NEW YORK, August 24 :
The move came on the eve of the Republican convention and after President Trump pressed the agency to move faster to address the pandemic.
The Food and Drug Administration on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients, allowing President Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention.
Mr. Trump cited the approval, which had been held up by concerns among top government scientists about the data behind it, as welcome news in fighting a disease that has led to 176,000 deaths in the United States and left the nation lagging far behind most others in the effectiveness of its response.
At a news briefing, he described the treatment as “a powerful therapy” made possible “by marshaling the full power of the federal government.”
The decision will broaden use of a treatment that has already been administered to more than 70,000 patients. But the F.D.A. cited benefits for only some patients. And, unlike a new drug, plasma cannot be manufactured in millions of doses; its availability is limited by blood donations. Mr. Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.
Mr. Trump has portrayed his demands to cut red tape and speed approval of treatments and vaccines as a necessary response to a public health emergency.
But Sunday’s announcement came a day after he repeated his unfounded claim that the F.D.A. was deliberately holding up decision-making until after the election, this time citing a “deep state.” That accusation exacerbated concerns among some government scientists, outside experts and Democrats that the president’s political needs could undermine the integrity of the regulatory process, hurt public confidence in safety and introduce a different kind of public health risk.
No randomized trials of the sort researchers consider most robust have yet shown benefit from convalescent plasma. But the F.D.A. said the data it had so far, including more than a dozen published studies, showed that “it is reasonable to believe” that the treatment “may be effective in lessening the severity or shortening the length of Covid-19 illness in some hospitalized patients,” in particular those who receive it early.
Patients less than 80 years old who received plasma with a high level of virus-fighting antibodies within three days of diagnosis, and who were not on a respirator, were about 35 percent more likely to be alive a month later compared with those who received plasma with a low level of the antibodies, according to Dr. Peter Marks, the director of F.D.A.’s center for biologics, evaluation and research.
Mr. Trump stripped away the agency’s nuanced language during his appearance before reporters at the White House, saying that convalescent plasma has been “proven to reduce mortality by 35 percent.”
The F.D.A., which is responsible for approving new medicines, delayed the authorization for about a week after top health officials, including Dr. Francis S. Collins, the director of the National Institutes of Health, and Dr. Anthony S. Fauci, the top infectious disease specialist, questioned whether the data was sufficient.
Mr. Trump complained in a tweet on Saturday, claiming without any evidence that officials were “hoping to delay the answer until after November 3rd” — Election Day — and urging the F.D.A. to “focus on speed, and saving lives!”
Mark Meadows, the White House chief of staff, also accused government regulators over the weekend of slow-walking the approval, calling it “a fumble.” Mr. Meadows said Mr. Trump was not trying to “cut corners,” but had “a real frustration with some of the bureaucrats who think they can just do this the way they normally do it.”
At his news conference, Mr. Trump struck a more positive note, saying the agency had “really stepped up,” especially “over the last few days.”
Democrats and some health experts said the president’s criticism of federal regulators undermined public confidence and threatened the credibility of the agency charged with determining whether drugs and medicines are safe and effective.
source– The New York Times