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Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie

Journal of Law and Health

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 …