Washington Law Review


Food and Drug Administration (FDA) regulatory reform has become a controversial, politically charged issue of particular significance to the biotechnology industry. The fundamental factors driving the movement for FDA reform include the prohibitive costs associated with developing a product approved by the FDA and the pressure to participate in the international harmonization of biotechnology product regulations. Two recent Congressional bills, Senator Kassebaum's Food and Drug Administration Performance and Accountability Act of 1995, and Representative Burr's Drug and Biological Products Reform Act of 1996 provide vehicles for analyzing the direction and goals of FDA reform as they apply specifically to the biotechnology industry.

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