Benefits vs. Risks
The benefits of a drug must exceed potential risks and possible side effects. The FDA agrees that the approval process needs to be accelerated for certain "last-chance" drugs. "Last-chance" drugs are those which are used to treat immediate life-threatening illnesses. Since 1987, the FDA has authorized the use of investigational new drugs (INDs) in the treatment of seriously ill patients. These "Treatment INDs" emphasize that the drug is administered to treat a patient, rather than to just collect data. This the reform was prompted in part of the clinical trials of AZT that concluded that the significant benefits of AZT outweighed undetermined risks. However, concern that reforms may swing too far and jeopardize the safety of the people who may use these drugs is also rising.