The TPA Controversy and the Drug Approval Process

Abstract

SEVERAL months ago, our panel considered two applications submitted to the Food and Drug Administration (FDA) for the approval of thrombolytic agents for treatment of patients with acute myocardial infarction. One of these was intravenous (IV) streptokinase and the other was IV recombinant tissue plasminogen activator (rt-PA). We recommended approval of IV streptokinase and postponement of approval of IV rt-PA. There followed considerable public debate in which we were accused of deciding to sacrifice thousands of American lives on an altar of pedantry ( The Wall Street Journal , June 2,1987). In essence, many observers opined that we had elected to debate picayune, unsolvable issues rather than make an important and lifesaving therapy available to the American public. Editorialists demanded that FDA Commissioner Frank Young repudiate the panel's suggestion and grant immediate approval of rt-PA. In response to one of the editorials in the lay press, we attempted to explain the issues