Stacks of paperwork and files in the office: work overload, files management and administration concept

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

America’s Blood Centers is working to reduce unnecessary and burdensome regulation to support innovation and blood product availability.

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.

Make Your Voice Heard

Latest Developments

Blood Community Sends Joint Letter to FDA for Update on HBV Testing Recommendations

June 28, 2022
Posted in
February 10 / 11:29 am

America’s Blood Centers, the Association for the Advancement of Blood & Biotherapies (AABB), and the American Red Cross submitted a joint letter to the U.S.…

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FDA Draft Report Comments & Plan on Best Practices Guidance

February 23, 2024
Posted in
February 10 / 11:29 am

America’s Blood Centers (ABC) has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the “FDA Draft Report and Plan on…

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Blood Center LDTs Exemption Urged to Congress

April 5, 2024
Posted in
February 10 / 11:29 am

America’s Blood Centers (ABC) is advocating for Congress to allow a blood center LDTs exemption in LDTs regulations. Specifically, ABC has submitted comments in response…

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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.