The FDA is considering updating its blood donation guidelines

 

The US Food and Drug Administration (FDA) is considering updating its blood donation guidelines to ensure the nation's blood supply remains safe from malaria. While malaria is not a significant threat to the US blood supply, experts predict that the disease could become more common due to increased travel and a warming climate.

The FDA is seeking advice from its independent advisers on the best way to achieve its goal of zero transfusion-related cases without unnecessarily prohibiting some people from donating blood. The agency is considering requiring blood banks to use a new test that can detect the parasites that cause malaria in certain donors' blood.

Malaria is a significant global health issue, with 249 million cases and over 608,000 deaths in 2022 alone. Although the US is considered malaria-free, there are still about 2,000 cases reported each year, mostly travel-related. However, there have been a handful of locally acquired cases in recent years, including a few in Texas, Florida, Maryland, and Arkansas last year.

The FDA approved the first test intended to screen donor blood for malaria in March. The Cobas malaria test can detect RNA and DNA from the parasite that causes malaria in donor blood, organs, and tissue. However, the agency is still considering how to implement the test and is seeking input from its advisory committee.

The current guidelines for blood donation are complex and rely on a donor history questionnaire to screen for people who have had malaria or lived in a country where the disease is endemic. However, this process is "error-prone" and may not catch asymptomatic donors, particularly those from countries where malaria is common.

The FDA is considering two strategies to update its guidelines. The first is to do selective testing of a donor's blood based on their history of malaria infection, travel to a malaria-endemic area in the previous three months, or having ever lived in a malaria-endemic country. The second option is to test all donors at least once and then selectively test donations from people at risk of exposure.

Most of the advisory committee members seemed to favor the first option, saying the second seemed like overkill. However, the committee members were less sure about the FDA's consideration of requiring testing of all blood donated in areas where there was even one locally transmitted malaria case recently.

During the meeting's public comment period, leaders of some blood supply organizations encouraged the FDA to take a cautious approach to changing the guidelines. They noted that while the new test for malaria holds promise for improving blood safety, there are no clinical studies that show it reduces the risk of transfusion-transmitted malaria.

The FDA did not vote on the proposed strategies but said it would take the discussion into consideration as it considers changing its guidance. The agency aims to balance the need to ensure the safety of the blood supply with the need to avoid unnecessarily prohibiting people from donating blood.