As blood donations fell, FDA eased rules to roll up a sleeve and give

WASHINGTON – It’s a familiar ritual to anyone who has donated blood – after the finger prick and before the needle stick comes to a medical history form that includes a long list of factors that can exclude or defer a donation.

The list is still long, but in an era of COVID-19 the deferrals are not.

The Food and Drug Administration in April eased a number of restrictions on blood donations in order to help blood banks across the nation keep up with the demand for blood. It came as infection concerns and stay-home orders were leading to widespread cancellations of blood drives and donation appointments.

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said the changes had been under review for some time, but the coronavirus “emergency essentially accelerated the need for us to get those through the pipeline.”

“We’ve actually been working on changes in our donor deferral policies over the past, we continually work on them,” Marks said. “But over the past number of months, there were a number of things that were essentially in the works.”

What the change means is that people who used to have to wait full year to give blood, depending on their circumstances, can now donate after just three months or less.

That applies to people who have gotten a recent tattoo or piercing as well as men who had sex with men or a woman who had had sex with such a man. The previous year-long wait to donate had been aimed at reducing transmission of HIV through blood transfusions, but officials are confident a three-month wait is just as secure.

The change also trims the wait for people who have traveled to a list of countries where malaria is prevalent, allowing them to donate after just three months – or less if FDA-approved devices are used to treat the blood for the malaria pathogen. And it eliminates the wait for people who had spent some in some European countries or served on military bases in Europe that was aimed at preventing transmission of Creutzfeldt-Jakob disease, a fatal neurodegenerative disorder.

Marks said the changes are not revolutionary but were modeled after existing policies in place in Canada and the United Kingdom that have been deemed safe.

“We actually think that it could potentially even make the blood supply … even be safer,” Marks said.

Despite the rash of donation cancellations, officials with the American Red Cross said they have been able to meet blood demand for now, but they welcomed the new guidelines for donors as one step to make sure the blood supply remains steady. And they are urging potential donors who are in good health to step up and donate, and to call if they have questions about eligibility.

“We are seeing schools, businesses, college campuses close and that is a source for the American Red Cross’ blood supply. And as a result, more and more blood drives are getting cancelled,” American Red Cross President and CEO Gail McGovern said of the shortfall.

Marks said that while the FDA changes were enacted in response to the coronavirus, he expects they will be here to stay.

“Unless there were to be some finding that there was something that said there was a safety concern, we fully expect those to be permanent,” he said.