In an extraordinary statement of authority, Alex M. Azar II, the secretary of health and human services, this week banned the nation’s health agencies, including the Food and Drug Administration, from signing new rules regarding foods, medicines and medical devices. of the nation. and other products, including vaccines.
Going forward, Mr. Azar wrote in a September 15 memorandum obtained by the New York Times, that power “is reserved for the Secretary.” The bulletin was sent to the heads of the operational and personnel divisions within H.H.S.
It is unclear whether or how the reminder would change the screening and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Political appointees, under pressure from the president, have taken a number of measures in recent months to interfere with standard scientific and regulatory processes at health agencies. For example, a much-criticized guideline on testing for coronavirus was not written by C.D.C. scientists and was posted on the agency’s public website for their objections. Friday was canceled.
Outside observers were alarmed by the new memo and concerned that it might contribute to a public perception of political interference in science-based regulatory decisions. Dr. Mark McClellan, who previously headed the F.D.A. and now runs Duke University’s health policy center, he praised the agency’s work on vaccine development but said the policy change was inappropriate.
“We are in the midst of a pandemic, when trust in the public health agency is needed more than ever,” he said. “So, I’m not sure what a takeover can be gained from F.D.A. when they are doing such critical work.”
Dr. Peter Lurie, president of the Center for Science in the Public Interest and former associate commissioner of the F.D.A., called the new policy “a power grab.”
Many rules issued by federal health agencies are signed by lawyers or the heads of agencies, including the F.D.A., under the auspices of H.H.S. The new memo requires the secretary to sign them, which, according to Dr Lurie, could lead to delays in the regulatory process.
“It will introduce an element of inefficiency into government operations that is completely unnecessary and is likely to chew things up,” he said.
Brian Harrison, Mr. Azar’s chief of staff, described the new policy as “a matter of cleanliness,” addressed to no particular agency. He said it would have no bearing on how the agency handled the coronavirus vaccines.
“This was simply pressing a reset button,” said Mr. Harrison. “This is good governance and shouldn’t have any operational impact.”
H.H.S. has long considered the rules-making process ripe for review. Dr Scott Gottlieb, who preceded Dr Hahn as commissioner, spent much of his nearly two years heading the agency defending himself against the new policy, which has been on the Conservative agenda for many years. The day before leaving office, he added his signature to a key tobacco and vaping rule that had been signed by a lower-ranking employee to ensure the rule would stay on the books, according to a former F.D.A. official.
Although the new memo covers the entire health department, which has 27 agencies and offices, the F.D.A. proposes far more regulations than other agencies, with the exception of the Centers for Medicare and Medicaid Services, which already require the secretary to sign the new rules.
A F.D.A. official, who was not allowed to speak on the minutes, said the agency was still deciphering what Mr. Azar’s memo would mean for their work.
But former senior officials of the F.D.A. and H.H.S. he speculated that the intent was to remove the regulatory power from Dr. Stephen Hahn, the FDA commissioner, and to send a signal to President Trump that no surprises would come from the agency in the weeks before the election.
“I can only conclude that this memorandum shows a lack of trust in the F.D.A. commissioner and other S.A.S. leader, “said William B. Schultz, former general counsel of H.H.S. and a partner of Zuckerman Spaeder, a law firm.