January 27, 2023

The FDA has hired the Reagan-Udall Foundation, along with unnamed experts, to conduct a review of key food and tobacco offices. The foundation, an independent group charged by Congress with advising the FDA and helping the agency improve its regulatory and oversight processes, will review the resources, procedures and organization of the two offices, as well as portions of the Office of Regulatory Affairs, the division that conducts inspections.

While the foundation has no statutory authority over the FDA, it has maintained a close relationship with senior agency officials and helped shape the commissioners’ priorities.

“I’d like to know more details about how the foundation will ensure their process is independent, especially given that the foundation’s purpose is to support the FDA’s mission,” said Brian Ronholm, former deputy undersecretary of food safety. at Agriculture. Department.

Part of the review will cover the agency’s Human Foods program, with a focus on the Office of Food Policy and Response, the Center for Food Safety and Applied Nutrition. “Fundamental questions about structure, function, funding and leadership need to be addressed,” Califf said, noting that the offices were particularly stressed due to the pandemic.

In addition, the review will cover the Center for Tobacco Products, which has been tasked with regulating tobacco products for the past 13 years. “Challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of new products that could potentially have significant public health implications,” Califf said.

Lawmakers on both sides have become increasingly critical of the agency’s response to the baby food shortage and Califf’s own response. Califf pointed in May to “systemic issues at the FDA” fueling response to baby food, encouraging Senate HELP chairman Patty Murray (D-Wash.) to demand a plan to fix those problems.

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“I continue to push to see that plan,” she said at a hearing in May. “I asked for this plan weeks ago and I won’t stop pushing until I see it. This is life or death, and Dr. Califf, it just shouldn’t have lasted this long.”

Califf and top FDA officials have also come under pressure from outside groups in private meetings in recent months, especially in recent weeks, urging them to appoint a Deputy Food Commissioner and push for bigger reforms in food programs. .

In addition, members of Congress have expressed dissatisfaction with the agency’s regulation of electronic cigarettes. Senate Majority Whip Dick Durbin (D-Ill.) has even gone so far as to demand Califf’s resignation over the fact that certain e-cigarette products remain on the market while the agency reviews their marketing uses. The FDA-imposed deadline to complete the e-cigarette marketing applications was September 9, 2021.

Last week, House Appropriations Chair Rosa DeLauro (D-Conn.) and Durbin have reintroduced legislation that would create a new food safety agency under HHS — splitting up food and drug regulators.

The announcement of the external review came as a surprise to former FDA officials. “It’s news to me,” said Mitch Zeller, former head of the Center for Tobacco Products. “I have no information and have no idea what caused it.”

“It is likely to prejudge the surveillance and [the Office of the Inspector General]and to give him the coverage to make organizational changes,” a former high-level FDA official told POLITICO, who was given anonymity to speak candidly about the review.

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Another person with direct knowledge of the matter said the Office of Regulatory Affairs has also been dealing with its fair share of the turmoil. The person said a lot of people have recently left the office. Some have retired, while others have chosen to leave the agency due to dissatisfaction with the inspection work, including organizational problems and insufficient pay.

“In light of certain events that have occurred in recent months, the Commissioner has determined that these areas deserve a further review of certain processes, procedures and resources, as well as a look at the current leadership structure,” an FDA spokesperson said via e-mail. e-mail to POLITICS.

“This has been a very difficult time for the agency,” said Ellen Sigal, chair of the board of directors for the Reagan-Udall Foundation, referring to Covid-19 and the FDA’s efforts to rapidly review new vaccines and treatments. Sigal said Califf has approached the foundation for the assessment.

“When Rob [Califf] came in, there were things going on that he really wasn’t a part of, but clearly inherited,” she said.

What’s next: In addition to this review, the Inspector General of the Department of Health and Human Services does an investigation into how the agency is granting accelerated approvals for certain drugs, fueled in part by the agency’s decision last year to approve a controversial Alzheimer’s drug from Biogen.

The Reagan-Udall Foundation will complete its first evaluation in 60 days. “It may take some time to implement the recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner,” Califf said.

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Erin Banco, Meredith Lee, David Lim and Sarah Owermohle contributed to this report.