FDA is now recommending the implementation of a new donor screening process that uses gender-inclusive, individual risk-based questions relevant to HIV risk.
FDA retained many of the existing HIV deferral recommendations and added a number of significant changes to donor eligibility policy.
A Closer Look at the Recommended Updates
Notably, the draft guidance recommends the removal of the following donor eligibility requirements:
- Defer for three months from the most recent sexual contact, a man who has had sex with another man during the past three months.
- Defer for three months from the most recent sexual contact, a female who has had sex during the past three months with a man who has had sex with another man in the past three months.
In addition, FDA is recommending the following new changes be implemented to donor eligibility:
- Defer permanently an individual who has ever taken any medication to treat HIV infection (i.e., ART).
- Defer for three months from the most recent dose, an individual who has taken any medication by mouth (oral) to prevent HIV infection (i.e., short-acting antiviral PrEP or PEP).
- Defer for two years from the most recent injection, an individual who has received any medication by injection to prevent HIV infection (i.e., long-acting antiviral PrEP).
- Defer for three months from the most recent sexual contact, an individual who has had a new sexual partner in the past three months and who has had anal sex in the past three months.
- Defer for three months from the most recent sexual contact, an individual who has had more than one sexual partner in the past three months and who has had anal sex in the past three months.
To inform these draft recommendations, FDA reviewed numerous data sources, including data from the United Kingdom and Canada, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, data assessing performance characteristics of nucleic acid testing for HIV, and results from the FDA-funded Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) study.
“Our approach to this work has always been, and will continue to be, based on the best available science and data.” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”
FDA is encouraging comments on the draft guidance before it begins work on the final guidance, scheduled for 60 days from today. Comments can be submitted to FDA through its website. https://www.regulations.gov/
#Blood Bank of Alaska follows all FDA mandates and guidelines.