FDA Seeks Public Comment on Blood Donor Deferral Policy to Decrease HIV Transmission

While the annual rate of new diagnosed cases has declined in the last 10 years, HIV still remains a significant concern. The Centers for Disease Control and Prevention (CDC) reports approximately 44,000 people were diagnosed with HIV in 2014 in the U.S. and more than 1.2 million currently have the virus, with the CDC estimating that 1 in 8 of those having the infection don’t know it.

In December 2015, the U.S. Food and Drug Administration (FDA) released “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry” (Recommendations). This month, it published a notice in the Federal Register soliciting comments on that document and suggestions for making sure blood donor deferral policies keep up with scientific developments and continue to reduce risk of HIV transmission. Specifically, the FDA seeks:

• Scientific evidence to support alternative policies regarding blood donor deferral
• Feedback on the “feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as individual risk assessments”
• Suggestions for studies to evaluate different policy options

The December 2015 Recommendations switched to a 12-month rather than an indefinite deferral period for men who have had sex with other men (measured since the last sexual encounter). This new period is more in keeping with the deferral period for men and women at risk due to blood transfusion or accidental needlestick infection, the agency said. “Ultimately, FDA concluded that the 12-month deferral period is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population.” But the FDA remains “committed to continuing to reevaluate and update blood donor deferral policies as new scientific information becomes available.”

With that in mind, the FDA is interested in public feedback on the merits of a deferral policy based on individual assessments—acknowledging that stakeholders indicated a preference for that basis for deferral. If individual assessments are used to determine donor deferral, the FDA explains that donors would need to be asked several questions to detect high risk behaviors. Therefore, the FDA asks for public comment on the following issues:

• The types of questions that would identify potential donors “at risk of transmitting HIV through blood donation”
• Suggested questions that would uncover recent risk behavior “such as within the 2 to 4 weeks” prior to blood donation
• Appropriate level of specificity for questions “regarding sexual practices while remaining understandable and acceptable to all blood donors” (for example, consider whether donors would accurately answer explicit questions about their sexual practices)
• Whether a short deferral period would be appropriate for high risk behaviors and if so, how long that period should be (the FDA seeks “scientific rationale” to support any such recommendation)
• Changes needed at the blood collection sites “to assure that accurate, individual HIV risk assessments are performed”
• Suggestions for designing studies to evaluate alternative deferral policy options

The notice document is published in the July 28, 2016 Federal Register. Comments need to be submitted by Nov. 25, 2016. To review the FDA’s 2015 Recommendations, see the Dec. 23, 2015 Federal Register.

Takeaway: Keeping HIV on the public radar, the FDA solicits public comment on any necessary updates to policies regarding deferral of blood donations.