United States v. 50 Boxes More or Less

The Food and Drug Administration (FDA) seized 50 boxes of Cafergot P-B Suppository (CPB), a prescription drug designed to stop vascular headaches and prevent nausea from two of the drug’s ingredients. Although Sandoz, the manufacturer of CPB, had successfully sold CPB for more than 35 years, the FDA had a legal right to seize the boxes of CPB if (1) CPB was a new drug; and (2) Sandoz failed to present substantial evidence that the CPB was effective. FDA approval of a new drug requires rigorous premarket testing standards, including adequate and well-controlled studies unless the drug is generally recognized among experts as safe and effective for use under the conditions prescribed in the labeling. The latter requirement, which can be found in 21 U.S.C. § 321(p)(1), is referred to as the GRASE standard, and despite its apparent alternative to the rigorous premarket testing standards required of new drugs, the courts have interpreted its substantial-evidence requirement to be the same as that for a new drug, meaning it in fact provides no exception. The district court granted summary judgment for the FDA after it found that Sandoz, who had not conducted such studies or premarket testing had not presented substantial evidence of CPB’s effectiveness, so CPB was not GRASE-exempt. Sandoz appealed and argued that it should be able to satisfy the substantial-evidence standard for GRASE with other evidence of a drug’s effectiveness that although not the same as costly well-controlled studies is at least as scientifically convincing.