No You Don’t, Drugmakers Tell County

OAKLAND, Calif. (CN) - The pharmaceutical industry challenged an Alameda County law, the first such law in the country, requiring drugmakers to pay for programs to dispose of expired and unused drugs.

The Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Biotechnology Industry Organization sued the county in Federal Court. They claim the Alameda County Safe Drug Disposal Ordinance, which the Board of Supervisors passed unanimously in July, violates the Commerce Clause of the Constitution.

The law requires that manufacturers of drugs sold or distributed in the county pay for and operate programs for consumers to turn in unused medicines for disposal. Drugmakers will face up to $1,000 a day in fines if they don't comply.

"Alameda County's drug take-back ordinance is unprecedented," the complaint states. "In obligating all drug manufacturers whose products are sold in the county to establish local drug take-back programs, the ordinance conscripts parties engaged in interstate trade to implement what would otherwise be a local government function paid for by local taxpayers. Far from fulfilling its responsibility to promote health and welfare within its territorial jurisdiction, Alameda County is attempting to shift governmental responsibilities onto interstate businesses."

The law requires drug companies to develop and submit comprehensive plans to the Alameda Department of Environmental Health by July 1, 2013 on how they will operate their drug take-back programs. The drugmakers say it violates the Commerce Clause in three ways.

"First, it directly regulates and burdens interstate commerce and its primary purpose and clear effect is to shift the costs of a local regulator program directly onto interstate commerce and out-of-county consumers. Second, the ordinance discriminates against interstate commerce by targeting interstate commerce and products delivered from outside the county for burdens. Finally, the ordinance favors local interests by deliberately shifting costs away from local consumers and taxpayers and onto drug manufacturers and pharmaceutical consumers nationwide."

More than 99 percent of drugs affected by the ordinance arrive from outside of Alameda County, according to the complaint. The law does not allow drug companies to impose fees to recoup costs.

Under the ordinance, drug companies must dispose of all covered medications, whether theirs or not, by incineration at a medical waste or hazardous waste facility and monitor the emissions from these facilities. They will have to provide advertising and promotional materials about the program, provide funding and technical support to law enforcement agencies, and compensate Alameda County for the costs of administering the ordinance.

"If this novel ordinance were permissible, then Alameda 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," the complaint states.

The ordinance will require "plaintiffs' members to enter into a new form of business - a combination of municipal waste disposal and local law enforcement," the complaint states.

The household trash can is a better and safer alternative, the drugmakers say.

"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 unused medicines for improper or illegal purposes. The costs of providing security for collection sites and sorting and processing facilities will be substantial and, regardless of the precautions taken, the potential for theft, diversion and improper use will persist," according to the complaint.

The plaintiffs want the law enjoined as unconstitutional.

They are represented by Craig Stewart with Jones Day.

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