Advocacy Agenda

Our Advocacy Agenda

America’s Blood Centers 2022 Advocacy Agenda urges the Administration, Congress, and industry stakeholders to promote the value of blood to patients, communities, and the healthcare system.

This agenda is designed to help America's community blood centers retain donors and ensure long-term stability of the nation's blood supply, including:

Streamlining product licensure to allow blood centers to adapt to changing donor needs,

Making permanent donor eligibility criteria changes made early in the COVID pandemic,

Ensuring blood centers are part of future disaster preparedness and prioritizing blood donation as a national imperative.

Download Now

Top Priorities

Streamline product licensure to allow blood centers to meet unprecedented challenges in blood availability.

Currently, blood centers wait as long as a year for blood components collected by automation to be fully licensed by the FDA.

With more donation sites opening around the country to meet the increased need for blood donations, this burdensome administrative process must be modernized to ensure the availability of blood components to patients.

Expand the pool of eligible blood donors and available blood by finalizing temporary changes to donor eligibility criteria and administrative regulations.

In 2020, FDA shortened the deferral period for certain individuals, including men who have sex with men (MSM), for the duration of the declared COVID-19 public healthy emergency. FDA also relaxed administrative regulations that limited the availability of blood components. The changes were based upon extensive safety data and allowed for the re-entry of thousands of previously deferred blood donors.

FDA must act to ensure these changes are made permanent beyond the public health emergency.

Ensure blood centers are part of pandemic response and future disaster preparedness.

The blood supply is a vital component of the healthcare system. During COVID-19, blood centers have struggled to receive prioritization for critical supplies and infrastructure, as well as receive support for workforce challenges, stressing the already strained blood supply.

Blood centers must be explicitly recognized in legislation to address issues in the healthcare workforce, to remedy current and future supply chain issues relating to the pandemic, and as a unique consideration for any pandemic or disaster preparedness plans.

Reducing Unnecessary and Burdensome Regulation

ABC works to:

Streamline product licensure to allow blood centers to meet unprecedented challenges in blood availability. Currently, blood centers wait as long as a year for blood components collected by automation to be fully licensed by the FDA.

Apply evidence-based decision making to FDA testing requirements to ensure testing burdens are justified by commensurate increases in safety, eliminating current FDA testing requirements without appropriate safety justifications (e.g. HBsAg).

Advocate for FDA approval of extended shelf life for cold stored platelets to expand platelet supply availability for rural areas and in trauma with massive bleeding.

Revisit FDA policy on the acceptance of international data for use in the approval of new products or technologies, and different policies and procedures.

Encourage FDA to establish donor policies which promote inclusivity with research-based donor-screening alternatives based on individual behavior, not sexual or gender identity, to provide equivalent or superior transfusion safety.

Lower the U.S. Platelet Content Requirement (PCR), the minimum number of platelets per unit, to expand platelet supply availability and in line with international standards.

Implement a rational, flexible approach to the regulation of plasma products, advocating FDA licensure of recovered plasma to give blood centers the ability to convert plasma from transfusable to further manufacture for more effective blood inventory management.

See the Latest

Promoting a Robust Donor Base

ABC works to:

Expand the pool of eligible blood donors and available blood by finalizing temporary changes to donor eligibility criteria and administrative regulations. In 2020, FDA shortened the deferral period for certain individuals, including men who have sex with men (MSM), for the duration of the declared COVID-19 public healthy emergency. FDA also relaxed administrative regulations that limited the availability of blood components. The changes were based upon extensive safety data and allowed for the re-entry of thousands of previously deferred blood donors.

Establish targeted federal initiatives to support increased diversity in the donor base such as funding for increased molecular red blood cell typing for frequently transfused patients such as those with Sickle Cell Disease or Thalassemia.

Establish funding for research on the predictive social and psychological factors in blood donor motivation in order to attract and retain donors and ensure long-term stability of the nation's blood supply.

See the Latest

Supporting the Vital Role of Blood in Healthcare

ABC works to:

Ensure blood centers are part of pandemic response and future disaster preparedness. The blood supply is a vital component of the healthcare system. During COVID-19, blood centers have struggled to receive prioritization for critical supplies and infrastructure, as well as receive support for workforce challenges, stressing the already strained blood supply.

Explore federal funding mechanisms to facilitate implementation of safety and technology measures when mandated by FDA, such as the recent platelet bacterial detection guidance, or when market incentives otherwise do not exist.

Increase federal resources for data gathering on the collection and utilization of blood components as needed to support evidence-based decision making in federal regulatory policy.

Expand availability of blood components to patients at the end of life by modifying hospice reimbursement rates to reflect the added cost of providing blood components.

See the Latest

How It Was Developed:
Our Value Framework

Our Advocacy Agenda was built through our Value Framework, which consists of five core pillars that emphasize the contribution ABC member blood centers bring to their local communities and the nation’s healthcare system.

ABC member blood centers ensure a safe and adequate blood supply, saving and improving the lives of millions of Americans each year;
ABC members promote the altruistic gift of blood from millions of individuals nationwide, maintaining a critical donor base and educating current and future generations on the need for blood;
ABC members re-invest in the health of their local communities through such things as cellular therapy services, transfusion medicine expertise, disease management programs, and research;
ABC members partner with federal, state, and local agencies to confront public health threats and promote medical and scientific innovation;
ABC members provide competition in the market, ensuring value while controlling overall healthcare market expenditures for blood components.

To maximize the value of community blood centers, ABC supports policies that:

Recognize the value of blood components to the overall healthcare system through fair and adequate reimbursement;
Promote safety through strong evidence and risk-based decision-making;
Foster education initiatives related to the need for appropriate use of blood;
Reduce regulation that otherwise fails to promote reasonable safety, value add, or innovation;
Safeguard the viability of community blood centers through fair competition within the healthcare market, ensuring continued patient access to safe and appropriate blood components.

Advocacy Agenda

Our Advocacy Agenda

America’s Blood Centers 2022 Advocacy Agenda urges the Administration, Congress, and industry stakeholders to promote the value of blood to patients, communities, and the healthcare system.

How It Was Developed: Our Value Framework

Our Advocacy Agenda was built through our Value Framework, which consists of five core pillars that emphasize the contribution ABC member blood centers bring to their local communities and the nation’s healthcare system.

To maximize the value of community blood centers, ABC supports policies that:

Contact

How It Was Developed:
Our Value Framework