Unused Pills Raise Issue of Disposal and Risks

Source: The New York Times

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Brand name drug makers and their generic counterparts rarely find themselves on the same side of an issue, but now they are making an exception. They have teamed up to fight a local law in California, the first in the nation, that makes them responsible for running — and paying for — a program that would allow consumers to turn in unused medicines for proper disposal.

Such so-called drug take-back programs are gaining in popularity because of a growing realization that those leftover pills in your medicine cabinet are a potential threat to public health and the environment.

Small children might accidentally swallow them and teenagers will experiment with them, advocates of the laws say. Prescription drug abusers can, and are, breaking into homes in search of them. Unused pills are sometimes flushed down the toilet, so pharmaceuticals are now polluting waterways and even drinking water. One study found the antidepressant Prozac in the brains of fish.

Most such take-back programs are run by local or other government agencies. But increasingly there are calls to make the pharmaceutical industry pay.

“We feel the industry that profits from the sales of these products should have the financial responsibility for proper management and disposal,” said Miriam Gordon, California director of Clean Water Action, an advocacy group.

In July, Alameda County, Calif., which includes Oakland and Berkeley, became the first locality to enact such a requirement. Drug companies have to submit plans for accomplishing it by July 1, 2013.

But the industry plans to file a lawsuit in United States District Court in Oakland on Friday, hoping to have the law struck down. The suit is being filed by the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents brand-name drug companies, the Generic Pharmaceutical Association and the Biotechnology Industry Organization.

James M. Spears, general counsel of PhRMA, said the Alameda ordinance violated the Constitution in that a local government was interfering with interstate commerce, a right reserved for Congress.

“They are telling a company in New Jersey that you have to come in and design and implement and pay for a municipal service in California,” he said in an interview.

“This program is one where the cost is shifted to companies and individuals who are not located in Alameda County and who won’t be served by it.”

Mr. Spears, who is known as Mit, said that the program would cost millions of dollars a year to run and that pharmaceutical companies were “not in the waste disposal business.” He said it would be best left to sanitation departments and law enforcement agencies, which must be involved if narcotics, like pain pills, were to be transported.

Nathan A. Miley, the president of the Alameda County Board of Supervisors and the champion of the legislation, said late Thursday, “It’s just unfortunate that PhRMA would fight this because it would be pennies for them.”

“We will win legally and will win in the court of public opinion as well,” Mr. Miley said.

The battle in Alameda could set the direction for other states and localities. Legislators in seven states have introduced bills to require drug companies to pay for take-back programs in the last few years, said Scott Cassel, founder and chief executive of the Product Stewardship Institute, a nonprofit group that advocates such programs. But none of the bills have passed.

Mr. Cassel said about 70 similar “extended producer responsibility” laws have been enacted in 32 states for other products, like electronic devices, mercury-containing thermometers, fluorescent lamps, paint and batteries. He said he was not aware that any had been struck down on constitutional grounds.

The pharmaceutical industry already pays for take-back programs in some other countries. The law in Alameda is modeled partly on the system in British Columbia and two other Canadian provinces. There, the industry formed the Post-Consumer Pharmaceutical Stewardship Association, which runs the programs.

Consumers can take unused drugs back to pharmacies, from which they are periodically collected. Drug companies pay for the program in proportion to their market share, said Ginette Vanasse, executive director of the association. The program for British Columbia, with a population over four million, costs about $500,000 a year, she said.

The extent of the problem of unused pills and how best to handle them are matters of debate.

The United States Geological Survey has found various drugs, including antidepressants, antibiotics, heart medicines and hormones, in waterways it has sampled. Sewage treatment plants and drinking water treatment plants are not meant to remove pharmaceuticals.

Still, it is not known what effect the chemicals might have. “It’s a hard-to-pin-down problem,” said Sonya Lunder, a senior analyst at the Environmental Working Group, an advocacy group. It is thought that trace amounts in drinking water are probably not harmful. But larger amounts found in wastewater could be having an impact on wildlife.

It is also unclear whether take-back programs will help. Experts generally agree that the bigger source of pollution is urine and feces containing the remnants of drugs that are ingested, not the unused pills flushed down the toilet.

PhRMA also argues that take-back programs will not help much with the problem of drug abuse either. Mr. Spears said that it was better to have consumers tie up unused pills in a plastic bag and throw them in the trash. That is more effective, he said, because people would not have to travel to a collection point. Such collection points could become targets for thieves and drug abusers.