Industry funding of the FDA: Effects of PDUFA on approval times and withdrawal rates

Nature Reviews Drug Discovery

Volumn 4, Issue 7, 2005, Pages 545-554

  Berndt, Ernst R ^a   Gottschalk, Adrian H B ^b   Philipson, Tomas J ^c   Strobeck, Matthew W ^d  

^a MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^b BIOGEN   (United States)

^c UNIVERSITY OF CHICAGO   (United States)

^d One Financial Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALOSETRON; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; ASTEMIZOLE; AZARIBINE; BENOXAPROFEN; BROMFENAC; CARDIOVASCULAR AGENT; CELECOXIB; CENTRAL NERVOUS SYSTEM AGENTS; CERIVASTATIN; CISAPRIDE; DEXFENFLURAMINE; ENCAINIDE; FENFLURAMINE; FLOSEQUINAN; GASTROINTESTINAL AGENT; GREPAFLOXACIN; HORMONE; MIBEFRADIL; NOMIFENSINE; ORPHAN DRUG; RADIOPHARMACEUTICAL AGENT; RAPACURONIUM BROMIDE; ROFECOXIB; ROTAVIRUS VACCINE; SUPROFEN; TEMAFLOXACIN; TERFENADINE; TIENILIC ACID; TROGLITAZONE; ZOMEPIRAC;

DRUG APPROVAL; DRUG CLASSIFICATION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SAFETY; DRUG WITHDRAWAL; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE QUALITY; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; STATISTICAL SIGNIFICANCE; UNITED STATES;

DRUG APPROVAL; DRUG INDUSTRY; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 22144470134     PISSN: 14741776     EISSN: None     Source Type: Journal    
DOI: 10.1038/nrd1774     Document Type: Review

References (28)

1. DiMasi, J. A., Hansen, R. W. & Grabowski, H. G. The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151-186 (2003).
2. US Food and Drug Administration. CBER About Us. [online], (2005).
3. PAREXEL's Pharmaceutical R&D Statistical Sourcebook 2003/2004 (ed. Mathiew, M. P.) 184 (Parexel International Corp., Waltham, 2003).
4. Grabowski, H. G., Vernon, J. H. & DiMasi, J. A. Returns on research and development for 1990s new drug introductions. PharmacoEconomics 20 (Suppl. 3), 11-29 (2002).
5. Carpenter, D., Chernew, M., Smith, D. G. & Fendrick, A. M. Approval times for new drugs: does the source of funding for FDA staff matter? Health Affairs - Web Exclusive 17 December W3-618-W3-624, (2003).
6. Olson, M. K. Explaining reductions in FDA drug review times: PDUFA matters. Health Affairs - Web Exclusive 30 January W4-51-W4-52, (2004).
7. US Food and Drug Administration. Prescription Drug User Fees - Overview. [online], (2004).
8. US Food and Drug Administration. PDUFA reauthorization performance goals and procedures [online], (2004).
9. FY 2003 PDUFA Financial Report. (Food and Drug Administration, 2004).
10. Budget in Brief FY 2004. (US Department of Health and Human Services, 2004).
11. Budget in Brief FY 2005. (US Department of Health and Human Services, 2005).
12. US Food and Drug Administration. Effect of user fees on drug approval times, withdrawals, and other agency activities. (US General Accounting Office, 2002).
13. Guidelines on Fees Payable to the EMEA [online], (2004).
14. Vilas-Boas, I. M. & Tharp, C. P. The drug approval process in the U. S., Europe, and Japan: some marketing and cost implications. J. Manag. Care Pharm. 3, 459-465 (1997).
15. Medicines and Healthcare products Regulatory Agency. About the MHRA [online], (2005)
16. Kaitin, K. I. & DiMasi, J. A. Measuring the pace of new drug development in the User Fee era. Drug Inf. J. 34, 673-680 (2000).
17. Kaitin, K. I. & Healy, E. M. The new drug approvals of 1996, 1997 and 1998: drug development trends in the User Fee era. Drug Inf. J. 34, 1-14 (2000).
18. Reichert, J. M., Chee, J. & Kotzampaltiris, C. S. The effects of the Prescription Drug User Fee Act and the Food and Drug Modernization Act on the development and approval of therapeutic medicines. Drug Inf. J. 35, 85-94 (2001).
19. Kaitin, K. I. & Cairns, C. The new drug approvals of 1999, 2000 and 2001: drug development trends after passage of the Prescription Drug User Fee Act of 1992. Drug Inf. J. 37, 357-371 (2003).
20. DiMasi, J. A. New drug development in the United States from 1963 to 1999. Clin. Pharmacol. Ther. 69, 286-296 (2001).
21. DiMasi, J. A. & Manocchia, M. Initiatives to speed new drug development and regulatory review: the impact of FDA-sponsor conferences. Drug Inf. J. 31, 771-788 (1997).
22. Berndt, E. R., Gottschalk, A. H. B., Philipson, T. & Strobeck, M. W. in Frontiers in Health Policy Research Vol. 8 (eds Cutler, D. M. & Garber A. M.) (MIT Press for the National Bureau of Economic Research, Cambridge, Massachusetts, in the press).
23. Friedman, M. A. et al. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 281, 1728-1734 (1999).
24. US Food and Drug Administration. Effect of user fees on drug approval times, withdrawals, and other agency activities. (United States General Accounting Office, 2002).
25. Center for Drug Evaluation and Research. 2003 Report to the Nation: Improving Public Health through Human Drugs. (US Department of Health and Human Services, Food and Drug Administration, 2004).
26. Berndt, E. R., Gottschalk, A. H. B., Philipson, T. & Strobeck, M. W. An economic evaluation of the Prescription Drug User Fee Acts. (MIT Sloan School of Management, Cambridge, Massachusetts, 2004).
27. Berndt, E. R., Gottschalk, A. H. B. & Strobeck, M. W. Opportunities for improving the drug development process: results from a survey of industry and the FDA. (unpublished manuscript, MIT Sloan School of Management, Cambridge, Massachusetts, 2004).
28. US Food and Drug Administration. PDUFA III Five-Year Plan [online], (2004).