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 Donald Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention.
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 FDA 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. Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.
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 FDA 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 shown benefit from convalescent plasma. But the FDA 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 younger than age 80 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% 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, director of FDA’s center for biologics, evaluation and research.
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%.”
The FDA, which is responsible for approving new medicines, delayed authorization for about a week after top health officials, including Dr. Francis Collins, the director of the National Institutes of Health, and Dr. Anthony Fauci, the top infectious disease specialist, questioned whether the data was sufficient.
Trump complained in a tweet Saturday, claiming without any evidence that officials were “hoping to delay the answer until after November 3rd” — Election Day — and urging the FDA 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.” Meadows said 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.”https://tpc.googlesyndication.com/safeframe/1-0-37/html/container.html
At his news conference, 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.
Nancy Pelosi, the House speaker, called Trump’s Saturday tweet “very dangerous.”
White House officials have been urging speedy approval not just of COVID-19 treatments, but of vaccines. Their public statements that a safe and effective vaccine could be just around the corner have alarmed scientists who fear that White House pressure will result in premature approval timed to increase the president’s reelection chances.
In a July 30 meeting with Pelosi and Sen. Chuck Schumer of New York, the Democratic minority leader, top administration officials suggested the administration might grant emergency approval for a vaccine before Phase 3 trials in the U.S. are complete, perhaps as early as September, according to two people briefed on the discussion. Such a move would be highly unusual and most likely prompt more concern about whether the administration was pressuring the FDA to approve drugs for political purposes.
During the discussion in Pelosi’s conference room, the people briefed on it said, Meadows indicated that a vaccine being developed by AstraZeneca and Oxford University was the most likely candidate for early approval. Their discussion was first reported by the Financial Times.
AstraZeneca is conducting Phase 3 trials in Britain, South Africa and Brazil, but only began its Phase 3 clinical trial in the U.S. a few days ago.https://tpc.googlesyndication.com/safeframe/1-0-37/html/container.html
Senior administration officials disputed the account of the meeting, saying Meadows and Treasury Secretary Steven Mnuchin were either being misquoted or had been misunderstood on every major point.
Nonetheless, their remarks suggested to at least some participants that the administration was hoping that robust results from AstraZeneca’s overseas trials would lead to early emergency authorization, using the same authority the FDA used to greenlight the use of convalescent plasma. An aide to Pelosi said she warned officials at the meeting against taking shortcuts.
The FDA typically requires clinical trials with American patients before approving vaccines for use in the U.S. Although there have been exceptions to that rule, experts said, approval of a coronavirus vaccine on the basis of overseas trials would present challenging issues for regulators, partly because of differences in demographics as well as in the size of the trials.
One senior administration official briefed on the meeting, who declined to speak about the discussion on the record, said neither Meadows nor Mnuchin suggested a vaccine could be approved as early as late September. The official said the administration would not approve a vaccine solely on the basis of foreign clinical trials.
Spokespeople for both Meadows and Mnuchin said neither man discussed AstraZeneca.
On Sunday, Trump again raised hopes for a successful vaccine, saying, “You’ll be hearing about” that “very soon, very shortly.” Collins, the NIH director, has said it “would be astounding” if a vaccine was ready for approval by October — and that even November or December is highly optimistic.
The decision by the White House to publicly increase the pressure on the FDA injected a political element into what some scientists called a notable advance in expanding the use of convalescent plasma. Other experts sounded a note of caution, saying the evidence was still preliminary.
In a statement, the president of the Infectious Disease Society of America, Dr. Thomas M. File Jr., said that the data on the treatment shows “some positive signals,” but that “we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment.”
In a phone call with reporters Sunday, Dr. Stephen Hahn, the FDA’s commissioner, said the agency would continue working with researchers studying the treatment and might update the authorization. He encouraged the continuation of randomized trials to prove the treatment’s effectiveness.
“This is not the end,” he said.
Hahn softened the president’s claim that the treatment reduces mortality by 35%, saying that will be true “if the data continue to pan out.” It was not immediately clear where the 35% figure came from; it did not appear to be included in technical documents released by the agency in support of the decision.
Marks told reporters that more than 70,000 patients had already received convalescent plasma under a special agency program. The decision to authorize the treatment so that even more doctors could use it was based on an analysis of months of data that suggested that when given early in the course of the disease, plasma “can improve outcomes and decrease mortality,” he said.
“We’re confident that convalescent plasma is safe to use in this setting,” he said, after reviewing results from the first 20,000 patients who received it.
Hahn said that the decision to authorize the treatment was made “solely on the basis of the science and the data and on nothing else.”