Amid shortage, FDA urged to ease rules on gay men donating blood

Pressure is mounting on the FDA to eliminate longstanding restrictions on gay or bisexual men donating blood in the United States as the blood shortage reaches a dire level.

22 U.S. senators penned a letter to the FDA and the Department of Health and Human Services Thursday, urging them to replace the “discriminatory” rule that requires gay and bisexual men to abstain from sexual activity for three months before donating blood.

“We must adopt evidence-based policies focused on assessment of an individual’s risk, not inaccurate and antiquated stereotypes,” they wrote. The group of senators also requested a briefing in the next month on the agency’s plan to update its blood donation policies.

The Human Rights Campaign, the nation’s largest LGBTQ+ civil rights organization, also added to calls this week, saying the current policy is “outdated” and that it “does not reflect the state of the science, and continues to unfairly stigmatize one segment of society.”

The American Red Cross announced Tuesday the U.S. is experiencing a national blood crisis for the first time ever and asked Americans to consider donating blood immediately. The nation’s blood reserve, which typically holds a five-day supply of blood, has dwindled to a less than one-day reserve.

The FDA, which is responsible for the regulatory oversight of America’s blood supply, first imposed a ban on gay and bisexual men donating blood in 1983, during the early years of the HIV/AIDS epidemic.

The FDA amended the policy in 2015 to allow them to donate blood after abstaining from sexual activity for one year. The wait was shortened to three months in April 2020, after a drop-off in donations during the first wave of the coronavirus pandemic.

A 2014 study from UCLA’s Williams Institute estimated that lifting the ban entirely could “increase the total annual blood supply by 2%-4%, adding from 345,400 to 615,300 pints of blood each year.” One pint of blood can save up to three lives.

The CDC requires all blood donations to be tested for infectious disease pathogens like HIV and Hepatitis C. The American Red Cross estimates the risk of getting an HIV-positive blood donation is 1 in 1.5 million for U.S. patients.

Last year, the FDA launched a study known as ADVANCE, or Assessing Donor Variability and New Concepts in Eligibility, to examine whether the three-month donor deferral period can be amended based on an individual risk assessment.

The study aims to enroll 2,000 men through 11 national blood banks in several participating cities. The American Red Cross, along with national blood banks like Vitalant and OneBlood, are conducting the study.

The study will evaluate whether updating the screening questionnaire that all donors fill out to focus more on individual risk would be as effective as a blanket, time-based deferral in reducing the risk of HIV in the blood supply.

“If the study’s scientific evidence supports the use of the different eligibility questions, it could lead to further efforts to change the MSM eligibility criteria,” a spokesperson for the American Red Cross wrote in a statement to CBS News.

The results of the ADVANCE study were expected in December 2021, but have been delayed due to lack of participation, according to the American Red Cross.

Ryan James Yezak, the founder of the National Gay Blood Drive, an organization that advocates for the equal treatment of blood donations by gay and bisexual men, says the federal government needs make more of an effort with the community to raise awareness and boost participation for the study.

“When you tell a group of people for decades that they can’t do this life-saving thing of donating blood, it kind of becomes ingrained in them that this isn’t something they can do,” Yezak said. “Now that the government is finally coming around and are trying to get past this discriminatory policy and you can’t get enough people, that is your own doing and you need to try harder.”

The enrollment period for the study has been extended through the spring to increase participation.

“The FDA remains committed to considering alternatives to time-based deferral by helping to generate the scientific evidence that is intended to support an individual risk assessment-based blood donor questionnaire,” an FDA spokesperson wrote in a statement to CBS News.

The agency added there is no specific timeline on when the studies may be completed.

Robert Califf, President Biden’s nominee to lead the FDA, said in his Senate confirmation hearing that he is aware of the individual risk assessment study and pledged to move quickly when the results come in.

This week, Greece and France have announced they were lifting their deferral periods, allowing gay and bisexual men to donate blood without restrictions.