FDA Commissioner Stephen Hahn said in a Twitter thread Monday night criticism of his comments about granting an emergency use authorization (EUA) of convalescent plasma as a treatment for the coronavirus were “entirely justified.”
The big picture: In his post, Hahn also addressed the politicization of the FDA, in an apparent reference to President Trump and his trade adviser, Peter Navarro, accusing senior health officials of being part of the “Deep State” amid a decision to put the plasma treatment on hold.
- Trump said at a news conference Sunday night the plasma “has proven to reduce mortality by 35%. Hahn echoed these remarks, saying: “What that means is — and if the data continue to pan out — 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma.”
What he’s saying: Hahn said in his Twitter post that what he should have said better was that “the data show a relative risk reduction not an absolute risk reduction.
“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.
“The convalescent plasma decision was made entirely by FDA scientists.
“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 decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.
“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.
“They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.
“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.”
Editor’s note: This article has been updated with new details throughout.
Originally published: 2020-08-24 21:13:23