Browsing HLS Student Papers by Title
Now showing items 351-370 of 498
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Post-Approval Testing By Pharmaceutical Manufacturers
(2002)A pharmaceutical manufacturer currently has an incentive to remain ignorant about a drug’s side effects after the Food and Drug Administration (“FDAâ€) approves the drug for ... -
Potential Hazards of Cellular Phone Radiation: Responses to Fear and Uncertainty
(2002)In recent years, the public has become concerned that the electromagnetic radio-frequency radiation (“RF radiationâ€) emitted by cellular telephones may pose serious health risks, including ... -
Pre-approval of Prescription Drug Advertisements in the Shadow of Central Hudson
(2003)The article examines the effects of prescription drug advertising on patients and physicians, and explains how a requirement of pre-approval by the FDA for prescription drug advertisements could eliminate many of the ... -
Predicting the Genetic Makeup of FDA
(2000)Genetic testing holds promise as the either the most beneficial or the most destructive creation of the new millennium. The consequences of genetic testing research are far-reaching, with the potential for finding cures ... -
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 ... -
The Prescription Drug User Fee Act: A Solution to Drug Lag?
(2003)For decades, scholars criticized the United States Food and Drug Administration for delaying consumers’ access to vital new drug therapies. They argued that the FDA regulated system of drug development ... -
The Presidential FDA: Politics Meet Science
(2001)This paper proceeds in four parts. Part I. maps the powers of the various branches over the FDA. Part II. describes the Clinton administration’s tobacco regulation. Part III. analyzes the repercussions ... -
Preventing the next Public Health Crisis: New Drug Approval after Vioxx
(2005)The U.S. Food and Drug Administration (FDA) drug approval system has sought to strike a balance between two goals: ensuring that new drugs are safe enough for human use, while getting therapeutically important medications ... -
THE PRICE WE PAY: The Efficacy Requirement for New Drugs Under the Food, Drug and Cosmetic Act
(1995)The newly sworn Republican-controlled Congress has, as one of its primary objectives, the downsizing of government. Speaker Newt Gingrich has specifically targeted the federal Food and Drug Administration (FDA) for the ... -
Prison Food Law
(2005)This paper examines the history and current framework of prison food law. Whereas food law generally is the result of a complex maze of national, state, and local statutory and regulatory law, prison food is primarily ... -
The Prisoner's Dilemma: The History, Ethical Dimensions, and Evolving Regulatory Landscape of Clinical Trials on Inmates
(2013-08-29)The history of research on prisoners in the United States is marred with a shameful past of abuse and coercion. With the development of research ethics arising from the Nuremberg Code and the Belmont Report, a critical ... -
Product Liability Law of Thailand: Analysis of Conundrums under Current Related Laws and Regulations with a Comparative U.S. Approach to the Same Problems Using Contract and Tort Law
(2006)The Thai legal system is a civil law system largely influenced by the legal tradition in continental Europe, especially Germany and Switzerland, and taking Japan as its model. One of the four basic codes of Thailand, the ... -
PROFIT WINDFALL OR PATIENT WINDFALL? The Orphan Drug Act and Proposals for its Reform
(1994)The Orphan Drug Act is a statute with a noble purpose but a controversial history. Originally designed to spur research into drugs for conditions with extremely limited patient populations,~ the Act has become a highly ... -
Progress Report: A Comprehensive Evaluation of the FDA's Battle against Counterfeit Drugs
(2006)Although drug counterfeiting is a major issue in many regions of the world, the U.S. drug supply is generally safe due to extensive federal and state oversight and steps taken by drug manufactures, distributors, and ... -
Progress Toward Replacing Animals in Toxicity Testing for Cosmetics
(2006)In the 1980’s, animal rights activists successfully motivated the cosmetic industry to begin researching alternatives to animal tests. The European Union has taken action to stimulate development and ... -
The Project BioShield Act of 2004: An Innovative Failure
(2006)On July 21, 2004, the President signed into law the Project BioShield Act of 2004. This legislation was intended to stimulate research, development, and procurement of countermeasures against biological, chemical, radiological ... -
Promotion of Unapproved Uses of Approved Drugs and Devices: An Analysis under the First Amendment
(2000)This paper seeks (1) to provide the background necessary to understand current commercial speech jurisprudence; (2) to explore the First Amendment analysis in recent cases against FDA; (3) to examine the landscape of food ... -
Protecting Pointless Premiums:Comparing Organic Certification Standards to Consumer Motivations for Purchasing Organics
(2010)This paper seeks to compare the organic certification standards adopted and enforced by USDA against consumer motivations for buying organic foods. A well functioning certification system should ensure that organic foods ... -
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 ... -
PROVIDING INCENTIVES TO INDUSTRY TO DEVELOP NEW CONTRACEPTIVES
(1995)This paper will discuss why this lack of contraceptive alternatives poses such a tremendous problem, and will describe the birth control options currently available. Additionally, the paper will describe the four main ...