The US Food and Drug Administration and Cardiovascular Medicine
Authors: Robert M. Califf
Journal: Circulation (2016)

he US Food and Drug Administration (FDA) is a remarkable hybrid.Part regulatory agency, part public health agency, it sits at the intersection of science, law, and public policy.The FDA's mission can be considered in the context of 2 broad dimensions: the products it regulates and its core functions.Both fall under the rubric of protecting and promoting the public health.The FDA's remit is both broad and diverse: altogether, the agency has regulatory responsibility for >20% of the US economy.The products it is charged with overseeing through its various centers 1 encompass food and cosmetics (regulated by the Center for Food Safety and Applied Nutrition); food and drugs for animals, including companion animals and animals used for food (regulated by the Center for Veterinary Medicine); and medical devices, drugs, and biologics (regulated by the Centers for Devices and Radiological Health, Drug Evaluation and Research, and Biologics Evaluation and Research, respectively).Tobacco products were added to the FDA's portfolio by the Tobacco Control Act of 2009, and are overseen by the Center for Tobacco Products.Regardless of the specific product regulated, the FDA's core mission remains the same: to protect the US population by helping to ensure the fundamental safety of the food Americans consume and the medical products prescribed by their clinicians.At the same time, this primary mission is complemented by a mandate to promote the public health by reviewing research and taking appropriate action on the marketing of regulated products in a timely manner.Not only do people need access to advances in nutrition and medical therapies, but also the American spirit is itself characterized by a strong current of scientific and technological innovation.At first glance, differences in these 2 priorities, protecting the public safety and promoting the public health through encouraging innovation, might seem to be a potential source of conflict.However, the emerging discipline of regulatory science, 2 as exemplified in the collaboration between the FDA and the National Institutes of Health on next-generation sequencing, 3 is helping to define approaches to regulation that strike an appropriate balance between these 2 important considerations.Another facet of the FDA's mission is supporting the creation and dissemination of accurate, science-based information that enables wise decision making about the products the agency regulates.This task is much more complex than some might imagine, especially in an era of rapidly proliferating information on the Internet and social media, not all of it reliable.Finally, the FDA, in concert with other agencies, has a fundamental role to play in helping the nation counter emerging threats, whether from bioterrorism, antimicrobial-resistant pathogens, 4 or epidemics of infectious diseases such as those caused by Ebola and Zika virus.Over the years, the FDA has developed a focus on decision making.As Dr Susan Ellenberg, a colleague who has migrated from FDA to academia, once taught me, "In academia, you finish your study and say 'more research is needed,' while at FDA a decision must be made based on the available information."Indeed, the FDA can be likened to a referee making calls based on a rulebook: in this case, the Federal Food,