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‣ James Wilson, Harvey Wiley, and the Bureau of Chemistry: Examining the “Political” Dimensions of the Administration and Enforcement of the Pure Food and Drugs Act, 1906-1912

Desai, Ronak
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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While much attention has focused on the individuals and events responsible for and leading to the passage of the historic Pure Food and Drugs Act of 1906, considerably less attention has focused on the implementation, administration, and enforcement of the law in the years directly following its enactment. It is this topic that will be the focus of this paper, specifically the politics surrounding the implementation of the landmark legislation. It is easy to forget that those within the Bureau of Chemistry charged with administrating the historic food and drug law were ultimately political actors operating against a political backdrop. This paper will seek to put this political dimension of the law into sharp focus, specifically examining and analyzing the bureaucratic politics, personal politics, partisan politics, and electoral politics surrounding the Bureau of Chemistry in its attempts to administer, implement, and enforce the landmark Pure Food and Drugs Act of 1906.

‣ An Extraterritorial FDA: Could the Food and Drug Administration Apply Its Informed Consent Requirement Abroad Consistent with International Law?

Schuman, Jacob David
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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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. Specifically, it examines the difficulty of enforcing the “informed consent” requirement for ethical scientific research performed in foreign territory. In poorer regions, a lack of government oversight, lower regulatory standards, and barriers to communication have too frequently resulted in allegations of human experimentation performed without its participants’ informed consent. In order to solve this problem, some commentators have suggested that the FDA could apply its human subject protections to foreign clinical research, and enforce them through injunctions or criminal prosecutions. However, the international legal limits on states’ prescriptive jurisdiction may prohibit this exercise of extraterritoriality. After analyzing the proposed extraterritorial regulation of foreign drug testing under the traditional bases and limitations of prescriptive jurisdiction, this paper concludes that such regulation would likely violate international law. However, because nonconsensual clinical research has previously been regarded as a crime against humanity...

‣ FDA Preemption After the Food and Drug Amendments Act of 2007

Hicks, Kristin
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Opposing the explosive rise in tort litigation in the last two decades has been a corresponding rise in federal preemption claims. In the FDA context, the controversy has largely surrounded the issue of whether federal law preempts state common-law “failure-to-warn” claims against drug and medical-device manufacturers. During the current Bush Administration, FDA changed its position regarding preemption of state tort law claims and for the first time asserted that that compliance with FDA-mandated labeling provisions preempts common law failure-to-warn claims. The changed position attracted considerable attention in the academic and legal community, and the preemption debate has consequently become one of fiercest battles in products liability litigation today. Indeed, the Supreme Court is scheduled to hear a case next Term addressing preemption of products liability claims against drug manufacturers. Any decision addressing preemption of drug-based products liability claims will have to consider the impact of the recent Food and Drug Amendments Administration Amendments Act of 2007 (“FDAAA”). This Act significantly expands FDA’s enforcement and surveillance powers, provides a framework for post-market risk identification...

‣ Journalistic Framing of the Food and Drug Administration: How Do Our Nation’s Most Respected Newspapers Report About the FDA?

Silberberg, Rebecca
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The Food and Drug Administration is committed to serving the public interest by approving drugs that have to be both safe and effective. Yet, the FDA is not just doing its job in a vacuum. Due to the nature of food and drug issues and their important implications for health, every FDA decision is put under intense scrutiny by the political figures in government, pharmaceutical and public interest groups, and, finally, by the consumers themselves. This paper explores how the FDA is represented in three major newspapers across the country. The aim of the paper is to discern whether any of the newspapers show a bias towards the FDA through negative or positive reporting and, similarly, whether some discrepancies among the newspapers might be explained by liberal or conservative tendencies. The paper begins with an overview of framing within the news media, explaining just how important news reporting can be for public perception of the FDA. It then addresses research methodology and research questions. Next, it analyzes, in detail, the newspaper reporting styles and possible bias of each newspaper individually. It concludes with a comparison of the three newspapers by testing this analysis against the original hypothesis and offering possible explanations for discrepancies.

‣ THE FOOD AND DRUG ADMINISTRATION AND THE PROPOSED REGULATION OF CIGARETTES

Prabhu, Jayani V.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Since the 1930s the Food and Drug Administration ("FDA") has taken broad Jurisdiction over eveiyday products in an attempt to ensure public health. Despite that mission, the FDA In particular and the Federal government In general has done little to regulate the tobacco Industry. Recently, however, the Commissioner of the FDA, Dr. David A. Kessler. raised the possibility of regulating the cigarette industry. But is the simple regulation of cigarettes permitted by the Federal Food, Drug and Cosmetic Act of 1938, which grants the FDA jurisdiction over products? Given the unanimity of opinion on the hazards of cigarette smoking, the answer to this question is no, and yet the conclusion that cigarettes must be banned seems too radical to seriously imagine. As a result, the context in which the FDA has approached cigarette smoking should be analyzed.

‣ FDA Regulation of Food and Drug Biotechnology

Thelen, A. J.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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In its broadest sense, referring to the application of a biological process to provide a good or service, biotechnology has been affecting the human food supply for centuries In products such as beer and cheese. Similarly, since the shift from hunters and gatherers to farmers humans have been selecting and propagating certain varieties of organisms based on their genetic makeup. The discovery of DNA as the mediator of this heritable property forty years ago introduced a novel type of biotechnology based on the new science of molecular genetics. This biotechnological process of transferring DNA of one organism to another is commonly referred to as genetic engineering. Thus, genetic engineering can be seen as an extension of these age-old techniques to improve the food supply. However, it can also be seen as a completely novel technology with a great potential for abuse, therefore demanding a high level of regulatory supervision. The debate as to how the Food and Drug Administration should treat genetically engineered foods reflects these tensions precisely. This paper will consider the FDA. approach to regulating genetically engineered foods and drugs. A critique of this system will be presented centered around the issues of processed-based regulation...

‣ "Phederalism": The Regulation of Pharmacy Compounding and Two Years in the Regulatory Turf War Between Pharmacy and the Food and Drug Administration

Fairfax, Roger A.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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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 regulated professions. The pharmacy profession has traditionally been regulated at the state level by legislatively-created state boards of pharmacy. These state agencies regulate all aspects of pharmacy practice, including admission to practice, standards of practice, and discipline of pharmacists. While the Food and Drug Administration closely regulates the manufacture and distribution of prescription drugs, the day-to-day practice of pharmacy traditionally has been left to these state boards of pharmacy.

‣ Regulating Homeopathic Drugs: Pragmatic Solutions for the Food and Drug Administration

Gelfond, Rebecca J.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Despite the growth of both the use of homeopathic drugs and the homeopathic drug industry, the Food and Drug Administration (FDA) has not altered its regulatory scheme for homeopathic drugs. As a result, homeopathic drugs are allowed on the market without any evidence that they are either safe or effective. The growing use of homeopathic drugs suggests that the FDA should reconsider its stance on homeopathic drugs so as to ensure consumer safety but yet preserve consumer choice.

‣ Regulating Food and Drug Companies Privately: A View of Lanham Act Cases Brought Against FDA-Regulated Products

Lantieri, Paul
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The Lanham Act provides a flexible self-help remedy to food and drug companies that are harmed by unfair competition in the marketplace. But is it desirable for private litigation to become the de facto regulation of the industry? In an FDA regulation concerning a warning on OTC drug labels, the agency asserted that “it is in the best interest of the consumer, industry, and the marketplace to have uniformity in presentation and clarity of message.â€99 However, increased regulation through private litigation can send a muddled and inconsistent message to food and drug companies. Private companies have their business interests in mind, and may even ask for damages. This is why the role of the FDA enforcement cannot be pushed aside, or replaced by private litigation. Although many of the cases discussed herein involved disputes over product claims that did not place public health at risk, ensuring truthful labeling and advertising for food and drugs nevertheless plays a vital role in protecting public health and safety.

‣ Who Shall Meet the Foe If Not She? Women’s Participation in the Movement Leading Up to the Federal Food and Drug Act of 1906, As Seen Through the Pages of Good Housekeeping

Diamond, Jenny A.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper examines women’s participation in the movement leading up to the Federal Food and Drug Act of 1906 through a close reading of Good Housekeeping magazine between the years 1885 and 1907. The piece offers a lengthy chronological overview of Good Housekeeping’s coverage of the problems of food adulteration and misbranding. Not only did the magazine campaign for state and national legislation, but it instituted its own certification system for pure foods as well. The paper also explores Good Housekeeping’s relationships with other actors in the pure food, drink, and drug movement, including women’s clubs, temperance advocates, and Harvey Wiley. Articles and editorials in Good Housekeeping illustrate various themes emphasized by women pure food reformers, such as moralism, faith in science, and the idea that pure food was uniquely a woman’s issue. This paper suggests that Good Housekeeping’s longstanding interest in the problems of pure food, drink, and drugs lends credence to historians who argue that women were a vital part of the campaign for a federal law from the very beginning.

‣ FOREIGN-LANGUAGE LABELING OF FOOD AND DRUGS IN THE WAKE OF RAMIREZ V. PLOUGH INC.: IS AN OFFICIAL LANGUAGE THE SOLUTION FOR AMERICA?

Yahr, Kimberly A.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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In 1993, the California Supreme Court handed down a decision in the case Ramirez v. Plough. Inc.1 holding that manufacturers of nonprescription drugs in that state have no duty under the tort law to print mandatory warnings in any language other than English. It was a question of first impression not only for California, but for the nation, and the public policy issues it raised were among the most difficult in food and drug law: whom should our food and drug laws protect, and is a gain in efficiency worth even a small cost in human life? Further, this case raised a broader, equally difficult question about the very identity of our immigrant nation: when an immigrant chooses not to learn English, how willing are we to change our institutions to accommodate that decision?

‣ Harvey Wiley, Theodore Roosevelt, and the Federal Regulation of Food and Drugs

Gaughan, Anthony
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The Roosevelt and Wiley story is important because it shows the role individuals can have on the course of history. Congressional passage of the Food and Drug Act, as well as the Meat Inspection Act, reflected sweeping changes underway in the shape and direction of the federal government. By advocating food and drug regulation as a federal responsibility, Roosevelt and Wiley helped facilitate the dramatic expansion of the federal government’s role in promoting the health and safety of American consumers. Although both grew up as staunchly pro-business Republicans, each came to see a pressing need for at least a degree of federal regulation of the marketplace, particularly in regard to consumer health and safety. Indeed, Roosevelt and Wiley envisioned the Food and Drug Administration as an important ally to free enterprise. They believed that federal regulation would give consumers a higher degree of confidence and security in purchasing food and drug products, which in turn would lead to further market growth. A century of federal food and drug law in the United States has born out that vision. The Roosevelt-Wiley story is thus not only an account of the birth of the Food and Drug Administration; it is an account of the birth of the modern federal government.

‣ Making Sense of Commercial Speech: A Theoretical Framework and A Case Study in Food and Drug Law

Sukhatme, Neel
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This Note creates a theoretical framework for understanding commercial speech as a form of hybrid expression. It describes how commercial speech shares some features with expressive conduct and other characteristics with fully regulable “speech†such as exterior product designs. It also discusses how courts have been increasingly treating commercial speech like core First Amendment expression, and how many food and drug regulations have been invalidated in recent years on commercial speech grounds. The Note explores the consequences of this doctrinal shift, and suggests strategies that food and drug regulators can use to immunize themselves from the commercial speech doctrine.

‣ The Next Big Thing: Radiofrequency Identification Technology in Industries Regulated by the Food and Drug Administration

Newman, Daniell
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Radio-frequency identification (RFID) is an emerging technology that could have the most significant transformative effect on the world of commerce since the Internet became available to the masses Currently, RFID has hundreds of applications including the tracking of objects, animals, and people; the effects of RFID are not only rippling throughout the United States economy, but are spurring sweeping changes in the way the world does business. The Food and Drug Administration is responsible for the oversight and regulation of approximately one-quarter of the goods and services exchanged in the United States each year. For this reason, the FDA is in the best position to monitor the impact of developments in RFID and to exercise regulatory control over its development, implementation and ongoing use. This paper first provides an introduction to the relevant technology including a description of the most common radio-frequency identification systems and examination of the market forces driving its mass-adoption. Secondly, this paper outlines the FDA’s broad scope of regulatory authority and surveys the landscape, detailing many of the applications of RFID within the industries that operate under the watchful eye of the FDA. Finally...

‣ Food and Drug Administration Regulation of Imported Foods and Compliance With International Trade Obligations

Ting, Richard T.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Actâ€) granted the Food and Drug Administration (“FDAâ€) new authority to improve response to both intentional and unintentional pathogenic contamination of food. The Bioterrorism Act imposes mandatory registration of food facilities, mandatory prior notice of all imported foods, and mandatory record-keeping by food facilities. Further, the Bioterrorism Act grants FDA authority to administratively detain potentially dangerous food. Although Congress and FDA might prefer stricter food safety policies, their power to regulate imported foods is constrained by international trade agreements. In particular, the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures and similar provisions in NAFTA apply to food safety measures. The Bioterrorism Act is subject to criticism that its requirements fail to comply with these international trade obligations.

‣ Hollow Government: Resource Constraints and Workload Expansion at the Food and Drug Administration [redacted version]

McGlinch, Peg
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper will examine the phenomenon of hollow government at the Food and Drug Administration during the 1990s. First, it will develop the concept of hollow government, describing its causes and effects and providing examples from other agencies. Next, because it is impossible to grasp the ramifications of organizational hollowing at FDA during the 1990s without understanding how the agency fared during the 1980s, the paper will provide the essential context. Then, it will proceed with a general assessment of the situation of the agency as a whole during the 1990s, followed by an in-depth assessment of changes in the workload and resources at each of the five major program Centers located within FDA. Finally, the paper will interpret the results of the empirical analysis to determine the degree to which FDA has experienced “hollowing†over the past decade.

‣ Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action

Crovetto, Alisha Marie
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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On December 7, 2011, newspaper headlines from coast to coast announced that Plan B One-Step, a form of emergency contraception, would not be made available to females under seventeen without a prescription. The denial of over-the-counter (“OTC”) status, though newsworthy itself, drew particular attention because of the unusual nature of the decision. As the New York Times announced, “[f]or the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration . . . . no health secretary had ever publicly done so . . . .”1 This paper analyzes the novel and much-discussed public overruling of the Food and Drug Administration Commissioner by the Secretary of Health and Human Services (“HHS”) regarding the prescription-only status of Plan B One-Step for women under seventeen. Part I begins by briefly detailing the history of emergency contraception from its creation through the new drug application process, court battles, and repeated efforts to obtain OTC status for Plan B. In Part II, I move forward in time to the most recent 2011 supplemental new drug application for Plan B and the subsequent December 7 decision, exploring in detail the declared reasoning of the FDA and HHS, the evidence presented...

‣ Beyond Food or Drug: An Examination of Food and Drug Law Through a Study of Cannibalism

Cheng, Howard
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper attempts to explore some of the limitations within the Food, Drug and Cosmetics Act's definition of "food" and "drug". Much of the preexisting scholarly debate has focused on hybrids between foods and drugs, dietary supplements, vitamins, weight loss products and the like. This paper attempts to investigate our current problematic definitions of food and drug through the study of an unabashedly unorthodox subject: cannibalism. Our current regime attempts to classify a product by its “intended use.†However, many foods and drugs do not have a single intended use; they are ingested for a myriad of reasons, economic, cultural and religious. And because cannibalism has throughout history taken many different forms and has shown up on almost every continent, it acts as an excellent lens for focusing on what we might think the true limitations of the Act might be. Often times, the motivation that lay within the cannibals mind behind his consumption of human flesh was often one of simply eating a meal. In other tribes or other instances of history, some cannibals felt that eating people was the only way to treat illness, to prevent aging, cure leprosy or even blindness. However, not all instances of cannibalism fell into these simple acts of consuming a food...

‣ English is not Enough: The Language of Food and Drug Labels

Arai, Ryan
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Food and drug labels must respond to the needs of the increasing linguistic minority population in the United States. Currently, the FDA only requires that food and drug labels be in English. Due to the growing segment of the population that cannot understand English, the FDA is not able to satisfy its goals of communicating valuable information to consumers through food and drug labels. The majority of the non-English speaking population speaks Spanish, suggesting that the FDA must target this specific linguistic minority with any policy response. The paper poses the question of whether the FDA should require food and drug labels in another language in addition to English. The paper is divided into five chapters. The first chapter covers the history of the FDA's approach to food and drug labels. The California Supreme Court's decision in Ramirez v. Plough is analyzed in the second chapter. The third chapter examines the Canadian model of bilingual French/English food and drug labels. Six possible policy options are covered in chapter four. Chapter five, the policy recommendation, concludes that the FDA should ask for comment on a proposal for bilingual English/Spanish warnings and directions on over-the-counter drugs combined with a foreign language patient package insert program for prescription drugs. The paper concludes that a mandate of bilingual over-the-counter drug labels combined with a foreign language patient package insert program is an appropriate and proportionate FDA response to the increasing needs of linguistic minorities.

‣ Ain't Misbehavin'? An Analysis of Prescription Drug Promotions by Pharmaceutical Manufacturers and the Regulatory Response of the Food and Drug Administration

Gelbwasser, Lara N.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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In evaluating the United States drug regulatory system in 1978, Richard J. Crout posed a choice between competing good values: "Do we want scientific rationality or personal freedom? And if we want the latter, are we willing to pay the price of a few frauds here and there?" While the superiority of one policy preference over the other remains uncertain, since the answer largely depends upon the perspective of the "chooser" (i.e. consumer advocate or member/representative of the drug industry), what has become clear over the intervening twenty-five years is that Crout's proposed tradeoff has materialized. Changes in the structure of the law including passage of the Food and Drug Administration Modernization Act of 1997 (FDAMA), FDA's 1997 draft guidance addressing advertisements through broadcast media (such as radio and television communications) incorporated under final regulations promulgated in 1999, recent trends in the courts' First Amendment treatment of commercial speech concerning drugs, and the January 2002 Health and Human Services (HHS) policy requiring FDA legal review of regulatory letters before they are sent to drugmakers, all embody, either in theory or in practice, a loosening of the restrictions placed upon pharmaceutical manufacturers. At the same time...