FDA proposes easing blood donor requirements

Regulatory NewsRegulatory News | 27 January 2023 |  By 

FDA's Peter Marks (left) and Robert Califf (right) spoke about the draft guidance.

The US Food and Drug Administration (FDA) proposed major changes to its blood donation policies that would make it easier for gay and bisexual men to donate blood. The agency said it will use gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted human immunodeficiency viruses (HIV) rather than the time-based deferral system that is currently in place.
Over the past decade, FDA has relaxed donor eligibility requirements that historically have prevented men who have sex with men (MSM) from donating blood due to concerns about the risk of HIV infection.
“The agency has proactively reviewed and considered the best available scientific data, including ongoing surveillance of the US blood supply and data from other countries, such as the UK and Canada, both of which have similar HIV epidemiology to the US and have already instituted this approach,” said FDA Commissioner Robert Califf during a virtual press conference on 27 January. “Today, the agency is recommending the elimination of time-based deferrals for certain populations at increased risk for HIV transmission.”
“Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or the availability of the US blood supply,” Califf said. 
FDA is proposing the following changes to its donor eligibility protocol:
  • The time-based deferrals for men who have sex with men and women who have sex with MSM would be eliminated.
  • The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
  • Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.
  • All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
  • A prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
  • There will be no change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use.
  • Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently.
  • Blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.
FDA said that people who take oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) to prevent HIV would be deferred for three months from their most recent dose. Those taking injectable PrEP would be deferred for two years from their most recent injection. The agency also said that some blood establishments already have deferral policies related to the use of medications to prevent HIV infections.
FDA argues that it needs to continue its time deferral policy for those on PrEP/ PEP because the drugs may delay HIV detection, resulting in false negative results.
“The agency recognizes that, while these draft recommendations, when finalized, will potentially increase the number of individuals eligible to donate blood, some individuals will still be deferred from donating blood,” said FDA. “However, this does not mean that individuals taking PrEP should stop taking these medications to donate blood. The FDA will continue to track the latest data relevant to PrEP and blood donation.”
Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), emphasized that the proposed changes follow “the best available science and data.” He added that the agency has adjusted its thinking on blood transfusion protocols as it has learned more about the levels of risk associated with different communities and transmittible diseases over the years.
“We're making this change because we believe that there will be no change to risk in the blood supply in terms of HIV, hepatitis B or hepatitis C,” Marks said during the press conference. “Otherwise, we wouldn't be able to with a straight face sit here and make that change because we have to maintain a very safe blood supply.”
FDA said its recommendations are based on data from the UK and Canada as well as surveillance data from the Transfusion Transmissible Infections Monitoring System. The agency also funded the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study, which looked at several HIV risk factors, such as anal sex, rates of HIV infection and rates of PrEP and PEP use among MSM study participants to develop its new protocol recommendations.
Human Rights Campaign (HRC), an LGBTQ rights advocacy group, lauded FDA’s proposal.
“Today’s announcement represents an important first step toward dismantling an antiquated and discriminatory blood donation policy that restricts gay, bisexual, and other men who have sex with men from donating blood,” said HRC President Kelley Robinson. “LGBTQ+ advocates and other health advocate leaders have worked for decades to pressure the FDA and other regulatory agencies to update policy and move toward adopting an approach rooted in science, not in identity.”
“So while today’s announcement is a victory, it’s not the end of the road; there is much more that needs to be done, and we urge the Biden administration to prioritize removing remaining barriers and ask the FDA to move expeditiously while ensuring the safety of the blood supply and a blood donation policy in-line with the science,” she added.
Marks said that FDA will review comments on the draft guidance in real-time and hopes to have a decision within weeks of the comment period’s closure. However, he cautioned that FDA is not the only agency involved in the clearance process.
“Some of this will be dependent on that clearance process after we're done with this, but I think there's a fair amount of commitment here to moving this through the process as quickly as possible,” said Marks.
Stakeholders can comment on the draft guidance on www.regulations.gov under docket no. FDA-2015-D-1211 until 28 March.
Draft Guidance


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