Industry Wants Supreme Court to Stop Calif. Drug Disposal Program

Drugmakers could end up paying millions of dollars on collection and disposal programs for unwanted drugs nationwide if industry groups aren’t able to stop a California county ordinance.

PhRMA, BIO and GPhA have asked the U.S. Supreme Court to hear their appeal over Alameda County’s 2012 ordinance requiring manufacturers to fund and maintain drug take-back programs. The groups want the high court to deem the ordinance unconstitutional and overturn a decision this fall by the Ninth Circuit Federal Court upholding the measure.

The financial stakes are high for the pharmaceutical industry. The cost to each manufacturer for maintaining a program is small, with Alameda estimating annual costs of $5,300 to $12,000. But if counties nationwide establish similar programs, then costs could balloon to millions a year per company, said Kurt Karst, an attorney with Hyman, Phelps & McNamara.

Other counties may pursue their own programs if the challenge is unsuccessful, Karst said. Momentum already is building for such programs. King County, Wash., has started a program, and several other California counties are considering the idea.

Under Alameda’s ordinance, a drugmaker that sells or distributes products in the county must establish its own program or join a group of companies to collect and dispose of any unused drugs. The ordinance prevents manufacturers from charging a fee to fund the program.

The ordinance, which went into effect this fall, requires manufacturers to submit plans to county officials on how they plan to establish the programs, explained Donna Ziegler, county counsel. She couldn’t say how many companies have already submitted plans.

The trade groups maintain the ordinance violates the U.S. Constitution’s Commerce Clause, which prevents local laws from regulating interstate commerce. Mandated take-back programs also contradict recommendations from the FDA and Drug Enforcement Administration that support in-home disposal, said John Murphy, PhRMA assistant counsel.

Advocates say the programs have proven themselves elsewhere. Manufacturers pay for take-back programs in countries such as Canada and Mexico, said Heidi Sanborn, executive director of the California Product Stewardship Council.

The Supreme Court is expected to issue a response to the appeal by Jan. 28. If the court doesn’t take up the case, Karst said industry may decide to sue other counties over their programs. If successful in another circuit, it would create an impetus for the Supreme Court to hear the case, he said. — Robert King