By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and RADM Denise Hinton, Chief Scientist
The FDA is known for its mission to protect and promote public health by ensuring the safety of the nation’s food supply as well as the safety and efficacy of medical products, and by regulating tobacco products to protect Americans from tobacco-related disease and death. However, less well known is that for us to accomplish our mission, the FDA carries out scientific activities and regulatory analyses at laboratories nationwide. These activities are essential to informing regulatory decision-making and policy development as well as to supporting the agency’s efforts to speed development of innovative, safe and effective medical products. A cornerstone of the FDA’s scientific work is to ensure that we operate our laboratories and workplaces in a safe and secure manner to protect personnel and the surrounding communities.
Many of the FDA’s more than 11,000 scientists are conducting research that contributes to the development of new approaches, standards, and methods for evaluating the safety, efficacy, quality, and performance of the diverse and complex products we regulate. FDA laboratories have also continued to analyze the quality and safety of product samples collected during mission-critical inspections as well as at ports of entry throughout the COVID-19 pandemic. Moreover, the FDA’s state-of-the-art laboratory complexes perform research supporting development of medical products, such as vaccines to combat potentially pandemic strains of influenza as well as vaccines and therapies for global diseases like HIV, tuberculosis, malaria, and, of course, COVID-19. The laboratory complexes house more than 2,500 researchers and have modern suites to ensure the safe and secure storage and use of biological materials and specimens.
As evidence of our commitment to lab safety at the FDA, each center and office works collaboratively and provides the flexibility to ensure that FDA laboratories across the agency each have the support they need, while leveraging one another’s knowledge and experience. Our Office of Laboratory Safety (OLS) in the Office of the Chief Scientist provides executive leadership in the area of lab biosafety, lab biosecurity, and other lab-related environmental and occupational safety and health programs.
The OLS also provides training and education related to compliance with federal, state, local and FDA regulatory standards, policies and other requirements. FDA centers and offices that directly manage our laboratories are staffed with industrial hygienists and safety staff who oversee daily operations to ensure continued employee safety.
Because the FDA is at the forefront of the COVID-19 pandemic response, many of our staff across the country are working to support the development of SARS-CoV-2 (also known as COVID-19)-targeted diagnostics, therapeutics and vaccines in our laboratories. OLS has collaborated with FDA centers and offices to develop internal laboratory safety guidelines for personnel who are working with the virus. The guidelines provide information from initiation of work to safe practices and procedures for work in the laboratory. They also provide a fact sheet on SARS-CoV-2 that is updated frequently to include current data and research references on SARS-CoV-2. Other recent OLS collaborations with FDA centers and offices include Interim Guidelines for working in laboratory and vivarium spaces during the COVID-19 pandemic. These guidelines aim to ensure safe practices in laboratories across the FDA and describe a six-step, layered approach to preventing transmission and exposure to COVID-19 in the laboratory and vivarium spaces. Also included are other resources, such as tools that enable the agency to determine how much personal protective equipment (PPE) laboratory staff have available to be able to complete their work safely, a return to laboratory operations checklist, and information on PPE and face coverings.
To support the implementation of the FDA’s lab safety program, OLS also developed a multi-year strategic plan. This plan provides an iterative process for periodic review of laboratory safety-related policy and procedures to ensure that laboratory work processes and roles successfully address new public health challenges.
As a part of the OLS continuous process improvement, FDA’s Chief Scientist, the Director of OLS Dr. Segaran Pillai, and our directors of center and offices meet regularly to review FDA-wide processes to ensure that the lab safety program is meeting the needs of the agency. Additionally, OLS and center and office laboratory leadership hold periodic reviews of current safety program roles, responsibilities, processes, communications, and governance to make sure they reflect the current organizational structures and agency needs. We are currently assessing our status with a view to updating and revising the strategy to align with ongoing, shifting, and future priorities. To further improve our safety program, OLS has also initiated a collaborative effort to adopt and standardize a laboratory safety audit and inspection process across the agency that will support the existing center-based safety staff and procedures.
Laboratory safety is of the highest priority in all of our scientific research and analytical facilities. All of the FDA’s leadership, scientists, and staff are fully committed to providing and using the needed tools to ensure laboratory safety and to promoting a culture of responsibility at the FDA, where each individual is dedicated to creating and maintaining a safe and secure working environment.