In “Power Grab”, Secretary of Health Eden Hazard claims authority over the FDA

A surprising declaration of authority, Department of Health and Human Services Secretary Alex M. Azar II has banned U.S. health agencies, including the Food and Drug Administration, from signing new rules on U.S. food, medicine and medical devices this week. did. Other products including vaccines.

From now on, Hazard wrote in a September 15 memorandum obtained by the New York Times that such authority was “trusted to the secretary.” The bulletin board was sent to the head of operations and staff within HHS

It is unclear if or how the memo will change the review and approval process Coronavirus vaccine, Three of them are in ongoing clinical trials in the United States. Under pressure from the president, political appointers Take a series of steps To interfere with standard scientific and regulatory processes in health institutions over the past few months. For example, highly criticized guidelines for testing coronavirus Not written by CDC scientists, And their objections were posted on the agency’s public website. It was Reversal On Friday.

External observers were surprised by the new memo and worried that it could contribute to public awareness of political interference in science-based regulatory decisions. Dr. Mark McClellan, who previously headed the FDA and now runs the Duke University Health Policy Center, praised the agency’s efforts in vaccine development, but said policy changes were delayed.

“We are in the midst of a pandemic when trust in public health is needed more than ever,” he said. “Therefore, when the FDA is doing such an important task, we don’t know what the changes in management regarding the FDA will bring.”

Dr. Peter Lurie, chairman of the Center for Public Interest Sciences and former vice chairman of the FDA, called the new policy “capturing power.”

Many regulations issued by the Federal Health Agency are under the umbrella of HHS and are signed by lawyers or heads of institutions, including the FDA. New memos require the secretary to be signed. ..

“It’s completely unnecessary and will introduce an element of inefficiency in government operations that is likely to make things worse,” he said.

Hazard’s chief executive, Brian Harrison, said the new policy was a “housework issue” that wasn’t specifically targeted at any agency. He said it had nothing to do with how the authorities treated the coronavirus vaccine.

“This was just a push of the reset button,” Harrison said. “This is good governance and should have no operational impact.”

HHS has long considered the rule-making process to be ready for revision. Dr. Scott Gottlieb, a former member of Dr. Hahn, Almost 2 years as the person in charge of the agency Dodge new policies that have been a conservative agenda for many years. According to a former FDA official, the day before he left the company, he added his own signature to the major cigarettes and vaping rules signed by his subordinate employees to keep the rules on the books.

The new memo covers the entire health sector, which has 27 institutions and offices, but the FDA has far more regulations than other institutions. Except for Centers for Medicare & Medicaid Services, which already require a secretary’s signature on the new rule.

FDA officials who were not allowed to talk about the records said authorities were still deciphering what Mr. Hazard’s notes meant for their work.

However, former FDA and HHS officials speculated that the purpose was to remove the authority to enact rules from FDA member Dr. Steven Hahn and signal President Trump. election.

“We can only conclude that this memorandum shows a lack of trust in FDA members and other HHS leaders,” said William B, a former adviser to HHS who was a partner of the law firm Zuckerman Spaeder. . Schultz said.