Edison Pharmaceutical Co. v. Food and Drug Administration

The Food and Drug Administration (FDA) rejected a New Drug Application (NDA) from Edison Pharmaceutical Co., the developer of Cothyrobal, an injectable drug intended to treat hypercholesterolemia and hypothyroidism. The drug, a combination of the thyroid extract, sodium levothyroxine, and cyanocobalamin (vitamin B12), was designed specifically to have vitamin B12 inhibit the toxicity of the levothyroxine while maintaining its medicinal benefits. The FDA denied the application because Edison failed to submit double-blind controlled studies comparing the effects of Cothyrobal and levothyroxine, which the FDA determined were necessary to prove the efficacy of Cothyrobal. Edison appealed the ruling and argued that the studies it did submit were as scientifically sound as possible. A panel reversed and ordered the FDA to hold a full evidentiary hearing to determine whether double-blind studies comparing the effects of levothyroxine and Cothyrobal could be conducted safely and to decide all relevant issues relating to the approvability of Edison’s NDA. The FDA held the required hearing and an administrative-law judge (ALJ) excluded the testimonial evidence proffered by Edison to prove the drug’s efficacy and determined that limited double-blind testing could be performed safely and that the studies submitted by Edison failed to demonstrate the safety and efficacy of Cothyrobal, as required by § 505(d)(5) of the Food, Drug, and Cosmetic Act of 1938. Edison did not dispute the inadequacies of its testing but appealed the exclusion of its testimonial evidence to establish the efficacy of its drug.