AHA urges FDA not to finalize draft guidance on blood platelets for transfusion

The AHA today urged the Food and Drug Administration not to finalize its draft guidance on bacterial testing of blood platelets for transfusion, citing serious concerns about possible unintended consequences and the potential impact on platelet supply. “Additional time, information and resources are needed to address these concerns,” wrote Ashley Thompson, AHA senior vice president for public policy analysis and development. “Furthermore, as the new administration works to decrease the cost of health care and reduce regulatory burden, we encourage the agency to re-examine this proposed guidance.”