Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago.
They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.
We unfortunately do not have randomized trials for convalescent plasma but must make decisions based on what we do have from the Mayo Clinic expanded access program.
The decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.
We at FDA do not permit politics to enter into our scientific decisions. This happens to be a political season but FDA will remain data driven. On behalf of FDA‘s 18,000 career employees, I want to reassure the American public about this commitment.
The convalescent plasma decision was made entirely by FDA scientists.
The authorization of emergency use of convalescent plasma is not a final approval. FDA will continue to monitor its use and will revoke authorization if needed. We feel broader use of plasma will truly benefit many patients but will require further study.
I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
