FDA commissioner Stephen Hahnduring a press conference at the White House on Sunday. Photo: Pete Marovich/Getty Images

FDA commissioner Stephen Hahn said in a Twitter thread Monday night criticisms 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: Hahn also addressed in his post 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," he added.
  • "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."

Of note: Hahn stressed that the decision was based on "significant data" from reliable sources including the Mayo Clinic, "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," he said.
  • "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.

Go deeper

19 hours ago - Health

Trump announces plan to distribute 150 million rapid coronavirus tests

President Trump announced on Monday that the federal government will distribute 150 million rapid, point-of-care coronavirus tests to states over the next few weeks, including to K-12 schools and vulnerable communities like nursing homes and assisted living facilities.

Why it matters: The Trump administration has stressed the importance of reopening schools in allowing parents to return to work and jumpstarting the economy.

Cuomo extends New York moratorium on evictions until 2021

New York Gov. Andrew Cuomo. Photo: Jeenah Moon/Getty Image

New York Gov. Andrew Cuomo (D) announced Monday the state will extend its moratorium on coronavirus-related evictions until Jan. 1, 2021.

Why it matters: The Centers for Disease Control and Prevention issued a nationwide ban on residential evictions through Dec. 31. But housing advocates said that the federal protections were not as far-reaching as some state policies and warned many New York renters would be at risk when the state protections under the Tenant Safe Harbor Act ended on Oct. 1.

Dave Lawler, author of World
14 hours ago - World

Global coronavirus death toll crosses 1 million

Data: Our World in Data; Chart: Sara Wise/Axios

The global toll of confirmed deaths from COVID-19 crossed 1 million on Monday, according to data from Johns Hopkins.

By the numbers: More than half of those deaths have come in four countries: the U.S. (204,762), Brazil (141,741), India (95,542) and Mexico (76,430). The true global death toll is likely far higher.