The FDA has hired the Reagan-Udall Foundation, along with unnamed experts, to conduct a review of key food and tobacco agencies. The Foundation, an independent group mandated by Congress to advise the FDA and help the agency improve its regulatory and oversight processes, will manage the resources, processes and organization of the two offices and portions of the Office of Regulatory Affairs, the Department that performs assessment of controls.
Although the foundation has no statutory authority over the FDA, it has enjoyed close relationships with senior agency officials and helped shape commissioners’ priorities.
“I’m excited to learn more details about how the Foundation will ensure its process is independent, especially considering the purpose of the Foundation is to support the FDA’s mission,” said Brian Ronholm, former deputy Secretary of State for Food Safety at the Agriculture Department.
Part of the review will relate to 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 must be clarified,” said Califf, pointing out that the offices were particularly burdened by the pandemic.
In addition, the review involves 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 address complex policy issues and establish enforcement actions for an increasing number of novel products that could have potentially significant public health implications,” Califf said.
Lawmakers from both parties have increasingly criticized the agency’s response to the baby formula shortage and Califf’s own response. Califf in May pointed to “systemic issues at the FDA” that fueled the baby formula response, prompting the Senate HELP chair Patty Murray (D-Wash.) calling for a plan to address these issues.
“I will continue to push to see this plan,” she said during a hearing in May. “I asked about this plan weeks ago and I won’t stop pushing it until I see it. This is a matter of life or death, and Dr. Califf, it just shouldn’t have taken this long.”
Califf and senior FDA officials have also received pressure from outside groups at private meetings in recent months, particularly in recent weeks, urging them to appoint an assistant food commissioner and enact major food program reforms.
In addition, members of Congress have expressed dissatisfaction with the agency’s regulation of electronic cigarettes. Senate Majority Whip Dick Durbin (D-Ill.) has gone so far as to call for Califf’s resignation over the fact that certain e-cigarette products will remain on the market while the agency reviews its marketing applications. The FDA’s court-ordered deadline for completing marketing applications for e-cigarettes was September 9, 2021.
Last week, house allocation chairman Rose DeLauro (D-Conn.) and Durbin reintroduced legislation that would create a new food safety agency housed under HHS — disbanding 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 no idea what triggered it.”
“It’s probably to forestall oversight and [the Office of the Inspector General]and to give it the cover to make organizational changes,” a former senior FDA official, who was granted anonymity to speak candidly about the review, told POLITICO.
Another person with direct knowledge of the matter said the Office of Regulatory Affairs has also faced its fair share of turbulence. The person said that a lot of people had recently left the office. Some have retired while others have left the agency due to dissatisfaction with the inspection work, including organizational problems and insufficient pay.
“In light of certain events that have occurred over the past several months, the Commissioner has determined that these areas merit a closer examination of certain processes, procedures and resources, as well as a look at the current governance structure,” an FDA spokesman said via email to POLITICS.
“This has been a very difficult time for the agency,” said Ellen Sigal, chair of the board of directors of the Reagan-Udall Foundation, citing Covid-19 and the FDA’s efforts to quickly review new vaccines and treatments. Sigal said Califf reached out to the foundation for the review.
“As Rob [Califf] came, there were things going on that he really had no part in, but which he clearly inherited,” she said.
What’s next: In addition to this review, Inspector General of the Department of Health and Human Services conducts an investigation how the agency is granting accelerated approval to certain drugs, prompted 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 assessment in 60 days. “Recommended changes may take time to implement, but I am committed to addressing 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.