The FDA as a Public Health Agency (New Eng Jour Med)

A "who we are" article from the new commissioner and deputy commissioner at the FDA ~ pinto

The FDA as a Public Health Agency
Margaret A. Hamburg, M.D., and Joshua M. Sharfstein, M.D.

A little more than a century ago, concerned about the potential dangers of food preservatives such as formaldehyde, Congress passed, and President Theodore Roosevelt signed, the Pure Food and Drug 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 in approval or safety problems can be prevented — a mandate that requires extensive and creative engagement with regulated industries, patient and consumer groups, and others. The FDA should actively pursue opportunities to help advance science in the domains it regulates and address threats to the safety of medical products and food — even if those opportunities and threats lie outside the realm of the agency's usual routines. We expect to collaborate with other federal agencies and outside partners to address problems that the agency cannot solve alone.

The New England Journal of Medicine is owned, published, and copyrighted © 2009 Massachusetts Medical Society. All rights reserved.

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http://content.nejm.org/cgi/content/full/360/24/2493?query=TOC