Unnecessary and burdensome regulations do not promote the safety or availability of the nation’s blood supply.
In fact, excessive regulations can hinder innovation, drive up costs, and impede timely access to life-saving blood products for those in need.
The Problem
Unnecessary regulation has sometimes decreased the availability of blood products while increasing costs without any commiserate increase in safety. ABC encourages federal agencies to take the following steps to support innovation and blood product availability without impacting the safety of the nation’s blood supply:
- Advocate for FDA licensure of recovered plasma to allow blood centers to convert plasma for further manufacturing without expiration, improving blood inventory management.
- Apply evidence-based decision making to FDA testing requirements to ensure testing burdens are justified by commensurate increases in safety.
- Lower the U.S. Platelet Content Requirement (PCR), the minimum number of platelets per unit, to expand platelet availability and align with international standards.
- Reexamine FDA's Approach to International Data in Product Approval.
Take Action
Federal agencies must act to support innovation and blood product availability without impacting the safety of the nation’s blood supply, and members of Congress should support those efforts.
Add your voice to these efforts by sending customizable, prewritten messages to your Members of Congress - it takes only minutes but could have a lasting impact.
Resources
Sickle Cell Disease Coalition
America's Blood Center is a proud partner of this collaborative initiative dedicated to amplifying the voice of the Sickle Cell Disease stakeholder community to enhance outcomes for individuals with SCD.
ABC Letter Welcomes Dr. Vinayak Prasad, Advocates for Regulatory Reforms
America’s Blood Centers (ABC) welcomes Dr. Vinayak Prasad to his new leadership roles at the FDA in a letter that underscores ABC’s significant contribution to…