Supreme Court to Weigh Ad Restrictions on Pharmacies that Compound Drugs
The Supreme Court on Monday agreed to decide whether the federal government can "restrict advertising by pharmacists who mix drug ingredients for patients in need of specialized medications," Dow Jones Business News reports. The mixtures, known as drug compounds, are not subject to FDA approval, but require a physician's prescription. They are used for "people with allergies or for children who need diluted doses." The dispute in question arose in 1997, when Congress said that pharmacists could advertise the fact that they mix drugs but "couldn't tout specific compounds in which they specialize." The goal of this provision was to give the public access to compounds while preventing pharmacists from "skirting the drug-approval process by mass-producing mixtures and advertising their sale." In 1998, eight pharmacies in seven states filed suit against the federal government, arguing that the restrictions violated pharmacists' free speech protections. A federal judge in Nevada and the 9th U.S. Circuit Court of Appeals both sided with the pharmacies; the latter concluded this February that "there was little evidence that the restrictions would protect the public" and that there was not "adequate proof that the curbs advanced any 'substantial interest' the FDA may have in limiting wider distribution of drug compounds." The Bush administration then appealed the decision to the Supreme Court, saying it threatened the balance of the FDA's drug approval process. "If compounders could actively promote their products through advertising without bearing [the cost of proving that a drug is safe and effective], they would enjoy an unfair advantage over traditional drug manufacturers, who must comply with the approval requirements," Justice Department attorneys wrote. A decision in the case is expected sometime in the middle of next year (Ritter, Dow Jones Business News, 10/29).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.