Big Pharma and its generic brethren teamed up in a lawsuit against Alameda County over the nation's first drug take-back program, which would make manufacturers responsible for leftover pharmaceuticals and the cost of their disposal.
The lawsuit filed Friday called the ordinance confusing, duplicative and unnecessarily burdensome on consumers and the environment.
But the real driver behind the lawsuit is an attempt to prevent other local governments from making companies absorb the responsibility and costs for the tens of thousands of pounds of unwanted pharmaceuticals that otherwise end up in waterways, landfills or medicine cabinets, where they can be fatal. The success or failure of the lawsuit could have groundbreaking effects on how the country decides to deal with the growing problem.
In fact, Supervisor Nate Miley said the county is still working with the state to "step up to the plate" with an effective way to regulate the unwanted drugs but was worried legislation from Sacramento would be "watered down." So the county decided to move ahead with its own rules.
"We've been expecting it, but just didn't know when," Miley said of the lawsuit filed by the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization and the Generic Pharmaceutical Association in the U.S. District Court for the Northern District of California.
They have long argued that the appropriate place for their unused products is the trash, the toilet or drop boxes, usually located in local law enforcement agencies. There are 128 such drop-off sites in the Bay Area.
The three allies blocked take-back programs launched in dozens of states in 2011, which the Generic Pharmaceutical Association called "onerous and burdensome" in its 2011 annual report. The ordinance puts "unprecedented" responsibilities on prescription drug manufacturers -- and only those manufacturers -- to develop, manage, execute and fund operations, the companies complained. Those duties, they continued, are more properly the responsibility of local and municipal governments and require other local entities to be effective.
Executives also argued that the program would do little to deal with the overabundance of leftover drugs, of which 60,000 pounds were disposed in Bay Area drop boxes in 2009 alone.
But the heart of the lawsuit is money.
"The ordinance favors local interests by deliberately shifting costs away from local consumers and taxpayers and onto drug manufacturers and pharmaceutical consumers nationwide," the lawsuit states.
The companies want residents here to shoulder the cost, even though the industry is paying for similar pilot programs in Canada and San Francisco. San Francisco's, however, is voluntary.
Alameda County's ordinance, in contrast, is mandatory and prevents the industry from imposing fees to pay for the program.
That means, according to Big Pharma executives, the costs will be passed on to consumers from other parts of the country, who will not benefit from the program. The manufacturers argue that it is unconstitutional and harms seniors and others on fixed incomes.
Alameda County based the ordinance on take-back programs for batteries and paint.
The difference, Generic Pharmaceutical Association spokesman Greg Howard said, is that the producers of those items don't have to foot the bill for their disposal. "Why are we being singled out?"
Alameda County Counsel Donna Ziegler said manufacturers do not have to pass on the cost to any consumers. The ordinance, she added, was crafted to prevent them from doing exactly that and makes them stewards.
Stewardship gives them the ability to be creative about developing a cost-effective way to do it. "They could work together to shoulder the cost," she said.
The $300 billion-plus industry, particularly lobbyists and Pharmaceutical Research and Manufacturers of America, were invited early on in the process to help craft the ordinance, which took more than a year to bring to a vote in July.
"They didn't shape it," Ziegler said. "Their idea was 'don't do it.'"