|
 Dr. Stephen Hahn said he was completely confident that FDA workers
were focused solely on the interests of the American people during
the coronavirus pandemic.
Without evidence, Trump on Saturday accused members of the so-called
“deep state” working within the FDA of complicating efforts to test
COVID-19 vaccines in order to delay results until after the Nov. 3
presidential election.
"I have not seen anything that I would consider to be 'deep state'
at the FDA," Hahn told Reuters in an interview. Trump's use of the
term "deep state" appears to refer to long-serving government
employees he believes are determined to undermine his agenda.
Hahn said he had a solid relationship with Trump, a Republican whose
re-election chances in November have been dampened by public
discontent over his handling of the coronavirus pandemic.
"I enjoy a very good relationship with the president and I have
discussed our decisions with him, and I feel very comfortable and
continue to feel comfortable with that relationship," Hahn said.
Trump's tweet, which tagged the commissioner, said: "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."
Trump has talked up the possibility of a coronavirus vaccine coming
soon and the White House is eager to have positive news on the
development of one before the election.
Trump and his advisers are also eager to show that his
administration is moving quickly to find both a vaccine and
treatments for the disease, even as scientists have warned that time
is required for testing.
Hahn said the FDA's recent authorization of a coronavirus treatment
using blood plasma from recovered patients was not made because of
political pressure and emphasized that on his watch any decision on
a vaccine would be based on science.
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Peter Marks, director of the FDA's Center for Biologics Evaluation
and Research and a regulator who will help decide the fate of
coronavirus vaccine candidates, has said he would resign if the
Trump administration approved a vaccine before it was shown to be
safe and effective.
Hahn said he had spoken to Marks and respected his judgment.
"I'm not going to ... speculate about what I would do," in such a
situation, he said. "But what I can tell you is that I will not
participate in a decision at FDA that's made upon anything other
than data and science. That I can assure you," he said.
Trump hailed the FDA "emergency use authorization" for convalescent
plasma on Sunday, shortly before the beginning of this week's
Republican National Convention.
Hahn said the decision was made by the agency's scientists and that
he concurred with it after looking at the data.
Hahn acknowledged that Dr. Anthony Fauci, the top U.S. infectious
diseases expert, and Dr. Francis Collins of the National Institutes
of Health had expressed concern that the data did not justify the
authorization.
"Previously when we did have a discussion with them, they were
concerned that the data might not be robust enough. That's why we
did the validation ... to provide further confirmation," Hahn said.
Fauci told Reuters on Monday that premature approval of a COVID-19
vaccine could undermine trials of other vaccine candidates.
Hahn said there was medical urgency to develop a vaccine.
"But we want to be as sure as we possibly can regarding safety and
efficacy," he said.
(Reporting by Jeff Mason; Editing by Peter Henderson and Tom Hogue)
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