Abstract
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 dwarfed 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.
Similar content being viewed by others
References
Food and Drug Administration. Guidance for Industry: Fast Track Drug Development Programs—designation, development, and application review. Rockville, MD: Food & Drug Administration; September 1998.
Another view on industry response to fast track program. US Regulatory Reporter. 1998 Sep;15(3):1–2.
Drug industry has not yet embraced FDAMA’s “Fast Track” program. US Regulatory Reporter. 1998 Aug; 15(2):1–3.
An interview with Director of the Division of Cardio-renal Drug Products Raymond Lipicky, M.D. US Regulatory Reporter. 1999 Oct;16(4):3–7.
PhRMA proposals for fast-track products. Pharma Marketletter. 1998 Apr 27;25(7):13.
Shulman SR, Brown JS. The Food and Drug Administration’s early access and fast-track approval initiatives: how have they worked? Food Drug Law J. 1995;50(4):503–531.
Cocchetto DM, Jones DR. Faster access to drugs for serious or life-threatening illnesses through the use of the accelerated approval regulation in the United States. Drug Inf J 1998;32(1):27–35.
DiMasi JA, Manocchia M. Initiatives to speed new drug development and regulatory review: the impact of FDA-sponsor conferences. Drug Inf J 1997;31(3):771–788.
Food and Drug Administration. Supporting statement for guidance for industry: fast track drug development programs designation, development, and application review (OMB No. 0910-0389). Rockville, MD: Food & Drug Administration; 1998.
Behrman RE. “Fast Track.” Presented at the Drug Information Association Annual Meeting, June 29, 1999, Baltimore, MD.
Parexel. An analysis of the FDA’s fast track initiative, March 2000. Parexel’s pharmaceutical R&D statistical sourcebook 2000. Waltham, MA: Parexel; 2000:232.
Risso ST. Fast track and priority review from the FD. perspective, http://www.fda.gov/cber/gdlns/fsttrk.pdf.
Senate Committee on Labor and Human Resources. Food and Drug Administration Modernization and Accountability Act of 1997 Senate Report 107-43, to accompany S830. 105th Congress 1st Session. Washington, DC: US Government Printing Office; 1997.
House Committee on Commerce. Prescription Drug User Fee Reauthorization and Drug Regulatory Modernization Act of 1997. House Report 105–310, to accompany H. 1411. 105th Congress 1 st Session. Washington, DC: US Government Printing Office; 1997.
Lumpkin MM. The ABC’s of interaction with the FDA. Presented at Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation, Boston, Tufts Center for the Study of Drug Development, February 18, 2000.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Milne, CP., Bergman, E. Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience. Ther Innov Regul Sci 35, 71–83 (2001). https://doi.org/10.1177/009286150103500108
Published:
Issue Date:
DOI: https://doi.org/10.1177/009286150103500108