• by Steve Ellwanger , December 27, 2022

 The head of the U.S. Food and Drug Administration says the agency will begin to take steps in January toward addressing widespread dysfunction within its Human Foods Program (HFP), as detailed by an outside review completed this month.

Conducted by the non-profit Reagan-Udall Foundation and prompted in part by this year’s infant formula shortage, the review found deficiencies in HFP leadership, cooperation among workers, operating transparency and technology.

The HFP encompasses the Office of Food Policy and Response, the Center for Food Safety and Applied Nutrition and certain activities of the Office of Regulatory Affairs.

Foremost among Reagan-Udall’s 51-page report is the conclusion that the FDA has yet to execute a “paradigm shift” following the 2011 passage of the FDA Food Safety Modernization Act (FSMA).

The FSMA was intended to “move food safety towards prevention rather than reaction,” the report notes.

Reagan-Udall cited data from the Center for Disease Control and Prevention indicating that an estimated 46 million Americans are sickened by foodborne illness each year—with 128,000 hospitalized and 3,000 dying.

“A significant proportion of foodborne illnesses are attributed to FDA-regulated products: in 2019, produce was implicated in 46% of foodborne illness outbreaks. This is not only a considerable food safety concern, but it could also work against recommendations to increase consumption of fruits and vegetables.”

FDA leadership needs to develop a “proactive, prevention-driven strategy,” the report advised.

“Leaders must also make their support clear to staff as they make decisions. Each staff member should operate in a culture with a preference for action, where they are empowered to respond quickly to challenges as they arise.”

Regarding transparency, Reagan-Udall concluded that the HFP doesn’t adequately engage with the industry it regulates—which precludes “having a constructive dialogue that could yield better and more informed decisions.”

Some of the HFP’s reticence derives from an aversion to risk, according to Reagan-Udall.

“For example, FDA’s Human Foods Program has at times appeared to be reluctant to take enforcement action unless they feel that, with certainty, the action could withstand legal challenges.

“This risk-averse culture also emerges in internal rules of governance intended to protect against possible negative outcomes—a not-surprising development in a program subject to significant external criticism.”

On Dec. 6, FDA Commissioner Dr. Robert Califf—who requested the Reagan-Udall probe—said the findings will “help to inform a new vision” for the HFP.

While the Reagan-Udall report does not provide specifics about the FDA’s response to the formula shortage, an internal investigation by the head of the agency’s Center for Veterinary Medicine (CVM)—also ordered by Califf—noted a “confluence of systemic vulnerabilities.”

The crisis began after the FDA received information about four cases of illness or deaths in infants who consumed powdered infant formula manufactured by Abbott Nutrition in Michigan.

That prompted an FDA investigation revealing unsanitary conditions at the plant followed by a voluntary recall by Abbott.

One issue was that the formula was contaminated by cronobacter sakazakii—requiring the FDA to address “a relatively poorly understood pathogen,” according to the investigation led by CVM director Dr. Steven Solomon.

In addition, “outdated technology” and a lack of coordination of tech systems made it difficult for the FDA to process information from internal and external stakeholders—including whistleblowers who tried to report conditions at the Abbott facility.

“A complaint sent via email and other delivery systems by a confidential informant to agency leaders at FDA’s White Oak campus was not delivered to the addresses,” Solomon wrote.