FDA Regulation of Blood and Blood Products: Recent Draft Guidance on Donor Eligibility

FDA Regulation of Blood and Blood Products: Recent Draft Guidance on Donor Eligibility

INSIGHTi

FDA Regulation of Blood and Blood Products:
Recent Draft Guidance on Donor Eligibility
February 13, 2023
The nation’s blood supply is largely managed by a network of independent blood centers and the
American Red Cross, with oversight from the Food and Drug Administration (FDA). FDA’s role includes
making policy to determine who may donate blood to minimize the risk for transfusion-transmitted
illness, such as Human Immunodeficiency Virus (HIV). FDA guidance has changed throughout the years
due to advances in science and social trends. Most recently, FDA published draft guidance for a 60-day
comment period on January 30, 2023, that would eliminate recommendations for time-based deferrals for
specific subpopulations and implement recommendations for individual risk assessments. This Insight
briefly explains FDA’s role in regulation of blood and the evolution of FDA’s deferral policy, and
discusses the potential risk of HIV transmission through blood under the recommendations in the January
2023 draft guidance.
FDA Blood Regulation and Guidances
FDA oversees the collection of blood and its components (e.g., plasma, red blood cells, and platelets)
intended for transfusion or for the manufacture of pharmaceutical products. FDA regulates blood and
blood products under two statutes: the Federal Food, Drug and Cosmetic Act (FFDCA) and the Public
Health Service Act (PHSA). Blood establishments must comply with FDA regulations governing blood
collection, storage, testing, and processing, among other things. FDA regulations also describe eligibility
criteria to donate blood that both protect the health of the donor and ensure the safety, purity, and potency
of the blood product. Current FDA guidances recognize an industry-prepared standardized donor history
questionnaire as an acceptable mechanism for determining eligibility. The donor history questionnaire
incorporates all FDA guidance and regulations pertaining to donor eligibility.
FDA guidances represent the agency’s “current thinking” on a particular topic and are framed as
recommendations; they are not legally binding. However, blood establishments treat FDA guidances as
requirements and use them to create standard operating procedures.
Reducing the Risk of HIV Transmission from Blood or Blood Products
Long-standing FDA guidance, first established in 1985, deferred men who have sex with men (MSM)—
including men who had sex with men even once—from donating blood for life. The intent of the deferral
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was to reduce the risk of HIV transmission by blood and blood products. At the time, the capability to test
donated blood for HIV did not exist, so life-time deferrals were the only mechanism available to protect
the blood supply.
In 1992, FDA issued a memo that reiterated the lifetime deferral for MSM and consolidated
recommendations regarding the deferral of donors at risk of HIV. FDA revised its recommendations in
2015 to narrow the application of the deferral to MSM from lifetime to 12 months; FDA also extended the
application of the 12-month deferral period to women who had sex with MSM. Additionally, individuals
who were tattooed or pierced, had sex in exchange for money or drugs, had engaged in nonprescription
injection drug use, had received a blood transfusion, had come into contact with another individual’s
blood, and/or had a history of syphilis or gonorrhea were required to defer blood donation for a period of
12 months from the last time that the activity took place.
Guidance issued in response to the COVID-19 pandemic revised the recommended deferral period
temporarily from 12 months to 3 months for each of these groups. Mitigation strategies to prevent the
spread of COVID-19, such as closures of schools and workplaces, led to blood drive cancellations,
resulting in a critical blood supply shortage at the time. The revised deferral period was intended to
increase supply by allowing individuals to donate who were previously unable. This revised guidance,
issued April 2, 2020, is still in effect for the duration of the public health emergency.
On January 30, 2023, FDA published draft guidance that would remove recommendations for time-based
blood donation deferrals and instead implement recommendations for individual risk assessments to
assess suitability for blood donation. Rather than a blanket 12-month or 3-month deferral for MSM or
other groups, the draft guidance recommends that all individuals regardless of gender be assessed for
whether they have had a new sex partner in the past three months and, if so, whether they had anal sex.
An individual answering yes to both of those questions would be deferred from donation for three months
from the sexual encounter. The draft guidance also would apply an individual risk assessment to anyone
in the other categories of at-risk activities listed above.
The draft guidance recommends that individuals defer permanently if they have ever taken medications to
treat an HIV infection (e.g. antiretroviral therapy). The draft guidance also recommends deferrals for
individuals taking pre-exposure prophylaxis (PrEP). There are currently two types of medications
approved by the FDA for PrEP: oral taken daily and an injection every two months. The recommended
deferral periods are three months for the oral medications and two years for the injectable medication.
Industry has already implemented these medication deferrals in advance of the final guidance.
Risk of HIV Transmission in the Blood Supply
Assessing donor suitability via an individual risk assessment appears unlikely to pose any additional risk
to the blood supply because (1) FDA already requires blood and blood components destined for
transfusion or for use in manufacturing blood products to be tested for HIV and other transfusion-
transmitted infections, and (2) other countries (notably the United Kingdom and Canada) have already
implemented individual risk assessments and have not reported any safety concerns following
implementation.
The draft guidance would continue to recommend requiring individuals determined to be at risk for HIV
infection to defer for a specified period of time. This would reduce the likelihood of donations from
individuals with a recent HIV infection who may be in the window period—a period of time where
infections are still undetectable using current testing methods.
FDA funded the Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) study, which
was carried out by multiple leading blood centers to determine whether a donor deferral policy different
from the one currently in effect under the April 2020 guidance could be used at blood centers nationwide

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while still maintaining the safety of the blood supply. The ADVANCE study was carried out in 2022, with
enrollment ending in September 2022. The study asked MSM additional questions to assess individual
risk of HIV infection as an alternative to the April 2020 guidance in effect for a three-month time deferral.
Blood donations were then screened for HIV to evaluate the safety of individual risk assessments. As of
publication, the results of the study are not publicly available. However, study results were considered
among the available data used for creation of the January 2023 draft guidance.

Author Information

Jared S. Sussman

Analyst in Health Policy

Disclaimer
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