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Finding value in the U.S. Food and Drug Administration's Fast Track program
Janice M Reichert1, Stephanie L Rochon, Bodi D Zhang
1Tufts Center for the Study of Drug Development, Boston, Massachusetts 02111, USA. janice.reichert@tufts.edu
Drug News & Perspectives
|February 12, 2009
Summary
The U.S. Food and Drug Administration
Area of Science:
- Drug development and regulatory science.
- Pharmaceutical policy and evaluation.
Background:
- The U.S. Food and Drug Administration's (FDA) Fast Track program aims to expedite drug development for serious conditions.
- Recent questions have arisen regarding the program's designation significance and overall effectiveness.
Purpose of the Study:
- To analyze metrics of FDA Fast Track candidates using data collected since 1998.
- To address questions about the program's common metrics and effectiveness.
Main Methods:
- Analysis of a dataset comprising 344 Fast Track candidates and nearly 400 designations.
- Examination of candidate characteristics and development histories.
- Assessment of clinical phase lengths and phase transition probabilities, acknowledging data limitations and biases.
Main Results:
- Fast Track candidates exhibited significant diversity in their characteristics and development pathways.
- Data limitations introduced biases in metrics like clinical phase lengths.
- Certain metrics, such as clinical phase lengths and phase transition probabilities, could be determined for specific subsets of candidates.
Conclusions:
- Evaluating the Fast Track program necessitates a nuanced perspective.
- Estimates of the program's value should incorporate the success of resulting marketed products.
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