• Thu. Nov 26th, 2020

Trump announces emergency authorization for COVID-19 treatment after accusing FDA of delays – NBC News

President Donald Trump announced Sunday his administration was providing an emergency authorization for the use of convalescent plasma to treat COVID-19, a treatment that more than 70,000 patients have already received.

One day prior to the start of the Republican National Convention, Trump made the announcement in an evening news conference. He said the authorization “will dramatically expand access to this treatment.”

“We’re years ahead of approvals if we went by the speed of past administrations,” Trump said, adding, “And that includes vaccines.”

The treatment, which involves taking antibody-rich blood product from recovered coronavirus patients and providing it to those afflicted with the virus, has shown some benefit to patients but evidence remains inconclusive about its effectiveness and appropriate dosage. The trials have been riddled with delays and issues with finding volunteers.

Hahn made clear the emergency use authorization was not the same as the treatment being approved by the FDA and that the treatment still needs to undergo randomized clinical trials to determine its safety and effectiveness.

Aug. 23, 202003:11

Speaking with CBS’s “Face the Nation” on Sunday, Trump’s former Food and Drug Administration Commissioner Scott Gottlieb said the treatment is “probably beneficial” though the emergency authorization amounts to an “incremental” change.

“The emerging data does not suggest convalescent plasma is that great,” Dr. Carlos Del Rio, an infectious disease physician at Emory University, told NBC News. “It is at best an incremental improvement but not a game changer.”

Nearly 180,000 Americans have already died of the virus, according to an NBC News tracker. With a vaccine not expected to be widely available until 2021, the push for effective treatments has intensified.

The authorization comes as Trump has ramped up criticism of his own administration, alleging they are slow-walking approvals for vaccines and therapeutics. On Saturday, Trump claimed with no evidence, “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.”

Trump has repeatedly promoted the conspiratorial idea that a “deep state” of officials throughout the administration is working against him and openly criticized top health officials who challenge his unproven claims. On Saturday, he accused the FDA of delaying approval of a vaccine until after the November election, which is far sooner than most experts have predicted a vaccine could be available.

“Obviously, they are hoping to delay the answer until after November 3rd,” Trump tweeted. “Must focus on speed, and saving lives!”

Earlier this month, Hahn said the agency would not “cut corners” to approve a vaccine, which Trump has promised before the end of the year. Top biotechnology executives responded to Trump’s tweet saying politics can play no role in vaccine and therapeutic development and said the FDA is moving at record speed to get drugs approved.

The president also expressed disdain over the FDA months ago rescinding its emergency use authorization for hydroxychloroquine to treat hospitalized COVID-19 patients, which the agency said carries too many risks without any apparent benefit.

White House chief of staff Mark Meadows on Sunday downplayed the tweets in an interview with ABC’s “This Week,” saying Trump is simply trying to make sure officials want to move as quickly as he does.

“They want to do things the way they’ve always done it,” Meadows said of career staffers at the FDA. “This president is about cutting red tape. That’s what the tweet was all about.”

Meadows added he believes “there are a number of people that do not see the same sense of urgency as [Trump] sees” in approving drugs to combat the coronavirus.

In July, former Vice President Joe Biden, the 2020 Democratic presidential nominee, called on Trump to “assure us all that the White House will respect the independent authority of the FDA to decide, free from political pressure, if the vaccine is safe and effective.”

Speaking with “This Week,” Biden’s deputy campaign manager Kate Bedingfield said “the American people need to be confident that the process of getting to a vaccine is not being politically manipulated.”

“And, right now, we’re not getting a whole lot of reason to believe that,” she said, adding, “And so, I think Americans are obviously eagerly awaiting a vaccine, they need to feel confident that the process is not being politically manipulated and they also need to feel confident that the president is going to be able to … get a vaccine equitably and quickly to people all across the country.”