Georgetown University Law Center

About: Georgetown University Law Center is a based out in . It is known for research contribution in the topics: Supreme court & Public health. The organization has 585 authors who have published 2488 publications receiving 36650 citations. The organization is also known as: Georgetown Law & GULC.

Truth and Consequences: The Perils of Half-Truths and Unsubstantiated Health Claims for Dietary Supplements

Abstract: The author examines the recent decision of the U.S. Court of Appeals in Pearson v. Shalala, which struck down on First Amendment grounds the Food and Drug Administration’s (FDA’s) regulatory scheme for approving health claims for dietary supplements. In its recent ruling, the Pearson court rejected the FDA’s view that health claims that cannot be proved as either true or false pose a serious risk to consumers. Although the court recognized that some health claims will mislead consumers, it reasoned that the FDA’s regulations are nonetheless impermissibly restrictive because they do not allow manufacturers to make health claims accompanied by clarifying disclosures when significant scientific agreement is lacking. The court suggested that disclaimers referring to the absence of FDA approval, or the inconclusive nature of the scientific evidence, might be sufficient to guard against consumer deception. The author explains why the reasoning of Pearson misconceives basic First Amendment commercial sp...

Sovereign Debt: Now What?

Abstract: The sovereign debt restructuring regime looks like it is coming apart. Changing patterns of capital flows, old creditors’ weakening commitment to past practices, and other stakeholders’ inability to take over, or coalesce behind a viable alternative, have challenged the regime from the moment it took shape in the mid-1990s. By 2016, its survival cannot be taken for granted. Crises in Argentina, Greece, and Ukraine since 2010 exposed the regime’s perennial failures and new shortcomings. Until an alternative emerges, there may be messier, more protracted restructurings, more demands on public resources, and more pressure on national courts to intervene in disputes that they are ill-suited to resolve. Initiatives emanating from wildly different actors — the United Nations General Assembly, the International Monetary Fund, the International Capital Market Association and the Jubilee coalition, among others — reflect broad-based demand for reform. Now is the time to reconsider the institutional architecture of sovereign debt restructuring, along with the norms and alliances that underpin it. In this symposium essay, I suggest broad criteria for evaluating a successor regime, and offer a package of incremental measures to advance sustainability, fairness, and accountability.

Safeguards for tobacco control: options for the TPPA.

Abstract: I. LEGACY OF 20TH CENTURY TRADE POLICYWith tobacco trade, the past is prologue. In the 1980s, the U.S. government used domestic trade remedies ("Super 301") to pry open markets for U.S. tobacco companies.1 The targets included Japan, South Korea, Taiwan, and Thailand.2 A grateful tobacco industry donated a renovation of the Treaty Room in the U.S. Department of State, declaring at the dedication: "Tobacco is intimately and historically associated with American diplomacy."3Thailand responded by banning imported cigarettes on grounds that the imports were more addictive and marketing of imports was driving up consumption. The United States then challenged Thailand for violating the General Agreement on Tariffs and Trade (GATT). The GATT panel ruled against Thailand, finding that the import ban failed to satisfy the health exception of GATT Article XX.4Studies showed that liberalizing tobacco trade in the 1990s resulted in lower tariffs, lower prices, aggressive marketing, and greater tobacco use-in the range of ten percent for all four countries.5 The same results held true for China, India, Indonesia, Malaysia, Pakistan, and the Philippines.6 By 1997, the mounting evidence of a "tobacco epidemic"-and the overt connection with trade agreements- prompted an apparent shift in U.S. policy. The U.S. Congress adopted the Durbin and Doggett Amendments, which prohibit federal agencies from promoting "the sale or export of tobacco or tobacco products" or seeking "the reduction or removal by any foreign country of restrictions on the marketing of tobacco or tobacco products, except for restrictions which are not applied equally to all tobacco or tobacco products of the same type."7 In 2001, President Clinton issued Executive Order 19393 to make clear that this policy applies to all executive agencies and "the implementation of international trade policy."8 Limiting trade negotiators aimed to promote coherence between health and trade policy.9In 2003, congressional leaders documented how the Office of U.S. Trade Representative (USTR) negotiated Korean tariff reductions on behalf of Philip Morris International (PMI), agreed to zero tobacco tariffs on the last day of negotiations on the U.S.-Chile Free Trade Agreement (FTA), and proposed ten of eleven amendments sought by PMI to weaken the draft Framework Convention on Tobacco Control (FCTC).10 Since the Doggett Amendment has been in effect, the USTR has negotiated with eighteen countries to eliminate tariffs on processed tobacco leaf and cigarettes.11 The United States continued to expand market access for tobacco-related services and extended investor rights to tobacco companies. Writing for the Council on Foreign Relations, Thomas Bollyky summarizes the legacy of twentieth century trade policy for tobacco:Tobacco companies are aggressively exploiting trade and investment agreements to expand their market in low- and middle-income countries. Lower tariffs reduce the price of imported cigarettes in countries without good taxation systems to compensate. Multinational tobacco companies use dispute resolution ... to block tobacco marketing and labeling regulations far more modest than those in the United States. Young women, who have historically smoked less than men in most parts of the developing world, are a major target of industry marketing campaigns.12Now the U.S. government is leading negotiations among eleven countries on a Trans-Pacific Partnership Agreement (TPPA), "a true 21st century trade agreement" that "will reflect U.S. priorities and values."13 The open question is whether a priority is to support tobacco trade as it contributes to 6 million deaths per year- one billion deaths in a twenty-first century epidemic.14 The TPPA has six chapters that might provide material support to the tobacco industry.15As trade agreements evolve through regional negotiations, the first global health treaty is emerging as a force to exercise, rather than restrict, regulatory authority. …

Law and Medicine

Abstract: The failure of the federal government to reform national health care has not stopped significant reform at the state level and within the private sector. Health care plans, particularly those that manage care, have thrived under state and private reform initiatives. Health care plans are sometimes criticized for withholding needed care as a method of cost savings by excluding or limiting coverage for chronic conditions such as human immunodeficiency virus (HIV) disease or mental illness, denying reimbursement for experimental procedures such as bone marrow transplants, or establishing maximum durations for inpatient hospital care such as for women giving birth. Legislative and judicial activity, as well as ethical discussion, has occurred in each of these controversial areas over the past year. State legislatures and courts, however, were often precluded from regulating risk retention (self-insured) health plans under the preemption provisions of the Employee Retirement and Income Security Act (ERISA); risk retention

Human Rights and the Framework Convention on Tobacco Control: Mutually Reinforcing Systems

Abstract: This article explores the connection between human rights and tobacco control, and in particular, the Framework Convention on Tobacco Control (FCTC). We address rights-based arguments used by the tobacco industry to argue against tobacco regulation. We demonstrate the weakness of these arguments, and that tobacco control and human rights are, in fact, not in conflict, but are mutually reinforcing. We also offer counter-arguments in favour of tobacco regulation based on international human rights obligations. Moreover, we argue that international human rights law and human rights bodies can provide tobacco control advocates with avenues for international monitoring and enforceability, which are lacking in the FCTC.