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Commissioner Califf, do not just rearrange the deck chairs – do something bold – do something that will fundamentally change how food safety is done

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Tomorrow is the long-anticipated day that Dr. Califf is set to announce his intentions on how or if to implement the recommendations of the Reagan-Udall Foundation panel’s review of the FDA’s human foods program.

On behalf of the 48,000,000 Americans sickened by a foodborne illness yearly in the U.S. and the millions who die of diseases brought on by too much salt, sugar and fat, I hope is that it is more that “rearranging the deck chairs on the USS FDA.

I have said too often that my vision of a more empowered food-side (food poisoning and nutrition) of the FDA would have been to create two Senate appointed commissioners – one with a portfolio of all aspects of food and one with a portfolio of drugs and medical devices. 

Here are many who I admire that have hope as well.

American Frozen Food Institute, Association of Food and Drug Officials, Consumer Brands Association, Consumer Reports, Environmental Working Group, International Fresh Produce Association, STOP Foodborne Illness, Western GrowersDiverse coalition calls on FDA to outline meaningful reforms in announcement on foods program

WASHINGTON, D.C. – A diverse coalition of food policy stakeholders representing consumers, industry, and state and local regulators reiterated its call for significant structural reform of FDA’s foods program ahead of the agency’s anticipated January 31 announcement on how it intends to implement recommendations from a report by the Reagan-Udall Foundation.

The coalition commended the report when it was released in December of last year, noting that the expert panel accurately captured problems related to the structure, leadership, culture, transparency, and accountability within FDA’s foods program. Importantly, the report reinforces the coalition’s call for an expert, empowered deputy commissioner for food who could unify the program and elevate its stature within FDA.

The coalition reiterated the need for bold reforms that incorporate the following elements:

Full Unification of the Human and Animal Foods Program under an Expert Leader

Establishing an empowered deputy commissioner position with direct line authority over all components of FDA’s human and animal foods program is foundational to its operational success and essential culture change. In practice, this means unifying into a cohesive organizational structure — headed by the deputy commissioner — the Center for Food Safety and Applied Nutrition (CFSAN), the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all the food-related components of the Office of Regulatory Affairs (ORA), including inspection and compliance, food-related laboratories, import oversight, state partnerships, training, and information technology.

Candidates for the empowered deputy commissioner role should possess the attributes recommended in the report, including expertise and knowledge in food safety and/or nutrition; demonstrated strong leadership, management, and communications skills; and the ability to lead and make timely decisions in a complex regulatory environment.

An Elevated, More Prominent Foods Program

The empowered deputy commissioner should be viewed internally and externally as the commissioner’s surrogate for all FDA food activities and as the agency’s leader, spokesperson and decision-maker for the foods program. The position should have the authority and standing within FDA and HHS, to represent FDA on foods program issues and funding before Congress, within the executive branch, as well as with stakeholders and foreign partners.

Culture Change and Modernization

Reframing the culture within the foods program is a prerequisite to the success of its structural reform. The current fragmented structure and lack of central authority and leadership contributes to a culture of silos, indecision, inaction, and delay in implementing the prevention mindset called for in the Food Safety Modernization Act (FSMA). The deputy commissioner should also be mandated to modernize the program in a way that facilitates transparency, timeliness, and meaningful stakeholder engagement as part of its decision-making process.

The FDA’s foods program is a distinctive part of the agency and deserves a structure and leadership model that is appropriately customized to fit its mission. We look forward to FDA Commissioner Califf’s pending announcement and remain committed to working with the agency as changes are implemented.

And, one would think the head of the FDA, would pay attention to those with the purse strings.

DURBIN, DELAURO URGE FDA COMMISSIONER CALIFF TO IMPLEMENT REFORMS AT THE AGENCY’S HUMAN FOODS PROGRAM

The letter follows the Reagan-Udall Foundation’s report which outlined significant flaws within FDA’s Human Food Program

WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Representative Rosa DeLauro (D-CT) sent a letter to the Food and Drug Administration (FDA) Commissioner Dr. Robert Califf urging him to make critical reforms within FDA’s Human Foods Program.  This follows the Reagan-Udall Foundation’s recent external evaluation and report, which outlined various flaws at FDA including their slow response to foodborne illness outbreaks, particularly with infant formula, and lack of implementing the Food Safety Modernization Act (FSMA), which Durbin and DeLauro authored.  In response to the report, Commissioner Califf plans to release a public update on his new vision of FDA soon. 

“We are writing regarding the Reagan-Udall Foundation’s critical review of the Food and Drug Administration’s (FDA) Human Foods Program,” wrote Durbin and DeLauro.  “You previously stated that this review would help inform a ‘new vision’ for FDA that will be announced at the end of this month.  As part of this ‘new vision,’ we encourage you to embrace the significant leadership and structural reforms that the Foundation recommended in its report.  American families cannot afford for FDA to continue its inadequate food oversight, especially when we now have a comprehensive analysis of how to start to remedy the agency’s food safety failures.”

FDA is responsible for the oversight of nearly 80 percent of food in the United States.  Too often, however, FDA has failed to protect Americans from dangerous food pathogens and outbreaks.  Every year, more than 48 million Americans are sickened, 128,000 are hospitalized, and 3,000 lose their lives because of some bacteria or virus in their food.  In 2011, FMSA was signed into law to transform the United States’ approach to foodborne illnesses.  FSMA requested FDA to be more proactive, not reactive, to foodborne illnesses to prevent outbreaks in the first place.  FSMA empowered FDA with new authorities, resources, and funding to accomplish this goal.  But, as outlined in the Reagan-Udall report, FDA has not made this shift, despite FSMA’s passage more than a decade ago.  FSMA required FDA to promulgate several rules so that it would prevent rather than respondto foodborne outbreaks.  However, more than a handful of times, FDA missed congressionally mandated deadlines to implement them.  FSMA also required FDA to “increase the frequency of inspection of all [food] facilities,” to ensure companies’ compliance with safety and quality standards.  But, FDA inspections have plummeted since FSMA was signed into law.

The letter cites FDA’s failures to respond to a compliance issue at Abbott Nutrition’s Sturgis, Michigan, facility which manufactures infant formula.

“However, despite the vulnerable population that consumes the products manufactured at this facility, FDA did not follow up and inspect the facility until January 2022, upon which it found several samples to suggest the presence of Cronobacter.  Even then, FDA did not request that Abbott initiate a recall of their infant formula—nor warn consumers—until mid-February 2022.  It’s difficult to explain why FDA moved this slowly, even when this issue hospitalized at least four infants, claimed two of their lives, and had the potential to harm the health and well-being of other infants across the nation,” the letter continued.

In July, Durbin, DeLauro, and Senator Richard Blumenthal (D-CT) introduced the Food Safety Administration Act of 2022, legislation that would establish the Food Safety Administration, a single food safety agency responsible for ensuring the safety of our nation’s food supply.  This new agency would take over food safety responsibilities currently housed at FDA.  In the Reagan-Udall Foundation’s report, this proposal was included as their first option for structural reform at FDA.

The letter also urged Commissioner Califf to empower a Deputy Commissioner for Foods with authority over the Human Foods Program; separate the Center for Food Safety and Applied Nutrition (CFSAN) into a “Center for Food Safety” and a “Center for Nutrition;” and directly integrate the Office of Regulatory Affairs’ (ORA) food-related inspectional and compliance responsibilities within the Human Foods Program.

The letter concluded, “As commissioner, you have the power to turn the FDA into an organization that meets its mission and prevents foodborne illnesses and outbreaks—saving and improving lives nationwide.  Now is the time for real reform at FDA—it is not the time for half measures or more excuses.  We look forward to learning more about your ‘new vision’ for FDA’s Human Foods Program later this month.”

Full text of today’s letter is available here and below:

January 30, 2023

Dear Commissioner Califf:

            We are writing regarding the Reagan-Udall Foundation’s critical review of the Food and Drug Administration’s (FDA) Human Foods Program.  You previously stated that this review would help inform a “new vision” for FDA that will be announced at the end of this month.  As part of this “new vision,” we encourage you to embrace the significant leadership and structural reforms that the Foundation recommended in its report.  American families cannot afford for FDA to continue its inadequate food oversight, especially when we now have a comprehensive analysis of how to start to remedy the agency’s food safety failures.

            In addition to its other duties, FDA is responsible for the oversight of nearly 80 percent of food in the United States—from peanut butter, to lettuce, to infant formula.  Too often, however, the FDA has failed to protect Americans from dangerous food pathogens and outbreaks.  Every year, more than 48 million Americans are sickened, 128,000 are hospitalized, and 3,000 lose their lives because E. Coli, Norovirus, Salmonella, or some other bacteria or virus in their food.  This pain, suffering, and loss of life is unacceptable; and, even more infuriating, it can be prevented. 

            In 2011, the FDA Food Safety Modernization Act (FSMA), legislation we crafted to transform our nation’s approach to foodborne illnesses, was signed into law.  It had a simple premise:  FDA was too reactive to foodborne illness outbreaks, acting only after a problem had arisen and people had been sickened.  We worked with bipartisan Members of Congress, consumer organizations, and food companies to turn FDA into an organization that would prevent outbreaks in the first place.  The FSMA empowered the FDA with new authorities, resources, and funding to accomplish this goal.  But, as outlined in the Reagan-Udall report, FDA has not lived up to its end of the bargain, despite the FSMA’s passage more than a decade ago. 

            For example, in October 2021, FDA was alerted to significant compliance issues at Abbott Nutrition’s Sturgis, Michigan, facility—a facility responsible for manufacturing infant formula.  However, despite the vulnerable population that consumes the products manufactured at this facility, FDA did not follow up and inspect the facility until January 2022, upon which it found several samples to suggest the presence of Cronobacter.  Even then, FDA did not request that Abbott initiate a recall of their infant formula—nor warn consumers—until mid-February 2022.  It’s difficult to explain why FDA moved this slowly, even when this issue hospitalized at least four infants, claimed two of their lives, and had the potential to harm the health and well-being of other infants across the nation.

            Americans deserve better than what FDA has done to ensure food safety.  That is why we introduced a bill last Congress to create a new, independent “Food Safety Administration” responsible for taking over FDA’s food oversight responsibilities.  In the Reagan-Udall Foundation’s report, this proposal was included as their first option for structural reform at FDA.  We understand that this change would require congressional action and would be difficult to accomplish in a divided Congress.  However, FDA should take this recommendation to heart and begin undertaking meaningful steps to improve the Human Foods Program in the meantime.

As was outlined in the report, the Human Foods Program must be unified under a single leader and restructured.  To this end, we urge you to empower a Deputy Commissioner for Foods with authority over the Human Foods Program; separate the Center for Food Safety and Applied Nutrition (CFSAN) into a “Center for Food Safety” and a “Center for Nutrition;” and directly integrate the Office of Regulatory Affairs’ (ORA) food-related inspectional and compliance responsibilities within the Human Foods Program.

As commissioner, you have the power to turn the FDA into an organization that meets its mission and prevents foodborne illnesses and outbreaks—saving and improving lives nationwide.  Now is the time for real reform at FDA—it is not the time for half measures or more excuses.  We look forward to learning more about your “new vision” for FDA’s Human Foods Program later this month.

Well, we shall see. Check back tomorrow to see of the USS FDA successfully avoided the iceberg.

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