But the FDA decided at the last minute to refrain from authorizing emergency use of plasma after top scientists at the National Institutes of Health claimed that data on the effectiveness of the treatment were still thin, the New York Times reported Wednesday. While NIH has no role in approving therapies, the Times wrote that NIH Director Francis Collins and National Institute of Allergy and Infectious Disease Director Anthony Fauci are raising alarms about the lack of definitive evidence.
More than 60,000 people in the U.S. have received plasma under a “compassionate use” program conducted by the Mayo Clinic, and clinical trials are ongoing. But there are still no results from randomized, controlled trials, which are considered the gold standard in medical research.
Michael Caputo, Assistant Secretary to HHS for Public Affairs, told POLITICO, “NIH Has No Role in Approving an EUA and the Affiliated Person” – H. Clifford Lane, Clinical Director at the National Institute of Allergy and Infectious Diseases, in The New York Times’ New Story – “Didn’t Attend Important Meetings on the Subject.”
The FDA declined to comment on the matter. “Per policy, we can not comment on whether or not we will take action regarding authorization for emergency use for recovery time plasma and we will make a decision at the appropriate time,” said Anand Shah, FDA Deputy Medical and Scientific Commissioner.
He added that plasma is available through multiple pathways including clinical trials, a nationwide extended access program and one-patient request to use it in an emergency.
NIH referred questions to NIAID, which did not respond to requests for comment. An NIH source told POLITICO that concerns about the lack of definitive data were brewing after the president appeared to be placing on plasma in recent press releases.
