E.R. Squibb & Sons, Inc. v. Bowen

In 1962, the Food, Drug, and Cosmetic Act of 1938 (FDCA) was amended to require that in addition to proving that a drug is safe for use, a New Drug Application (NDA) applicant must also prove that its drug is effective in use to obtain Food and Drug Administration (FDA) approval. Thereafter, the FDA reviewed its pre-1962 drug approvals for compliance with the new standard and delegated preliminary effectiveness evaluations to the National Resource Council (NRC). Based on NRC conclusions, the FDA announced in 1969 that it would delete drugs that contained the combination of antibiotic and antifungal agents from its list of certified drugs. E.R. Squibb & Sons, Inc., the manufacturer of one such combined drug, Mysteclin, that received FDA approval in 1950, filed objections. At an evidentiary hearing, it presented evidence of its labeling claim that Mysteclin was effective in suppressing candida overgrowth in the intestinal tract. An administrative-law judge found that Squibb failed to show that Mysteclin was effective in use and ordered that its certification be withdrawn. On appeal, the Commissioner affirmed, finding that the effective in use standard required a drug manufacturer to show not only that its drug had the effect claimed on its label, but also that the claimed effect is of some medical significance. Squibb appealed and argued that under a plain language reading of the FDCA and its regulations, the standard is met simply by showing that a drug does what its label says it does.