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FDA Statement

FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories

For Immediate Release:
Statement From:
Statement Author
Leadership Role
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.

The U.S. Food and Drug Administration’s 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, has always relied on a rigorous analysis of the scientific data available and a strong commitment to safety. We are dedicated to helping ensure the safety of the American public through our work and the safety of all of our staff by continuing to support and strengthen a culture that prioritizes workplace safety.

FDA staff across the nation work diligently to help ensure the safety of FDA-regulated products. I’ve seen this same dedication in their shared commitment to protecting each other and prioritizing safety across the agency, including our laboratories across the country. As we work together to build upon our strong safety charge, I’ve recently stood up a new cross-agency working group with support from the FDA’s senior leadership to optimize and further foster a holistic, cohesive, and collaborative safety culture. As part of their charge, the group will review our current organization structure and reporting relationships that support our safety program. This working group will explore best practices and incorporate and leverage the expertise of the existing safety councils within our agency to optimize ongoing efforts. The group will focus broadly on several areas in the safety space to include occupational safety and health, environmental safety, and laboratory safety; and will look to best practices in industry to determine if they can complement our regulatory organization. This effort is meant to strengthen the already robust safety measures that staff and senior leadership have implemented. I look forward to continuing my work with the FDA’s senior leadership to bolster an already strong culture of safety and security within the agency.

As part of this broader safety effort, this new working group will also work to support ongoing safety initiatives at the FDA’s laboratories. We are committed to ensuring laboratory safety to protect our personnel and their research. To accomplish this important task, each center and office will continue to work collaboratively with the FDA’s Office of Laboratory Safety (OLS) to safeguard strong laboratory safety and security, and other laboratory-related environmental and occupational safety and health programs. This structure helps to leverage knowledge and experience from different laboratories, centers and offices at the agency to identify areas across the FDA that may benefit from agency-wide safety updates. It also creates a flexible model that can be adapted to reflect the diversity of research programs and potential hazards and risks that may be unique to specific programs or centers.

Work carried out by the FDA experts at these laboratories is integral in informing regulatory decision-making and policy development, as well as in supporting efforts to help facilitate the development and availability of innovative, safe and effective medical products and a safe food supply. The FDA’s laboratories house more than 2,500 researchers and analysts, whose work 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. Across the FDA, laboratory facilities help advance the work that we do to support our regulatory mission, from facilitating development of safe and effective medical and veterinary products to helping ensure the safety of the American food supply.

Recently, the Government Accountability Office (GAO) issued several recommendations in a report to the FDA surrounding laboratory safety. We plan to use the input from this GAO study, along with the results of a multi-phase effort led by the agency’s Office of Planning and Evaluation, to update the current OLS Strategic Plan, which will further ensure the success of a strong laboratory safety program. Assessing and revising that plan is a key component to assuring continuous improvements and operational efficiency in FDA laboratory safety.

The OLS Strategic Plan includes an iterative process to help ensure that laboratory work processes and roles are reviewed, improved and revised as needed to ensure that the agency continues to stand ready to address public health challenges. Throughout the past months, as our agency has responded to the COVID-19 pandemic, I have seen the pivotal role many of our laboratories have played in responding, and I’m committed to ensuring that our laboratories continue to have the full support of FDA leadership to maintain this high level of excellence.

Safety and a commitment to scientific excellence remain at the core of the FDA’s mission and guide our work at our scientific research and analytical facilities and across all of our programs. All of the FDA’s leadership, scientists and staff continue to demonstrate their full dedication to a safe and secure work culture and environment. I look forward to building upon this strong foundation as we consider ways to enhance and support the importance of safety at our agency.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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