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# Blood Plasma Emergency Use Authorization Stalls
- URL: https://www.fdaweb.com/blood-plasma-emergency-use-authorization-stalls/
- Published: 2020-08-19T12:00:00.000Z
- Updated: 2026-09-14T16:25:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147465

FDA has temporarily put the brakes on an emergency use authorization (EUA) for using blood plasma therapy for treating Covid-19 patients until more data are presented to demonstrate its effectiveness, according to several media reports. NIH director **Francis Collins** and National Institute of Allergy and Infectious Diseases director **Anthony Fauci** reportedly intervened in the EUA review arguing the data were not robust enough to support such a move. So far, FDA is not commenting on the matter.

The FDA’s delay comes on the heels of four former commissioners who have urged U.S. regulators, researchers and Covid-19-recovered patients to join in an effort to collect blood plasma and begin clinical trials to determine whether the plasma from recovered patients can help those who become sick. Writing earlier this month in a *Washington Post* [opinion piece](https://www.washingtonpost.com/opinions/2020/08/03/4-former-fda-commissioners-blood-plasma-might-be-covid-19-treatment-we-need/?ref=fdaweb.com), **Mark McClellan**, **Margaret Hamburg**, **Robert Califf** and **Scott Gottlieb** supported a coordinated group called “[The Fight Is In Us](https://thefightisinus.org/en-us%23home?ref=fdaweb.com)” to demonstrate that such a therapy is safe and effective. They describe the group as a “broad coalition of medical and research institutions, blood centers, life science and technology companies, philanthropic organizations and covid-19 survivor groups” who are working to drive awareness and recruit plasma donors across the country.

The former commissioners used the confusion surrounding hydroxychloroquine to illustrate why randomized trials are quickly needed to determine if convalescent plasma’s benefits outweigh its risks in Covid-19 patients. “Thousands of covid-19 patients have been treated with plasma, but we are not much closer to definitively answering those questions,” they contended. “Its use makes common sense, and preliminary studies are promising, but we won’t know how to best use convalescent plasma products until we complete randomized clinical trials in which some people are treated and others receive usual care.”

“Given the urgency of the covid-19 crisis,” the former officials wrote, “we need to create new pathways for quickly advancing promising therapies while clearly determining whether they’re safe and effective. We can’t waste precious time and put people at risk by treating them with therapies that don’t work or miss opportunities to collect data and determine when a treatment is beneficial.”