The number of local governments looking to mandate that drug manufacturers pay for environmentalist-crafted programs to collect and dispose of unused prescription drugs is growing even as the legality of the law is being examined by the U.S. Supreme Court.
In 2012 California’s Alameda County decided that it would no longer pay for its prescription drug take-back program. The county’s Department of Environmental Health enacted an ordinance requiring any company with a drug that was sold in or brought into the county to take responsibility for the disposal of unused prescription drugs.
The pharmaceutical industry saw the ordinance as a blatant violation of the U.S. Constitution’s Commerce Clause, but a federal court disagreed, and other government officials took notice. Four local governments, including San Francisco’s, have adopted similar laws, and at least a dozen more are considering doing the same.
Alameda says the ordinance is not about shifting costs; it is about protecting the environment and its citizens’ health.
A University of Michigan study found that drug take-back programs are not the best way to curb pollution and are not worth the extra "time, money, or greenhouse gas emissions."
It is better to throw unused drugs in the trash than to flush them down the toilet, according to the study, which claimed to be the first to take a scientific look at take-back programs. Both the Federal Drug Administration and Drug Enforcement Administration support in-home disposal.
One issue cited is that the compliance rate for take-back programs, in which individuals would need to bring their unused medications to designated kiosks, is difficult to measure.
Not only is it unclear how many unused medications exist at a given time, it is also impossible to know how much of the pharmaceutical material that ends up in the water ended up there because it was improperly disposed by flushing it down a toilet.
Most of the drugs people take do not completely metabolize in the body and end up in the water supply even though they are used properly, according to a separate University of Michigan report.
Alameda County’s liaison for the drug take-back program did not respond to a request for comment.
Despite the scientific uncertainty surrounding take-back programs, Pharmaceutical Research & Manufacturers of America (PhRMA), the group that petitioned the Supreme Court to look at the issue, believes that Alameda and other localities have the right to carry the programs out—they just need to pay for them.
"If Alameda wants a take-back program that benefits their local constituents, then Alameda needs to figure out how to pay for it locally," said Mit Spears, executive vice president and general counsel of PhRMA. "While we believe that in-home disposal is the best option in terms of cost, compliance, and environmental benefit, we recognize the right of local elected officials to come to a different conclusion."
Spears says the problem with the program is that local consumers are reaping supposed benefits while the costs are passed on to everybody else.
"What we object to is shifting the costs of a program that only benefits local consumers onto patients and consumers located in other parts of the country," said Spears. "We think that’s wrong, unfair, and violates the Commerce Clause of the Constitution."
Spears also fears that allowing Alameda to maintain its ordinance would create a "slippery slope."
Spears says the decision may open the floodgates and tempt localities to charge industries for municipal costs they are indirectly tied to—for example, charging the plastics industry for recycling costs or distillers for sobriety checks.
"The precedent here represents an extraordinarily slippery slope," he said. "This model suggests that it is impossible for interstate companies—of any industry—to sell their products into the national marketplace without becoming subject to the direct regulatory control of local government to serve exclusively local interests."
Despite the industry’s active fight against the law, it has submitted plans to comply with the ordinance.
The process of bringing more than 290 different companies from around the world together to come up with a single plan for Alameda County has been a costly and difficult task, according to an industry source familiar with the compliance efforts.
Among the many obstacles has been how to divide responsibility between brand-name and generic drugs—the former makes much more money but is in much less quantity than the latter. Another difficult question is whether companies selling drugs that are more likely to end up in the water supply should be more responsible for the program.
The companies also feel they must be responsible for 24/7 security for each kiosk, which they fear would become a magnet for anybody seeking controlled substances. Before the ordinance, the kiosks for Alameda County’s take-back program were located in police stations, which are secure and regularly deal with disposal of controlled substances.
The growing concern for the pharmaceutical industry is that if Alameda County gets its way, this logistical headache will have to be solved in thousands of counties across the country.