FDA Commissioner Robert Califf provided additional insight Tuesday on a restructuring of the agency's human foods program that he intends to finalize this fall.
New details provide additional direction on how the Food and Drug Administration would combine the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the Office of Regulatory Affairs (ORA).
The agency said the reorganization plan will include a "newly designed structure, an established budget, and a detailed mapping and crosswalk of staff from the current to new organization," the agency said.
“I cannot stress enough that my vision is focused on a new, agency-wide model where the activities and responsibilities of the regulatory programs and ORA are better synced to improve efficiency and effectiveness with clear decision rights so that everyone knows who has authority," Califf said.
Califf said his search for a new deputy commissioner for human foods is underway. He will look at both external and internal candidates for the new position.
FDA’s explanation of the plan said it will focus the Office of Regulatory Affairs on its core activities of inspections, investigations, laboratory analysis and import operations.
FDA will create a larger executive team for the human foods program that which will include a principal associate commissioner for human foods position, reporting to the deputy commissioner, to “provide strong, effective operational management of the program’s day-to-day operations,” the agency said.
In addition, “a team of executives for the program’s major areas of responsibility will be created to provide the necessary management infrastructure.”
FDA will create an Office of Animal Biotechnology Innovation in the Center for Veterinary Medicine (CVM), which is not part of the new human foods program, to advance the FDA’s ongoing regulation of animal biotechnology signaling they expect to continue to have oversight rather than handing it over to USDA.
“There will be a robust cross collaboration between CVM and the Human Foods Program on agricultural biotechnology innovation,” according to a fact sheet on the organizational changes.
FDA said it will also create a Center for Excellence in Nutrition “to elevate and empower action on nutrition science, policy, and initiatives to reduce diet-related chronic diseases and improve health equity.” An Office of Critical Foods will be included within this center to manage the regulation of infant formula and medical foods, the agency added.
Despite the additional details offered on FDA's changes, Califf came under intensified criticism Tuesday as consumer and food groups said he disregarded structural modifications called for under the Reagan-Udall Foundation report.
The coalition may now look to push action on Capitol Hill to bring about desired change as FDA’s timeline stretches into the fall.
“This is the second big announcement that kicks the can until the fall to provide a full picture of FDA plans. And the announcement today does not go far enough to give any of us confidence that FDA’s leadership is up to the challenge to make bold and needed changes in the restructuring of FDA’s food program,” said Donna Garren, vice president of science and policy at the American Frozen Food Institute.
Mitzi Baum, CEO at Stop Foodborne Illness, said the commissioner’s proposed changes do not get to the root of the deeply embedded cultural issues at FDA, specifically the insularity of the Office of Regulatory Affairs.
“They operate separately from science and policy areas and continue to have a culture of reaction rather than shifting to a proactive approach as mandated in the Food Safety Modernization Act,” she said.
FDA’s second round of details came on the one-year anniversary of the infant formula recall, the perfect storm which exposed the dysfunction of FDA’s food program, Baum said. “The commissioner continues to defy the very experts he enlisted and has chosen to ignore the most glaring issues” identified in the Reagan-Udall report, she added.
Jennifer McEntire, chief food safety and regulatory officer at the International Fresh Produce Association, said her association met last week with dozens of current FDA employees and associate commissioners who would be brought under the newly devised Human Foods Program. None could provide a clear answer on how decision-making would be streamlined under the new plan.
“With the proposal continuing to divide the science and policy side from the inspection and imports side, I don’t see that sort of situation changing,” McEntire said.
Roberta Wagner, a 28-year year FDA veteran who is vice president of regulatory and technical affairs at the Consumer Brands Association, said she’s seen firsthand that the management plan proposed by FDA has not worked. “In fact, it’s no secret this management strategy has stunted successful Food Safety Modernization Act implementation for over a decade,” Wagner said.
“While FDA efforts to modernize IT and business processes for inspections and compliance activities are commendable. they aren't a substitute for bolder structural and governance changes,” Wagner added.
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Garren said FDA’s actions show they remain “okay with the status quo of making decisions by committee and allowing various programs involved in supporting FDA’s food program to remain autonomous and allowed to protect their respective turfs.”
However, the coalition of food and consumer groups said the lack of authority with how Califf outlined the deputy commissioner position will hamstring anyone who takes on the role. “With a job description that would set anyone up to fail, I'm certain qualified candidates will be deterred from applying for the vacant deputy commissioner role,” Wagner noted.
Garren said the food industry deserves a strong and effective leader who can set priorities and make decisions quickly, however, that will remain impossible with Califf assigning authorities divided amongst the different various program.
Brian Ronholm, director of food policy for Consumer Reports, anticipates it will be hard to recruit a potential candidate when he or she discovers that he or she won't have direct authority over inspections, testing, investigations and two thirds of the food safety budget.
Ronholm said if FDA continues down a path that ignores the Reagan-Udall report recommendations, legislative language might be appropriate to move forward with an empowered deputy commissioner that would have direct line authority over all the key components of the foods program.
Wagner added the plans unveiled by FDA Tuesday “leaves us no other option” but to go to Congress and seek the empowered deputy commissioner as the coalition has advocated. Bipartisan support exists for the requests made by the coalition, and Califf will likely be grilled about his decisions when he testifies before Congress in the upcoming weeks.
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