Secretary of Health and Human Services Alex M. In a spectacular declaration of Azar II’s authority, this week, the country’s health agencies, including the Food and Drug Administration, were banned from signing any new rules on the nation’s food, drugs, medical devices and other products, including vaccines.
New Oliver Contraras for the New York Times
In the memo, Mr Azar wrote that the power to issue or sign new rules was “reserved to the Secretary.”
Going forward, Mr. Azar wrote in a memorandum obtained by the New York Times on September 15 that such power was “reserved for the Secretary.” Bulletin HHS Was sent to the heads of the operating and staff department in
It is unclear how Memo will change the coronavirus vaccine screening and approval process, three of which are in advanced clinical trials in the United States. Political appointments under pressure from the president have taken steps in the last few months to interfere with standard scientific and regulatory processes in health agencies. For example, many criticized guidelines for testing for coronavirus were not written by CDC scientists, and their objections were posted on the agency’s public website. It was overturned on Friday.
Outside observers were appalled by the new memo and worried that it could contribute to the public perception of political interference in science-based regulatory decisions. Dr. Mark McClain, formerly head of the FDA and now managing Duke University’s Health Policy Center, praised the agency’s work on vaccine development, but said the policy change was a bad time.
“We live in the midst of an epidemic, when trust in the public health agency is more important than ever,” he said. “So, I’m not sure what to do with the management change in terms of the FDA when they do such a crucial task.”
Interest. Peter Luri, president of the Center for Public Interest Science and a former FDA associate commissioner, called the new policy a “power grab.”
Many of the regulations issued by federal health agencies are HHS. The new memo has to be signed by lawyers under the umbrella of or by the head of agencies including the FDA. The regulatory process could be delayed, Luri said. .
“It will introduce an element of inefficiency in government operations that is completely unnecessary and likely to like things.”
Mr Azar’s chief of staff, Brian Harris, called the new policy a “housekeeping matter”, not specifically for any agency. He said how the agency dealt with the coronavirus vaccine would have no effect.
“This was just pressing the reset button,” Mr. Harris said. “This is good governance and should have no operational impact.”
The HHSA has long considered the rule-making process as appropriate for repetition. Dr. Scott Gottlieb, who, before appointing Dr. Hahn as commissioner, spent almost several years as the head of the agency defending the new policy, which has been on a tenacious agenda for many years. According to a senior FDA official, the day before he left office, he added his signature to a major tobacco and evaporation rule, signed by a lower-ranking employee to ensure the rules were on the books, a senior FDA official said. .
Although the new memo covers the entire health department, with 27 agencies and office fees, the FDA lays down more rules than other agencies, except for Medicare and Medicaid services centers, which require the Secretary’s signature on the new rules.
An FDA official, who was not allowed to speak on the record, said the agency was still deciding what Mr. Azar’s memo would mean for his work.
But former senior officials with the FDA and HHS speculated that the purpose was to remove FDA Commissioner Dr. Stephen Hehn from the rule-making power and send a signal to President Trump that no surprises would come from the agency in a week. Election.
“I can only conclude that this memorandum demonstrates a lack of trust between the FDA commissioner and other HHS leaders,” said William B., a former general adviser to the HHS and partner at the law firm Zuckerman Spider.
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