Law Commons^™

Undue Process At The Fda, Lisa Heinzerling

Georgetown Law Faculty Publications and Other Works

For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA …

Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …