In the case of United States v. Pharmaceutical Corp. v. Weinberger, Secretary of Health, Education, and Welfare et al., 1972, the U.S Supreme Court was asked to determine whether a drug manufacturer could be required by the Food and Drug Administration (FDA) to prove that its product is effective as well as safe before it can be marketed. The court ruled in favor of FDA's authority to require proof of both safety and efficacy prior to marketing approval for drugs under the Federal Food, Drug & Cosmetic Act (FDCA). This decision upheld an earlier ruling by a lower court which had also sided with FDA’s position on this issue.

The dissenting opinion in the case of USV Pharmaceutical Corp. v. Weinberger, Secretary of Health, Education, and Welfare et al., argued that the majority's decision to uphold the Food and Drug Administration's (FDA) authority to require proof of effectiveness before approving a drug for market was an overreach of administrative power. The dissenters believed that Congress did not intend for such extensive control by the FDA when it passed legislation regulating drugs. They contended that requiring pharmaceutical companies to provide substantial evidence proving their drugs' effectiveness would stifle innovation and potentially delay life-saving treatments from reaching patients who need them most urgently. Furthermore, they expressed concern about potential bias within the FDA itself as well as its ability to objectively evaluate all available data on a given drug’s efficacy.