On July 27, 2012, the Alameda County Board of Supervisors, located in Northern California, passed the Safe Drug Disposal Ordinance (Ordinance). The Ordinance, which was scheduled to go into effect on November 1, 2013, requires Producers to fund or operate “take-back” programs in Alameda County, if they sell, offer for sale, or distribute Covered Drugs, including both brand name and generic drugs. Pursuant to the Ordinance, the Producers of Covered Drugs are responsible for creating, administering, and financing the “take back” programs. The Producers must operate a Product Stewardship Program, either individually or jointly with other Producers, and implement an approved Product Stewardship Plan (Plan) to collect, transport, and dispose of unwanted prescription drug products. The Ordinance requires Producers of Covered Drugs to submit a Plan to the Alameda County Department of Environmental Health for approval.
In December 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA, together with PhRMA and BIO, the Plaintiffs) filed suit in the United States District Court for the Northern District of California in opposition of the Ordinance. The Plaintiffs alleged, among other things, that the Ordinance is an unconstitutional burden on interstate commerce under the Commerce Clause. On August 28, 2013, District Court Judge Richard Seeborg ruled in favor of Alameda County; the Plaintiffs appealed to the Ninth Circuit Court of Appeals. On September 30, 2014, the Ninth Circuit upheld the District Court's ruling, and confirmed the authority of local governments to require drug manufacturers to fund the collection and disposal of their medicine. On December 29, 2014, the Plaintiffs petitioned the United States Supreme Court for a Writ of Certiorari to review the Ninth Circuit's decision.
While the Plaintiffs and Alameda County await the Supreme Court's decision on whether it will grant the petition, the Board of Health in King County, Washington has decided to move forward with its own drug take back regulations. King County passed the Secure Medicine Return Regulations (Regulations) on June 20, 2013. The Regulations establish a program to collect and properly dispose of unwanted medicines from local residents. According to the Regulations, the program will be funded and operated by drug manufacturers whose prescription and over-the-counter medicines are sold for residential use in or into King County. Additionally, the Regulations require pharmaceutical drug wholesalers that sell prescription or non-prescription drugs in or into King County to submit a list of manufacturers of those drugs to the by October 25, 2013. Wholesalers are then required to provide an updated list annually by January 15th of each year.
As in Alameda County, the Plaintiffs filed a joint lawsuit against King County, the King County Department of Public Health, and the Director of the Department alleging that the Regulations are unconstitutional. Because the lawsuit against Alameda County is similar to the King County lawsuit, the King County Department of Public Health recently decided to move forward with implementing the Regulations, and has extended the implementation deadlines outlined in its Regulations. Accordingly, Producers had until November 14, 2014, to "(a) identify in writing a stewardship plan operator, including contact information, and (b) notify all retail pharmacies and law enforcement agencies in King County of the opportunity to participate as a drop-off-site and the process to form an agreement with the stewardship plan." Producers will have until February 12, 2015, to submit a proposed stewardship plan and plan review fee.