Government Regulation of Health-Care Drugs of Questionable Efficacy

Rutherford and similar cases present several interesting questions. The threshold inquiry in the federal court cases is whether a substance like laetrile falls within the scope of certain sections of the Food, Drug, and Cosmetic Act and is therefore subject to the safety and efficacy requirements of the Act. If the Act is applicable, and the substance is not approved for interstate shipment, it is necessary to determine whether an individual has a fundamental constitutional right to obtain and use drugs of questionable efficacy for personal health care. If that right were recognized, it would become necessary for the government to show a compelling state interest and to use narrowly drawn means to justify infringement upon the right. A final question is whether distributors and physicians have standing to assert the health-care rights possessed by the user of a substance like laetrile