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Report to the Commissioner: FDA Review of the 2014 Discovery of Vials Labeled &ldquo;<i>Variola</i>&rdquo; and Other Vials Discovered in an FDA-Occupied Building on the NIH Campus

Report to the Commissioner: FDA Review of the 2014 Discovery of Vials Labeled &ldquo;<i>Variola</i>&rdquo; and Other Vials Discovered in an FDA-Occupied Building on the NIH Campus

The report, "FDA Review of the 2014 Discovery of Vials Labeled 'Variola' and Other Vials Discovered in an FDA-Occupied Building on the NIH Campus," issued on Dec. 13, 2016 details the FDA’s findings, including specific corrective actions taken to date or in progress, following the FDA’s internal investigation into the discovery of vials of variola in an FDA shared cold storage room located on the NIH campus in Bethesda, Maryland in July 2014.

On April 20, 2016, Dr. Segaran Pillai, Director of Laboratory Science and Safety at FDA, testified in front of the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, regarding the safety of the FDA’s bioresearch labs. This hearing provided an opportunity for the subcommittee to ask questions about the 2014 discovery. During this hearing, the FDA highlighted steps taken following the 2014 discovery, as well as those in progress to improve laboratory safety and security practices across the agency.

It was noted that an internal, inward-looking investigation by the FDA had not formally started at the time of the hearing because both the CDC and FBI were in the midst of their own investigations of the incident.  However, FDA informally started an internal review and audit of the incident to understand the failure points to implement best policies and practices to prevent such incidents from happening in the future.

Following this hearing, Chairmen Fred Upton (R-MI) and Tim Murphy (R-PA) of the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations reached out to the FDA with follow-up questions and requested a copy of the FDA’s internal investigation upon its completion. This report was shared with the Committee in response to their request.