Managers and the Legal Environment 7th Edition by David Madsen, Constance Bagley

Exercise 1

The Food and Drug Administration (FDA), which is charged with implementation of the Federal Food, Drug and Cosmetic Act, refused to approve the cancer-treatment drug Laetrile on the ground that it failed to meet the statute's safety and effectiveness standards. Terminally ill cancer patients sued, claiming that the safety and effectiveness standards implemented by the FDA could have no reasonable application to drugs used by the terminally ill. The statute contained no explicit exemption for drugs used by the terminally ill. The U.S. court of appeals reviewing the case agreed with the plaintiffs and approved intravenous injections of Laetrile for terminally ill cancer patients. The U.S. Government appealed to the Supreme Court. Under what standard should the Supreme Court review the FDA's determination that an exemption from the Federal Food, Drug and Cosmetic Act should not be implied for drugs used by the terminally ill? [ United States v. Rutherford, 442 U.S. 544 (1979).]