Press Releases

WASHINGTON, D.C. - Representatives Earl L. “Buddy” Carter (R-GA), Michael Burgess (R-TX), and Morgan Griffith (R-VA), along with 10 other members, joined together to shine a spotlight on actions taken by blood collectors that are foreclosing choice for hospitals and other health care providers in their districts and across the country. 

“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,” Carter said. “I’m concerned that these decisions, if left unchecked by the FDA, will lead to higher health care 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."

In December 2020, the Food and Drug Administration (FDA) issued a Final Guidance document addressing an urgent public health matter: bacterial contamination in platelet transfusion. Because platelets are stored at room temperature, they are particularly susceptible to bacterial growth. Bacterial infiltration of platelet donations can and does lead to fatal septic reactions in vulnerable patients; as a result, these donations must be screened and/or treated for potential contamination.

In its Final Guidance, FDA offered the market three avenues for compliance, each with unique benefits, risks, and costs. The agency does not characterize any option as better than the others, providing hospitals freedom to select the solution best suited for their particular needs and resources. FDA provided these choices because it recognized that hospitals have different patient populations, supply chain concerns, and operational and economic priorities and feasibilities, many of which are driven by geographic location. For example, rural hospitals with limited access to blood products supply may prefer a platelet product with a longer shelf life and that contains more concentrated amounts of platelets - both factors which vary depending on how platelets are tested and treated for bacteria.

A significant percentage of market share is held by a few blood collectors, but some of these collectors are only offering a single platelet product. As a result, hospitals may be required to accept platelets prepared to the blood collectors’ choice, regardless of expense or work force requirements.

Others have also expressed profound concern that decisions by blood collectors will limit provider decision making. Leading transfusion medicine professionals submitted a public letter to the FDA dated November 25, 2020, and the principal professional association for transfusion medicine, the Association for the Advancement of Blood & Biotherapies (AABB), issued Bulletin #21-02 on June 2, 2021. Each of these communications addresses the impacts of Guidance implementation, emphasizing strongly the need for hospitals to have a choice as to how they will reduce the risks addressed by the Guidance.

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 among those complying with the Guidance, in order to best serve patients and communities.

Read the full letter here. 

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