The Deregulatory State

Abstract

The Deregulatory State Lawrence O. Gostin (bio) Public health can be achieved only through collective action. Individuals acting alone cannot protect themselves from work hazards, unsafe or ineffective vaccines and pharmaceuticals, impure food and water, a polluted environment, or epidemics. Only a well-regulated society can secure the essential conditions for health. Yet in this country, successive administrations have eroded health and safety protections. The consequences include deaths in the mining industry, lead in toys, industrial solvents in toothpaste, harmful bacteria in peanut butter and spinach, and unsafe and ineffective pharmaceuticals (such as COX-2 inhibitors and non-statin cholesterol medications). The "Deregulatory State" is a result of a conservative campaign that has created and reinforced deep-seated concerns about overbearing government. The political dialogue used to describe agency action is pejorative and effective: "big government," "centralized," "top-down," and "bureaucratic." This antigovernment narrative has set the terms of the debate about the role of government in protecting the public from market excesses and failures. The Deregulatory State takes many subtle forms, including self-policing, so that industry discloses and corrects its own safety violations; incapacitating, so that agencies are starved of expertise and resources; devolving, so that residual regulation is focused at the local level; preempting, so that the federal government denies states the authority to protect their citizens; and privatizing, so that government functions are conducted by "for-profit" or voluntary entities. In this column, I will focus on two broad categories of deregulation: federal preemption and privatization. Regulatory Vacuums through Preemption Congress has the power to preempt, or supersede, public health regulation at the state level, even if the state is acting squarely within its police powers. Federal preemption may seem like an arcane doctrine, but it has powerful consequences for the public's health and safety. The Supreme Court's preemption decisions can effectively foreclose meaningful state regulation and prevent people from turning to the courts for legal redress.1 Preemption has had antiregulatory effects on issues ranging from tobacco control to occupational health and safety, motor vehicle safety, and employer health care plans. From 2001 to 2006, Congress enacted twenty-seven statutes that preempt state health, safety, and environmental policies, demonstrating the potential breadth of federal power to override state public health safeguards.2 The Bush administration has vigorously advocated preemption to invalidate state public health efforts in both amicus curiae briefs and preambles to agency rules. On February 20, 2008, the Roberts Court handed the administration a victory in two major preemption cases. In Rowe v. New Hampshire Motor Transport Association, the Court held that a federal transportation statute preempted Maine's laws designed to prevent minors from buying cigarettes on the Internet.3 In Riegel v. Medtronic, Inc., the Court ruled that manufacturers are immune from tort liability for medical devices, such as implantable defibrillators or heart pumps, that received premarket approval and meet Food and Drug Administration specifications.4 The Court just heard another FDA preemption case on whether tort liability can be based on fraud for misrepresenting or withholding information from the agency during the approval process. And next term, the Court will decide whether FDA drug approval preempts personal injury suits. In effect, the executive and judicial branches are dismantling a long-standing civil justice safety net for consumers and patients who suffer from industry misconduct left unchecked by federal and state regulations. Outside the courtroom, multiple agencies charged with protecting public health, safety, and the environment have systematically pushed for preemption through administrative rulemaking. Federal agencies have inserted preemptory language in preambles to rules governing everything from seatbelt placement (this from the National Highway Traffic and Safety Administration) and mattress flammability (the Consumer Product Safety Commission) to drug labeling (the FDA) and railroad safety (the Railroad Administration). This troubling trend is made all the more worrisome by the administration's failure to provide an opportunity for public comment on the preemption language in rule preambles. This sweeping preemption of state regulation and tort actions has created regulatory vacuums. Instead of advocating devolution or otherwise supporting state authority to protect the public's health, the federal government has consistently derailed state regulation. At the same time, it has dismantled federal...