Author Affiliation: Maryland Department of Health and Mental Hygiene, Baltimore.
Anyone who spends a day at the US Food and Drug Administration (FDA) will appreciate the scale of its responsibilities. Hundreds of drugs, devices, and biologics under review; thousands under surveillance. The safety of approximately four-fifths of the food supply. Nutrition labeling. Animal drugs. A new regulatory structure for tobacco products. And cosmetics too.
Anyone who spends a week at the FDA will experience the agency's many roles. For patients with severe illness and for their physicians, the FDA is the judge of whether promising ideas in the laboratory can make it to the bedside. For entrepreneurs, the agency is the gatekeeper that determines the viability of investments in innovative products. For consumers, the FDA is the last line of defense before an unsafe treatment or food threatens the public.
Sharfstein JM. The FDA—A Misunderstood Agency. JAMA. 2011;306(11):1250–1251. doi:10.1001/jama.2011.1345