Browsing HLS Student Papers by Title
Now showing items 93-112 of 498
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A Difficult Proposition: Oral Contraceptives' Switch from Prescription to Over-the-counter Status
(1997)The choice between maintaining oral contraceptives at their current prescription drug status or switching the drugs to over-the-counter status, like so many other decisions in Food and Drug Law, has as much to do with ... -
Direct-to-Consumer Advertising of Alzheimer’s Disease Drugs
(2012)Use of direct-to-consumer (DTC) advertising by pharmaceutical manufacturers has skyrocketed in the past few decades as patients demand more information on drugs and the FDA has gotten more relaxed in its regulation of ... -
Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws
(2002)The purpose of this article is to highlight the main issues raised by the Food and Drug Administration’s (“FDAâ€) approval process relating to new drugs and the treatment ... -
DISEASE-PREVENTION CLAIMS AND THE FIRST AMENDMENT: "WHO WILL PROTECT US FROM OUR PROTECTORS?"
(1994)The area of disease-prevention claims ("health claims") for food poses a broad spectrum of dilemmas that often arise in the food and drug law area and in other regulatory situations. These recurring questions include: How ... -
The Dividing Line Between the Role of the FDA and the Practice of Medicine: A Historical Review and Current Analysis
(1997)Over the years, the Food and Drug Administration ("FDA") has consistently asserted that it does not regulate the practice of medicine (the "Practice of Medicine Exception") . This prohibition has never been specifically ... -
DNA Sequences as Unpatentable Subject Matter
(2001)Man has played no part in creating DNA. It is nature which created and perfected DNA over thousands of years of evolution. What required man’s ingenuity was isolating, purifying, and sequencing the DNA. ... -
Dollar and Senses: Pharmaceutical Product Design is Becoming Vivid
(2003)Prilosec purple, Viagra blue, and Prozac green and cream: pharmaceutical product design is on the rise, and the future is even brighter. As design features come into view, protection against copying is critical to maintaining ... -
DOPING IN SPORT: AN OVERVIEW AND ANALYSIS OF DOPING AND ITS REGULATION IN INTERNATIONAL SPORT
(2003)At an early age, every one of us learns to despise cheating. Whether it be on the playground or in the classroom, cheating is wrong. Even as we grow up and appreciate the nuances of competition in business and in social ... -
A DOSE OF YOUR OWN MEDICINE? DRUG TESTING ON CHILDREN AND LABELING DRUGS FOR PEDIATRIC USE--ESSENTIAL NEEDS
(1997)Children are not just miniature adults; a child metabolizes and absorbs drugs differently than adults, making drug testing and labeling regarding pediatric use essential. This paper first addresses these needs in more ... -
Dr. Koch: A Cancer Quack?
(2006)This paper discusses the life and medical research of Dr. William F. Koch, a physiologist who claimed to have discovered a cure for cancer in the 20th century. Dr. Koch’s early education and research is ... -
Drafting organic Food Regulations: The Case for Incorporating Congressional Intent and Interest Group Commentary
(1999)The scope of the organic food debate has embroiled more constituents than simply consumers and producers of organic food. At each step along the way various interest groups such as small organic farmers, private organic ... -
Drug Reimportation: Prescription, Placebo, or Poison?
(2002)This paper examines drug reimportation as a means of reducing prescription drug prices paid by U.S. consumers. Specifically, this paper examines the provisions of the MEDS Act of 2000, which was passed by Congress right ... -
Drug Shortages: The Problem Of Inadequate Profits
(2014-03-18)Drug shortages are a growing problem in the United States. The scope and severity of drug shortages has caught the public eye and prodded the FDA into action. Among the potential causes of drug shortages are Medicare Part ... -
DRUG THERAPY AND PREGNANCY: UNKNOWN RISKS LEAD TO HARD CHOICES [REDACTED VERSION]
(2001)This paper is a proposal to improve the quality of information available to pregnant patients in selecting treatment options. By providing drug companies with extended grants of exclusivity, the FDA has the ability to ... -
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 ... -
A DUE PROCESS FOR BIOETHICS
(2002)With the sequencing of the human genome, biomedical science has entered what is likely to be an era of remarkable progress. This progress will bring tremendous improvements to human life, but it also raises difficult ethical ... -
Due Process, Choice of Law, and the Prosecution of Foreign Nationals for Providing Material Support to Terrorist Organizations in Conflicts Abroad
(2015)In November 2012, a grand jury in the Eastern District of New York indicted Ali Yasin Ahmed, Mahdi Hashi, and Mohamed Yusuf under 18 U.S.C. § 2339B for knowingly and intentionally conspiring to provide material support and ... -
AN ECONOMIC ANALYSIS OF FOOD AND DRUG LAW: Selected Topics in FDA Enforcement
(1995)In this paper, I hope to introduce the world of Law & Economics to the world of FDA enforcement. By no means is this an effort to analyze every problem dealing with the subject of FDA enforcement. Similarly, the purpose ... -
An Edict from the Thought Police: Reconciling American and European Approaches to Geographical Designations
(1997)The United States is, relatively speaking, a young country, built by immigrants who tried to replicate the best of the world they left behind. The European Union is, strictly speaking, even younger than the U.S., but its ... -
Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate
(2003)Because of its importance to determining drug usage, information has always been an important part of the regulation of prescription drugs. The Food and Drug Administration (FDA) and the pharmaceutical industry are in a ...