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FDA Vows to Further Improve Food and Nutrition Programs in Response to GAO Advice

Wednesday, March 07, 2018
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has vowed to further improve its food and nutrition programs in response to a recent report by the Government Accountability Office. FDA Commissioner Scott Gottlieb said his agency has undertaken a concerted effort to modernize its food safety metrics in conjunction with parallel efforts to modernize the food safety regulatory structure. Moving forward, the FDA plans to put in place outcome-based performance measures that can more accurately reflect the public health impact of the agency’s actions.

The GAO found that since the enactment of the FDA Food Safety Modernization Act in January 2011 the FDA has conducted numerous food safety- and nutrition-related activities, determining its priorities for those activities based on statutes and its strategic goals. The agency has published 33 proposed or final key regulations and 111 draft or final key guidance documents, focused mainly on food safety, and has also conducted other key activities related to food safety and nutrition such as conducting inspections and developing risk-assessment tools, responding to foodborne illness outbreaks, and providing outreach and education.

While the FDA has set goals for its food safety- and nutrition-related activities since fiscal year 2011, it has not fully developed the necessary framework to assess progress toward those goals, the GAO found. For FY 2016 through 2025 the agency’s Foods and Veterinary Medicine Program, which is primarily responsible for carrying out these activities, has set a food safety goal to protect American consumers from foreseeable hazards and a nutrition goal to foster an environment that promotes healthy and safe food choices. The program has developed performance measures to assess progress toward five of eight strategic objectives but three objectives still lack such measures. 

For each developed performance measure, the FDA reports both targets set and measurements taken for specific time frames. For one such measure related to the FDA’s evaluation of food safety hazards, the agency targeted the completion of 50 percent of evaluations by their due dates in the first quarter of FY 2017 and achieved 89 percent. Leading practices in performance management state that federal programs should use performance information to achieve program goals and each objective should be tracked through performance measures that have targets and time frames. According to agency officials, the program is developing additional measures for its food safety- and nutrition-related objectives but it had not finalized them as of January 2018. The GAO noted that until the program develops measures with associated targets and time frames for all eight objectives the FDA cannot fully assess progress toward achieving its goals.

FDA officials further indicated that the agency plans to pursue the food safety and nutrition strategies identified in the FVM Program’s 10-year strategic plan. According to the GAO, however, the specific time frames for the activities that would support those strategies are unclear because the FDA has not developed a plan that includes actions, priorities, and milestones to implement the strategic plan. Until the program completes such an implementation plan, the GAO reported, it will be difficult for the FDA to ensure it is prioritizing and sequencing the necessary actions to achieve the program’s objectives.

In light of these findings, the GAO has advised the FDA to (1) ensure that FVM Program staff uniformly document the bases for their decisions for issuing either regulations or guidance related to food safety and nutrition, such as by using concept papers or guidance initiation sheets; (2) ensure that the FVM Program develops performance measures with associated targets and time frames for all eight of the FDA’s food safety- and nutrition-related objectives; and (3) complete an implementation plan that includes specific actions, priorities, and milestones for the FVM Program’s strategic plan. The FDA is already making progress in these areas, including through the establishment of internal documentation and review and clearance procedures for policy documents as well as by expanding the use of outcome-based performance measures to monitor and report programmatic impact.

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