America’s Blood Centers (ABC), the Association for the Advancement of Blood & Biotherapies (AABB), and the American Red Cross have submitted joint comments to the U.S. Food and Drug Administration (FDA) regarding the PMI (patient medication information) proposed rule for blood and blood components. The title of the rule is “Medication Guides: Patient Medication Information.” The PMI proposed rule would “amend” the agency’s labeling regulations for medication guides (FDA-approved written prescription drug product information distributed to patients) “[requiring] applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. PMI would be a one-page document with standardized format and content that would be submitted to FDA for approval” with the aim of im-proving public health and safety.
In the the PMI proposed rule for blood comments, the three organizations urged the agency to “exclude PMI for blood and blood components from the Patient Medication Information rule that has been proposed since patients receive information on the risks associated with blood transfusions, and are pro-vided with the ability to ask questions, decline transfusion or select alternative treatment options, through the informed consent process; blood and blood components are always transfused by a healthcare professional; and PMI for blood and blood components will not achieve the intended results of aiding in ‘pre-venting the introduction, transmission, or spread of communicable disease,’ because these elements for blood safety must be addressed through a well-established, extensive system of robust safety requirements by FDA and AABB prior to labeling for distribution.”
Additionally, the PMI proposed rule for blood comments addressed specific questions posed by FDA regarding the potential requirement of PMI for blood and blood components. The blood community explained that “all hospital transfusion services have the Circular of Information for the Use of Human Blood and Blood Components and can use this comprehensive resource to develop informed consent materials.” ABC, AABB, and the American Red Cross encouraged FDA to “consider the PMI as addenda to the Circular. Therefore, the documents would be submitted to FDA for review with the next version of the FDA-recognized Circular through the longstanding, existing process. They would not be subject to a new or separate approval process…if FDA decides to require PMI documents for blood and blood components, the blood community can jointly develop the PMI documents by creating a subgroup of subject matter experts under the AABB Circular of Information Task Force and incorporating the PMI documents into the longstanding collaborative process used to develop the Circular.”
Also, in the Patient Medication Information rule comments, the blood community “advised against introducing additional regulatory burdens by mandating [that] PMI details be electronically housed on the FDA website.” The PMI for blood and blood component comments also noted how “burdensome it would be to require providers to give patients a PMI before every blood transfusion, when established informed consent processes and procedures do not necessarily require providers to obtain a patient’s informed consent before each transfusion.” ABC will continue to provide updates regarding the PMI proposed rule for blood and blood components.
You can find an archive of all letters and comments on America’s Blood Centers’ blood advocacy initiatives here.