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A guide to drug discovery

Trends in development and approval times for new therapeutics in the United States

Nature Reviews Drug Discovery volume 2, pages 695–702 (2003)Cite this article

Abstract

The process of clinical development and regulatory review of new therapeutics in the United States was significantly changed by a number of legislative acts passed in the 1980s and 1990s. These acts were designed to encourage the development of innovative products, especially for rare, serious or life-threatening diseases, and to ensure that patients had timely access to these treatments. To assess the effects of the various modifications to the process, the Tufts Center for the Study of Drug Development analysed clinical development and approval data for 554 therapeutics (504 small molecules, 40 recombinant proteins and 10 monoclonal antibodies) approved in the United States from 1980–2001. Trends in the number of approved products and the clinical development and approval times indicated that the effects of these changes were generally beneficial as of the mid- to late-1990s, but that the gains have not been sustained in the early 2000s. Current efforts by the FDA, and the pharmaceutical and biopharmaceutical industry, to reverse the recent tendency toward fewer new approvals and longer approval times are discussed.

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Figure 1: Number of small-molecule drugs, recombinant proteins and monoclonal antibody therapeutics approved in the United States during 1980–2001.
Figure 2
Figure 3: Mean clinical phase lengths for small-molecule drugs in five therapeutic categories approved during five time periods.
Figure 4: Median clinical phase lengths for small-molecule drugs in five therapeutic categories approved during five time periods.

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Acknowledgements

The author gratefully acknowledges the work of Elaine Bergman, Catherine Cairns and Cherie Paquette in maintaining the marketed new chemical entity and biopharmaceutical databases, and thanks Drs Kenneth Kaitin and Joseph DiMasi for helpful comments and suggestions.

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  1. Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, 02111, Massachussets, USA

    Janice M. Reichert

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FURTHER INFORMATION

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Drug Evaluation and Research

Glossary

CLINICAL PHASE I

Studies performed in a small number of patients or normal volunteers to evaluate pharmacokinetic properties (absorption, distribution, metabolism and excretion in humans) and establish a safe dosage range.

CLINICAL PHASE II

Trials performed in a small number of patients to evaluate the safety and effectiveness of a product in comparison with a standard or control treatment.

CLINICAL PHASE III

Large trials performed in patients to confirm safety, efficacy and optimal dosage range of a product in comparison with a standard or control for treatment of the targeted indication.

INVESTIGATIONAL NEW DRUG APPLICATION

(IND). Document filed by a drug sponsor to notify the Food and Drug Administration of its intent to conduct clinical studies in human subjects.

NEW DRUG APPLICATION, BIOLOGICS LICENSE APPLICATION, PREMARKET APPROVAL APPLICATION

(NDA, BLA, PMA). Marketing applications that contain the results of clinical Phase I, II and III studies and are submitted to the FDA for review. If the applications are approved, the product can be marketed in the United States.

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Reichert, J. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov 2, 695–702 (2003). https://doi.org/10.1038/nrd1178

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