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Case Studies of Expedited Review: AZT and L-Dopa

Published online by Cambridge University Press:  29 April 2021

Kenneth I. Kaitin
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Extract

The HIV epidemic has led to a reassessment of attitudes regarding public access to new therapeutic agents for the treatment of life-threatening and severely debilitating diseases. People with AIDS and their advocates have relentlessly attacked the process by which new drugs are developed and approved for marketing in this country, a process characterized as overly conservative, risk-averse, and paternalistic. In response to growing pressure to accelerate access to important new therapeutic agents, the Food and Drug Administration (FDA) has issued several bold initiatives designed to facilitate the development of experimental drugs used in the treatment of serious or immediately life-threatening diseases.

The clinical testing and regulatory review of new therapeutic agents in the United States are lengthy processes. A recent analysis of new chemical entities (NCE) approved by the FDA in 1987,1988, and 1989 has revealed that, on average, the clinical development phase for new drugs exceeds five years (63 months).

Type
Article
Information
Law, Medicine and Healthcare , Volume 19 , Issue 3-4 , Fall Winter 1991 , pp. 242 - 246
Copyright
Copyright © American Society of Law, Medicine and Ethics 1991

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References

Kaitin, K.I. DiCerbo, P.A. Lasagna, L., “The New Drug Approvals of 1987, 1988, and 1989: Trends in Drug Development”, Journal of Clinical Pharmacology, 31(1991): 116–22, at 117.Google Scholar
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See, e.g.: Comptroller General's report to the Subcommittee on Science Research and Technology, United States House of Representatives. “FDA drug approval: A lengthy process that delays the availability of important new drugs”. Washington, D.C., U.S. General Accounting Office, HRD 80–64, May 28, 1980; “Final Report of the National Committee to Review Current Procedures for the Approval of New Drugs For Cancer and AIDS” (The “Lasagna Committee Report”), August 15, 1990.Google Scholar
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The FDA first proposed initiatives to speed the development and review of important new drugs in the mid-1970s. The agency's drug classification system and end-of-phase II conference procedure were two such initiatives designed to expedite new drug availability. For a discussion of these initiatives and an analysis of their impact on development and review times, see Kaitin, K.I. et al, “Therapeutic Ratings and End-of-Phase II Conferences: Initiatives to Accelerate the Availability of Important New Drugs”, Journal of Clinical Pharmacology, 31(1991):17–24.Google Scholar
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Id., 41521. Expedited development and review will no doubt leave many questions about the drug unanswered at the time marketing approval is granted. This section acknowledges that if NDA approval “is gained on the basis of limited, but sufficient, clinical trials, it will usually be important to conduct postmarketing clinical studies that will extend the knowledge about the drug's safety and efficacy and allow physicians to optimize its use.”Google Scholar
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Supra note 20.Google Scholar
This finding was corroborated in a recent PAR update covering the years 1985 and 1986. See Richard, B.W. Melville, A. Lasagna, L., “Postapproval Research as a Condition of Approval: An Update, 1985–1986”, Journal of Clinical Research and Drug Development, 3(1989): 247–57.Google Scholar
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The longer clinical and review phases for drugs with PAR were due in part to the relatively high percentage of central nervous system, cardio-renal, and anesthetic-analgesic drugs (drugs with typically long development and review times; see supra note 2). Within each therapeutic category, however, there was very little difference in phase lengths between drugs with PAR and those without.Google Scholar