US FDA's Drug Shortage Effort Questioned By GAO
GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.
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Congressional oversight agency urges FDA to make better use of foreign offices with more effective performance measures and staffing goals; GAO notes agency’s progress towards risk-based inspections – and its plan to revisit every site at least once every five years.
GAO report prompts vigorous action – and some defensiveness – by the agency.
But agency's policy changes have failed to ameliorate ongoing shortages, GAO finds.