I. INTRODUCTION
The newly sworn Republican-controlled Congress has, as one of its primary objectives, the downsizing of government. Speaker Newt Gingrich has specifically targeted the federal Food and Drug Administration (FDA) for the conservative wrath. The political climate that led to the change in power in Congress is partly based on the nation's anti-regulatory demeanor -- the belief, whether correct or mistaken, that the regulators have run riot, that there is too much power in the hands of a few appointed bureaucrats. The FDA draws specific attention because of the palpable effects of its rulings in the lives of all citizens. Specifically, the requirements for the pre-market approval of new drugs have been criticized for being too cumbersome. This paper will attempt to draw a compromise between the observed problem of overregulation in that area and the still important policies underlying the federal Food, Drug, and Cosmetic Act (FDCA). It will call for the elimination of the efficacy requirement for new drug applications (NDA) as a way to reduce the costs of developing new drugs, while maintaining the safely requirement in order to ensure the public health.
NDAs are covered by section 505 of the FDCA. The provisions of that section prohibit the introduction into interstate commerce of "new drugs" unless approved by the FDA. Approval may be refused by the Secretary if the applicant falls to show the drug's safety or fails to submit substantial evidence of the drug's efficacy. Such evidence, however, can only be garnered by animal and clinical testing. The NDA itself generally consists of two to fifteen volumes of summary material of such testing and may be accompanied by as many as 200,000 pages of raw data. ...