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FDA is suspending its inspections outside of the US through April in response to the coronavirus (COVID-19) pandemic.
Inspections outside of the U.S. would be deemed “mission-critical” and would be considered on a case-by-case basis. The measure would be effective immediately.
In a release, FDA Commissioner Stephen Hahn, MD said, “We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”
FDA said it based this decision on several different factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees; Centers for Disease Control and Prevention travel recommendations; access restrictions being imposed on foreign visitors by certain countries; guidance from the Office of Personnel Management; and the importance of the health and safety of its employees.
The agency has taken measures and worked to get out in front of coronavirus. In late January, FDA laid out a multi-pronged strategy to handle any potential coronavirus outbreaks. Early last month, FDA granted EUA for the Centers for Disease Control and Prevention’s Coronavirus detection test. Up until then, the Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel has only been used at CDC laboratories.
FDA’s most recent measure comes at a time when President Trump is working on two different pieces to handle the coronavirus pandemic. Last week, Trump signed an $8.3 billion spending plan to help combat the coronavirus. Specifically, the bill would fund vaccine development efforts to help assist state and local government in their response, according to a report from WSJ.
The president is also proposing a payroll tax break to deal with the financial fallout related to coronavirus.
To date, there have been about 773 coronavirus cases in the U.S. with 28 dead and 15 recovering, according to statistics from worldometer.