A new moniker for investigational drugs was introduced in the Food and Drug Administration Modernization Act (FDAMA), which became law in November 1997. This moniker, the “fast track designation,” is intended to offer a means for sponsors to propose, and FDA to officially recognize, that a specific investigational drug has demonstrated the potential to address an unmet medical need in the treatment of a serious or life-threatening condition. Such recognition is intended to facilitate development and expedite review of regulatory applications for fast track products (1). The purpose of this manuscript is to describe the fast track program. Information will be presented on the criteria to earn the fast track designation, benefits and challenges of the designation, and lessons learned from experiences reported in the public domain in the first two years that this designation has been available.
Food and Drug Administration.Guidance for Industry. Fast track drug development programs—designation, development, and application review.Rockville, MD: Food and Drug Administration; September 1998.
2.
21 CFR 312.81(a).
3.
Food and Drug Administration.Investigational New Drag, Antibiotic, and Biological Drug Product Regulations; Procedures for Drags Intended to Treat Life-Threatening and Severely Debilitating Illnesses. Interim rule. Federal Register. October 21, 1988;53:41516–41524.
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Food and Drug Administration.Investigational New Drug, Antibiotic, and Biological Drug Product Regulations; Treatment Use and Sale. Federal Register. May 22, 1987;52:19466–19477.
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FDA expects to grant 90% of 60 fast track requests received annually.F-D-C Reports: The Pink Sheet. October 26, 1998; p 6.
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GoldmanB. Fast track. Presentation at the Annual Conference of the Regulatory Affairs Professionals Society, October 3–6, 1999, Washington, DC.
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Food and Drug Administration.Center for Drug Evaluation and Research. Manual of Policies and Procedures (MAPP) 6020.3. Priority Review Policy. Rockville, MD: Food and Drug Administration; April 22, 1996. and Food and Drug Administration. Center for Biologics Evaluation and Review. Manual of Standard Operating Procedures and Policies (SOPP) 8405. Complete Review and Issuance of Action Letters. Rockville, MD: Food and Drug Administration; May 1, 1998.
8.
21 CFR 314.50(d)(1)(iv).
9.
Glaxo Wellcome Ziagen.F-D-C Reports: The Pink Sheet. June 29, 1998; p 32.
10.
Gilead Sciences adefovir dipivoxil.F-D-C Reports: The Pink Sheet. July 5, 1999; p 32.
11.
BioMarin will file 1999 BLA based on 10-patient clinical package.F-D-C Reports: The Pink Sheet. June 28, 1999; pp 25–26.
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BioMarin's MPS-1 filing delayed.Scrip. November 22, 1999.
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Ilex/Lilly development agreement grows out of CRO contract for cancer drug.F-D-C Reports: The Pink Sheet. March 1, 1999; p 31.
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Campath filed in the US.Scrip. January 4, 2000.
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Vertex/Glaxo Wellcome Agenerase.F-D-C Reports: The Pink Sheet. October 19, 1998; p 32.
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Matrix IntraDose.F-D-C Reports: The Pink Sheet. May 17, 1999; p 28.
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US FDA grants Matrix's IntraDose fast track status.Scrip. June 1, 1999.
18.
Interneuron's CerAxon for stroke to be fast-tracked.Scrip. April 6, 1998.
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Cubist.F-D-C Reports: The Pink Sheet. January 18, 1999; p 28.
20.
Genentech's Herceptin “fast-track” review aided by rolling BLA.F-D-C Reports: The Pink Sheet. July 20, 1998; p 9.
21.
Immunex Enbrel.F-D-C Reports: The Pink Sheet. August 10, 1998.
22.
Cell Pathways Aptosyn.F-D-C Reports: The Pink Sheet. August 30, 1999; p 33.
23.
Positive results in SLE from Genelabs.Scrip. September 24, 1999.
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Genelabs GL701 lupus NDA will be complete in second half of 2000.F-D-C Reports: The Pink Sheet. November 29, 1999; pp 23–24.
25.
Glaxo/Vertex's protease inhibitor gets fast-track status.Scrip. December 20, 1999.
26.
Sugen's new sponsor is P&U; $650 mil. deal supplants AstraZeneca. F-D-C Reports: The Pink Sheet. June 21, 1999; p 21.
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Miravant's macular degeneration drug to be fast-tracked.Scrip. July 8, 1998.
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Shaman hopes move from biotechnology to botanicals can rekindle magic.F-D-C Reports: The Pink Sheet. February 8, 1999; p 18.
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Trimeris T-1249.F-D-C Reports: The Pink Sheet. May 17, 1999; p 28.
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Foscan receives orphan status for head and neck cancer.Scrip. November 17, 1999.
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Genentech Herceptin approval meets patient group deadline.F-D-C Reports: The Pink Sheet. October 5, 1998; p 3.
32.
Purdue takes $100 million option on Altarex Mabs.Scrip. May 17, 1999.
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Synsorb's product fast-tracked by FDA.Scrip. January 14, 2000.
34.
Wyeth Lederle vaccines.F-D-C Reports: The Pink Sheet. June 7, 1999; p 32.
35.
FDA public log of fast track designated indications needed—PhRMA.F-D-C Reports: The Pink Sheet. March 1, 1999; p 7.
36.
Food and Drug Administration.New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval. Final rule. Federal Register. December 11, 1992;57:58942–58960.
