Neali H. Lucas, Ph.D., supervisory consumer safety officer, Office of Biologics Products Operations/Division 2/Investigations Branch, Office of Regulatory Affairs, Food and Drug Administration
I am Lt. Commander U.S. Public Health Service Commissioned Corps Officer Neali Lucas and a supervisory consumer safety officer in the FDA Office of Regulatory Affairs, Office of Biological Products Operations, Division 2, Investigations Branch. Americans use biological products in a variety of ways, including blood for transfusions, plasma-derived products for immunotherapy, and tissue-derived products such as reproductive tissues and stem cell therapies. My branch works to ensure that blood, blood products, and tissue-derived products are manufactured in a manner that minimizes the risk of communicable diseases for recipients.
After completing graduate school, I pursued a career that would allow me to directly impact public health. I was employed by a pharmaceutical service organization where I prepared documents for submission to FDA. I assisted in getting new therapies to market but, as a service provider, I found the focus on financial considerations to be at odds with my core values. In 2010, I was fortunate enough to be hired by FDA as an investigator working in the Biologics and Bioresearch Monitoring Program areas. This new career path is where my work and values aligned as a public servant. As an investigator, I also became a sort of truth-teller: I identify what’s going on at a firm with “no bias” and “no bend.”
I appreciate that my work has a tangible and positive impact on the health and safety of the community and the nation. For example, last year we received notification from a state partner that there was an outbreak of severe bleeding among individuals who recently used illegal synthetic cannabinoids, also known as K2/Spice, that was contaminated with brodifacoum, a very long-acting anticoagulant commonly used in rat poison. Individuals suffering from K2/Spice-related bleeding events reported donating source plasma at different facilities throughout the state. My team conducted a thorough investigation of one of the firms where an individual with severe bleeding was known to have donated plasma. Because of the investigation, the firm developed a new corporate directive and procedures for donors who admit to using synthetic marijuana. The firm implemented the directive and procedures at all of its facilities spanning multiple states. These procedures, prompted by our investigation, directly protected the applicable donors from the bleeding risks and the potential for contamination of blood products donated by individuals who used these substances. Due to the expanding scope, the FDA commissioner released a statement on the risks associated with synthetic cannabinoid product use.
I was introduced to the U.S. Public Health Service Commissioned Corps after joining FDA. At a training session, an officer shared information with me about the corps and its commitment to protect, promote, and advance the health and safety of our nation. As a member of the corps, I have additional opportunities to positively impact my community and the public health.