FDA Revises Blood Donation Restrictions

May 12, 2023

The FDA this week finalized recommendations to assess who can donate blood, calling for the use of risk-based questions for every donor, regardless of gender or sexual orientation.

The new recommendations will potentially expand the number of people eligible to donate blood, while maintaining the appropriate safeguards to protect the safety of the blood supply, FDA officials said. This updated policy is based on scientific evidence and is in line with policies in place in the United Kingdom and Canada.

“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, MD, PhD., director of the FDA’s Center for Biologics Evaluation and Research.

Here’s what you need to know:

• What’s new?:  All prospective blood donors will answer a series of individual, risk-based questions to determine eligibility and reduce the risk of transfusion-transmitted HIV.
• The change:  The policy eliminates time-based deferrals and screening questions that were specific only to men who have sex with men (MSM) and women who have sex with MSM.
• Noteworthy:  Those taking medications to treat or prevent HIV infection (antiretroviral therapy), pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP), will also be deferred.
  • The FDA said these therapies are safe but their use may delay detection of HIV by currently licensed screening tests for blood donations.
• Rationale:  FDA officials said they facilitated and reviewed the scientific evidence supporting an individual risk-based assessment blood donor questionnaire to replace the prior eligibility standards.
• Quotable:  “The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place,” Marks said.

During March, the American Hospital Association (AHA) wrote a letter to the FDA urging the agency to finalize the proposal and work with the “health care provider and LGBTQ+ communities, to raise awareness of the importance of blood donation and provide education about the new policy.”

“The AHA applauds and supports this life-saving and science-based decision by the FDA to eliminate the current time-based blood donor deferral for men who have sex with men while preserving the safety of blood as an essential product for the care hospitals and health systems provide to their patients,” the AHA letter said.

Additional information about the FDA recommendation is available online.