The Food and Drug Administration has established new procedures to make promising investigational drugs available for treatment of patients with immediately life-threatening or serious diseases as early in the drug development process as possible and well before general marketing begins. The purpose of this article is to inform the medical community about these new procedures and to facilitate their implementation. Examples of immediately life-threatening and serious diseases are given and the procedures that physicians should use to obtain a drug under the new regulations are described. The treatment use of zidovudine (Retrovir), while still in the investigational phase, is described as a case study. The article also summarizes the Food and Drug Administration's new procedures under which drug sponsors can charge for investigational drugs.

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This edition of the Journal is the first to be published for the American Society of Law 8c Medicine by the Massachusetts Institute of Technology (MIT) Press. It is also the first edition in our new quarterly publication schedule.Correspondence to the Journal during our first two years of publication indicates that we are meeting an important need: the need for a scholarly yet practical journal providing timely, in-depth articles and selective, thorough reference materials in the field of medicolegal relations. We believe that our expanded publication schedule and our new relationship with the Massachusetts Institute of Technology will enhance our ability to meet this need successfully.With the Journal on a firm footing, we are better prepared than ever to confront and to begin to resolve the most significant medicolegal problems of our time. We enthusiastically welcome old and new subscribers alike as supporters of, and participants in, our endeavor.What are today's key issues at the interface of law and medicine? Many exist, and we hope that our articles and reference materials will address as wide a range of such problems as possible. But in my view, five problems in particular cry out for immediate, constructive input from medicolegal professionals, specialists in health-related fields, and the public.Government Regulation. Undeniably, state and federal involvement in the organizing, financing, allocation, and monitoring of health care services is burgeoning. Accompanying this involvement is an intense new level of government regulation of the health care industry. Particularly active in regulation are those states which are hard pressed to meet their financial commitment to publicly funded health programs. Hospitals and other health institutions now must wade through a maze of regulations, audits, and other forms of governmental or quasi-governmental involvement. Many of the matters that once were within a hospital's own sound management or professional judgment are now controlled by federal, state, or quasi-public agencies. Unfortunately, many times the regulatory efforts of these agencies seem to have been counterproductive.

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