Gottlieb defends FDA from Trump allegations of political influence

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Washington — Former Food and Drug Administration chief Dr. Scott Gottlieb, who helmed the agency for two years under President Trump, defended the agency Sunday after the president suggested it was part of a scheme orchestrated by the so-called “deep state” to delay trials for a coronavirus vaccine and therapeutics, with the goal of hurting his reelection prospects.

“I firmly reject the idea that they would slow-walk anything or accelerate anything for that matter, based on any kind of political consideration and any consideration other than what’s best for the public health and a real sense of mission to patients,” Gottlieb told “Face the Nation.”

Gottlieb was responding to a tweet from Mr. Trump on Saturday, in which he wrote, “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.”

But Gottlieb stressed that in his years working at the Food and Drug Administration, which included two stints under former President George W. Bush and a third under Mr. Trump, “when it comes to regulatory decision-making in that agency, it’s a foundational truth that will guide that agency as science and a deeply seated sense of public health mission that permeates that agency.”

Gottlieb said he believes the president’s attack on the FDA is related to convalescent plasma, as the agency put on hold an emergency use authorization due to concerns from the National Institutes of Health. But the former FDA commissioner said there are reasons officials have questions about its use as a treatment.

“The trial that that’s going to be based on, 70,000 patients, wasn’t a very rigorously done trial. It was an open-label study where everyone got treated, so it’s hard to draw conclusions,” he said. “I believe plasma is probably beneficial. It’s probably weakly beneficial in the setting of this treatment. But I think some people wanted to see more rigorous data to ground that decision. And I think that’s part of what is going on here with respect to that tweet and questions about the FDA decision-making.” 

Gottlieb said he believes the FDA “is on firm ground taking their time to try to closely evaluate that information.”

Gottlieb also defended the speed with which private companies have developed a coronavirus vaccine, noting that vaccine trials have enrolled patients “very fast.” Gottlieb sits on the board of one of those companies, Pfizer.

“To say that these products aren’t moving at a really historic pace I think is wrong,” he said.

While the coronavirus crisis continues across the U.S., where there have been more than 5.6 million confirmed cases, Gottlieb said there are “some signs of good news,” as new infections and deaths have begun to decline. Hospitalizations, too, have fallen below 40,000.

But he warned there could be a third iteration of the epidemic.

“It could be more diffuse spread across a broader section of the Midwest and the West, because cases are building in those parts of the country. And that’s what’s concerning people right now,” he said.

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