Sage Journals: Discover world-class research

Abstract

Survey data were used to examine the effects that various factors may have on the length of the new drug development and approval processes. These factors include the use of formal conferences between the Food and Drug Administration (FDA) and drug manufacturers. Analyses were based on the type, number, and timing of formal FDA-sponsor meetings for new chemical entities (NCEs) approved from 1987 through 1995. The practice of holding formal conferences was widely applied; 91% of the NCEs were the subject of at least one conference during development or regulatory review, and 46% of the NCEs were the subject of at least three conferences. In addition to conferences, a number of other factors conjectured to have an effect on development and approval times were examined as explanatory factors in multiple regression analyses. The regression results for the new drug application (NDA) phase (NDA submission to NDA approval) indicated that pre-NDA meetings and NDA Days were associated with shorter approval times. Other factors that were shown to be associated with shorter approval times are a priority rating by the FDA, treatment IND status, the submission of a computer-assisted NDA (CANDA) simultaneously with the paper application, and inclusion in the user fee program.

Regressions on the investigational new drug application (IND) phase (IND filing to NDA submission) showed that pre-IND meetings and end-of-Phase II conferences were associated with shorter clinical development times, while NCEs with treatment INDs and NCEs that were subject to the user fee program were associated with longer clinical development times. These results provide empirical support for the hypothesis that collaboration between the FDA and drug sponsors has generally expedited new drug development and regulatory review.

Keywords

FDA-sponsor conferences Clinical development time Approval time CAN-DAs Fast-track initiatives

Get full access to this article

View all access options for this article.

References

Clinton

Gore

. National Performance Review: Reinventing Government. Washington, DC: The White House; 1995.

FDA Regulatory Reform: A Proposal by the Biotechnology Industry Organization. Concept Paper: 2/27/95. BIO, Washington DC, 1995.

Epstein

Lenard

Miller

Tollison

Viscusi

Wardell

. Advancing medical innovation: health, safety and the role of government in the 21st century. Washington, DC: The Progress and Freedom Foundation; February 7, 1996.

Clinton

Gore

. Reinventing the Regulation of Cancer Drugs. Washington, DC: The White House; March 29, 1996.

The Patient is Waiting. Washington, DC: Pharmaceutical Research and Manufacturers of America; May 1996.

FDA Performance and Accountability Act of 1995 (S 1477).

Drug and Biological Products Reform Act of 1996 (HR 3199).

Proposal to Create an Accelerated Study and Approval Partnership (A.S.A.P.). Washington, DC: BIO; 1996.

Prescription Drug User Fee Act of 1992. Pub law 102–571 (1992 Oct 29); 21 USC 379; 106 Stat 4491.

10.

FDA/industry user fee reauthorization bill to address clinical holds, meeting requests; other FDA reform proposals under discussion on Feb. deadline. The Pink Sheet. 1996 Dec 9;58(50):3.

11.

Shulman

Kaitin

. The Prescription Drug User Fee Act of 1992: A five-year experiment for industry and the FDA. PharmacoEcon. 1996;9:121–133.

12.

DiMasi

. A new look at United States drug development and approval times. Am J Ther. 1996;3(9): 1–11.

13.

Fourth Annual Performance Report: Prescription Drug User Fee Act of 1992: Fiscal Year 1995 Report to Congress. Rockville, MD: Food and Drug Administration; Dec 1, 1996.

14.

Kaitin

Manocchia

. The new drug approvals of 1993, 1994, and 1995: Trends in drug development. Am J Ther. 1997 Jan;4(1):46–54.

15.

Kaitin

. The Prescription Drug User Fee Act of 1992 and the new drug development process. Am J Ther. 1997 May;4(5).

16.

Peck

. Modernizing effectiveness and safety testing in drug development. Statement before the Committee on Labor and Human Resources, US Senate, February 21, 1996.

17.

Content and format of an application. 21 CFR 314.50.

18.

Subpart B—investigational new drug application. 21 CFR 312.20–312.38.

19.

Drugs intended to treat life-threatening and severely debilitating illness. 21 CFR 312.80.

20.

Kaitin

Phelan

Raiford

Morris

. Therapeutic ratings and end-of-phase II conferences: Initiatives to accelerate availability of important new drugs. J Clin Pharmacol. 1991;31(1):17–24.

21.

Kaitin

Walsh

. Are initiatives to speed the new drug approval process working?. Drug Inf J. 1992;26:341–349.

22.

DiMasi

Seibring

Lasagna

. New drug development in the United States from 1963 to 1992. Clin Pharmacol Ther. 1994;55(6):609–622.

23.

DiMasi

Hansen

Grabowski

Lasagna

. Research and development costs for new drugs by therapeutic category: A study of the US pharmaceutical industry. PharmacoEcon. 1995;7(2):152–169.

24.

Treatment use of an investigational new drug. 21 CFR 312.34.

25.

Shulman

Brown

. The Food and Drug Administration's early access and fast-track approval initiatives: How have they worked?. Food and Drug Law J. 1995;50(4):503–531.

26.

Kaitin

Melville

Morris

. FDA advisory committees and the new drug approval process. J Clin Pharmacol. 1989;29:886–890.

27.

DiMasi

Grabowski

Vernon

. R&D costs, innovative output, and firm size in the pharmaceutical industry. Int J Econ Bus. 1995;2(2):201–219.

28.

FDA drug approval: review time has decreased in recent years. (GAO/PEMD-96–1) Washington, DC: United States General Accounting Office; Oct 1995.

29.

Second annual performance report: Prescription Drug User Fee Act of 1992: fiscal year 1994 report to Congress. Rockville, MD: Food and Drug Administration; December 1, 1994.

30.

Kmenta

. Elements of econometrics. 2nd edition. New York: Macmillan; 1986:419–420.

31.

Formal Meetings Between CDER and CDER's External Constituents. Manual of Policies and Procedures, Center for Drug Evaluation and Research, Office of Training and Communications, Food and Drug Administration. MAPP 4512.1, Rockville, MD: Food and Drug Administration; Mar 3, 1996.

32.

FDA/industry “PDUFA II” proposal would cut NDA review deadline from 12 to 10 months; NAPM to begin discussing generic user fees with agency & Congress. The Pink Sheet. 1997 Feb 3;59(5):6–7.

Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences

Abstract

Keywords

Get full access to this article

References