Supreme Court Hears Arguments on Compounders' Right to Advertise
At issue is the constitutionality of a provision in the FDA Modernization Act of 1997 (FDAMA). Seven pharmacies contend that the provision, which states that they cannot promote or advertise specific compounded drug products, violates the pharmacies' right of free speech under the First Amendment. Promotion or advertisement of a specific compounded drug product, counters the Department of Health and Human Services (HHS), means that a pharmacy has manufactured the product and must abide by the relevant FDA regulations and laws, including those covering the new-drug approval process.
The argument first hit the federal court system in 1998 when a group of compounding pharmacies sued the HHS secretary and the FDA commissioner. After the U.S. District Court for Nevada ruled in the pharmacies' favor, HHS and FDA appealed the decision.
A three-judge panel of the 9th U.S. Circuit Court of Appeals, with jurisdiction over nine western states including Nevada, agreed with the lower court (see April 15, 2001, AJHP News). But the judges added that the provisions against promotion and advertising cannot be declared unconstitutional without striking down all of FDAMAs compounding provisions.
HHS Secretary Tommy G. Thompson and FDA Acting Principal Deputy Commissioner Bernard A. Schwetz appealed the circuit court's decision, and the United States Supreme Court agreed to hear the government's and pharmacies' arguments.
According to legal sources, the questions asked by the nine justices during a hearing give little hint to the opinion that the majority will reach.
The case is known as Thompson v. Western States Medical Center. Besides Western States, based in Nevada and now doing business as Kronos Compounding Pharmacy, the pharmacies in the case are Women's International Pharmacy, in Wisconsin; Health Pharmacy, Wisconsin; Apothecure, Texas; College Pharmacy, Colorado; Lakeside Pharmacy, Tennessee; and Wedgewood Village Pharmacy, New Jersey.
Until the Supreme Court issues its opinion, FDA considers all of FDAMA to be valid outside of the 9th Circuit. An October 2001 warning letter from FDA to a Texas compounding pharmacy that, at the time, distributed or sold only 20% of its compounded drug products directly to individual patients stated that the pharmacy was acting as a manufacturer. FDA warned the pharmacy that it had been distributing "misbranded" drug products and not adhering to current good manufacturing practices.