The prospective review and approval of drugs is central to the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers to generate information about their products' safety and efficacy enables the agency to evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access to an array of drugs that are proven to be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved. However, this majoritarian view overlooks the concentrated costs that the drug approval process imposes upon minority groups within society. Drug testing is both resource intensive and time consuming, with an average of eight years required for human clinical testing alone. For individuals suffering from terminal illness who have exhausted conventional therapies, this delay in access can be fatal. Many terminally ill patients are therefore willing to tolerate vastly greater therapeutic risks in an effort to find a cure. Under the current regulatory structure, however, willingness to tolerate risk does not necessarily translate into access to unapproved drugs.
Peter M. Currie, Restricting Access to Unapproved Drugs: A Compelling Government Interest, 20 J.L. & Health 309 (2006-2007)