On March 30, 2016, the US Food and Drug Administration (FDA) announced that an investigational blood screening test is available to screen blood donations for Zika virus. The FDA clarified that the investigational blood screening test may be used under an Investigational New Drug Application (IND). The IND process enables sponsors of investigational drugs to obtain an exemption to the federal regulatory requirement that prohibits the transport of unapproved drugs across state borders.
The FDA hopes that the availability of an investigational test to screen blood donations for Zika virus will bolster the FDA’s efforts to maintain the safety of the nation’s blood supply. Yesterday’s announcement follows shortly after FDA’s February 2016 published guidance, which includes recommendations for blood establishments that collect whole blood and blood components. For areas without active transmission of Zika virus, the FDA recommended enhancing donor education efforts and deferring donors who are at risk for infection with Zika virus. For areas with active transmission of Zika virus, the FDA recommended obtaining whole blood and blood components from areas without active transmission of Zika virus to fulfill orders. The FDA encouraged blood establishments to immediately heed its February 2016 guidance.
As a result of the FDA’s February 2016 guidance, local blood collection in Puerto Rico was temporarily suspended. Following the FDA’s endorsement of the new investigational test, local blood collection efforts in Puerto Rico will resume once screening using the investigational test begins.
*Blake Walsh is admitted only in Tennessee. Her practice is supervised by principals of the firm admitted in the District of Columbia.