Blood Community Urges FDA to Exclude Blood Products From PMI Requirements

AABB, America’s Blood Centers (ABC) and the American Red Cross (ARC) urged the Food and Drug Administration to exclude blood and blood components from the agency’s patient medication information (PMI) requirements, first outlined in a May 2023 proposed rule.

This proposed rule, if finalized, would require applicants of all new and approved new drug applications (NDAs) and biologics license applications (BLAs) to create a new, one-page medication guide (referred to as PMI) for prescription drugs used, dispensed or administered on an outpatient basis. The proposed rule would apply to biological products, including blood and blood components transfused in the outpatient setting.

In a Nov. 27 letter to Commissioner of Food and Drugs Robert M. Califf, MD, the blood community commended the agency for its work to ensure that patients have access to information that enables them to understand the risks and benefits of prescription medicines; However, AABB, ABC and ARC believe that existing processes and framework can more efficiently and effectively deliver PMI and support the intended outcome.

Specifically, the blood community noted that under current processes, patients already receive information on the risks associated with blood transfusions. Through the informed consent process, they are provided with the ability to ask questions, decline transfusion or select alternative treatment options. Additionally, while blood and blood may be transfused in an outpatient setting, blood products are always transfused by a health care professional.

Finally, the organizations emphasized that PMI for blood and blood components will not achieve the intended results of aiding in “preventing 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.

AABB, ABC and ARC also addressed specific questions from the agency related to potential PMIs for blood and blood components. If FDA requires PMI for blood and blood components, the blood community recommended that FDA avoid creating new regulatory burdens by incorporating PMI into the existing process used to update the FDA-approved Circular of Information for the Use of Human Blood and Blood Components. The PMI documents could serve as addenda to the Circular, and their distribution to providers can be facilitated through the existing dissemination system for the Circular.