Browsing HLS Student Papers by Title
Now showing items 340-359 of 498
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"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. -
The Politics of Food: How Cuba Teamed Up With U.S. Food and Agricultural Interests to Outmaneuver the Pro-Embargo Lobby
(2003)This paper will show that in the recent past the Cuban government, with the help of the U.S. food and agricultural lobby, has altered its strategy for dealing with the U.S.—at least with respect to the ... -
The Politics of Steroid Contraceptives: The FDA's Impact on Birth Control in the United States
(2002)Steroid contraceptives were created during a period of societal support of pharmaceutical research and development and a climate of eugenics. The eugenics movement, which sought a solution to expanding poor and uneducated ... -
Pop-Tarts and Elixirs of Death: An Examination of FDA’s Recall Authority
(2005)In spite of all the regulations that aim to prevent unsafe products from initially entering the market, the Food and Drug Administration must often use its enforcement powers, both formal and informal, to remove hazardous ... -
Portion Distortion and Public Perception: How Serving Size Guidelines are Over-Serving and Under-Serving the Consumer
(2003)This paper examines public perceptions regarding the serving sizes listed on the labels of packaged foods. The author conducted four surveys toward this end: 1) a survey of Brown University undergraduates in which students ... -
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 ...