Case Studies of Expedited Review: AZT and L-Dopa
Kaitin, Kenneth I.
Law, Medicine and Health Care. 1991 Fall-Winter; 19(3-4): 242-246.
On October 21, 1988, the Food and Drug Administration issued its Interim Rule on Procedures for Drugs Intended to Treat Life-Threatening and Severely Debilitating Illnesses, or Subpart E procedures. Based on the agency's impressive success in expediting the availability of AZT (see below), the Subpart E procedures described a series of mechanisms for speeding the development and review of promising new drugs to treat AIDS and other serious diseases. The new procedures include four key components....This paper will focus on the last component of FDA's new procedures, i.e., the agency's use of Phase IV postmarketing studies as a condition of approval to accelerate the availability of promising new drugs. The developmental histories of AZT and L-Dopa, two drugs that benefitted from required Phase IV studies in terms of rapid development and review times, will be examined, and the potential merits of this practice will be discussed.