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

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0092-86 15/91 Copyright G 1997 Drug Information Association Inc.

FDA REFORM: SETTING THE STAGE FOR EFFORTS TO REFORM THE AGENCY KENNETHI KAITIN,PHD Associate Director, Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts

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. Key Words: FDA reform; Drug development; Congress; Phase I; Foreign marketing

INTRODUCTION

FDA reform bill in the near term appear unlikely, the issue of reform will probably resurface in the 105th Congress as various Congressional committees once again debate the question of to what degree the FDA contributes to the slow pace and high cost of pharmaceutical innovation in the United States. In this report, several of the factors that provide the underpinnings of these FDA reform efforts are considered. In particular, the increasing time required to develop a new drug, the growing trend for United Statesbased firms to initiate Phase I clinical testing overseas, and the delayed marketing of new products in this country relative to other markets, will be reviewed. A reform agenda will then be presented.

THE FDA AND THE research-based pharmaceutical industry are in the midst of an historic moment. Several FDA reform bills under consideration in the United States Congress (1, 2), as well as reform efforts proposed by the Executive Branch (3), pharmaceutical lobbying groups (4,5), and the FDA itself ( 6 ) reflect a serious commitment to restructure various aspects of the agency’s function, accelerate the availability of new medical therapies, and foster pharmaceutical innovation in this country. Although, at present, prospects for passage of a substantive

Presented at the DIA 32nd Annual Meeting “The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June 9-13, 1996, San Diego, California. Reprint address: Kenneth I Kaitin, PhD, Associate Director, Tufts Center for the Study of Drug Development, Tufts University, 192 South St., Suite 550, Boston, MA 021 11; e-mail: KKAITIN@INFONET. TUFTS.EDU.

INCREASING DRUG DEVELOPMENT TIMES A chief concern of those interested in improving the efficiency of the FDA and the regulated industry is the relentless rise in new 27

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Kenneth I Kaitin

drug development times ove