US President Donald Trump on Saturday accused members of the “deep state” at the Food and Drug Administration, without providing evidence, of working to slow testing of COVID-19 vaccines until after the November presidential election.
In a Twitter post, Trump said the deep state “or whoever” at the FDA was making it very difficult for drug companies to enroll people in clinical trials to test vaccines and therapies for the novel coronavirus.
The comment came after Reuters exclusively reported on Thursday that a top FDA official said he would resign if the Trump administration approved a vaccine before it was shown to be safe and effective.
“Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” Trump wrote, tagging FDA Commissioner Stephen Hahn in the tweet.
House Speaker Nancy Pelosi said it was a “dangerous statement” and that the president was “beyond the pale” for accusing the FDA of playing politics.
The FDA could not immediately be reached for comment.
Drug manufacturers in coordination with the FDA and National Institutes of Health are ramping up production while testing is underway in order to respond as soon as possible with a vaccine for COVID-19, which has killed nearly 800,000 people worldwide.
Trump often uses Twitter to criticize federal agencies, sometimes accusing them of being controlled by the “deep state” in an apparent reference to long-serving staff who, in Trump’s eyes, are determined to undermine his agenda.
His tweet increases the pressure on the FDA after Peter Marks, director of its Center for Biologics Evaluation and Research, last week said on a conference call with government officials, pharmaceutical executives and academics that he would resign if the agency rubber-stamped an unproven vaccine.
Scientists, public health officials and lawmakers are worried that the Trump administration will push the FDA to approve a vaccine in advance of the vote, even if data from clinical trials do not support its widespread use.
Marks, whose division regulates cutting-edge biotech treatments, vaccines and gene therapies, told Reuters he has not faced any political pressure and that the FDA would be guided by science alone. Should that change, he said on Thursday, “I would feel obligated (to resign) because in doing so, I would indicate to the American public that there’s something wrong.”
Pelosi blasts Trump for 'very dangerous' attack on FDA
Meanwhile, House Speaker Nancy Pelosi (D-Calif.) bashed Trump on Saturday after he called on the FDA to expedite the approval of coronavirus treatments, warning that the US president was undermining public safety to help his reelection.
"The FDA has a responsibility to approve drugs, judging on their safety and their efficacy, not by a declaration from the White House about speed and politicizing the FDA," Pelosi said during a rare Saturday press briefing in the Capitol.
"This was a very dangerous statement on the part of the president," she added. "Even for him, it went beyond the pale in terms of how he would jeopardize the health and well-being of the American people."
The FDA must approve drugs or vaccines based on their safety and effectiveness – NOT political pressure from the White House.
The President’s dangerous attempt to inject himself into the scientific decisions of @US_FDA jeopardizes the health & well-being of all Americans. https://t.co/Dt7CBVjX1D— Nancy Pelosi (@SpeakerPelosi) August 22, 2020
The back-and-forth arrives amid a growing controversy over the FDA's role in approving vaccines, tests and other treatments for the fast-spreading coronavirus, which has infected more than 5.6 million people in the United States, 175,000 of them fatally, according to data released by The New York Times.
On Wednesday, the Health and Human Services Department announced that the administration will not require FDA approval of COVID-19 tests developed by private labs — a move that reportedly infuriated some FDA officials.
Pelosi on Saturday defended those internal critics, saying it was galling for Trump to accuse the FDA of playing politics "when he is the one who has tried to inject himself in the scientific decisions of the Food and Drug Administration."
(Source: News agencies)