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President Donald Trump called out the Food and Drug Administration for politically motivated delays in producing coronavirus vaccine and drug trials.
The president tweeted a message tagging FDA Commissioner Dr. Stephen Hahn and accusing the “deep state, or whoever” at the agency for impeding vaccine development efforts in order to “delay the answer” until after Election Day.
“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 tweeted Saturday.
“Obviously, they are hoping to delay the answer until after November 3rd,” he added. “Must focus on speed, and saving lives!”
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. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
Trump’s criticism comes after his administration acted this week to block the FDA from regulating lab-developed tests, essentially allowing some laboratories — such as Quest Diagnostics, LabCorp — to distribute them without initially submitting documentation for a review process.
“The Trump Administration is committed to combating COVID-19, to ensuring that the American people are protected against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts,” the US Department of Health and Human Services said in an announcement this week.
FDA clearance, approval or emergency use authorizations can still be sought by the labs for their tests but they are no longer required to do so, thereby speeding up the process.
“Those opting to use [Laboratory Developed Tests] in their laboratories without FDA premarket review or authorization may do so with the understanding that they would not be eligible for PREP Act coverage absent approval, clearance or authorization and would remain subject to regulation by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988,” the announcement said.
Some critics expressed concern over the change, such as the head of the bioethics division at NYU Langone Health in New York who told CNN “there is kind of a bureaucratic fight between HHS and FDA.”
Art Caplan expressed his concern about “what that means for the accuracy of these lab tests.”
“Basically, these are things that are done in individual labs — almost like boutique testing — and then you have a worry that they’re not going to be very accurate or that people will cut corners knowing that no one is looking over their shoulder to check their test,” Caplan said. “While testing is great, accurate testing is greater — it’s better.”
The director of the FDA’s Center for Biologics Evaluation and Research expressed that a premature release of a COVID-19 vaccine would cause him to resign.
“I could not stand by and see something that was unsafe or ineffective that was being put through,” Peter Marks told Reuters though he admitted that he has not faced any political pressure.
But the HHS argued that the FDA does not have the authority to regulate lab-developed tests, including for COVID-19, regardless of the situation. It is also unclear if there will be enough people enrolled in vaccine trials to provide meaningful data for review by the FDA ahead of the election.
Trump’s concerns about the FDA potentially slowing down research on treatments for the coronavirus could be political, and he took another shot on Twitter at the agency’s decision in June to prohibit the emergency use authorization of the drug hydroxychloroquine for treating Covid-19.
“Many doctors and studies disagree with this!” he tweeted.
Many doctors and studies disagree with this! https://t.co/fpLVJZMvHS
— Donald J. Trump (@realDonaldTrump) August 22, 2020
Despite what his critics said, many Twitter users agreed with the president’s concerns about his own agency slow-walking the process.
— LIBERTY (@AllyGallentine) August 22, 2020
I have stopped questioning Trump’s statements, he’s right almost always.
— Tony Haines (@tony_spp) August 22, 2020
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