Experimental Drugs

Report Outline
Special Focus

Overview

They are mostly young men and they had not expected to face death in their 20s or 30s. They have AIDS (acquired immune deficiency syndrome) and they are desperate. Hundreds, perhaps thousands, of them in recent years have journeyed to the farmacias in Tijuana, Mexico, to buy isoprinosine and ribavirin, drugs considered experimental in the United States and so not commercially available here. But now a promising AIDS drug appears to be winning Food and Drug Administration (FDA) approval for use in this country. The drug is azidothymidine (AZT) and it has moved rapidly through the FDA's review system.

On average, it takes 7–9 years for new drugs to get from the point at which they are first tested on humans to final approval by the FDA for commercial use. In the case of AZT, the journey will have taken about a year-and-a-half if the drug receives final FDA approval soon.

For AIDS-related drugs at least, AZT's quick trip through the regulatory process appears to reflect an effort by the federal government to ensure that urgently needed new drugs reach the marketplace with a minimum of delay.