On July 28, 2016, Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research, issued a statement regarding the effect of the Zika virus on the nation’s blood supply. Dr. Marks began by stating that the FDA is tasked with taking important steps to respond to Zika cases in the United States. One of the agency’s key public health responsibilities is to help ensure the safety of the nation’s blood supply.
Recently, the Office of the Florida Department of Health State Surgeon General announced that it is conducting an epidemiological investigation into a number of non-travel related cases of Zika virus in Miami-Dade and Broward Counties. These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States. Miami-Dade County and Broward Counties are adjacent counties in South Florida.
In consideration of the possibility of local transmission of the Zika virus, and as a prudent measure to help assure the safety of blood and blood products, the FDA is requesting that as, of July 28, 2016, all blood establishments in Miami-Dade County and Broward County cease collecting blood immediately until the blood establishments implement testing of each individual unit of blood collected in the two counties with an available investigational donor screening test for Zika virus RNA or until the blood establishments implement the use of an approved or investigational pathogen inactivation technology.
Additionally, the FDA recommends that adjacent and nearby counties implement the precautions above to help maintain the safety of the blood supply as soon as possible.
The FDA is also working closely with companies that are making blood screening tests available under an Investigational New Drug application (IND) to ensure that these companies are ready to expand testing as needed. Blood collection establishments in the rest of the United States may also choose now or in the future to participate in testing under IND, even in the absence of local mosquito-borne transmission of Zika virus. The FDA continues to support those regions of the United States at risk of local mosquito-borne Zika transmission that have already started screening their blood supply for Zika virus and encourages other areas at high risk to begin doing so.
The FDA will continue to monitor this potential outbreak in cooperation with the CDC and Florida State public health authorities, and will provide updates as additional information becomes available.
Dr. Marks closed by stating that, in addition to protecting the nation’s blood supply, the FDA is prioritizing the development of diagnostic tests that may be useful for identifying infection with the virus, helping to facilitate the development and evaluation of investigational vaccines and therapeutics, and reviewing technology that may help suppress populations of the mosquitoes that can spread the virus.
See the FDA Announcement
See also Medical Law Perspectives, June 2016 Report: How Risky Is Going to the Hospital? The Dangers and Liabilities of Healthcare-Associated Infections
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks