Browsing HLS Student Papers by Title
Now showing items 229-248 of 498
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Ideals and Issues From a Critical View of the Supreme Court’s Jurisprudence in FDA Regulation of Human Drugs
(2003)Since Congress first enacted an extensive regulatory regime for human drugs in 1906 with the Pure Food and Drug Act, the Supreme Court has shaped the contours of federal drug regulation with a variety of legal doctrines ... -
The Illusory Promise: Patents (Lack of) Power to Incentivize Drug Development for Poor Countries
(2006)Low-income countries suffer infectious and communicable diseases at a greater rate than any other income group. Because people living in these countries are not able to pay high drug prices, pharmaceutical companies do not ... -
The Image and Politics of Coca-Cola: From the Early Years to the Present
(2001)This paper examines the history of Coca-Cola from its early years to the present and discusses how the Company perpetuated the various images it sought for Coke through brilliant leadership, marketing, and the manipulation ... -
IN CIPRO WE TRUST: BUT HOW DO WE FEEL ABOUT OUR DRUG PATENT LAWS? (2002 Third Year Paper)
(2002)In many ways, the terrorist attacks of September 11, 2001, crystallized national debate over drug patents both in Canada and the United States. This became clear when, at the height of the anthrax attacks in October, NBC's ... -
THE INADEQUATE RESPONSE OF THE FDA TO THE CRISIS OF AIDS IN THE BLOOD SUPPLY
(1995)The response of the blood industry and the Food and Drug Administration (FDA) to the problem of acquired immune deficiency syndrome (AIDS) in the nation's blood supply has been called "inadequate and abysmal," "unnecessarily ... -
Incrementalism in Pharmaceutical Research: Incentives and Policy Implications
(2006)The tremendous commercial success of drugs which scientific data suggest are of no benefit to most patients relative to pre-existing drugs is illustrative of a phenomenon in pharmaceutical markets whereby products can ... -
AN INDECIPHERABLE DEBATE? AN OVERVIEW OF OPPOSING PERSPECTIVES AND THE SEARCH FOR A COHERENT REGULATORY SCHEME FOR THE REPROCESSING AND REUSE OF SINGLE-USE MEDICAL DEVICES
(2000)Caught in the middle of this controversy, the FDA has struggled for only the past few years to devise a conclusive regulatory strategy for medical device reuse. Many critics claim, however, that this action by the FDA comes ... -
Infant formula: A comparison of legislation in the United States and Taiwan
(2014-03-18)This paper examines and contrasts the legal framework in the United States and comparable legislation in Taiwan. Prompted by the Syntex incident, the U.S. Congress passed the Infant Formula Act of 1980, and delegated the ... -
THE INFERTILITY INDUSTRY: INSPIRING TECHNOLOGY GIVES BIRTH TO COMPLEX MORAL UNCERTAINTIES
(2002)Assisted reproductive technologies (ART) are rapidly advancing, permitting more couples and individuals to overcome their infertility. These advances, taking place largely outside the reach or view of government regulation ... -
Informal Guidance and the FDA
(2011)This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as its primary method of ... -
"Informed" Consent and Human Experimentation: Present Status, Pitfalls, and the Need for Reform
(2001)To demonstrate the inadequacies of informed consent in the contemporary context and the need for better subject protection, this paper begins by scrutinizing the rise of modern informed consent doctrine in international ... -
Injury in Fact, Then and Now (and Never Again): Summers v. Earth Island Institute and the Need for Change in Environmental Standing Law
(2009-11-20)This article has 3 goals: to describe the origins and development of environmental standing law, to present theoretical objections to the requirement that environmental plaintiffs demonstrate an “injury in fact” as it is ... -
Inside Insite: How a Localized Social Movement Led the Way for North America’s First Legal Supervised Injection Site
(2015)This paper explores the connection between law and social change by looking at Insite, North America’s first legal supervised injection site, as a case study. The paper focuses on how the Canadian Supreme Court was primed ... -
Insufficient FDA Resources: Levelling the Playing Field and Reducing Fraud by Altering Incentives
(2001)This paper seeks to explore the problems illustrated by the Procter and Gamble orange juice example ; namely, the peculiar side effects of inadequate FDA funding upon competition and rule compliance. Part I of this paper ... -
INSURANCE COVERAGE OF PRESCRIPTION CONTRACEPTIVES
(2002)Since the FDA approved the first oral contraceptive in the 1960s, prescription contraceptives have become a major part of women’s health care. Yet even though contraceptives are central to womenâ ... -
Interlocking Directorates in the European Union: An Argument For Their Restriction
(2016)The EU Commission has recently undertaken a review of the EU Merger Regulation. In this process it has published a White Paper that proposes to extend the Regulation to cover situations in which firms acquire minority ... -
Internet Hoaxes: Public Regulation and Private Remedies
(2000)This paper begins with a brief overview of the psychology of rumor and a discussion of the impact of Internet technology on the dissemination of rumors. Part II examines the three consumer rumors presented above as case ... -
Internet Pharmacies: Regulatory Problems and Potential Solutions
(2002)This paper will analyze the growing problem “rogue†Internet pharmacies—Internet pharmacies that conduct illegal or unsafe prescribing and dispensing practices that endanger ... -
Intrinsa: An Inquiry into Female Sexual Dysfunction and Testosterone
(2006)In December 2004, the Food & Drug Administration rejected Intrinsa, a testosterone transdermal system for the treatment of hypoactive sexual desire disorder in surgically menopausal women. Intrinsa, as well as the FDA's ... -
Is Rulemaking Old Medicine at the FDA?
(1997)The first three parts of this paper describe the major burdens placed on agency rulemaking by each branch of the government over the past thirty years, with specific focus on the burdens that presently affect FDA rulemaking. ...