serious risk posed by the drug, and one or more of those measures take the form of patient communications about the drug, then such communications are not marketing, even if the communication is funded by the drug manufacturer. Government-mandated communications to individuals are not considered marketing under the Privacy Rule, even if such communications are paid for by a third party whose product or service is being described. As with communications to individuals concerning government and government-sponsored programs, government-mandated communications to individuals are not commercial in nature. Thus, a covered entity may use or disclose an individual’s protected health information without the individual’s authorization to send the individual educational or other information concerning a prescribed drug that is required by a REMS, even if the communication is funded by the drug manufacturer.