What the Alliance Told the Commissioner About Food Safety

On Friday, January 20, the Alliance had an opportunity to discuss food safety and nutrition with Commissioner Califf and Deputy Commissioner Woodcock. It was a productive meeting and reinforced the importance of the Alliance as an advocate for FDA and CFSAN funding. 

Here are some of the key points we made:

The entire stakeholder community wants a single point of accountability, vested in someone who has experience in food and nutrition.  Accountability needs to be embedded in any structural solution. Food safety and nutrition programs--funded through CFSAN, CVM, ORA, OC, and NCTR-- cannot spend money effectively and with appropriate intentionality, unless there is an empowered decisionmaker in charge.   

Industry and consumers are anxious to see change. They will support increased resources if they see strong leadership and a comprehensive, transparent strategy for change. Part of reform should include truly embracing the intent of FSMA and using more risk-based policies rather than hazard-based policies and enforcement.

The Leadership Structure for Food Safety Does Not Need to Be Duplicated in Medical Products  FDA’s food responsibilities are quite different from the agency’s medical products responsibilities, notably because ORA plays a significantly larger role in food safety. The goal should always be “how do we structure food programs to achieve excellence in food safety and nutrition.”

FDA needs more than just increased funding levels. Maintaining and expanding well-trained professional staff is critical, as is maximizing the contribution of outside expertise. Likewise, IT and advanced data technology are key to a more effective and efficient FDA. Food safety and nutrition would certainly benefit from investment in better tools and systems.

Effective food programs, accountability and transparency start with a budget request that is understandable and provides clarity on funding and specific programs. Budget documents should include budget and staffing levels by each office from prior years to permit analysis of shifts in resources and focus. FDA should generate a strategic plan for technology modernization of food programs, modeled on what CDC did.

Additional resources for FDA food programs should be sized to assure that the food supply is safe and perceived to be so, and nutritional information is widely available and supported by science. The metric of need is not the level of resources available to other centers---which have different missions and different funding needs.

 Regardless of how one feels about food user fees, they are not feasible now or in the near-term. Among other things: two pre-conditions are not met (no industry buy-in and no fee-able event). There are also obstacles (e.g., four committees must approve user fees (easy to stop). Sometimes user fee proposals are offered to offset the cost of the agency’s base BA or increases that would otherwise have been offered as proposed BA. In that case, the non-adoption of the user fee program forces appropriators to find additional BA outside the framework of the President’s budget request. That makes their jobs immeasurably harder and almost guarantees the agency will receive less than it sought   

 Members of Congress have to eat and so do their constituents. It is feasible for the Alliance to undertake a campaign to significantly increase funding of food safety and nutrition programs. Despite the difficult overall budget situation for FY 24, the Alliance has been successful in galvanizing support behind areas of extreme need, as it did after release of the 2008 Science Board report.

A personal note. The RUF report proved to be strong and forthright, which surprised many. Having worked in the past with former Commissioner Jane Henney, John Taylor, and other panel members, I knew they would insist that the report be cogent, practical, and relevant.

Similarly, Drs. Califf and Woodcock understand that empowered leadership has been missing. They are  committed to replacing it with a sound structure and clear program direction.

I urge stakeholders to stay positive and look for ways to support and improve upon FDA’s efforts.