Browsing HLS Student Papers by Author "Peter Hutt"
Now showing items 1-17 of 17
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The Elusive Silver Bullet: FDA Failures, Rejected New Drug Applications, and the Search for an Obesity Cure
Canton, Allison Nina (2011)Over the past forty-five years, America has fallen victim to an obesity epidemic, affecting more than thirty percent of American adults. If the incidence of obesity continues at current rates, an estimated forty-percent ... -
Evergreening: A Common Practice to Protect New Drugs
Gaudry, Katherine (2011)Exclusivity periods serve as an incentive for pharmaceutical companies to engage in the costly and risky activities underlying drug discovery and development. Patents offer one form of exclusivity. Other exclusivities are ... -
An Extraterritorial FDA: Could the Food and Drug Administration Apply Its Informed Consent Requirement Abroad Consistent with International Law?
Schuman, Jacob David (2012)This paper addresses the regulatory challenges wrought by the increasing amount of human subject drug testing conducted in developing countries in support of new drug applications to the Food and Drug Administration. ... -
FDA and Social Media: The Impact of Social Media on Prescription Drug Advertising
Liu, Kassity Yefei (2011)The U.S. Food and Drug Administration (FDA) regulates the promotion of prescription drugs. With the emergence of Web 2.0 technology and social media, the FDA faces new regulatory challenges as pharmaceutical companies have ... -
Federal Enforcement of the Controlled Substances Act: Striking a Balance Between Enforcement and the Regulation of Medical Practice
Washington, Whitney (2009)In the Controlled Substances Act of 1970, Congress made the conscious decision to vest the regulation and control of drugs in two executive branch departments. The Attorney General, through the DEA, is responsible for law ... -
Federal Preemption of Municipal Tobacco Ordinances:New York City and the Federal Cigarette Advertising and Labeling Act
Klein, Jennifer Michele (2011)In contrast to the Family Smoking Prevention and Tobacco Act of 2009, which appears to preserve a strong role for states and cities to participate in and strengthen tobacco regulation, the Federal Cigarette Labeling and ... -
Four Loko a.k.a. Blackout in a Can: The Federal Regulation of Caffeinated Alcoholic Beverages
Mayberger, Caroline Layne (2011)Caffeinated alcoholic beverages (“CABs”) such as “Four Loko” exploded onto the drinking scene in recent years, creating a youth culture fad and sparking concern and even outrage among politicians, the media, law enforcement ... -
Health Care Fraud Liability for Pharmaceutical Manufacturers
Williams, Jennifer Adrienne (2011)Fraud is an increasingly expensive cost to the health care industry, and the regulatory and prosecutorial focus during the fast few decades have focused on health care fraud by pharmaceutical manufacturers. This paper ... -
A Heavy Burden: Rethinking the F.D.A.’s Safety Balancing in the Evaluation of Weight Loss Medications
Kraus, Erica Justine Hemphill (2011)The Food and Drug Administration has recently rejected three drugs for the treatment of obesity based on safety concerns, engendering debate about the standards the Agency should use in evaluating weight loss medications. ... -
Herein of Scandal and Advancement: A Chronicle of Human Experimentation in the United States
Aidenbaum, Whitney Lee (2011)An account of the history of human experimentation in the United States necessarily involves a recounting of scandals and the research policies that developed in response. This paper aims to provide a review of this ... -
Informal Guidance and the FDA
Lewis, Kevin Michael (2011)This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as its primary method of ... -
Lifting the Fog: The Problem of Antipsychotic Drug Use in Nursing Facilities
Lewin, Carly Serena (2011)With the rapid increase in the elder population nationwide, the problem of excessive dependence on risky antipsychotic drug treatment for dementia-related behavioral problems in nursing facilities must be addressed. At ... -
Loco for Four Loko: Regulating Caffeinated Alcoholic Beverages
Kan, Jennifer Yince (2011)Young people across the nation have been going loco for Four Loko, a caffeinated alcoholic beverage (CAB) that some college students have dubbed “blackout in a can.” Just a few months ago, the Food and Drug Administration ... -
The Next Frontier in Food: FDA Regulation of Genetically Engineered Animals
Dickos, Peter George (2011)Genetically engineered (GE) animals designed for human use, whether to be eaten as food, to produce drugs, or to be enjoyed as pets, carry the potential for enormous benefits and enormous harm. Currently, the Food and Drug ... -
The Past, Present, and Future of Direct-to-Consumer Genetic Testing: What we have Learned and Why Increased Regulation is Warranted
Bair, Stephanie Plamondon (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 ... -
Protecting Pointless Premiums:Comparing Organic Certification Standards to Consumer Motivations for Purchasing Organics
Osborn, Benjamin R., (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 ... -
Tightening Your Belt: Inequities and Inconsistencies Regarding the Treatment of Food, Prescription Drugs, and Cigarettes In the United States Bankruptcy Code
Bramson, Jeffrey Scott (2011)Debtors seeking to file bankruptcy may do so under either Chapter 7 or Chapter 13 of the Bankruptcy Code. In either case, the bankruptcy system must determine what expenses will be allowed for the debtor in bankruptcy, ...