Coalition has many questions about how FDA Commissioner will protect consumers with new organizational chart


Expensive Dr. Califf, FDA Commissioner
February 6, 2023

As a broad coalition of FDA stakeholders, together with business and shopper teams and state meals regulators, we recognize the eye you will have given to the issues in FDA’s Meals Program, which had been highlighted within the Reagan-Udall Basis (RUF) report in December. We are also appreciative of your acknowledgment in your January 31 announcement that the Meals Program requires a management and administration construction that allows it to satisfy its mission and is distinctive from the medical product packages.

The announcement contained some vital constructive parts – together with creation of a deputy commissioner place with line administration authority over the present CFSAN and the features of ORA’s state partnership workplace. It additionally indicated that sure different unspecified ORA features “might be unified right into a newly envisioned group referred to as the Human Meals Program.” In response to the announcement nonetheless, ORA’s core meals inspection, laboratory, compliance, and import oversight features would stay in a separate ORA group led by an Affiliate Commissioner for Regulatory Affairs (ACRA) reporting presumably to you.

Primarily based on our understanding of this plan, it’s tough to reconcile this proposal with the evaluation and findings within the RUF report. All 5 of the report’s structural choices included unifying ORA’s operational features with different parts of the Meals Program in a direct line reporting relationship to the highest program chief. We’re involved that the plan doesn’t embody that, and thus doesn’t create a unified meals program beneath a single chief.

Our concern about that is based mostly on our intensive expertise working with, and in some instances inside, the FDA Meals Program, and encountering how its organizational fragmentation hinders coordination, collaboration, and the timeliness and consistency of decision-making. Presently, FDA’s food-related operations are run by three massive organizations – CFSAN, CVM and ORA – all reporting individually to the commissioner. It seems that this organizational fragmentation would proceed throughout the newly proposed construction.

Whereas the assertion suggests the Deputy Commissioner would have “decision-making authority over coverage, technique, and regulatory program actions throughout the Human Meals Program, in addition to useful resource allocation and risk-prioritization,” we now have considerations about whether or not and the way this might work within the absence of line administration authority. The RUF report intently hyperlinks FDA’s tradition issues to its “disparate construction” and asserts that the Meals Program wants “a definitive and facilitative construction” and “a transparent overarching chief.” It additionally says that FDA’s tradition points had been “foremost among the many Panel’s issues when making suggestions for potential structural change.”

On that foundation, the entire RUF report’s structural suggestions included having ORA’s meals features reporting on to the “single overarching chief.” We acknowledge the challenges related to shifting a deeply engrained tradition, and proposing a construction that might be perceived as diminishing the autonomy of components of the Company. Nevertheless, that is exactly what the RUF report suggests is required to enhance the perform of the Company.

Given our considerations, we request a chance to debate the plan with you in individual earlier than it’s finalized. The next questions mirror each our considerations and our uncertainties about how the envisioned plan would enhance FDA’s efficiency:

  • Assuming the ACRA place continues to exist, what’s the scope of its duties? To whom would the ACRA report? By means of what mechanism would the ACRA be accountable to the deputy commissioner?
  • What’s your imaginative and prescient for “reworking ORA’s working construction into an enterprise-wide group that helps the Meals Program and all different FDA regulatory packages”?
  • Would the deputy commissioner have direct administration management over all meals program actions, together with ORA? How would this work in apply?
  • Would the deputy commissioner have administration authority to find out allocation of sources throughout ORA’s food-related features? For instance, would the deputy commissioner be accountable for the formulation and execution of your complete meals program price range, together with the portion of the Human Meals Program price range that ORA at the moment receives?
  • Would the deputy commissioner have direct administration authority over ORA’s meals operations, together with inspection, compliance, lab operations, import oversight, coaching and IT?
  • Would the deputy commissioner have administration authority to conduct evaluations of every of ORA’s food-related features and direct strategic and operational change?

Would the deputy commissioner have the authority to:
o Set up place descriptions for ORA administration and program employees?
o Make choice selections for ORA senior administration positions?
o Set up efficiency plans for ORA administration positions?
o Conduct efficiency evaluations of the ACRA and senior ORA managers and log off on bonus suggestions?

Would the deputy commissioner have full entry to all ORA food-related knowledge programs and authority to revamp ORA knowledge assortment and evaluation programs to fulfill the wants of the Human Meals Program?

  • Would the deputy commissioner have administration authority to direct how CVM conducts its operations associated to meals security packages working within the middle?
  • Would the deputy commissioner have authority to require scientifically applicable harmonization amongst knowledge and strategies used to judge the protection for people of meals and feed components and residues of animal medicine in human meals?
  • In what method is the authority of the deputy commissioner codified in FDA’s administration system?

Thanks in your openness to a dialogue with us on how finest to arrange FDA’s Meals Program for future success. We hope that the plan stays open to the likelihood for change that addresses our considerations and sit up for offering assist for this difficult course of.

American Frozen Meals Institute
Affiliation of Meals and Drug Officers
Client Manufacturers Affiliation
Client Studies
Environmental Working Group
Worldwide Contemporary Produce Affiliation
STOP Foodborne Sickness
Western Growers


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