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GAO says FDA needs to work on ‘prioritizing and sequencing’

The Food and Drug Administration has been getting at least $1 billion annually in recent years, including salaries for at least 4,300 full-time professionals, for food safety and nutrition.

Since the enactment of the Food Safety Modernization Act (FSMA) in January 2011, FDA has published 33 proposed or final key recommendations, and 111 draft or crucial final guidance documents, focused mainly on food safety.

FDA oversees the safety of about 80 percent of the nation’s food supply and promotes nutrition. The U.S. Government Accountability Office (GAO), an independent, nonpartisan agency that works for Congress, has found some gaps in how FDA is doing with all its new responsibilities.

In a study released Monday, GAO acknowledges FDA accomplishments in implementing FSMA while continuing to conduct inspections and investigate outbreaks of foodborne illnesses. At the same time, GAO is calling upon FDA Commissioner Scott Gottlieb to implement three recommendations generated by the study:

  • Direct the Food and Veterinary Medicine (FVM) program staff to uniformly document the basis for their decisions on issuing either regulations or guidance related to food safety and nutrition, such as using concept papers or guidance initiation sheets.
  • Develop FVM program performance measures with associated targets and timeframes for all eight of FDA’s food safety and nutrition-related objectives.
  • Complete an implementation plan including specific actions, priorities and milestones for the FVM program’s strategic plan.

GAO gave a draft of the study to the Department of Health and Human Services to review on behalf of FDA. The parent agency of FDA, the federal health department  said FDA “generally concurred” with the suggestions.

Congress asked GAO to review FDA’s food safety and nutrition-related activities and resources. About 98 percent of the $1 billion dedicated to those purposes goes for food safety and about two percent for nutrition.

The 79-page report examines how FDA has handled these programs since the 2011 FSMA enactment, including how the agency is determining its priorities. It also looks at how FDA used its resources from 2011 to 2016.

GAO also looks at how FDA set goals and time frames by analyzing documents and data from 2011 to 2018. It found that in the long term, time frames for FDA’s food safety and nutrition activities are currently unclear.

FDA officials said they hope to address that problem in the agency’s 10-year strategic plan. GAO says FDA’s challenge is prioritizing and sequencing the necessary action’s to achieve program objectives.

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