FDA chief says he "could have done a better job explaining" emergency plasma order
Food and Drug Administration Commissioner Stephen Hahn defended his decision to grant emergency use authorization to a COVID-19 treatment using the plasma of recovered patients, but acknowledged he "could have done a better job" explaining the decision during a press conference with President Trump.
"First thing I'd like to say is that I personally could have done a better job, and should have done a better job at that press conference explaining what the data show regarding convalescent plasma," he told "CBS This Morning" Tuesday. "I can assure the American people that this decision was made based upon sound science and data."
After a Sunday press conference alongside Mr. Trump, Hahn was accused of bowing to White House pressure just a day before the start of a Republican National Convention that championed Mr. Trump's heavily-criticized response to the coronavirus pandemic.
"The timing was totally based on when we got the data," Hahn said.
The data came from a Mayo Clinic program in which convalescent plasma was infused into more than 35,000 patients' blood. While no placebo or comparison group was used, Hahn said the numbers reflected what he called the "promising efficacy" of the treatment.
Mr. Trump said the treatment reduced the number of COVID-19 deaths by 35%, though scientists have questioned the accuracy of that figure, which overstated the study's preliminary results.
Hahn said the decision came Sunday after "three or four weeks" of research because of a number of contributing factors. They include the coming end of the Mayo Clinic's program, analyzing "additional data" received in recent weeks and the aim to "maintain availability of plasma for patients and doctors" after trials were over.
Clinical trials are still ongoing for the treatment, despite the early authorization. While Hahn said they would be updating the research as more data came in, he said the "risk-benefit assessment" of what they already had met the criteria for an emergency order.
He lauded the scientists who "independently made this decision" and said that doctors on the front lines supported the authorization as well.
"There's a great demand for this. Doctors are ordering this for patients around the country," he said.
Accusations against Hahn, a Trump appointee, of bowing to pressure from the president come on the heels of a new round of attacks on the FDA. The president tagged the commissioner in a tweet accusing the "deep state, or whoever" of sabotaging efforts to test COVID-19 vaccines and treatments.
Hahn defended his relationship with Mr. Trump, calling it "very good."
"I spoke to him several times this weekend," Hahn said. "He wants us to be focused on the urgency of the situation and moving things forward, and I have great faith in the 17,000 FDA employees who are terrific scientists, doctors and nurses that we're going to do that moving forward for the American people."