FDA Announces External Review of Food and Tobacco Regulatory Offices

The FDA hired the Reagan-Udall Foundation, along with anonymous experts, to conduct a review of key food and tobacco bureaus. The foundation, an independent group appointed by Congress to advise the FDA and help the agency improve its regulatory and oversight processes, will assess the resources, procedures, and organization of both offices, as well as parts of the Office of Regulatory Affairs, the division that performs inspections.

Although the foundation has no statutory authority over the FDA, it maintains close relationships with senior agency officials and has helped shape the commissioners’ priorities.

“I’ll be eager to hear more about how the foundation will ensure the independence of its process, especially since the foundation’s goal is to support the mission of the FDA,” said Brian Ronholm, former Assistant Undersecretary for Food Safety in Agriculture. Department.

Part of the review will focus on 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 have been particularly strained in the wake of the pandemic.

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

Lawmakers on both sides have increasingly criticized the agency’s response to the infant formula shortage and Califf’s own reaction. Califf in May pointed to “systemic issues at the FDA” fueling formula response, prompting Senate Speaker HELP Patty Murray (D-Wash.) to require a plan to fix these issues.

“I’m going to keep pushing to see this plan,” she told a hearing in May. “I asked for this plan weeks ago, and I won’t stop pushing until I see it. It’s life and death, and Dr. Califf, it just wouldn’t have must have taken so long.

Califf and top FDA officials have also come under pressure from outside groups in private meetings in recent months, particularly in recent weeks, urging them to appoint a deputy food commissioner and enact reforms. most important food programs.

Additionally, members of Congress have expressed dissatisfaction with the agency’s regulations on e-cigarettes. Senate Majority Whip Dick Durbin (D-Ill.) went so far as to seek Califf’s resignation over the fact that certain e-cigarette products remain on the market while the agency reviews their marketing applications. The court-ordered deadline for the FDA to finalize e-cigarette marketing applications was September 9, 2021.

Last week, House Appropriations Chair Rosa DeLauro (D-Conn.) And Durbin reintroduced legislation that would create a new HHS-housed food safety agency — breaking up the food and drug regulatory agencies.

The announcement of the external review came as a surprise to former FDA officials. “This is news to me,” said Mitch Zeller, former director of the Center for Tobacco Products. “I have no information and I have no idea what triggered it.”

“It’s probably to get ahead of the surveillance and [the Office of the Inspector General]and to give it the cover to make organizational changes,” a former senior FDA official told POLITICO, who was granted anonymity to speak candidly about the review.

Another person with direct knowledge of the matter said the Office of Regulatory Affairs has also faced its fair share of turmoil. The person said a large number of people had 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 remuneration.

“In light of certain events over the past few months, the commissioner has determined that these areas warrant further evaluation of certain processes, procedures and resources, as well as a review of the current leadership structure,” a spokesperson said. word of the FDA by e-mail to POLICY.

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

“When Rob [Califf] happened, things were happening that he really had no part in but clearly inherited,” she said.

And after: In addition to this review, the Inspector General of the Department of Health and Social Services investigate on how the agency grants fast-track approval for certain drugs, which was triggered 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 initial 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.

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


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