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Upton, Dingell Request Clarity on Requirements for FDA Emergency Use Authorization for Convalescent Plasma to Treat COVID-19

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Washington, August 25, 2020 | Josh Paciorek (202-225-3761) | comments

WASHINGTON, DC — Today, U.S. Reps. Fred Upton (R-MI) and Debbie Dingell (D-MI) pressed FDA Commissioner Stephen Hahn to urgently address issues in COVID-19 patients from being able to receive convalescent plasma.

Upton and Dingell heard directly from Michigan hospitals that are facing barriers in using convalescent plasma to treat COVID-19 patients after a change in FDA regulations. This week, the FDA issued a new Emergency Use Authorization (EUA) for the treatment of hospitalized patients with COVID-19 that adds a new unit labeling requirement. This requirement acts as a barrier to use for certain convalescent plasma products distributed prior to the EUA issuance, potentially limiting the use of convalescent plasma collected and distributed prior to August 23.

“The EUA also mandates new labeling requirements on convalescent plasma, including information on the concentration of antibody titers,” the lawmakers wrote. “However, 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. 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.”

“The resulting delays could have an impact on patient outcomes, with preprint data indicating that time to transfusion is a key factor correlated with lessening the severity or shortening the length of illness,” the lawmakers continued. “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 full text of the letter is available here and below:

Dear Commissioner Hahn:

            We are writing to request that the Food and Drug Administration ensure that the August 23, 2020 Emergency Use Authorization for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 allow for the use of certain convalescent plasma products distributed prior to the EUA issuance. The unit labeling requirements for the EUA potentially limit the use of convalescent plasma collected and distributed prior to August 23 and could result in delays in treatment if not promptly addressed.

            On August 23, 2020, the FDA issued an EUA to allow for wider use of convalescent plasma, based on “historical evidence using convalescent plasma in prior outbreaks of respiratory viruses, certain preclinical evidence, results from small clinical trials of convalescent plasma conducted during the current outbreak, and data obtained from the ongoing National Expanded Access Treatment Protocol (EAP) sponsored by the Mayo Clinic”. The EUA also mandates new labeling requirements on convalescent plasma, including information on the concentration of antibody titers.

However, 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. 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. The resulting delays could have an impact on patient outcomes, with preprint data indicating that time to transfusion is a key factor correlated with lessening the severity or 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. Thank you in advance for your attention to this request.

 

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