Changes to the requirements for emergency use authorization (EUA) of convalescent plasma as a COVID-19 treatment by the U.S. Food and Drug Administration (FDA) has raised new barriers for hospitals, and a new line of questions from U.S. Reps. Debbie Dingell (D-MI) and Fred Upton (R-MI).
In a letter to FDA Commissioner Stephen Hahn, Dingell and Upton charged that Michigan hospitals were complaining that the new EUA blocks certain convalescent plasma products distributed before the update from being used. At the heart of the issue is a new unit labeling requirement, which bars the use of convalescent plasma collected and distributed before Aug. 23 and demands new labeling requirements, including information on the concentration of antibody titers.
“These labeling requirements differ substantially from those previous in use for the national Expanded Access Program for convalescent plasma led by the Mayo Clinic, which did not have titer indications labeled when distributed,” the lawmakers wrote. “This presents potentially significant barriers to access of convalescent plasma under the EUA, given the regulatory barriers and testing required to relabel units already distributed across the country.”
They warned of potential delays that could result, and of the impact this could have on patient outcomes. Preprint data, they noted, shows that the time taken for transfusion is critical in keeping the virus from worsening and shortening the length of illness.
“Given this unforeseen consequence, we are requesting that FDA take prompt action to ensure that these requirements do not unduly inhibit patient access to convalescent plasma,” the representatives said.