GAO Wants FDA to Assess its Foreign Inspections for Drugs and Food
[Thursday, April 11, 2019] FDA needs to complete its assessment of foreign inspections program for drugs and food, something that was originally recommended in 2016. Specifically, GAO requested, and FDA agreed to evaluate the effectiveness of its foreign offices with regards to drug safety-related outcomes, such as inspections, import alerts, and warning letters. FDA told GAO that since 2016 it has developed new performance measures for these offices and a monitoring and evaluation plan which it would complete in fiscal year 2019 and report to GAO for verification. Another GAO recommendation from 2015 has been regarding foreign inspection of food facilities from where food is imported into the US. GAO requested, and FDA agreed to evaluate the sufficiency of the annual number of foreign food inspections to ensure comparable safety of imported and domestic food. The FDA Food Safety Modernization Act (FSMA) mandates certain number of foreign good inspections by FDA; FDA is required to report if those number of inspections are sufficient or if additional resources are needed to increase the number of food inspections. Overall, GAO’s annual list of priority recommendations for FDA for the year 2019 included total of 5 recommendations for FDA including evaluating programs for assessing pesticide in agricultural products, drug residues in seafood, and arsenic residues in imported rice. Most of these GAO recommendations have been open for 3-5 years. FDA has been addressing these suggestions but GAO would want these activities to be prioritized and completed in the 2019 fiscal year.
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