US Food and Drug Administration (FDA) commissioner Stephen Hahn has faced heavy criticism over the perceived politicization of the emergency use authorization (EUA) for COVID-19 convalescent plasma and the scientific veracity of comments he made at a press conference to disclose the news.
Now, Hahn and the FDA are coming in for more criticism over the specifics of the EUA. MichBio, the bioscience trade association for Michigan, called for the FDA to make changes after seeing the labeling requirements for the EUA.
The concerns center on the requirement for each unit of plasma to display the antibody titer. That requirement was absent from the expanded access program under which plasma has been collected and distributed so far. The issuance of the EUA led to the closure of the expanded access program.
MichBio estimates that hundreds, perhaps thousands, of existing plasma units lack the required labels but are otherwise ready to use. The newly created barrier to the use of those units led Rep. Fred Upton (R-MI) and Rep. Debbie Dingell (D-MI), after being contacted by MichBio, to write to the FDA to request a change in the terms of the EUA.
“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,” Upton and Dingell wrote in a letter to Hahn.
Upton and Dingell want the FDA to take “prompt action” to stop the EUA labelling requirements from limiting access to convalescent plasma. The units could be relabeled but MichBio said that would be a “monumental undertaking” for blood centers and impossible for transfusion services.
In the absence of a revised policy, MichBio said healthcare providers could be forced to see plasma units could go to waste or risk their transfusion services licenses by knowingly violating the rules.
While the situation is worked out, plasma units that could potentially be used to treat patients with COVID-19 may be sitting on shelves. The evidence for the efficacy of convalescent plasma is a subject of debate, but a Mayo Clinic preprint paper that supported the EUA found the survival rate was higher in patients treated with plasma within three days of diagnosis, suggesting timing may be important.