The US Food and Drug Administration (FDA) announced on 28 February that it has begun its national search for a new Deputy Commissioner for Human Foods.

This updat comes a month after the New Food reported that FDA had announced revolutionary changes to its Human Food Program following Frank Yiannas stepping down as Deputy Commissioner.

With the aim of enhancing “coordination, prevention and response activities”, Robert M. Califf, FDA Commissioner, said: “My search for a new Deputy Commissioner for Human Foods is underway, the first recruitment effort open to both external and internal candidates under the agency’s expanded Title 21 hiring authority for a foods-related position.”

Hoping to start the interview process and make a selection “as soon as possible”, Califf highlighted that the role of Deputy Commissioner will be an “important position” within the Administration.

“There have also been a number of questions about the proposed operational changes for ORA (Office of Regulatory Affairs) and how these plans will work with changes to the Human Foods Program,” continued Califf.

“I cannot stress enough that my vision is focused on a new, agency-wide model wher 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.”

The search begins

The role of the next “empowered” Deputy Commissioner for Human Foods will be to report directly to the FDA Commissioner. With this in mind, the agency is scouting a candidate that will be able to provide leadership over the FDA’s nutrition and food safety programmes (including ones aimed at preventing and responding to chemical, microbial, and other hazards).

In addition, the “ideal” candidate will possess “executive-level and real-world experience” that can be used to lead the newly envisioned Human Foods Program and its “vast remit”. The FDA is also looking for someone with “a clear line of authority” over the proposed Human Foods Program, including of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain human foods-related components of ORA.

An agency-wide transformation

The FDA has said that, while looking for a new Deputy Commissioner, it is also working on an “agency-wide transformation effort” of how the programmes and field functions are organised.

Going forward, the proposal is something that the FDA says will create a new model that “better integrates ORA’s enterprise-wide expertise in field-based operations with product subject matter experts who sit in all the agency’s programs”.

The vision includes the programme leads, including the new Deputy Commissioner, setting strategic direction for food inspections and have authority over program resource allocation, something that could improve overall food safety in the US.

Taking action

The FDA has said that it already has changes underway, including looking into:

• Unifying the specific functions of ORA, CFSAN and OFPR into a new Office of Integrated Food Safety Systems Partnerships. The plans are for this single office to engage with state, local, tribal, and territorial food safety regulatory partners.
• Analysing inspection and compliance functions that sit within both ORA and program offices across the agency. This analysis will be used to “determine opportunities to streamline operations and clarify decision-making authority at each step of the inspection process”. The FDA also has plans to integrate new automation and information technology (IT) support. It has said that this new process will enable ORA and programme personnel to function as a multidisciplinary team, which it claims will eliminate sequential steps, thus “speeding decisions”.
• Investigating how “best to empower” the Deputy Commissioner for Human Foods and leaders of other programs, as well as the Associate Commissioner for Regulatory Affairs, in order to oversee programme and field resource allocation. This includes publicly mapping the budget to functional activities so as to provide clarity on resource allocation.
• Working on ensuring a “seamless coordination” across the FDA and state-operated food laboratory operations through evaluating the foods laboratory programmes. This includes the relationships, roles, and responsibilities among CFSAN, CVM, ORA and state-operated laboratories.

To read the full list of plans the FDA has put in place to achieve its new vision, click here.

“Our proposal specifically tackles issues identified in two independent evaluations of our food programmes, one conducted by the Reagan-Udall Foundation and an internal evaluation of the agency’s infant formula response,” said Califf.

Fixing for the future

Having heard “loud and clear” that the FDA’s current resource distribution and operational model between the FDA’s regulatory programs and field operations are “siloed”, Califf noted that there has been “too much duplication”, however he pledged  “we intend to fix this and strengthen both the regulatory programs and field force.”

“Both subject matter experts in the programmes and the expertise of our investigators in the field will see more interaction as part of multidisciplinary teams that have clarity on who is in charge of making decisions.”

The FDA has said that it is looking to finalise its proposal in Autumn 2023, when the package will be reviewed before advancing to Congress for a 30-day notification period which will allow members to any concerns that the FDA may need to address. Following this, the agency has said that it will issue a Federal Register Notice to engage in negotiations with the unios for impacted staff, prior to initiation of the new proposal.

To listen to New Food’s emergency podcast episode regarding changes at the FDA, click here.