In a formidable statement of authority, Alex M. Azar II, the secretary for health and human services, this week prevented the country’s health authorities, including the Food and Drug Administration, from signing new rules for the country’s food, drugs and medical devices, and others Products including vaccines.
In a September 15 memorandum for the New York Times, Mr. Azar wrote that this authority was “reserved for the secretary.” The bulletin was sent to the heads of operations and human resources at HHS
It is unclear whether or how the memo would change the review and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the U.S. Under pressure from the President, political representatives have taken a number of steps in recent months to intervene in the standard scientific and regulatory processes of the health authorities. For example, a much-criticized guideline on testing for the coronavirus was not written by CDC scientists and posted on the agency’s public website about their objections. It was reversed on Friday.
External observers were alarmed by the new memo and feared that it could contribute to public awareness of political interference in scientifically based regulatory decisions. Dr. Mark McClellan, who previously headed the FDA and now heads Duke University’s Health Policy Center, praised the agency’s work on vaccine development but said the policy change was not timely.
“We are in the middle of a pandemic that requires trust in the health department more than ever,” he said. “So I’m not sure what a change in management can achieve with the FDA when they are doing such critical work.”
Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Deputy Commissioner of the FDA, called the new policy a “takeover”.
Many rules issued by federal health officials are signed by attorneys or by the heads of government, including the FDA, under the umbrella of HHS. The new memo requires the secretary to sign it, which 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 likely to mess things up,” he said.
Brian Harrison, Mr Azar’s chief of staff, described the new policy as “a budgetary matter” not addressed to any specific agency. He said it would not affect how the agency handles coronavirus vaccines.
“This was just a reset button,” said Mr. Harrison. “This is good governance and should not have any operational implications.”
HHS has long viewed the rulemaking process as ripe for revision. Dr. Scott Gottlieb, the Dr. Hahn preceded as commissioner spent much of his nearly two years as head of the agency fending off the new policies that have been on the conservative agenda for many years. The day before he left office, he added his own signature to an important tobacco and vaping rule that had been signed by a subordinate to ensure the rule stays on the books, according to a former FDA chief Official.
Although the new memo covers the entire health department with 27 agencies and offices, the FDA sets far more regulations than other agencies, with the exception of the Centers for Medicare & Medicaid Services, which already require the secretary’s signature on new rules.
An FDA official who was not allowed to speak on the file said the agency was still deciphering what Mr Azar’s memo would mean to their work.
However, former senior officials from the FDA and HHS speculated that the intent was to get Dr. Stephen Hahn, the FDA commissioner, to evade rule-making powers and send a signal to President Trump that the agency will in the weeks leading up to the election.
“I can only conclude that this memorandum shows a lack of confidence in the FDA Commissioner and other HHS executives,” said William B. Schultz, former General Counsel at HHS and partner at Zuckerman Spaeder, a law firm.