Browsing HLS Student Papers by Keyword "drugs"
Now showing items 1-20 of 21
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Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies
(2001)This paper examines both the Food and Drug Administration’s Final Rule, which mandates drug sponsors to conduct pediatric research on their products prior to FDA approval and Section 111 of the Food and ... -
Adopting the Therapeutic Orphan? A Legal and Regulatory Assessment of the FDA's Pediatric Testing Rule
(2000)This paper explores the legality and the proper limits of the FDA's rule. Part I lays out the background for the rest of the paper by exploring the complicated policy and ethical problems posed by inadequate pediatric ... -
The Anticompetitive Impact of Settlements in the Pharmaceutical Industry: The Need for Revisions to the Drug Price Competition and Patent Restoration Act of 1984
(2002)This paper will begin by briefly examining the theories behind antitrust law and intellectual property law. Then it will look at the provisions of the Hatch-Waxman Act and at how Congress tried to balance the incentives ... -
Atypical Antipsychotic Drugs for Schizophrenia: Access, Reimbursement and the Struggle for Parity
(2002)This paper discusses the impact of schizophrenia on American society and advocates for health care reform to address the lack of access by the mentally ill to a class of innovative drugs, called “atypical ... -
Beyond Food or Drug: An Examination of Food and Drug Law Through a Study of Cannibalism
(2002)This paper attempts to explore some of the limitations within the Food, Drug and Cosmetics Act's definition of "food" and "drug". Much of the preexisting scholarly debate has focused on hybrids between foods and drugs, ... -
DTC Prescription Drug Advertising: The History and Impact of FDA Regulation
(2002)This paper traces the history of direct-to-consumer (DTC) advertising for prescription drugs in the United States, beginning with the enactment of the Federal Food, Drug, and Cosmetics Act in 1938 and continuing through ... -
The Food and Drug Administration and Drug Legalization: A Brief Model of Regulation
(2002)This paper offers a brief model of FDA regulation of currently illegal narcotics in the United States. Given that nearly three out of four Americans believe that the drug war has failed, recent calls from prominent liberal ... -
FOOD, DRUGS, AND THE ENVIRONMENT: HOW THE FOOD AND DRUG ADMINISTRATION HAS INTERACTED WITH THE NATIONAL ENVIRONMENTAL POLICY ACT OF 1969
(2000)The paper proceeds in three parts. Part II provides an overview of NEPA. The section examines the statutory text and foundational case law to understand how the statute operates and the obligations it imposes on agencies. ... -
THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY
(1999)This paper attempts to provide a chronological history of the significant events and influences that have shaped the regulation of biotechnology by the Federal Food and Drug Administration. This paper first chronicles the ... -
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 ... -
A Look at The Drug Price Competition and Patent Term Restoration Act of 1984
(2002)The DPC-PTR Act was a piece of legislation that was fought over bitterly by the generic and research-based industries, and passed only when a tenuous balance was reached through last-minute negotiations. "One indication ... -
Off-Label Use of Prescription Drugs should be Regulated by the FDA
(2003)The FDA does not subject all uses of drugs to a rigorous approval process. There are many justifications given for this. I lay out a system that divides drug-indication sets into four categories: (1) FDA approved; (2) ... -
On The Right to Get High
(2002)This paper argues that the criminalization of drugs, via the criteria the FDA [Food and Drug Administration] uses to put drugs into different schedules, is illegitimate on scientific and philosophical grounds. The most ... -
PRESCRIPTION DRUG PRICING: HOW MUCH IS TOO MUCH?
(2000)There are numerous proposals for controlling the increasing cost of prescription drugs. Some of these rely on more market-based approaches; some of them resemble traditional command and control. Many of the arguments that ... -
Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Safety?
(2000)Recently, five approved prescription drugs were recalled in a one-year period after the Food and Drug Administration (FDA or the agency) deemed them to be too unsafe for patient use. Notorious among them was fenfluramine ... -
Shocking the Conscience of the World: International Norms and the Access to AIDS Treatment in South Africa
(2003)This paper examines the emergence and institutionalization of a new international norm supporting greater access to lifesaving drugs in developing countries, particularly for HIV/AIDS drugs in South Africa. In order to ... -
A Spurious Solution to a Genuine Problem: An In-Depth Look at The Import Drugs Act of 1848
(2002)The Import Drugs Act has been relatively ignored by the academic community, and is most often relegated to a passing reference in a footnote. Yet the Act represents an important step in our nation’s ... -
Take a Label Claim, and Pay Me in the Morning: A Challenge to FDA's Argument that its Final Rule (Jan. 2000) on Structure/Function Claims for Dietary Supplements Does Not Constitute a Compensable Regulatory Taking Under the Fifth Amendment
(2000)On January 6, 2000, the Food and Drug Administration ("FDA") published its final rule prescribing the kinds of statements which can be made about the effect of a dietary supplement on the structure or function of the body ... -
Taming "Rogue" Pharmacy Websites: The Response to Illegal Prescription Drug Sales on the Internet
(2000)What has emerged from recent media coverage, White House statements, and congressional hearings is a fairly clear picture of the threat to public health posed by "rogue" online pharmacies and the obstacles facing state and ... -
THERAPEUTIC MDMA (ECSTASY): THE FEDERAL GOVERNMENT: A CLOUDY PAST & A HOPEFUL FUTURE
(2000)This Paper will present a comprehensive review of the evolution of MDMA including the historical, legal and medical issues. Part I will present the history of ecstasy prior to its criminalization in 1986. Part II will ...