The FDA as a public health agency.

n engl j med 360;24 nejm.org june 11, 2009 2493 Act. The act sought to prevent the “manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors.” The office initially charged with this responsibility was the Bureau of Chemistry of the Department of Agriculture. Since that time, the bureau has grown into the Food and Drug Administration (FDA), an agency in the Department of Health and Human Services (DHHS) responsible for oversight of more than $2 trillion in medical products, food, and other consumer goods. What has remained constant is the agency’s “overriding purpose,” in the words of the Supreme Court, of protecting the public health.1 As the new commissioner and principal deputy commissioner of the FDA chosen by President Barack Obama, we would like to provide a broad overview of how we intend to embrace this role. The Institute of Medicine has defined the mission of public health as “fulfilling society’s interest in assuring the conditions in which people can be healthy.” To be healthy, people need access to a safe and nutritious food supply and to innovative, safe, and effective medical products. The FDA’s job is to support this access and, in doing so, to promote health, prevent illness, and prolong life. The ultimate measures of the FDA’s success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved. The urgent need to develop and produce a vaccine against H1N1 influenza virus provides an illustration of the agency’s public health role. Laboratory scientists at the FDA are growing the virus and will make reagents for vaccine-potency testing, reviewers will help to design and oversee the clinical trials, and inspectors will oversee the quality of the production process. The agency’s success will be determined by the nation’s access to a safe and effective vaccine. The traditional tools of a regulatory agency are regulation, approval or disapproval of applications, and enforcement. As a public health agency, the FDA should always ask whether delays The FDA as a Public Health Agency