House Members Seek FDA Action on Bacterial Mitigation for Blood Platelets

WASHINGTON — Several members of Congress are asking HHS and the FDA to enable hospitals to have more choice when it comes to ensuring their blood platelet donations are free of bacterial infection.

“We are concerned that many, if not most, healthcare providers are not being afforded the ability to select between FDA’s three accepted options” for bacterial mitigation, 10 House members wrote in a February 16 letter to HHS Secretary Xavier Becerra and FDA Commissioner Robert Califf, MD. “We share FDA’s desire to ensure provision of safe, timely, and effective blood transfusions to patients in need by offering providers flexibility in managing their care. As a result, we ask that FDA consider whether additional actions are necessary to preserve the benefits of choice and competition … in order to best serve patients and communities.”

Red Cross Decision

In December 2020, the FDA’s Center for Biologics Evaluation and Research issued guidance for industry on “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.”

The guidance outlined three options for bacterial mitigation: pathogen reduction, large volume delayed sampling (LVDS), and rapid testing. FDA also gave healthcare providers until March 31, 2021 to implement their chosen mitigation method; that deadline was later extended to October 1. Each method carries a different price tag; pathogen reduction, which is usually done by the donation collector, runs about $150 to $200, while LVDS is about $83, and rapid testing — done at the point of use, which is often at a hospital — is about $25.

However, the Red Cross, which supplies about 40% of the nation’s blood products, announced in July 2020 that it would transition to using the pathogen reduction method, although it would also continue using the LVDS method in certain circumstances until it could complete the full transition to pathogen reduction. The Red Cross also said that it would increase its clients’ fees by either $83 or $150 per unit, depending on which method was being used for the product a client received. Eventually, all Red Cross blood products will undergo pathogen reduction, so the $150 fee will then apply to all Red Cross clients.

In a fall/winter 2020 publication, the Red Cross explained its thinking on bacterial mitigation, noting that the limitations of one type of rapid test — the Verax Pan Genera Detection (PGD) test — “include implementation, the need for additional testing to confirm an initial positive result, and a significant false positive rate (0.51%).” The publication quoted a 2020 study by researchers at the Red Cross that found that “between 2013 and 2018, using the Red Cross hemovigilance database, a total of 475 initially reactive PGD tests were identified, of which only 1.5% turned out to be true positives … Based on their analysis the authors conclude that initially reactive PGD test results have an adverse impact both on platelet inventories and blood center costs.”

But a Verax spokesman said in a phone call that the Red Cross was using old data and the false-positive issue has since been corrected. He pointed to a study by Verax researchers — published a few months later in the same journal — which showed that an updated version of the Verax test “yielded no false‐positive results among 3,802 individual indate platelets of seven different types (observed specificity, 100%).”

Implications for Rural Hospitals

The Red Cross’s decision to use the pathogen reduction test is bad news for hospitals, especially rural hospitals, Rep. Earl “Buddy” Carter (R-Ga.), RPh, one of the chief authors of the HHS/FDA letter, said in a phone interview. “It is raising the cost to them,” he told MedPage Today. “The rapid test is advantageous for a number of reasons. First of all, it’s less expensive than the other two. Not only that, but it has a longer shelf life, and that’s particularly important to the rural hospitals,” who may not use their blood products as quickly as urban and suburban facilities. In addition, he said, there have been reports of blood products that were found to be infected with bacteria even after the pathogen reduction method had been used.

“What we’re trying to achieve here is to make sure that patients and providers have choice, and they deserve to have that choice,” Carter, a pharmacist, said. “They deserve to have the best product available.” (Disclosure: Carter wrote an opinion piece on this issue that was published on MedPage Today last September.)

Although the letter to HHS and FDA was signed only by Republican representatives, Carter said he has gotten support from some House Democrats, as well as from some senators. “This is not a partisan issue,” he said, adding that he is hoping that the letter will “make sure that HHS and FDA understand that we’re paying attention in Congress and we know what’s going on, and we want to make sure they know what’s going on. We also want them to look at these methods and to address this situation,” perhaps by ranking the mitigation methods in order of preference or by giving some other guidance.

Carter noted that he hopes Congress won’t have to step in. “Sure, we can do something legislatively, but I don’t want to have to do that — my hope is that FDA and HHS will address this situation so we don’t have to,” he said. “But if they don’t, we’re not going to just sweep it under the rug. We’re serious about this and we’re paying attention.”

He added that the issue is further complicated by the fact that there is a blood shortage going on. “Blood donations are down over 50% or 60% from before COVID,” he explained. “When there’s blood shortages already, the costs of blood tend to go up, but at the same time, these hospitals that are ordering blood have to order it ahead of time so they have it when they need it. And if the shelf life of the blood being provided to them as a pathogen reduction product only lasts 5 days, there’s also waste attributed there because they won’t use it all. If they have the rapid testing, it lasts longer — up to 7 days.”

Red Cross’s Response

Asked to respond to these concerns, a Red Cross spokesperson said in an email that based on the organization’s “many years of operational experience with manufacturing pathogen-reduced platelets, we believe pathogen inactivation is a key to maintaining a readily available platelet supply for patients in need as no additional testing is required.” In addition, “pathogen-reduced platelets offer cost offsets associated with babesia, CMV testing and irradiation that are not afforded the other bacterial mitigation options.”

As to giving its clients a choice of mitigation methods, the spokesperson said that “the Red Cross does not restrict rapid testing by its hospitals; rather, because the Red Cross has performed pathogen inactivation and LVDS upfront in its manufacturing process, the need to rapid test for bacteria becomes unnecessary.”

The Association for the Advancement of Blood & Biotherapies (AABB, formerly the American Association of Blood Banks), whose members include the Red Cross and other blood banks, issued its own bulletin in June 2021 to supplement the FDA guidance. The bulletin noted that “every risk control strategy is supported by the FDA and are ‘therapeutically equivalent’; however, each methodology will have some impact on platelet quality, dose, availability and other factors that could affect clinical utility … Notably, no strategy has been shown to eliminate all contaminants.”

Asked to comment on the current controversy, an AABB spokesman wrote in an email that “federal regulations prohibit AABB from discussing pricing” and that “AABB does not interfere in contractual arrangements between hospitals and their suppliers.”

As for the House members’ letter, an FDA spokesperson said, “Addressing bacterial control risk strategies, and blood safety overall, is a high priority for the agency. The FDA is aware of the letter and will respond to the House … committee members directly.” An HHS spokesperson wrote in an email that the agency received the letter and will be reviewing it.