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‣ 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 HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY

Stepp, David L.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper attempts to provide a chronological history of the significant events and influences that have shaped the regulation of biotechnology by the Federal Food and Drug Administration. This paper first chronicles the evolution of each of the separate fields of regulation into which biological products are categorized by the FDA (drugs, biologics, devices, and foods). Part III of this paper then discusses the first call for governmental regulation of biotechnology and the struggle for regulatory form that this shift in administrative authority created. Part IV describes the Coordinated Framework for the Regulation of Biotechnology. Part V discusses subsequent efforts, both Congressional and administrative, to reform the regulation of biotechnology by FDA.

‣ FDA Regulation of Health and Fitness Equipment

Moss, Nicole J.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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As new "quasi-medical" devices continue to push the bounds of the FDCA definition of a medical device and with growing popular support for using the FDA to regulate previously off-limit products such as tobacco, the FDA may very well broaden its regulatory scope into the health and fitness industry. By focusing on the specific example of the scuba industry, this paper will examine first, whether the FDA has the authority to regulate athletic equipment as medical devices. Part two will explore the plausible reasons for why the FDA in the past has chosen not to regulate athletic equipment and whether those rationales still make good sense. Part three will discuss whether the scuba industry can serve as an example for other sectors of the health and fitness industry that seek to avoid FDA regulation.

‣ FDA Regulation of Imported Foods in an Age of Globalization

Schisa, Michael W.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This essay will explore the intersection between the FDA’s regulation of imported foods and the United States’ obligations under the General Agreement on Tariffs and Trade (GATT) the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement), and the Agreement on Technical Barriers to Trade (TBT Agreement), three of the foundational documents underlying the WTO system. I will argue that the FDA’s import regime violates US trade obligations both by virtue of its use of a different standard for denying imported food access to the US market than for determining whether domestically produced food is fit for consumption and by virtue of the relatively informal manner in which FDA is able to exercise virtually limitless statutory authority over imported foods. Additionally, the essentially ad hoc determination of what imported food is inspected or detained, while not necessarily inconsistent with the WTO regime, is susceptible to abuses that could give rise to trade complaints.

‣ FDA and the Challenge of Alternative Medicine: Realistic Assessments and Regulatory Flexibility

Hwang, Tricia
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Alternative medicine has already established a role for itself in the health care of many Americans. FDA, however, has been slow to develop a meaningful and coherent regulatory response to this growing phenomenon. Reluctant to change its mind-set, FDA acts under the mistaken belief that the current regulatory scheme can accommodate any alternative medicine that will be useful to the public. Because of their conceptual and philosophical differences from conventional medicine, however, many alternative therapies simply cannot meet the demands of the current regulatory system. This reality does not imply that such medicines are not valuable. While it is true that many practices that are labelled alternative are nothing more than health fraud and often dangerous, there are also many medicines with great potential to improve how Americans think about and use medicine. A coherent policy toward alternative medicine and a more flexible regulatory scheme are required of FDA if Americans are to be given the freedom to choose different forms of health care safely and wisely.

‣ FDA Regulation of Food Labeling

Yang, Hannah Y.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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As one strolls down a grocery aisle, shift through the maze of cosmetic counters, or sits in front of the television, one is transported into various fantasies, identities, and scenarios. The power of advertisements and package designs to influence the consumers has grown tremendously over the years. Food and cosmetic manufacturers, cognizant of this power, have invested an enormous amount of their resources into the both advertising and packaging – so much so that a fissure has formed between the “image†and the “actuality†of the product. Manufacturers prey on the consumers becoming more impulsive and vulnerable, and the amplification of the product’s “image†has helped this cause. No agency or body of law is curtailing this growth and use of the power except the Food and Drug Administration. Through its stringent labeling regulations throughout this century, the FDA has limited how far the manufacturers can go with their package designs. By imposing its numerous requirements, the FDA has provided the consumers with an “awareness,†and room to dilute the appeal of the “image.†In this sense...

‣ Ephedra and the FDA

Ehlers, Brandi E.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The adverse events experienced after ingesting ephedra and other dietary supplements have demonstrated the need for FDA intervention. The FDA has an important role to play in safeguarding the health and safety of the American public. The FDA has been criticized as contravening the Congressional intent underlying DSHEA because of its attempts to regulate the dietary supplement industry, when in fact, the FDA has not overstepped its bounds. The agency has only taken the measures it felt necessary to protect the public and "implement a complex and ambiguous law." However, the FDA does need to focus on more effective procedures and systems for collecting adverse event reports and could take additional steps toward public awareness. In order for the FDA to address the overall problems with the regulating the dietary supplement industry efficiently and effectively, they will need additional funding.

‣ Insufficient FDA Resources: Levelling the Playing Field and Reducing Fraud by Altering Incentives

McFarland, Joshua L.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper seeks to explore the problems illustrated by the Procter and Gamble orange juice example ; namely, the peculiar side effects of inadequate FDA funding upon competition and rule compliance. Part I of this paper will describe the problem in detail, exploring the FDA’s resources and responsibilities, their effects on competition and compliance, and the various externalities associated with this particular issue. Part II of this paper will discuss ways in which various industries have attempted to circumvent and supplement FDA regulation. Part III of this paper proposes a way in which limited FDA resources could be used more efficiently to encourage industry to notify the agency of violations while simultaneously encouraging violators to cease their offending behavior before formal FDA action is taken towards them or an industry leading scapegoat. My proposal seeks to alter the costs and benefits of FDA rule violation by increasing penalties when appropriate and making enforcement more likely, thus reducing the aggregate amount of rule violation and leveling the playing field. I argue that this goal can be accomplished without significant increases in FDA spending, and perhaps could even reduce spending and increase funding.

‣ Flying Below the Radar Screen: The Absence of Information About the FDA

Trainer, Nancy G.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper is a study of how the American people interact with and understand a complicated governmental agency, the FDA. Part I examines the traditional role of media in providing information to people about government; Part II examines the FDA’s role in government, and the public’s overall perception of the FDA; Part III focuses on media coverage of the four drug recalls mentioned above; following this are a few concluding remarks.

‣ FDA Enforcement and the Constitution: The Validity of FDA Seizures under the Due Process and Just Compensation Clauses

Shane, Andrew L.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper explores the way in which enforcement actions by the Food and Drug Administration (FDA) interact with certain constitutional rights, and it queries whether the system does its most to protect those rights while preserving the public interest in safety. The paper is essentially an analysis of the intersection of section 304 of the Food Drug and Cosmetic Act, involving FDA seizures, with the due process and just compensation clauses of the Fifth Amendment to the U.S. Constitution. The due process section of the paper relies heavily on the Supreme Court’s decision in Ewing v. Mytinger & Casselberry. The just compensation section provides a review of select takings cases, including in particular Miller v. Horton and Jarboe-Lackey Feedlots, Inc. v. United States. At the end of each of these sections is a thought section discussing whether the law should be changed. There is also a brief analysis of the relationship of seizure law to the Fourth Amendment. The paper’s conclusion is that the current state of affairs is not a disaster but could be improved.

‣ Bioterrorism and the Food Drug Administration: H.R. 3448, Related Legislation, and the FDA’s Expanding Role in Preventing and Responding to Biological Attack

Kirk, Christine E.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper examines the potential impact of recent and proposed bioterrorism legislation on the U.S. Food and Drug Administration (FDA). It concludes that at least one such piece of legislation, H.R. 3448, the “Public Health Security and Bioterrorism Response Act of 2001,†would significantly impact the authority and activities of FDA, as well as affecting FDA-regulated entities and other stakeholders. The paper includes recommendations for further FDA action, noting that as the federal agency responsible for the safety and efficacy of food, drugs, medical devices, vaccines, and other biological and non-biological products across the nation, FDA holds a unique and critical position in bioterrorism prevention and response.

‣ THE REGULATION OF SPORTS PRODUCTS AS DIETARY SUPPLEMENTS: SHOULD THE FDA HAVE STRICTER REQUIREMENTS?

King, Carlotta D.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Since the Food and Drug Administration (“FDAâ€) has control over the regulation of dietary supplements, this paper discusses whether the current regulation is sufficient to guard the safety of the individuals using “sports products.†Recently, the sudden deaths of a number of professional and collegiate athletes have been linked to the use of performance enhancing sports products, and despite other possible causes, many families and scholars have blamed dietary supplements for these lost lives. Therefore, this paper purports to prove that the current FDA regulations are not stringent enough because they do not subject dietary supplements to the pre-market approval as with drugs and allow life-threatening products to enter and remain in the market. For evidence, this paper compares different past and present FDA regulations, the scientific risks of the most popular sports supplements, the rigorous regulation by other associations, and the real life stories of athletes’ deaths. In conclusion, this paper will demonstrate that the current drug requirements should apply to dietary supplements to give the FDA the ability to regulate further dietary supplements that warrant stricter regulation.

‣ Off-Label Use of Prescription Drugs should be Regulated by the FDA

Tiwary, A Devesh
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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The FDA does not subject all uses of drugs to a rigorous approval process. There are many justifications given for this. I lay out a system that divides drug-indication sets into four categories: (1) FDA approved; (2) effective; (3) insufficient information; and (4) ineffective. Each category is treated differently so manufacturers have an incentive to get as many indications into the FDA approved category as possible. Physicians will be required to submit de-identified patient data and when prescribing drugs for indications that have insufficient data. They, or their patients, may not be reimbursed for that care unless it is part of a study. My system saves money, improves health care, and advances medical knowledge at the cost of decreased physician autonomy and possibly slightly higher regulatory cost to drug manufacturers.

‣ A Retrospective Review of FDA v. Brown Williamson Tobacco Corporation and the Issue of Congressional Intent

Brooks, Angela
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Contrary to a tradition of the FDA (Federal Food and Drug Administration) consistently maintaining that it could not assert jurisdiction over tobacco products, the agency issued a determination of jurisdiction over cigarettes and smokeless tobacco and proposed a set of regulations in 1996 in an effort to combat the public health problems caused by tobacco products. Rather than a complete ban, the FDA proposed regulations aimed solely at younger Americans due to its conclusion that such an approach was safer for the public health. Despite a variety of arguments by the FDA, the Supreme Court held that the FDA could not assert jurisdiction over tobacco products because Congress had directly addressed that precise question and had precluded the FDA from regulating cigarettes and smokeless tobacco. Examining the FDA regulatory scheme as well as the several pieces of tobacco-specific legislation enacted by Congress, the Court found that the FDA’s regulation of tobacco products would be contradictory to the FDCA (Food, Drug, and Cosmetic Act) as a whole and to Congress’ intent to adopt a separate regulatory regime for tobacco products. Through a narrow interpretation of the FDCA and a broad reading of the tobacco-related legislation broadly...

‣ Better Fighting Through Chemistry? The Role of FDA Regulation in Crafting the Warrior of the Future

Anonymous, Anonymous
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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This paper examines how FDA might respond to attempts by the U.S. military to offer troops an experimental, performance-enhancing drug or medical device to improve alertness, prevent fatigue, and obviate the basic human need for sleep. This paper chronicles military performance enhancement throughout human history, identifies future approaches to military performance enhancement currently being pursued by the American military, and examines the historical relationship between FDA and the military. Based on this historical and policy background, this paper argues that the unique regulatory concerns raised by experimental military performance enhancement technologies will create new strains on the relationship between FDA and the American military.

‣ Borrowing Trouble: Should the FDA Regulate Human Cloning?

Carmody, Allison R.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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Less than a year after scientist Ian Wilmut announced the birth of Dolly, the world's first cloned sheep, entrepreneur and physicist Richard Seed stated on National Public Radio that he intended to establish a for-profit clinic to clone human beings as soon as the technology was available. An immediate, visceral reaction to the prospect of human cloning reverberated throughout the nation and the rest of the world, as private and public organizations alike rushed to impose moratoriums, pass legislation, and appeal to scientists' morality to suppress any attempts to clone a human being. In the thick of this debate it became apparent that no existing arm of the federal government had jurisdiction to monitor privately-funded research. The Food and Drug Administration (FDA) then stepped forward and asserted that it, in fact, did have authority to regulate human cloning under the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. Since then the dust has settled. More than one legal scholar has questioned the FDA's claim to authority, and the FDA itself concedes to be re-evaluating its position. While legal scholars struggle to define the scope of the FDA's power, ethical scholars appear engaged in a debate over the moral implications of cloning a human. What these groups have failed to address satisfactorily...

‣ The Truth Hurts?: FDA Regulation of Truthful Speech

Collins, Elisebeth
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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One of the more frightening pictures in our society is one of a speaker being silenced, simply by virtue of who the speaker is; yet, the FDA engages in that type of censorship on a regular basis. The FDA censors manufacturer dissemination of truthful information concerning unapproved ("off-label") uses of prescription drugs, and does so at the expense of the First Amendment. Nor does the FDA further its mission of protecting the health and safety of the American public through its censorship. In fact, the FDA's rigid policy creates more harm than good. Although off-label drug use can present serious harms, there are more efficient and less constitutionally offensive means to minimize such harms than through the FDA's current regulations. Parts I and II of this essay will set forth the relevant regulatory scheme and the current rubric for commercial speech jurisprudence. Part III examines the FDA's asserted justifications and rationales for regulating information pertaining to off-label drug-use. Parts IV and V include a policy analysis of the regulations, and set forth a few alternative solutions. This essay concludes that not only do the FDA regulations violate the First Amendment, they do not make good policy sense. The freedom agencies enjoy in the face of the First Amendment is a serious problem in our society...

‣ Toward National Uniformity for FDA-Regulated Products

Semet, Amy E.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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In this paper, I will argue that national uniformity should be granted to all FDA-regulated products and should include preemption of both state labeling and safety standards as well as state product liability laws. Cosmetics and food should be treated the same as FDAMA treats OTC drugs. Although the FDA has developed different regulatory regimes for each product, the FDA has established the optimal standards for all of its products, and states should not interfere to preclude harmonization. Congress should also prevent state courts and lay juries from interfering with the goals of the FDA to both ensure the safety of products, while at the same time, encourage innovation. The Supreme Court has said, "state regulations can be as effectively exerted through an award of damages as through some form of preventive relief. The obligation to pay compensation can be, indeed is designed to be, a potent method of governing conduct and controlling policy." Congress needs to recognize that state tort claims impose requirements for safety and effectiveness that can be just as detrimental to the goals of national uniformity as state labeling and safety standards. The benefits of national uniformity for FDA-regulated products can never be fully realized if state tort suits interfere as an additional regulatory tool to monitor safety. FDAMA itself is inherently contradictory...

‣ Predicting the Genetic Makeup of FDA

Yang, Tamara J.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
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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 to diseases such as cancer, or destroying an individual's life by changing insurance ratings, employment opportunities, and reproductive decisions. The scientific, legal, socioeconomic, and ethical implications of genetic testing demand appropriate regulatory controls. The responsibility of regulation falls on various governmental agencies, including the Food and Drug Administration (FDA). However, the neophyte genetics industry, ever evolving through biotechnological developments, does not have sufficient safeguards to meet the challenges posed by the impending completion of the Human Genome Project. Whether FDA is the appropriate regulatory body to solve these imminent problems is a question requiring a detailed exploration of genetic testing, the Human Genome Project, FDA's history, current regulation of genetic testing, critiques of FDA involvement, and alternative solutions.

‣ Do Faster FDA Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

Grabowski, Henry; Wang, Richard
Fonte: SSRN eLibrary Publicador: SSRN eLibrary
Tipo: Artigo de Revista Científica Formato: 334925 bytes; application/pdf
Publicado em //2008 Português
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times have significantly declined since the passage of PDUFA in 1992, while agency resources have expanded through user fees. After the recent withdrawal of Vioxx and other high-profile products, there have been increasing concerns that PDUFA has adversely affected drug safety. Combining several comprehensive databases, we analyze how FDA review time, drug novelty, and U.S. launch lag affect the occurrence of serious adverse events 1992-2002 U.S. new drug introductions. We find that more novel drugs and those with shorter U.S. launch lags have a larger number of serious events. After controlling for these and other factors, there is no association between FDA review time and adverse events. Many novel products, with significant anticipated benefits and risks, have black box warnings at the time of product launch. We find that black box warnings (except for pregnancy ones) are associated with more serious events. Notably, many serious adverse events involve rare occurrences that are not observable in pre-market clinical trials. Policymakers should consider our findings in future PDUFA changes, including dedicating a portion of user fees to post-marketing surveillance.