Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
FAST TRACK PRODUCT DESIGNATION UNDER THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT: THE INDUSTRY EXPERIENCE CHRISTOPHER-PAUL MILNE, DVM, MPH, JD Senior Research Fellow
ELAINEBERGMAN, B A , MGS Research Assistant Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts
With the passage of the Food and Drug Administration Modernization Act (FDAMA), existing programs for expedited development and approval for treatments of serious or life-threatening diseases were codified and consolidated under the administrative rubric of fast track product designation. The four basic programs available with fast track designation have been categorized by FDA as consisting of meetings, written correspondence, review programs, and dispute resolution. Despite some early skepticism by industry, and even FDA, that the benefits of designation were not readily apparent since the individual programs are generally available without designation, there are indications that fast track designation will be the improvement Congress intended. Unlike the individual expedited development and approval programs, which affect only part of the drug development timeline, fast track designation has the potential to facilitate the entire process. Industry requests for fast track designation have dwarjed pre-FDAMA industry participation. Yet, the best predictor of the future success or failure of fast track designation is how well it is working now. In order to evaluate this, the authors surveyed the biotechnology and pharmaceutical sponsors of 32 fast track designated products identified from public information sources and present their findings in this paper. Key Words: Fast track; Fast track designation; FDA Modernization Act; FDAMA; Food and Drug Administration;Expedited development; Accelerated approval;Rolling review; FDA-sponsor meetings; Priority review
INTRODUCTION
things to many people. To some, it meant FDA’s expedited development and accelerPASSAGE OF THE FDA Modernated review programs, also commonly called ization Act in late 1991, fast track was many by the section in which they appear in FDA drug regulations, Subpart E and Subpart H, respectively. To others, the term referred to Presented at the 36th DIA Annual Meeting, June 1 1 the early ‘‘fast track review” available for 15, 2000, San Diego, California. high-priority New Drug Applications (NDAs) Reprint address: Christopher-Paul Milne, Senior to submit SoResearch Fellow, Tufts Center for the Study of Drug whose sponsors were called ‘‘rolling NDAS.” T O still others, it can Development, Tufts University, 192 south St., Suite 550, Boston, MA 021 1 1 . refer just to any drug given “priority” status 71
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Christopher-Paul Milne and Elaine Bergman
after the Prescription Drug User Fee Act adequacy of the sponsor’s Phase I1 or I11 (PDUFA) of 1992 implemented specific time- development plans. Review programs refer frames for
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