U.S. Rep. Buddy Carter (R-GA) recently led a dozen of his GOP colleagues in requesting that the Biden administration help ensure risks are reduced by Food and Drug Administration (FDA) final guidance that addresses bacterial contamination in platelet transfusions.
In its December 2020 final guidance, titled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” the FDA offers the market three avenues for compliance with the guidance, each having “unique benefits, risks and costs,” according to a Feb. 16 letter Rep. Carter and his colleagues sent to U.S. Department of Health and Human Services Secretary Xavier Becerra and FDA Commissioner Dr. Robert Califf.
The lawmakers pointed out that the FDA does not prioritize an option in order to give hospitals freedom to select the best solution for their needs and resources. However, they are concerned that “many, if not most, healthcare providers are not being afforded the ability to select between FDA’s three accepted options.”
For instance, they wrote that a significant percentage of market share is held by a few blood collectors, including the American Red Cross, and said that it’s not uncommon for geographic regions to have access to only one blood collector.
“As a result, hospitals may be required to accept platelets prepared to the blood collectors’ choice, regardless of expense or work force requirements,” they wrote. “Others have also expressed profound concern that decisions by blood collectors will limit provider decision making.”
“There are many reasons why a hospital might choose a different compliance strategy than what is being offered by their blood products provider. Cost, convenience and efficacy are all important considerations that hospitals should be allowed to take into consideration,” Rep. Carter said. “I’m concerned that these decisions, if left unchecked by the FDA, will lead to higher healthcare costs and exacerbate the current blood shortage.
“We need to look at these niche issues that can have a big impact on preserving flexibility for hospitals during these challenging times and our overall health system,” he said.
In their letter, the Republicans asked that the FDA consider whether additional actions are necessary “to preserve the benefits of choice and competition among those complying with the guidance in order to best serve patients and communities.”
Among the members who also signed the letter are U.S. Reps. Michael Burgess (R-TX), Mariannette Miller-Meeks (R-IA), Larry Bucshon (R-IN), and John Joyce (R-PA).