The Food and Drug Administration is officially reconsidering its blood donation policy, which currently restricts men who have had sex with other men in the past year from giving blood.
As part of this reassessment, the agency put out a formal request for public comment in the Federal Register on Tuesday, asking people to submit ideas on what other blood donor policies could look like.
“Specifically, the FDA invites comments on the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessment. The agency also invites comments regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in an emailed statement to CNN on Wednesday.
“The FDA will carefully consider all of the information submitted as it determines the appropriate next steps, and we will continue to review the agency’s donor deferral policies to ensure they reflect the most up-to-date scientific knowledge,” he said. “We are committed to obtaining the needed scientific evidence to move to alternative donor assessment strategies in the future.”
What the current policy says
Such recommendations for blood donation practices (PDF) date to 1985, when FDA policies were first established to reduce the risk of the human immunodeficiency virus (HIV) being transmitted by a blood donor. The FDA’s recommendations previously prohibited all blood donations from gay or bisexual men, but in December, its policy was updated to the yearlong ban.
“The 12-month figure follows the lead of seven other countries, particularly Australia, which reported that its 12-month deferral had no negative effect on the blood supply,” said Jason Silverstein, a lecturer in the department of global health and social medicine at Harvard Medical School.
“On the contrary, increasing the number of possible donors did exactly what you’d expect,” he added, “it increased the number of donors and increased the amount of blood available to save lives.”
Some research also suggests that gay men donating blood does not increase the risk of HIV transmission, Silverstein said. “Italy implemented an individual risk assessment in 2001, and research shows that there was no increase in HIV infection.”
Currently only about one in 2 million blood donations might carry and transmit HIV if given to a patient, according to the National Heart, Lung, and Blood Institute.
‘A top priority for the agency’
Now, the FDA is considering individual risk assessment as a possible option for the United States.
“We hope that the work that we are doing in this area combined with the input that we receive will allow us to be able to move toward more individual risk assessment while maintaining the safety of the blood supply for those individuals who need blood transfusion,” Marks said in the statement. “Because this process must be data-driven, the timeframe for future changes is not something we can predict. However, please note that this is a top priority for the agency.”
Democratic lawmakers and gay-rights advocates have long urged the FDA to overturn its blood donation policy, which restricted many gay men from giving blood in wake of the Orlando mass shooting last month.
“There are experts who suggest that there are screening strategies that yield a safe blood supply but do not rely on blanket bans of segments of the population,” said Gary Gates, former research director of the Williams Institute at the University of California, Los Angeles School of Law.
All donated blood is required by the FDA to be tested for infectious diseases, including HIV, before transfusion.
National blood supply could get a boost
How could changes to current policy affect the country’s blood supply?
Well, if the FDA lifted its previous total ban of gay and bisexual men donating blood, it could have increased the nation’s annual blood supply by 4%, according to a 2014 research brief (PDF) that Gates co-authored and that was published by the Williams Institute.
“Based on analyses I conducted with my co-author Ayako Miyashita about two years ago,” Gates said, “we estimate that a complete lifting of the ban could add more than 360,000 new blood donors each year and increase the blood supply by 615,000 pints.”
As Silverstein put it, “That is enough blood to help 6,000 car accident victims.”