At the end of November, three pharmaceutical industry associations filed suit against King County, Washington and its Department of Public Health over the county’s “Secure Medicine Return Rule & Regulation” that was adopted in June. This drug take-back law is similar to Alameda County’s Safe Drug Disposal Ordinance, as it requires all “producers” who manufacture covered drugs sold in King County to develop or contribute to a privately administered drug take-back program. The program does not include items such as cosmetics, vitamins, or soaps. Notably, it includes over-the-counter drugs (Alameda’s ordinance does not), as well as prescription drugs.
Like a suit the industry associations filed challenging the Alameda ordinance, which we blogged about here and here, this suit also is a dormant Commerce Clause challenge. First the associations claim that the regulation places an impermissible burden on interstate commerce as it transfers a government responsibility to the producers of the drugs. Secondly they claim it violates the Commerce Clause by shifting the cost of a local regulatory program onto interstate commerce. Lastly, the associations state that the regulation has an impermissible extraterritorial impact because it regulates entities that are not significantly tied to King County. They also claim that the regulation is an unconstitutional tax. The complaint highlights another way the county could accomplish its goals, without running afoul of the Commerce Clause: “[t]he county could accomplish all of the purported benefits of an unwanted-drug collection program without any interstate burden - i.e., by conducting such a program through government officials paid by the local taxpayers and consumers served by the program."
While a solution such as this would alleviate the burden on industry, it will only be implemented if the regulation is struck down. Much depends on the Alameda challenge, which is on appeal to the Ninth Circuit and will set precedent for the King County lawsuit. The Ninth Circuit Court of Appeals struck down a dormant Commerce Clause challenge to California’s low carbon fuel standard (LCFS) earlier this fall. While the cases have obvious factual differences, the Ninth Circuit’s recent LCFS ruling may not bode well for Commerce Clause challenges to drug take-back regulations. In case of a similar ruling, both prescription and over-the-counter drug manufacturers should begin preparing their drug take back compliance strategies now.