MichBio Issues Statement on New EUA Labeling Requirements for Convalescent Plasma

ANN ARBOR, Mich.--(BUSINESS WIRE)--Following the release of the U.S. Food & Drug Administration (FDA) Emergency Use Authorization (EUA)/Declaration on Emergency Use of Covid-19 Convalescent Plasma on August 23, 2020, and concerns raised immediately within the Michigan clinical transfusion services community, MichBio President Stephen Rapundalo issued the following statement:

“MichBio supports industry and Congressional efforts that seek clarity from the FDA on the labeling requirements for units of Covid-19 convalescent plasma (CCP) to be used for transfusion into patients.

Yesterday morning, MichBio became aware of the unit labeling requirements, as spelled out in the "Fact Sheet for Health Care Providers"¹ issued by the FDA in conjunction with the EUA. It calls for display of the antibody titer on each unit. These labeling requirements are significantly different than previously in use for CCP collected and distributed for the Expanded Access Program (EAP) led by the Mayo Clinic. To make matters worse, the EAP was closed upon the EUA issuance, and thus no existing units can be utilized under the auspices of that protocol.

MichBio immediately raised alarm over the incongruences in requirements with Rep. Fred Upton (R-MI) and Rep. Debbie Dingell (D-MI), both members of the U.S. House Energy & Commerce Committee that overseas the FDA. Both legislators expeditiously communicated our concerns in a letter² to FDA Commissioner Stephen Hahn for his timely response and action.

The new labeling requirements mean that transfusion services at health systems across Michigan and nationally cannot legally transfuse existing CCP units to any patients who present to a provider institution and qualify for transfusion. In addition, the change caught blood suppliers like the American Red Cross unaware, and so procurement of CCP from their inventory were impacted too.

It can be assumed that hundreds, if not thousands, of in-date, ready to transfuse CCP units across the country have been rendered unusable by the specifics of the EUA. While, in theory, it may be possible to relabel some of these units appropriately, this is a monumental undertaking by blood centers, and any transfusion services that have units in-house are unable to relabel them.

When we consider the major driver of this decision to release an EUA was based on the Mayo EAP pre-print, it logically follows that time to transfusion data is the most important factor that lead to the EUA. This labeling issue, if not rapidly corrected, will lead to significant delays in transfusion of patients across the country for the foreseeable future, or, put transfusion services licenses at risk for willfully violating FDA requirements.

Reps. Upton and Dingell correctly noted in their letter to Commissioner Hahn that “the resulting delays could have an impact on patient outcomes…” and asked that “the FDA take prompt action to ensure that these requirements do not unduly inhibit patient access to convalescent plasma.”

MichBio thanks Reps. Upton and Dingell for their prompt action. We too hope that the FDA will clarify the labeling requirements swiftly and avoid placing valuable CCP units in jeopardy and waste, placing patients at risk, and not to mention adding significant expense needlessly to providers and the overall U.S. healthcare system.”

For more information on MichBio visit michbio.org

MichBio is the trade association committed to driving growth in Michigan's biosciences industry and its many sectors, including agri-biotech, food and nutrition, bio-based technologies and renewable chemicals, industrial and environmental biotech, medical devices and technologies, pharmaceuticals and consumer healthcare, diagnostics and research products, testing and research services, and clinical research. MichBio members include bioscience companies, academic and research institutions, bioscience service providers, and related organizations. For more information, visit www.michbio.org or follow us on Twitter @MichBio.

¹ https://www.fda.gov/media/141478/download
² https://upton.house.gov/uploadedfiles/uptondingellhahnletterfinal.pdf