Proposal to make investigational new drugs available without clinical trial participation in certain cases is receiving mixed responses

A LONG-standing controversy over allowing patients access to drugs before Food and Drug Administration (FDA) approval has surfaced again with revival of a 1983 proposal to make it easier for some patients to obtain certain experimental drugs. The proposed change has appeared in theFederal Register, and is expected to take effect in a few days. In one respect the FDA's new proposal codifies a decade-long but ad hoc situation. This has to do with so-called compassionate investigational new drugs (INDs). In certain circumstances and on a case-by-case basis, compassionate INDs have allowed patients access to a drug still under investigation. Under the new proposal, the agency would permit the physician of a patient with a life-threatening or serious illness to obtain an experimental drug, if it is likely the patient would benefit and even if the patient is not participating in a clinical trial of that drug. The FDA's