Supreme Court Strikes Down Law Barring Pharmacies From Advertising Compounded Drugs
The Supreme Court yesterday struck down part of a 1997 federal law that prohibited pharmacies that mix prescription medicines from advertising such products without federal approval, the San Francisco Chronicle reports. In a 5-4 decision, the Supreme Court ruled that a section of the 1997 FDA Modernization Act barring pharmacies from advertising the prescription drugs they mix, known as "compounds," violates the pharmacies' right to free speech (Russell, San Francisco Chronicle, 4/30). In the majority opinion, Justice Sandra Day O'Connor wrote that the government "should find another way" to regulate compounding pharmacies (Holland, AP/Washington Post, 4/30). Compounding involves a pharmacist altering a drug to make it easier for a patient to consume, such as removing an ingredient that causes allergic reactions. The court majority suggested that the government could regulate compounding pharmacies by allowing compounds to be mixed only when a physician writes a prescription, limiting out-of-state sales of mixed drugs or banning the use of "large-scale equipment" to manufacture such drugs. The court majority wrote, "There is no hint that the government even considered these or any other alternatives. If the First Amendment means anything, it means that regulating speech must be a last -- not first -- resort. Yet here it seems to have been the first strategy the government thought to try" (Denniston, Boston Globe, 4/30). Although the decision gives support to pharmacies' rights to advertise their products, the ruling could allow the FDA to "reassert its authority to regulate compounded drugs in a manner that does not clash with the First Amendment's free speech clause," the Chronicle reports (San Francisco Chronicle, 4/30).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.