FAQ: Proposed Changes to the FDA Blood Donation Policy

Answering Your Questions on the recent FDA blood donation policy revisions.

Answering Your Questions on the Proposed Change to the FDA’s Blood Donation Policy

Read through these FAQs to learn more about this recent proposed change. Scroll to the bottom to learn where to send any further questions. Sources are also listed so readers can access further information.

What exactly is the policy change?

The U.S. Food and Drug Administration (FDA) has proposed a policy revision for blood donation protocols that would remove time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM.

Instead of receiving automatic deferral, people under this category would be determined for eligibility based on a personalized, recent, risk-based assessment. The purpose of the policy change is to create updated safeguards against transfusion-transmitted HIV based on the best and most up-to-date data available. (See more on this on the FDA website.) 

The proposed changes align with policies already in place in countries like the United Kingdom and Canada. Current data confirm that, provided potential donors completely meet the protocols, revising blood donation policies to some MSM and women who have sex with MSM would be both safe and effective in increasing possible blood donations.

The updated policy would not change the deferral time periods for any individual who: 

Sources 

FDA Office of Media Affairs. (2023, January 27). FDA proposes individual risk assessment for blood donations, while continuing to safeguard U.S. blood supply. U.S. Food and Drug Administration. Retrieved February 16, 2023, from https://www.fda.gov/news-events/press-announcements/fda-proposes-individual-risk-assessment-blood-donations-while-continuing-safeguard-us-blood-supply 

Schulman, R. (2023, January 31). FDA issues draft guidance updating blood donation policy: AHA Special Bulletin. American Hospital Association. Retrieved February 16, 2023, from https://www.aha.org/special-bulletin/2023-01-31-fda-issues-draft-guidance-updating-blood-donation-policy

Why did this policy change take so many decades? Was it discriminatory?

The FDA’s original policy on MSM and their partners donating blood was put into place in 1983 at the height of the HIV/AIDS crisis. Based on what was known about the infection then, it was determined that deferring MSM and women who have sex with MSM from blood donation was the safest course of action for public health.  

Many Americans consider this policy to be discriminatory due to its perceived assumptions about sexual practices between MSM being statistically more likely to spread HIV than sex between other partners, even when currently known risk factors are not actually present.  

These changes in deferral policies fall in line with the current deferral policies of the United Kingdom and Canada. Most recently, Canada implemented a universal donor deferral screening policy as of December 2022 and have reported no increased risk to end-users of blood and plasma derived products.

To learn more about the policy’s history and the perspective of it being considered discriminatory, read this op-ed from the American Medical Association.

Due to updated knowledge about HIV and factors that may increase the spread risk, the FDA has determined that this policy change would coincide with its current standards for keeping donated blood and blood products safe for those who need them.

What does this change mean for people receiving blood or blood products for medicinal purposes?

Donated blood and blood products will continue to be held to the best possible standards of safety. Currently, the FDA requires that all donated blood samples go through five processes to ensure the products’ safety and quality:

  1. Donor screening 

Donors are provided with educational material and asked to self-defer if they have risk factors that may affect blood safety. They are then asked specific questions about their medical history and other risk factors that may affect the safety of their donation. This screening identifies ineligible donors.

  1. Donor deferral lists 

Blood establishments must keep a current list of deferred donors. They must also check all potential donors against that list to prevent the collection of blood from deferred donors.

  1. Blood testing 

Each unit of donated blood is tested for: 

  1. Quarantine 

The blood is kept in quarantine until it is tested and shown to be free of transfusion-transmitted infections.

  1. Problems and deficiencies screening 

Blood establishments must investigate manufacturing problems, correct all deficiencies, and notify FDA when product deviations occur in distributed products.

If a donation or its processing violates any of these safeguards, it is automatically considered ineligible for transfusion.

All blood samples collected and accepted for use would comply with all these current safeguards. The new policy simply means that more people would be able to donate blood, provided they meet the updated requirements.

Source 

Office of the Commissioner. (2023, January 27). Have you given blood lately? U.S. Food and Drug Administration. Retrieved February 16, 2023, from https://www.fda.gov/consumers/consumer-updates/have-you-given-blood-lately

Where do I go if I want more information?

For more information about the updated policy, read the FDA’s official news release here.

Where does NHF stand on this change? 

Read NHF’s statement here. You can also read about NHF’s work with the APLUS Coalition on this matter here.

Who at NHF do I contact for more information on this matter?

Contact NHF’s Vice President of Public Policy, Nathan Schaefer, at nschaefer@hemophilia.org. If you have questions related to your mental health around this matter, please email them to askasocialworker@hemophilia.org. 

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