Health Reform WK-EDGE FDA needs to develop performance measures
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Monday, March 12, 2018

FDA needs to develop performance measures

By Jeffrey H. Brochin, J.D.

Although the FDA has set goals for its food safety- and nutrition related activities, it has not fully developed the necessary framework to assess progress toward those goals. The U.S. Government Accountability Office (GAO) has undertaken an extensive study of the Food and Drug Administration’s (FDA’s) food safety and nutrition-related activities following the enactment of the FDA Food Safety Modernization Act (FSMA) in January 2011 (GAO Report, GAO-18-174, January, 2018).

The study found that from the date of enactment through September, 2017, the FDA has conducted numerous food safety-and nutrition-related activities, and has published 33 proposed or final key regulations and 111 draft or final key guidance documents focused mainly on food safety. The FDA 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, and has dedicated at least $1 billion annually, including salaries for at least 4,300 full-time equivalent (FTE) staff, to food safety and nutrition activities in fiscal years 2011 through 2016.

How the study was conducted. The GAO report examined: (1) the FDA’s key food safety- and nutrition-related activities since FSMA’s enactment in 2011 and how the FDA determined its priorities for those activities, (2) the resources that the FDA dedicated to those activities in fiscal years 2011 through 2016, (3) the extent to which the FDA set goals for those activities in fiscal years 2011 through 2017 and how it is assessing progress toward those goals, and (4) the FDA’s planned food safety- and nutrition-related activities and associated time frames.

FDA responsible for key food-related laws. As part of its study, the GAO reviewed the laws which form the basis of the FDA’s mandate to oversee food safety and nutrition, including: the federal Food, Drug, and Cosmetic Act (FDC Act), the FSMA, the National Nutrition Monitoring and Related Research Act of 1990, the Nutrition Labeling and Education Act of 1990, and the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148).

What the GAO study found. Among the findings of the GAO report were the following:

  • The FDA dedicated at least $1 billion annually—including salaries for at least 4,300 full-time equivalent (FTE) staff—to food safety and nutrition activities in fiscal years 2011 through 2016. About 98 percent of those resources were dedicated to food safety each fiscal year, and about 2 percent were dedicated to nutrition.
  • Since fiscal year 2011, the FDA has set goals for its food safety-and nutrition-related activities but has not fully developed the necessary framework to assess progress toward those goals.
  • Most recently, for fiscal years 2016 through 2025, the agency’s FVM 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. These goals are supported by eight strategic objectives. The program has developed performance measures to assess progress toward five of these objectives but not for the other three.
  • 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 FDA targeted the completion of 50 percent of evaluations by their due dates in the first quarter of fiscal year 2017 and achieved 89 percent.
  • According to agency officials, the FVM Program is developing additional measures for its food safety- and nutrition-related objectives, but it had not finalized them as of January 2018. 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.

GAO Recommendations. The GAO tendered recommendations to the FDA at the conclusion of its study, that the FDA (1) develop performance measures with associated targets and time frames for all eight of its food safety-and nutrition-related objectives, and (2) complete a plan that includes specific actions, priorities, and milestones for implementing the FVM Program’s strategic plan. The agency agreed with the GAO’s recommendations and identified actions to implement them.

ReportsLetters: GAOReports AgencyNews FoodNews NewsFeed

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