Pharmaceutical Industry Expresses Opposition to County's Safe Drug Disposal Ordinance

After holding its , the Alameda County Board of Supervisors recently received a letter of opposition from the pharmaceutical industry (see attached PDF).

“We received their letter and it seems like a fairly generic response to what I believe to be a pretty innovative ordinance,’’ said Supervisor Nate Miley.

In a three-page letter drafted by Pharmaceutical Research and Manufactures of America (PhRMA), which represents the country’s leading pharmaceutical research and biotechnology companies, an official said the ordinance is "impractical and will have numerous unintended consequences, including possibly increasing health care costs, risking access to medicine and unintentionally increasing the diversion of medicines."

the plan is sponsored by Miley and supported by several work group organizations wanting to hold pharmaceutical manufacturers and distributors responsible for the safe disposal of medication. Currently, the cost to dispose of medication is being handled by local governments and taxpayers.

“We continue to encourage the industry to step forward and develop a plan to safely dispose of their unused and expired products," Miley said.

Close to 30 sanitary district department heads, elected officials and organizations across Alameda County have sent in letters of support for the ordinance.

If adopted, Alameda County would be the first county in the nation to make pharmaceutical companies responsible for disposing of unused and expired medications.

PhRMa gave the following reasons of opposition:

• Given the Drug Enforcement Administration (DEA) is already drafting federal rules per the federal Secure and Responsible Drug Disposal Act of 2010 for the secure disposal of controlled medicines, it is premature to consider funding non-law enforcement drug collection programs. DEA guidance could drastically change the collection of unused medicines.

PhRMa is concerned that drug take-back programs without law enforcement will create a greater likelihood of theft of misappropriation of collected medicines. It said that if passed, the county law may not conform with upcoming federal regulations.

• Drug take back programs do not address the issue of pharmaceuticals in the environment.

Based on studies PhRMA found, most drugs enter the environment after passing through wastewater treatment plants. It added that drug take-back programs are not expected to reduce the amounts of pharmaceuticals that enter the environment.

• Research demonstrates that household trash disposal is effective for disposing of unused medicines.

PhRMA also said that based on industry research, household trash disposal and take-back for incineration are both equally effective at reducing pharmaceuticals from entering water systems.

• Creating a new process for disposing of unused medicines is a complex task: it will require significant financial resources to secure medicines from diversion, transport medicines for disposal, and incinerate aggregated medicines in compliance with federal and state EPA and DEA laws and regulations.

Despite the ordinance enabling pharmaceutical companies to charge for disposal of medications at the point of sale, PhRMA said the overall cost of medications will increase. It stated "these costs can be avoided if patients dispose of medicines in the household trash," which PhRMA believes to be done in compliance with federal laws and is environmentally responsible.

• Several programs already in place are accomplishing the same goal of removing unused medicines from the home.

SMARxT DISPOSAL is one such program, developed by Fish and Wildlife Service, the American Pharmacists Association and PhRMA, which the industry gave as an example as providing consumers guidance on proper disposal of unwanted medications.

Several drug take-back programs that operate with law enforcement were also mentioned such as the American Medicine Chest Challenge, held in November.

Traci Cross of Castro Valley Community Action Network (CVCAN), a coalition working to reduce substance abuse among youths and adults in the community, is one of several workgroups in support of the ordinance. She's helped host the in the past and said that there should be a permanent drug take-back program, not just events scattered throughout the year.

"Other countries are already doing it so what's the hold up here?"

In Miley said the ordinance stresses product stewardship among the pharmaceutical industy.

"The proposed ordinance asks no less than what customers have already grown to expect from printer cartridges, paint or battery industry stewardship programs," he said.

This ordinance was approved 4-0 by the Board of Supervisors on Feb. 28. Supervisor Nadia Lockyer was absent from the meeting. The board will make its final decision on March 13 at 10:30 a.m. at the fifth floor of 1221 Oak St. in Oakland.

Pharmaceutical companies will then have until Jan. 1, 2013 to come up with a take-back disposal blueprint that covers generic and brand name drugs according to The Oakland Tribune. The county will then hold a public hearing within 90 days after receiving the plan.

The Alameda County Department of Environmental Health would oversee the program, implemented by the fees paid by the manufacturers.

Pharmaceutical companies would not be able to pass on any extra costs to customers, under the this measure. Companies that do not comply with it would be fined $1,000 per day and worst offenders would face misdemeanor charges.