The array has failed, the system has crashed; The FDA needs a new food approach End-shutdown


Editor’s note: This was written in response to comments made by FDA Commissioner Dr. Robert Califf in his exclusive interview with Food Safety News editor Bill Marler published on February 27.

Dear doctor calif,

The FDA Food Program is different. The food system and food safety are complex, but the core of FDA’s food safety role and Congressional mandate are simple. FDA sets industry standards and guidance and engages with industry and regulatory partners in multiple ways to ensure compliance with those standards. The mission of the Food Program is fundamentally different from that of Google or a hospital.

As logical as matrix management may seem, it is a recipe for the FDA to continue to fail to live up to the vision and mandates of the Food Safety Modernization Act (FSMA).

As representatives of the food industry and consumers, and state food regulators who have worked directly for many years with all levels of the Food Program and share an ongoing commitment to FDA food safety success, we offer:

  1. Cultural change requires central leadership. FDA food safety success depends on headquarters and field inspection, laboratory, and import units working seamlessly with a common vision, sense of mission, and priorities. The necessary change will not be achieved simply by defining decision rights in a matrix management system. It’s about cultural change and leadership that can transform field units from their entrenched culture of react and enforce to one of public health prevention and collaboration to achieve food safety, supported by enforcement where appropriate. necessary.
  1. Previous Matrix Management attempts have failed. Starting with a partially empowered Deputy Commissioner for Food and Veterinary Medicine from 2010 to 2018 and Commissioner Hamburg Program Alignment, matrix management for FSMA implementation has been attempted for over a decade in multiple formulations and failed blatantly. . We see no basis to believe that it will be successful now.
  1. The need for an empowered single leader is well documented.. The Reagan-Udall Foundation Panel of Independent Experts painstakingly documented the failure of matrix management in the Food Program. On that basis, the panel recommended that all elements of the Food Program be unified under a single leader with full-line management authority to lead its essential culture change and program modernization. So far, there has been no convincing explanation to refute this recommendation.
  1. Food security requires an integrated food program. For the FDA to be successful in food safety, its large frontline workforce must think of itself and become an integral part of the Food Program, not remain a separate organization protecting its independence and culture. obsolete of insularity and reaction to food safety problems. .
  1. Sales force integration does not undermine efficiencies. Desirable efficiencies in logistical and administrative support to Food Program field activities can be achieved through shared services with medical product programs, rather than clinging to the fragmented structure of the ORA Food Program that blocks the progress of food safety.

We urge you to reconsider your plan to rely on a failed matrix management approach to lead and transform the Food Program. We recognize that major organizational changes are often met with resistance and internal questions. These should be considered, but the stakes are too high to allow bureaucratic problems to block progress that is so vital to the health of the United States and to the public’s confidence in FDA oversight of food safety.

Food safety success requires and deserves better.

STOP Foodborne Illness
Consumer Reports
Consumer Brand Association
Association of Food and Drug Officials

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