THE FOOD and Drug Administration (FDA) has finalized new rules to facilitate the availability, outside of clinical trials, of promising new therapies being investigated in clinical trials. Effective June 22, 1987, investigational new drugs (INDs) have been available to treat "desperately" ill patients (those patients with serious or immediately life-threatening illnesses) as early in the drug development phase as possible. These new therapeutic options are referred to as "treatment INDs.1 Patient access to these drugs, usually limited to clinical trials, is conditioned on an absence of comparable or satisfactory therapy and on adequate enrollment in ongoing clinical trials.
The FDA postulates that requiring adequate clinical trial enrollment before access to treatment INDs is permitted will prevent the undermining of the clinical trial process. Only time will tell whether the trial process will be harmed. However, without this provision, not included in the rule as initially proposed, the FDA would have