Pharma fights back over Californian meds disposal plans

Plans to force pharmaceutical companies to set up and fund take-back programmes for unused prescription medicines in California are being resisted by the industry.

The new bill was introduced in San Francisco towards the end of last month and is intended to prevent controlled substances from being diverted into the hands of addicts, to avoid accidental overdoses and prevent unused medicines entering waterways.

Under the proposals - which are already required in one Californian county (Alameda) and have been the subject of a legal dispute that reached the federal appeals court - drugmakers would have to bear the full cost of designing and operating a collection scheme for unused medicines in the home. At the end of September, the appeals court ruled that Alameda's ordinance could stand, giving a green light for San Francisco to press ahead with its own scheme.

The Pharmaceutical Research and Manufacturers of America (PhRMA) and some individual pharma companies have voluntarily contributed towards a pilot take-back programme in San Francisco in recent years, providing $200,000 which covered around 40 per cent of its costs, according to local news reports.

The pilot led to the collection of 18.5 tons of medicine in the first 26 months of operation, according to Debbie Raphael, director of the San Francisco Department of the Environment, and a permanent solution is now being sought.

A joint statement from five pharmaceutical trade organisations - BayBio, the Biotechnology Industry Organization (BIO), PhRMA, the Generic Pharmaceutical Association (GPhA) and the Consumer Healthcare Products Association (CHPA) - described the ordinance as "seemingly well-intended," but argued it would have little impact in protecting patients, safeguarding the environment or curbing abuse.

The pharma industry is particularly concerned that the Californian ordinance could encourage other local authorities to implement similar schemes and raise costs significantly for companies selling medicines in the US.

"The drug manufacturing industry supports efforts to help consumers safely dispose of unwanted medicines," said the organisations.

"However, there is no rationale for mandating new, costly and redundant disposal options when both the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) support voluntary in-home disposal in conjunction with voluntary programmes, national and local take-back days." For instance, the nonprofit National Association of Drug Diversion Investigators (NADDI) supplies drop-off boxes through its Rx Drug Drop Box scheme.

"We support safe disposal of medications, and today consumers have several options available to them that are both safe and effective," said the industry groups.

Along with the FDA and DEA, the Environmental Protection Agency (EPA), the Office of National Drug Control Policy (ONDCP) and the US Department of Fish and Wildlife (USFW) have all said that in-home disposal is an easy and environmentally friendly option for consumers who wish to dispose of expired and unused pharmaceutical products from their home, they continued.

"The drug manufacturing industry will continue to actively work with all relevant stakeholders to educate them on the appropriate use of medicines with the goal of helping to prevent the abuse and misuse of medicines and promote safe disposal practices."