The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Developm
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
THE EFFECTS OF THE PRESCRIPTION DRUG USER FEE ACT AND THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT ON THE DEVELOPMENT AND APPROVAL OF THERAPEUTIC MEDICINES JANICEM. REICHERT,PHD, JENNIFERCHEE,BA, AND CLAIRE S. KOTZAMPALTIRIS, BA Tufts Center for the Study of Drug Development, Boston, Massachusetts
The Prescription Drug User Fee Act of 1992 and the Food and Drug Administration Modernization Act of 1997 include provisions that were intended to increase the efficiency of the processes requiredfor the clinical development and regulatory review of therapeutic medicines. The expected effects of the legislative acts were decreases in the time required for clinical development and product approval. Results from the analysis of the clinical (Investigational New Drug filing date to Biologic License Application [BLA]/New Drug Application [NDA]submission date) and approval (BLA/NDAsubmission date to approval date) phases for 54 applications for new biopharmaceutical products submitted to the Food and Drug Administration during fiscal years I981 through 1998 indicate that while clinical phases consistently increased, the rate of increase slowed substantially for fiscal years I997 through 1998. The approval phase forfiscal years 1997 through 1998, however; proved to be the shortest of any time period examined. Taken together, the data from fiscal years 1997 through 1998 show the first decrease in the mean total length of time required for clinical development and approval of biopharmaceuticals. Similar analyses of data for 384 applications for new chemical entities indicate that mean clinical and approval phase lengths were shorter f o r fiscal years 1997 through 1998 than for any other time period included in the study. The results of this study suggest that the regulatory reforms associated with enactment of PDUFA and FDAMA have had a marked effect on the development and approval of therapeutic medicines. Key Words: Prescription Drug User Fee Act; Food and Drug Administration Modernization Act; Biopharmaceutical; Drug development; Regulatory review
INTRODUCTION
will continue to be, greatly affected by two legislative acts passed in the 1990s: the Prescription Drug User Fee Act of 1992 (PDUFA) (1) and the Food and Drug Administration Modernization Act of 1997 (FDAh4A) (2). A primary objective of both PDUFA and F D M A was the improvement of the clinical development process and the Food and Drug Administration’s (FDA’s) review procedures. Since the development and approval of new thera-
THE PROCESS OF pharmaceutical development and regulatory review has been, and Preliminary results were presented at the DIA 36th Annual Meeting, June 11-15.2000, San Diego, California. Reprint address: Janice M. Reichert, PhD, Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, MA 021 11. E-mail: ianice. reichert @ tufts.edu .
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Janice M. Reichert, Jennifer C
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