Special Edition; Dr. Woodcock on Food Program Reforms

On March 2, the Alliance for a Stronger FDA hosted a webinar with FDA’s Principal Deputy Commissioner Dr. Janet Woodcock, a key player in FDA's reexamination of food programs.  At the start of this webinar, Dr. Woodcock offered a summary of the food program changes FDA announced on January 31, and supplemented with additional details this week.

Dr. Woodcock said FDA had realized that the food program has been in dire straits.  While there have been some funding increases, food programs have been under-resourced compared to their mission. The experience with infant formula provided lessons learned and what could be done better.  The independent review by the Reagan Udall Foundation provided a thorough and robust report in December.

The planned restructuring of the foods program will bring together multiple offices, including portions of ORA, CFSAN, and the animal food and feed component of CVM into a new Human Foods Program that will be headed by a Deputy Commissioner. CVM will remain independent but will be matrixed into food matters.  ORA will continue as an independent office but will be more strategic with respect to food, as well as matrix managed. 

It was also announced this week that the cosmetics program will be moved out of CFSAN and put under the Office of the Chief Scientist.

State, local, and tribal operations will be put under an integrated food safety office.  There will also be an evaluation of international programs to see if they should be part of this integrated office.

Dr. Woodcock said there will be an “implementation and change management” group.  This group will have four work streams: budget (map budgets to actual activities to tag actions more carefully to see where funding goes); identify all candidates for the integrated food safety office; laboratories (collaborate state and other laboratories); and inspection process developing a workflow management program.  Other projects for the implementation and change management group include the development of a unified risk prioritization project aligned with its budget and strategy, and training for state inspectors and expected new hires.

Dr. Woodcock, at several points in her presentation, noted that the reorganization plan does not itself provide additional resources for the projected activities.

Alliance Executive Director Steven Grossman pointed out that the Alliance exists to advocate for the resources that FDA needs to assure Americans that they have a safe and nutritious food supply and safe and effective medical products.   The Alliance has taken the position that food program reform and increased funding for food programs are intertwined. The Alliance does not support specific ways of achieving that reform; just that money cannot be well-spent without appropriate means of spending the money and without transparency and accountability.

During a question and answer period, Dr. Woodcock addressed several topics.

With respect to what Dr. Woodcock and Commissioner Califf have seen as the primary problems for which a direct and forceful response was needed, she replied that programs have been relatively successful, citing menu labeling as an example.  However, the food program has been struggling against organizational obstacles that can be streamlined.  The food program appears to have been assembled by aggregation rather than intent.   They are looking for a systematic buy-in.

Regarding how much money does FDA need—and how soon—to rectify the situation, and the priorities for this funding, Dr. Woodcock said there first is the need to sort out the organization.   Key needs she identified included leveraging state and local regulatory participation, including training; having more boots on the ground; moving IT development and determining if IT is a money or a design problem.  She specifically said the scientific and nutrition side are under resourced.

She said that she expects the Deputy Commissioner will have financial and strategic oversight of resources, with a matrix of operations involving significant modifications of ORA. 

Dr. Woodcock noted the challenge  of keeping food programs going while the reorganization occurs, but it must be done.  Not all problems will be fixed, and priorities will need to be selected.  Developing an organization that can evolve is important.

When asked if this reorganization will be reflected in the Presidents FY 2024 Budget  Request, FDA’s Budget Director William Tottle said he cannot speak about this until the President’s budget is submitted. The suggestion was made that a follow-up meeting on this issue - after the submission of the President’s budget - would be beneficial to the Alliance’s efforts to support strong funding for FDA.

Other questions raised during the webinar included:

·       The status of the White House Strategy involving commitments from FDA’s foods program, including front-of-package nutrition labeling and added sugars/sodium reduction;

·       The likelihood of maintain the 6-7 percent of CFSAN’s budget flowing into the new center;

·       The reform effort’s impact on the relationship between ORA and CFSAN;

·       The vision for “transforming ORA’s operating structure into an enterprise-wide organization that supports the Foods Program and all other FDA regulatory programs”;

·       The response of law makers, including the appropriators thus far;

·       Expectations for dietary supplements; and

·       ORA and medical products;

Dr. Woodcock concluded her responses by offering to hold another session on these topics with the Alliance in the future.