But the FDA decided at the last minute to hold off on authorizing emergency use of the plasma after top scientists at the National Institutes of Health argued that data on the treatment’s efficacy was 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 raised alarms about the lack of definitive evidence.
More than 60,000 people in the U.S. have received plasma under a “compassionate use” program run by the Mayo Clinic, and clinical trials are ongoing. But there are no results yet from randomized, controlled studies, which are considered the gold standard in medical research.
Michael Caputo, assistant secretary of HHS for public affairs, told POLITICO, “NIH has no role in approving an EUA and the person quoted” — H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases, in the New York Times story — “did not attend key meetings on the topic.”
The FDA declined to comment on the matter. “Per policy, we are not able to comment on whether or not we will take any action regarding emergency use authorization for convalescent plasma and will render a decision at the appropriate time,” said Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs.
He added that plasma is available through multiple pathways including clinical trials, a national expanded access program and single-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 had been brewing after the president appeared to latch onto plasma in recent press briefings.