Sage Journals: Discover world-class research

Abstract

Efforts within Congress, the Executive Branch, and the Food and Drug Administration (FDA) itself to reform agency function reflect a serious commitment to improve the new drug development process in this country and speed patient access to important new medical therapies. In this report, various factors that provide the underpinnings of these FDA reform efforts are considered. Important considerations are the increasing time spent in clinical development for new drugs, the growing trend for United States-based firms to initiate Phase I clinical testing overseas, and the delayed marketing of new products in this country relative to other markets. The result has been several strategic themes that are integral to most of the major reform proposals currently under consideration.

Keywords

FDA reform Drug development Congress Phase I Foreign marketing

Get full access to this article

View all access options for this article.

References

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

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

Clinton

Gore

. National performance review: reinventing government. Washington DC: The White House; 1995.

New Drug Regulatory Improvement Act of 1995 (draft document June 14, 1995). Washington, DC: Pharmaceutical Research and Manufacturers of America; 1995.

FDA regulatory reform: a proposal by the Biotechnology Industry Organization. Concept Paper: 2/27/95. Washington, DC: BIO; 1995.

Clinton

Gore

. Reinventing the regulation of cancer drugs. Washington, DC: The White House; March 29, 1996.

DiMasi

Seibring

Lasagna

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

Shulman

Kaitin

. The Prescription Drug User Fee Act of 1992: A five-year experiment for industry and the FDA. Pharmaco Econ. 1996 Feb; 9(2):121–133.

Kaitin

. Pharmaceutical innovation in a changing environment. Part II Chapter 7 in Contested ground: public purpose and private interest in the regulation of prescription drugs. Davis

ed. New York: Oxford University Press; 1996:109–123.

10.

Cullen

. Pharmaceuticals inter-country diffusion. Manag Decision Econ. 1983;4:73–82.

11.

Kaitin

Mattison

Northington

Lasagna

. The drug lag: An update of new drug introductions in the United States and the United Kingdom, 1977 through 1987. Clin Pharmacol Therapeut. 1989; 46(2):121–138.

12.

Wardell

. Introduction of new therapeutic drugs in the United States and Great Britain: An international comparison. Clin Pharmacol Ther. 1973 Sep-Oct;14(5) 773–790.

13.

Kessler

. Remarks at the Food and Drug Law Institute Annual Meeting. Washington DC, December 12, 1995. and Kessler DA Haas AE Fieden KL Lumpkin M Temple R. America's rapid access to new drugs: an international comparison. JAMA. 1997.

14.

FDA drug approval: review time has decreased in recent years. (GAO/PMED-96–1) Washington, DC: U.S. General Accounting Office; October 1995.

15.

Third annual performance report: Prescription Drug User Fee Act of 1992: Fiscal Year 1995 Report to Congress. Rockville, MD: Food and Drug Administration; December 1995.

FDA Reform: Setting the Stage for Efforts to Reform the Agency

Abstract

Keywords

Get full access to this article

References