Pharmaceutical trade groups have hit a California county with a lawsuit less than 6 months after it made the industry pay for disposal of unused meds. And the outcome could have widespread implications, with other parts of the U.S. watching to see if they can pass on the responsibility and cost to drugmakers, too.
Alameda County unanimously voted to pass the law--which makes pharma companies liable for the disposal of unused and expired drugs--despite strong opposition from the industry. But the industry has hit back, with PhRMA, BIO and the Generic Pharmaceutical Association teaming up to sue Alameda County. The case brought by the trade groups claims that the pharma industry is ill-suited to the task of drug disposal.
"Take-back programs require the meaningful involvement of local solid waste disposal and police functions and thus should be managed by local government," PhRMA Senior VP Matt Bennett told Pharmalot. Having local authorities handle the task is, in Bennett's view, the only way to "achieve necessary efficiencies and ensure local officials are accountable to their communities for the operation and cost of the programs." As PhRMA sees it, Alameda County is asking the drug industry to expand beyond its core business into "a combination of municipal waste disposal and local law enforcement."
Official estimates place the cost of the current program--where residents drop drugs off at 28 sites--at $330,000. The trade groups are particularly aggrieved that the law prohibits them from adding a local point-of-sale fee to cover costs they incur. Without this, PhRMA claims citizens in the rest of the U.S. will have to foot the bill, making the law unconstitutional.
Alameda County officials view the cost as chicken feed for pharma, but the industry fears that the law would open the door for drug disposal laws across the U.S. Just 0.5% of the U.S. population lives in Alameda County, so a crude calculation suggests nationwide drug disposal costs could near $70 million. In recent years, legislators in 7 states have tried to make industry pay for take-back programs. PhRMA and its allies would rather see cash spent on education programs to encourage people to just dispose of old drugs in the trash.
But unless PhRMA can win in the courts, drugmakers have until July 1 to send take-back plans to Alameda County.
- here's the Pharmalot piece
- read the NYT article
- check out the lawsuit (pdf)