HHS Secretary Alex Azar sent out a memorandum Sept. 15 that bans the country's health agencies, including the FDA, from signing any new rules, The New York Times reported.
In the memo, obtained by the Times, he wrote that the power to sign new rules "is reserved to the secretary," so any new rules made by federal health agencies must be signed by Mr. Azar.
Outside experts are concerned the memo may contribute to public fear of political influence in approving a COVID-19 vaccine, according to the Times.
"We’re in the midst of a pandemic, when trust in the public health agency is needed more than ever. So, I’m not sure what is to be gained with a management change with respect to FDA when they are doing such critical work," Mark McClellan, MD, PhD, who formerly headed the FDA and now runs Duke University’s health policy center, told the Times.
Peter Lurie, MD, president of the Center for Science in the Public Interest, told the Times the change could lead to delays in the regulatory process for medicines, medical devices, vaccines and other products.
Brian Harrison, chief of staff for Mr. Azar, said the new policy was simply "housekeeping" and wasn't aimed at a particular agency. He said it wouldn't affect how the agency deals with COVID-19 vaccines, according to the Times.
"This was simply pushing a reset button," Mr. Harrison said. "This is good governance and should have no operational impact."
An anonymous FDA official told the Times the agency is still figuring out how the memo affects its operations. Former senior FDA and HHS officials told the Times they believe the change was made to take away rule-making power from Stephen Hahn, MD, the FDA commissioner, and to signal to President Donald Trump that no surprises would come from the agency before the presidential election.
Read the full article here.
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