SEATTLE (CN) - Drug-makers' trade groups sued King County, home to Seattle, claiming a new law requiring pharmaceutical companies to take back expired medication violates the Commerce Clause and is unnecessary because dumping drugs in the trash is "safe, convenient, and effective."
The King County Board of Health adopted the "Secure Medicine Return Rule & Regulation" in June this year. The program must be "financed and operated by drug producers selling medicines in or into King County for residential use," according to the federal lawsuit.
The plaintiffs - the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association, the Biotechnology Industry Association, and the Consumer Healthcare Products Association - sued King County and its Department of Public Health.
They claim the ordinance is an unconstitutional state regulation of interstate trade.
"In obligating all drug manufacturers whose products are sold in the county to establish local drug take-back programs, the regulation conscripts parties engaged in interstate trade to implement what would otherwise be a local governmental function," the lawsuit states. "It would shift costs of waste disposal from local taxpayers and/or local consumers to consumers located in other regions of the county. Far from fulfilling its responsibility to promote health and welfare within its territorial jurisdiction, King County is attempting to shift governmental responsibilities onto interstate businesses and local costs onto out-of-state consumers."
The new law requires drug manufacturers whose products reach King County to run or contribute to a privately administered drug take-back program. Some items are excluded, including vitamins, herbal remedies, cosmetics, soaps, detergents and drugs that already are part of a take-back program.
Companies are barred from charging extra fees to recoup the costs of the program and will incur fines if they don't participate.
The pharmaceutical trade groups claim the regulation violates the Commerce Clause in three ways: by burdening interstate commerce by transferring a governmental responsibility onto drug producers; by shifting costs of a local regulatory program onto interstate commerce; and by regulating entities with no significant ties to King County and controlling conduct across county lines.
"Even if the regulation were not a per se infringement of the Commerce Clause, it would still be unconstitutional," the complaint states. "The regulation imposes an excessive burden on interstate commerce because the 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."
The drug makers claim that tossing expired medication into the garbage is safer and more secure than having collection sites, where theft will "inevitably occur."
"Disposal of unwanted pharmaceuticals in household trash is safe, convenient, and effective," the complaint states. "Promptly throwing away unwanted pharmaceuticals ensures that those medicines are inaccessible to children, adolescents, and other unintended users. And double-lined active landfills approved for use by the EPA and equipped with sophisticated leachate collection systems virtually eliminate the possibility that active pharmaceutical ingredients could leach out into the environment if disposed of along with household trash."
Other groups that defend the safety of in-home disposal include the Food and Drug Administration, the Environmental Protection Agency, the Office of National Drug Control Policy, the American Pharmacists Association, and the Department of Fish and Wildlife, a spokeswoman for one of the plaintiffs noted in an email.
"Given the very real dangers of prescription drug abuse thanks to diversion of medicine by people who would abuse them, it's a much safer and efficient method of disposal, as compared to saving up one's medicine waiting to transport it to take back events," spokeswoman Kaelan Hollon, of the Pharmaceutical Research and Manufacturers of America, said in an email.
The complaint also notes that in-home disposal "minimizes the potential that unwanted medicines would be stolen, diverted or improperly used."
"Collection kiosks, bins and other handling facilities used in take-back programs can become a target for thieves and others who might wish to steal unwanted medicines for improper or illegal purposes," the complaint continues. "The costs of providing around-the-clock security for collection sites and sorting and processing facilities will be significant and, regardless of the precautions taken, some level of theft, diversion and improper use will inevitably occur. The disposal of unwanted medicines in household waste eliminates the problem of 'reconcentration' and reduces the likelihood of theft, diversion and improper use."
The drug makers claim they are being unfairly singled out, as the county doesn't make other industries recycle their own used products.
"If the regulation were permissible, then King County could likewise require interstate news publications to conduct the county's paper recycling program or require interstate food producers to collect and dispose of all spoiled food or similar garbage. Localities would have a green light to get something for nothing, simply by free-riding on interstate commerce and transferring the financial burdens to out-of-state consumers. Because such policies offend the dormant Commerce Clause at least as directly as a tariff, the court should declare the regulation unconstitutional and permanently enjoin its implementation," the groups say.
They want the regulation enjoined as unconstitutional.
They are represented by Gregory Hollon, with McNaul Ebel Nawrot & Helgren, in Seattle, and Michael Carvin, with Jones Day, in Washington, D.C.
The 11 largest pharmaceutical companies reported $85 billion in profits last year, according to publicly available reports.
Read the Top 8
Sign up for the Top 8, a roundup of the day's top stories delivered directly to your inbox Monday through Friday.