REFORMING DRUG APPROVAL IN THE UNITED STATES: MEASURES NECESSARY TO ALLEVIATE THE CASH CRUNCH FACED BY SMALL BIOTECHNOLOGY COMPANIES
McWilliams, Douglas E.
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CitationREFORMING DRUG APPROVAL IN THE UNITED STATES: MEASURES NECESSARY TO ALLEVIATE THE CASH CRUNCH FACED BY SMALL BIOTECHNOLOGY COMPANIES (1995 Third Year Paper)
AbstractOver 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.
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