FDA Announces External Review of Food and Tobacco Safety Authority

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

While the foundation has no legal authority over the FDA, it maintains close relationships with senior agency officials and helps shape commissioner priorities.

“I would be happy to learn more about how the foundation will ensure the independence of their process, especially given that the purpose of the foundation is to support the mission of the FDA,” said Brian Ronholm, former Deputy Undersecretary for Food Safety at the Department of Agriculture. .

Part of the review will focus on the Agency’s Human Nutrition program with a focus on the Food Policy and Response Office, Center for Food Safety and Applied Nutrition. “Fundamental questions about structure, function, funding and leadership need to be addressed,” Kaliff said, noting that offices have been particularly stressed as a result of the pandemic.

In addition, the audit will affect the Center for Tobacco Products, which has been entrusted with the regulation of tobacco products for the past 13 years. “Challenge lies ahead as we determine how the agency will address complex policy issues and determine enforcement efforts for a growing number of new products with the potential to have major public health implications,” Kaliff said.

Legislators from both parties are increasingly critical of the agency’s response to the lack of infant formula and Califf’s own response. Kaliff in May pointed to “systemic issues at the FDA” fueling the backlash against infant formula, prompting HELP Senate chairman Patty Murray (Y-Your.) Demand a plan for solving these problems.

“I will insist on seeing this plan,” she said during a hearing in May. “I asked for this plan a few weeks ago and won’t stop pushing until I see it. It’s life or death and Dr. Kaliff, it just shouldn’t have taken so long.”

California and senior FDA officials have also come under pressure from outside groups in private meetings in recent months, especially in the past few weeks, urging them to appoint a deputy food commissioner and push for broader reforms in food programs.

In addition, members of Congress expressed dissatisfaction with the agency’s regulation of e-cigarettes. Majority Whip in the Senate Dick Durbin (D-Ill.) Went so far as to call for Kaliff to resign due to the fact that some e-cigarette products remain on the market while the agency reviews their marketing applications. The deadline set by the FDA to complete e-cigarette marketing applications was September. 9, 2021.

Last week the President of the House of Representatives Rosa DeLauro (D-Conn.) And Durbin reintroduced legislation that would create a new food-safety agency housed under the HHS-breaking 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 head of the Tobacco Products Center. “I have no data and I have no idea what triggered this.”

“Probably to get ahead of supervision and [the Office of the Inspector General]and give him cover to make organizational changes,” said a former senior FDA POLITICO official, who was granted anonymity to speak candidly about the review.

Another person with direct knowledge of the matter said that the Office of Regulatory Affairs also faced a lot of turmoil. The person said that a lot of people had recently left the office. Some retired, while others decided to leave the agency due to dissatisfaction with the inspection work, including organizational problems and insufficient pay.

“In light of certain developments in recent months, the Commissioner has determined that these areas merit a more thorough assessment of certain processes, procedures, and resources, as well as an examination of the current leadership structure,” an FDA spokesperson said via email. POLITICS.

“This has been a very difficult time for the agency,” said Ellen Segal, chairman of the board of directors of the Reagan-Udallah Foundation, citing Covid-19 and the FDA’s efforts to review new vaccines and treatments as soon as possible. Segal said Kaliff had approached the foundation for a review.

“When Rob [Califf] came, there were things that he really did not participate in, but clearly inherited, ”she said.

What’s next: In addition to this review, Inspector General of the Department of Health and Human Services is investigating in the way the agency grants fast-track approvals for certain drugs, prompted in part by the agency’s decision last year to approve Biogen’s controversial Alzheimer’s drug.

The Reagan-Udall Foundation will complete its initial evaluation in 60 days. “Any recommended changes may take some time to implement, but I will try to address them in a timely manner and bring them to the attention of the public,” Kaliff said.

Erin Banquo, Meredith Lee, David Lim and Sarah Overmole contributed to this report.