Administrative Law Commons^™

Reforming And Strengthening The Centers For Disease Control And Prevention: Five Key Reforms To Renew The Agency’S Stature And Effectiveness, Lawrence O. Gostin, Sandro Galea

Georgetown Law Faculty Publications and Other Works

The US Centers for Disease Control and Prevention (CDC) is the world’s leading public health agency, so admired that whole regions and countries have borrowed its name—in Africa, Europe, even China. In past epidemics, CDC’s expertise was transformative, such as in AIDS, Ebola, Zika, and Influenza H1N1. If there ever were a moment for the CDC to show leadership domestically and globally, it was the COVID-19 pandemic. Yet, the CDC’s stature was diminished—not enhanced—in an administration that not only eschewed science and politically pressured the CDC, but also gave notice of withdrawal from the World Health Organization (WHO), where CDC …

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 …

Implementing Public Health Regulations In Developing Countries: Lessons From The Oecd Countries, Lawrence O. Gostin, Emily A. Mok, Monica Das Gupta, Max Levin

Georgetown Law Faculty Publications and Other Works

The enforcement of public health standards is a common problem in many developing countries. Public health agencies lack sufficient resources and, too often, enforcement mechanisms rely on slow and erratic judicial systems. These limitations can make traditional public health regulations difficult to implement. In this article, we examine innovative approaches to the implementation of public health regulations that have emerged in recent years within OECD countries. These approaches aim to improve compliance with health standards, while reducing dependence on both the legal system and the administrative resources of public health agencies.

This article begins by discussing some traditional forms of …

Reducing Distracted Driving: Regulation And Education To Avert Traffic Injuries And Fatalities, Lawrence O. Gostin, Peter D. Jacobson

Georgetown Law Faculty Publications and Other Works

In this article, we consider the legal and policy implications of distracted driving (the tendency of people to use electronic devices while operating a motor vehicle). After reviewing the empirical evidence showing that distracted driving has serious adverse consequences, we discuss the legal basis for governmental interventions to reduce distracted driving. These interventions include laws restricting the use of electronic devices while driving, especially sending text messages. Since drivers have at best a reduced expectation of privacy, these restrictions should easily survive legal challenges. At the same time, it is important to consider the responsibility of automobile manufacturers to improve …

The Emergent Logic Of Health Law, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The American health care system is on a glide path toward ruin. Health spending has become the fiscal equivalent of global warming, and the number of uninsured Americans is approaching fifty million. Can law help to divert our country from this path? There are reasons for deep skepticism. Law governs the provision and financing of medical care in fragmented and incoherent fashion. Commentators from diverse perspectives bemoan this chaos, casting it as an obstacle to change. I contend in this Article that pessimism about health law’s prospects is unjustified, but that a new understanding of health law’s disarray is urgently …

Pandemic Influenza: Ethics, Law, And The Public's Health, Lawrence O. Gostin, Benjamin E. Berkman

Georgetown Law Faculty Publications and Other Works

Highly pathogenic Influenza (HPAI) has captured the close attention of policy makers who regard pandemic influenza as a national security threat. Although the prevalence is currently very low, recent evidence that the 1918 pandemic was caused by an avian influenza virus lends credence to the theory that current outbreaks could have pandemic potential. If the threat becomes a reality, massive loss of life and economic disruption would ensue. Therapeutic countermeasures (e.g., vaccines and antiviral medications) and public health interventions (e.g., infection control, social separation, and quarantine) form the two principal strategies for prevention and response, both of which present formidable …

Preemption And Regulatory Failure, David C. Vladeck

Georgetown Law Faculty Publications and Other Works

This symposium was convened to address the growing and seemingly conflicting jurisprudence governing federal preemption of state damage actions. One way to evaluate the evolution of preemption law is to examine it through the lens of litigation under the preemption provision of the 1976 Medical Device Amendments ("MDA") to the federal Food, Drug, and Cosmetic Act - a provision that in many respects is typical of express preemption provisions in regulatory statutes and has spawned a high volume of litigation. The question raised in cases under the MDA is whether the Act's preemption provision nullifies state damage actions based on …

The "Gag Rule" Revisited: Physicians As Abortion Gatekeepers, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

To the surprise of many and the dismay of some, the U.S. Supreme Court took it upon itself last term to proclaim a national compromise on the question of abortion. The Court's announced truce, an elaboration on Justice O'Connor's "undue burden" idea, is pragmatic in design but unlikely to prove stable in practice. The three justices who spoke for the Court disparaged Roe with reluctant praise, then upheld its outer shell on the ground that social expectations and the need to sustain the appearance of the rule of law made it impolitic to do otherwise. This awkward doctrinal invention seems …