Browsing HLS Student Papers by Title
Now showing items 327-346 of 498
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Past, Present and Future in the Search for the Perfect Anti-epileptic Drug
(2002)This paper explores the development of anti-epileptic drugs, starting with the earliest forms of treatment, moving to the drugs currently in use and those recently approved by the FDA, and ending with the drugs (and devices!) ... -
The Past, Present, and Future of Direct-to-Consumer Genetic Testing: What we have Learned and Why Increased Regulation is Warranted
(2011)Almost a decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized ... -
Patent Law, Antitrust Enforcement, and Public Access to Pharmaceuticals and Medical Technologies
(2003)Patent and antitrust laws impact public access to pharmaceuticals and medical technologies. Two instances—one involving Roche’s new class of HIV/AIDS drugs, the other an antitrust ... -
Patents – the Starting Gun in the Race for the Human Genome
(2005)The race to sequence the human genome between the federal government’s Human Genome Project and the private firm Celera Genomics is one of the most fascinating tales in the history of science. This paper explores the role ... -
Paternalism, Hostility, and Concern for the Slippery Slope: Factors in Judicial Decision-Making When Religion and Regulation Collide
(1997)This paper will examine religious claims as they pertain to food and drug law issues, as exemplified by litigation surrounding 1) the Church of Scientology's use of an instrument known as the Hubbard Electrometer, and 2) ... -
PBM and Pharmaceutical Company Mergers: Policy and Regulatory Implications
(1994)A recent trend in the pharmaceutical industry has been for large pharmaceutical companies to acquire or merge with PBMs (prescriptionlpharmacy-benefits-management companies). Merck started this trend in November 1993 by ... -
Pelman v. McDonald's: An In-depth Case Study of a Fast Food & Obesity Lawsuit.
(2005)This paper analyzes a lawsuit filed against McDonald's by plaintiffs alleging that the restaurant chain bore liability for their obesity and health problems. The paper analyzes the plaintiffs' novel tort and statutory ... -
Penis Enlargement, Cheap Viagra, and Noni Juice: Evaluating and Winning the War Against Health Product Spam
(2004)Unsolicited commercial e-mail, or “spamâ€, is an exponentially increasing annoyance for millions of Americans every day. Health product spam – spam which promotes drugs, ... -
PEREZ v. WYETH LABORATORIES INC. & THE WISDOM OF AN ADVERTISING EXCEPTION TO THE LEARNED INTERMEDIARY RULE
(2000)On August 9, 1999, the Supreme Court of New Jersey issued the first high-level court opinion to recognize a direct-to-consumer ("DTC") advertising exception to the learned intermediary rule. Although the manufacturer in ... -
Performance Enhancing Drugs: History, Medical Effects & Policy
(2006)The goal of this paper is to serve as a general treatise on the vast topic of use of performance enhancing drugs in athletic competition. It begins by laying out the extensive history of doping in sports, from the ancient ... -
THE PERVASIVELY REGULATED BUSINESS EXCEPTION AND THE FDA
(1995)Section 704 of the Federal Food, Drug and Cosmetic Act authorizes the Food and Drug Administration to conduct inspections of regulated business establishments. In the statute. Congress required that the inspections be at ... -
A PHARMACIST'S DUTY TO WARN: SOUND ECONOMICS, EFFECTIVE MEDICINE, AND CONSISTENT WITH DRUG REGULATION THEORY
(1995)This paper argues in favor of a duty to warn on the part of the pharmacist. In the next section, I begin with a discussion of two common regulatory approaches to warning patients of prescription drug hazards and flesh out ... -
PHARMACY.COM
(2002)The Internet takes the purchase of prescription drugs from the local pharmacy to the Internet superstore across the nation or around the world. It is expected that the market for Internet pharmacies will grow from a virtual ... -
"Phederalism": The Regulation of Pharmacy Compounding and Two Years in the Regulatory Turf War Between Pharmacy and the Food and Drug Administration
(1998)Pharmacy has long been considered among the most popular of professions, with pharmacists consistently topping surveys of whom Americans consider the most honest and ethical professionals. Pharmacy is also one of the most ... -
PhRMA-Dynasty: How to Provide Antiretroviral Access to Developing Nations while Aligning Research Incentives for Pharmaceutical Companies in the Form of Profit and Intellectual Property Protection
(2006)The AIDS revolution has led to shockingly high rates of mortality in the developing world. Governments of developing and developed nations alike are on high alert, attempting to design appropriate strategies to combat the ... -
PHYSICIAN PRESCRIBING PRACTICES AND ADVERSE DRUG REACTIONS: A Proposal for Further FDA Regulation of Prescription Drugs
(1995)In 1938 the Food and Drug Administration (FDA) adopted regulations which created a category of prescription drugs to be distributed only by order of a physician or other licensed medical personnel. This categorization, ... -
Placebo or Panacea: The FDA's Rejection of ImClone's Erbitux Licensing Application
(2003)This paper draws upon the media reports, congressional hearing testimony, and company press releases to recount events surrounding the FDA’s refusal to issue a license to ImClone’s ... -
Placing Blame for the Vioxx Debacle
(2006)The purpose of this paper is to tell the complete story, from creation to termination to litigation, of the Merck Pharmaceutical Company drug, Vioxx. This paper will explain the type of drug Vioxx is and the way in which ... -
A POLICY ANALYSIS OF HOW FDA SHOULD REGULATE HUMAN BONE MARROW TRANSPLANTATION
(1995)Over the past twenty years, physicians have carried out bone marrow transplants with increasing success. As the procedure gains in acceptance and availability over the coming years, our nation will be faced with important ... -
Political Science and the FDA
(2001)This essay collects and analyzes the important political science works on FDA, with an eye both to serving as a springboard for future research on FDA decision-making and to drawing conclusions from extant research.