FDA moves to ease blood donor restrictions on gay men amid national shortage

• An option under discussion is moving from a three-month deferral period to individual risk assessments based on questionnaires about recent sexual activity, the agency confirmed to Axios.
• Approximately 25% of community blood centers across the U.S. have a one-day supply or less as of Thursday afternoon, according to the America's Blood Centers' daily tracker.
• If the FDA lifts the three-month deferral period, the annual blood supply would increase by 2% to 4% annually, according to the Williams Institute, a research center at the UCLA School of Law.

Zoom out: The FDA has lifted blood donor restrictions in other situations while other federal health services have more broadly reevaluated medically disqualifying conditions, including HIV.

• The FDA recently removed restrictions for people who lived in European countries that had had outbreaks of Mad Cow Disease, a brain disorder, for fear of transmission.
• This decision has made it possible for hundreds of thousands of people to become eligible to donate, which could help increase the number of U.S. blood donations, per AP.
• The U.S. Public Health Service on Thursday said it is changing its medical standards to accept future applicants living with chronic hepatitis B and HIV, citing treatments that have made both manageable chronic conditions.

State of play: LGBTQ rights advocates and health experts have urged the FDA to get rid of its blood donation policy for men who have sex with men — and calls intensified after the American Red Cross declared its first-ever "national blood crisis," saying that the U.S. was experiencing its "worst blood shortage in over a decade."

• The White House's Presidential Advisory Council on HIV/AIDS called the FDA's current policy on gay and bisexual men "discriminatory," saying that it is stigmatizing.

What they're saying: "Now, the question to the FDA ... is, to what extent is this policy based in science and and to what extent is it based in identity?" said Lindsey Dawson, associate director for HIV Policy at the Kaiser Family Foundation.

• "A shift in the policy landscape could mean that no longer would a policy single out a sexually active gay man based on their identity alone, but actually, based on true risk factors," Dawson added.

What we know: An FDA spokesperson told Axios that the potential new screening policy "will be gender neutral and science-based."

• Currently, "a man who has protected sex with another man in the three months prior to a blood donation cannot be a donor, but a man or woman who has unprotected sex with multiple partners of the opposite sex over the same time period remains eligible," according to the American Medical Association.

• Lesbian and bisexual women do not have a deferral period.

The background: Donor restrictions for men who have sex with men date to the early 1980s, when the FDA imposed a lifetime ban in response to the HIV epidemic.

• The agency updated the policy in 2015, requiring gay or bisexual men to abstain from sex for a year before they could donate blood. That was shortened to a three-month waiting period in 2020, after the American Red Cross said that the COVID pandemic caused a "severe blood shortage."

Details: "The FDA remains committed to evaluating alternatives to the time-based deferral policy by helping to facilitate the generation of the scientific evidence that might support an individual risk assessment-based blood donor questionnaire," the agency said in an emailed statement.

• The FDA is reviewing results of an agency-funded study conducted by blood centers that is designed to evaluate whether it is safe to change the donor deferral policy.
• "Although we do not have a specific timeline for when our analysis will be complete, the agency believes the initial data from the study ... will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of HIV transmission," the FDA said.

What's next: The agency said it expects to issue updated draft guidance "in the coming months," once it finishes its study review.