Dr. Scott Gottlieb, the former head of the Food and Drug Administration (FDA), criticized a new policy by the Department of Health and Human Services (HHS) giving only the secretary the authority to sign off on new rules, saying the timing "makes no sense" and risks creating the perception that the agency he helmed is being bullied.
"I think that this is the wrong move at the wrong time," Gottlieb said Sunday on "Face the Nation. "At a time that they should be reaffirming the independence and the integrity of these agency, to do this now just makes no sense."
The New York Times reported on Saturday that Health and Human Services Secretary Alex Azar signed a new order prohibiting the nation's top health agencies from signing any new rules, including those affecting medical products and vaccines.
According to the September 15 memo, which CBS News obtained, such power "is reserved to the Secretary" going forward.
"Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded," the memo signed by Azar and sent to the heads of operating and staff divisions states.
Gottlieb said Sunday he opposed the policy change while working for the Trump administration. Just before leaving the FDA, Gottlieb himself recodified an Obama-era tobacco regulation because he was concerned that HHS, which oversees the FDA, would centralize the rule-making authority and question its legitimacy.
"The timing of this is just really poor right now because it's going to distract the agency and frankly create headlines that could lead to the perception that the agency is being bullied," he said.
The revelations about the new memo are likely to stoke concerns about the independence of health agencies like the FDA, which will oversee approval of a coronavirus vaccine, and the Centers for Disease Control and Prevention (CDC), also a division of HHS. In several instances, the actions of political appointees have elevated fears of political interference in the science-based decision-making process.
Gottlieb has repeatedly defended the scientists at the FDA and said they will make decisions, including on approval of a coronavirus vaccine, based solely on the science. But he warned the policy change approved by Azar creates "an implication or at least a specter that the independence of that agency is being eroded or influenced."
"It's a distraction to FDA at a time when they should be focused on the COVID response," he said. "The timing of this makes no sense. I don't believe in the underlying basis of what they did."
Gottlieb added that the new policy "sends exactly the wrong message at a time that we want to reaffirm the independence of these agencies."
While the number of confirmed coronavirus cases continues to rise and the death toll in the U.S. is nearing 200,000, President Trump has shifted his focus to development and distribution of a vaccine, and has repeatedly claimed one would be ready by the election. Phase 3 trials are underway for several coronavirus vaccine candidates.
But Mr. Trump's claims about a vaccine put him on a crash course last week with CDC Director Dr. Robert Redfield, who told the Senate a coronavirus vaccine would not be widely available until mid-2021.
Mr. Trump claimed Redfield "made a mistake" and was "confused."
But Gottlieb echoed Redfield's timeline and said he doesn't believe a vaccine will be licensed for general use until the second or third quarter of 2021.
There could, however, be a vaccine that receives an emergency use authorization from the FDA that is administered to select groups, he said.
First published on September 20, 2020 / 12:16 PM
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