REGULATORY UPDATE: Blood Community Urges Continued Support of FDA’s Regulatory Science Research Programs

The blood community voiced its continued support for the Food and Drug Administration’s regulatory science research laboratories in a statement submitted to the Blood Products Advisory Committee (BPAC) ahead of the Committee’s Dec. 8 meeting.

In the joint statement, AABB, America’s Blood Centers and the American Red Cross urged “adequate, sustained and dedicated funding” for two laboratories within the Office of Blood Research and Review’s Division of Emerging and Transfusion Transmitted Diseases – the Laboratory of Emerging Pathogens and the Laboratory of Molecular Virology. The organizations emphasized that these laboratories are essential to ensuring the continued safety of the nation’s blood supply.

“The unprecedented level of blood safety we currently enjoy is a direct result of the robust research of these expert career scientists and programs,” the organizations said in the joint statement.

In addition, AABB, ABC and ARC highlighted the many regulatory contributions these investigators make beyond their primary research responsibilities. These include developing policy, drafting guidance documents with recommendations for blood donor screening questions and tests, reviewing diagnostic devices and providing scientific and technical advice to other agencies and government entities. AABB, ABC and ARC concluded by underscoring that this work depends on adequate funding support.

“It is vital to attract and retain career research scientists with critical scientific expertise within the FDA and to adequately fund the agency’s research to facilitate the assessment of interventions that ensure the continued safety of the blood supply and support effective, efficient regulatory review of lifesaving blood and biological products,” the organizations wrote.