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‣ 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)
Português
Relevância na Pesquisa
36.73261%
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.

‣ Jeremy Rifkin: An Examination of the Efforts of an Anti-Biotechnology Activist

Naik, Paul S.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
36.80794%
This paper attempts retrospectively to examine the impact of the efforts of Jeremy Rifkin on the rules and regulation, and ultimately the mission, of the Food and Drug Administration (FDA) pertaining to biotechnology. Rifkin arguably single-handedly raised the consciousness of the American public, and indeed the world, to the potential risks of the technology, at least as he saw them. In this way, he positioned himself as a biotechnology gadfly who became the bane of the biotechnology industry and federal agencies regulating biotechnology. It seems fitting, therefore, to study the impact of anti-biotechnology activism on federal regulation of biotechnology by focusing on Rifkin’s efforts. In the course of examining Rifkin’s activities that were targeted specifically at the FDA, this paper also discusses his efforts aimed at curbing recombinant DNA research regulated by the National Institutes of Health and genetic engineering activities that fell under the jurisdiction of the United States Department of Agriculture (USDA) and Environmental Protection Agency (EPA).

‣ REFORMING DRUG APPROVAL IN THE UNITED STATES: MEASURES NECESSARY TO ALLEVIATE THE CASH CRUNCH FACED BY SMALL BIOTECHNOLOGY COMPANIES

McWilliams, Douglas E.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
36.90343%
Over the past decade, the infant biotechnology industry, led by small biotechnology companies, has produced numerous breakthrough drugs which have saved lives, reduced suffering and cut the cost of health care. Given that the biopharmaceutical industry has only been in existence for a little over 20 years, biotechnology holds enormous potential for the advancement of medical treatments. Unfortunately, even with biotechnology, as with the more traditional methods of drug development, the government mandated testing and approval of new therapeutic products takes a considerable amount of time and costs an exorbitant amount of money. The United States has the most demanding drug approval process in the world. Under the current Food and Drug Administration's drug approval process, the time required to gain approval for new drugs averages between 10 to 12 years and the cost approximates $350 million. In addition, the Food and Drug Administration (FDA) has come under attack as taking too conservative of an approach to approving beneficial new drugs. The purpose of this paper is to analyze the effects of this costly drug approval process on small biotechnology companies, to determine the effects of a decline in small biotechnology companies on the United States and to analyze current proposals to change the current Food and Drug Administration's drug approval process to ensure the survival of small biotechnology companies. Part II of this paper identifies the various stages of the drug approval process. Part III explores the policy behind the FDA's extensive drug approval process. Part IV examines the adverse affects of the drug approval process on small biotechnology companies. Part V analyzes the effect of a declining biotechnology industry on the United States. Part VI addresses current proposals to change the FDA drug approval process focusing on their ability to help small biotechnology companies.