The Various Regulatory Clinical Development Pathways to Obtain Marketing Approval
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
THE VARIOUS REGULATORY CLINICAL DEVELOPMENT PATHWAYS TO OBTAIN MARKETING APPROVAL THOMAS A. HAYES,MD, MFPM Senior Director, Promotional Compliance, Bristol-Myers Squibb Company, Princeton, New Jersey
D. P. GANGI,PHD Pharmaceutical Consultant, Brookside, New Jersey
In response to criticism a generation ago, the United States Food and Drug Administration (FDA) has made many changes to the regulatory approval process. This paper highlights those changes. Descriptions of relevant Federal Register notices are provided. Many of these changes, while claiming to foster faster and more efficient review, have actually increased FDA’s influence over industry activities. Key Words: Marketing approval; Food and Drug Administration; Regulatory approval process
A GENERATION AGO THE health industry charged the Food and Drug Administration with having created a drug lag. Critics asserted that the FDA regulatory system took an excessive amount of review time before marketing approval for a new drug product was obtained. The 1962 “efficacy” amendments to the Federal Food Drug & Cosmetic (FD&C) Act required more detail than previous applications and resulted in new drug application (NDA) submissions which, in some cases, languished awaiting primary review and, in others, stimulated tedious requests for additional information from the sponsor or underwent other vicissitudes. Resultant delays meant that patients in the United States were, therefore, being deprived of new drugs which were available earlier in Europe and elsewhere.
Reprint address: Thomas A. Hayes, MD, MFF’M, Senior Director, Promotional Compliance, Bristol-Myers Squibb Company, PO box 4500, Princeton, NJ 0 8 5 4 s 4500.
Seeking an answer to whether or not a drug lag exists is like some ancient riddle. It depends on whom one asks. The FDA denied that a drug lag existed but, as a result of pressure exerted not only by the industry but also by Congress and consumer interests, the agency undertook an extensive analysis to determine how to make the review process more efficient and enable new drug products to reach the marketplace sooner. Thus, the Federal Register notices of February 22, 1985 and March 19, 1987, known familiarly as the NDA Rewrite and the IND Rewrite, were born. Following passage of the Orphan Drug Act in 1983, however, an earlier response by the FDA to such outside pressure had been the establishment of the Office of Orphan Products Development to act as an ombudsman for sponsors before and during review of the submissions by the division(s) in facilitating the handling of questions regarding “orphan” drug and biological products. Explicit and implicit in both the NDA and the IND Rewrites, regulatory principles were
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Thomas A. Hayes and D. P. Gangi
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established by which the health authorities not only redefined how they intended to decrease the extant review time but also established procedures throu
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