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FDA loosens blood donation restrictions in wake of COVID-19

Advocates say discriminatory policies have the number of limited potential donors

The Food and Drug Administration announced on Thursday it would lift a series of restrictions on blood donation, as the need for blood grows due to the COVID-19 health emergency.

Groups like The American Red Cross have made urgent calls for additional blood and blood component donations in the wake of a nationwide shortage. Some advocates have argued that discriminatory policies are limiting the supply of potential donors, such as men who have sex with other men.

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The FDA issued a series of recommendations on Thursday that would ease some of these restrictions, but some contend the policies do not go far enough.

The new guidelines would decrease a recommended deferral period from 12 months to three months for three categories of individuals that have a greater potential of transmitting HIV, according to the FDA.

The loosened restrictions affect blood donations from men who recently had sex with another man; women who have had sex with a man who had sex with another man; and on individuals who recently received tattoos or piercings.

In addition, the FDA announced it would lift restrictions on individuals who have traveled to malaria-endemic areas from 12 months to three months and on those who have spent time in certain European countries at risk for Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease. 

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a call with reporters estimated that tens of thousands of people could become eligible to donate blood because of these changes.

FDA stopped short of allowing all men who have sex with men to be able to donate blood, he said, in part based on policy changes in other countries.

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The United Kingdom and Canada have both eased restrictions on blood donations on men who have sex with men to a delay of three months after the most recent interaction without issues, he said.

“We feel like there is a good amount of scientific evidence that we can hang our hats on… as we change this to a three-month deferral,” said Marks.

FDA guidelines meant to limit blood donations by men who have sex with men have been in place since 1983, at the height of the HIV/AIDS epidemic, according to the Human Rights Campaign, an advocacy group for LGBTQ rights.

But the policy has been under more intense criticism by LGBTQ advocates in recent days as the COVID-19 pandemic has compelled blood banks to close, at the same time some hospitals experience an onslaught of patients. 

The American Public Health Association has said the policy “is not based in science” and “appears to be modeled after other countries’ choices and fears.”

A 2014 analysis by the Williams Institute found lifting the ban would increase the blood supply by as much as 615,000 pints, about 4 percent of total supply. 

“It shouldn’t have taken a pandemic and a resulting urgent blood shortage to make progress on this issue,” said Sen. Tammy Baldwin, D-Wis.

Human Rights Campaign said the policy change was a step forward, but argues that any waiting period is rooted in stigma.

The organization says that blood donation policy should be guided by individual determinations of risk factors, not blanket policies based on sexual orientation, gender identity or perceptions about sexual monogamy.

“To be clear, today’s announcement is not an outright victory, it is only a step forward,” said HRC President Alphonso David on a call with reporters Thursday.

Advocates also expressed some doubt that changing the period gay and bisexual men have to defer sex in order to donate blood from 12 months to three months would lead to a surge in new donors. 

“I don’t think you’re going to get a whole lot more people who are willing to abstain from sexual activity for three months,” said Scott Schoettes, HIV Project Director at Lambda Legal.

Last week, a group of 17 senators wrote a letter ​​to FDA Commissioner Stephen Hahn urging the agency to ease restrictions on LGBT blood donors.

“In light of this shortage, we urge you to swiftly update blood donor deferral policies in favor of ones that are grounded in science, are based on individual risk factors, do not unfairly single out one group of individuals, and allow all healthy Americans to donate,” the letter reads. “We strongly encourage you to consider this critical solution as you work to develop a comprehensive response to the COVID-19 outbreak and ensure that Americans have access to life-saving blood transfusions.”

FDA said that while individual donor centers were taking social distancing precautions to prevent the spread of COVID-19 among blood donors, there is little risk of the virus being passed to an individual receiving a blood transfusion because COVID-19 is a respiratory disease.

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