Melinda M. Katz


This Comment will examine the U.S. Food and Drug Administration (FDA) as a regulatory agency, and the status of pharmaceutical products liability. The Comment will describe Prozac, an antidepressant drug currently caught in the products liability dilemma; its compliance with FDA regulations; and opposition to the drug since FDA approval. The Comment will then review American problems with pharmaceutical products liability, and solutions that other commentators have proposed. Finally, the Comment will propose that Congress erect barriers to filing claims against manufacturers for drugs that meet or exceed a higher level of FDA approval, like Bendectin and Prozac, through a special preemption process; and that Congress establish a system to compensate victims of expected, yet unavoidable, adverse drug reactions from those drugs meeting a higher standard