Aids, Experimental Drug Approval, and the Fda New Drug Screening Process

One of the most important statutory mandates that guides the Food and Drug Administration (FDA) serves to designate the agency as protector of the American people against commercial introduction of new drugs that are either unsafe or ineffective.1 Over the past sixty years, this mandate has often placed the FDA at the center of controversy as a series of medication-induced calamities led to repeated episodes of public outrage and to tighter controls on pharmaceutical development.2 Determinations with regard to the safety and efficacy of new drugs entail a highly technical regulatory process drawing on the esoterica of medicine, pharmacology, biostatistics, and clinical trial design.3 Thus the FDA, in fulfilling its mandate, has historically served as a buffer against dangers that the public was unequipped to evaluate directly.4 Ironically, the turn of the twenty-first century sees