Takeback Updates at the Local, State, and Federal Levels

Feb. 8, 2016

Following a series of stakeholder hearings, Board of Supervisors meetings, and staff discussions in which CLSA has taken an active part, Los Angeles County’s Extended Producer Responsibility Working Group proposed its final draft ordinance on drug and sharps takeback in January.

CLSA has continued to convey concerns about the effectiveness of mandatory takeback proposals and the unprecedented burden on a single industry. CLSA has played a key leadership role in coordinating strategies of industry partners such as AdvaMed, BIO, the Consumer Health Products Association (CHPA), Generic Pharmaceutical Association (GPhA), and Pharmaceutical Research and Manufacturers of America (PhRMA). A new industry-supported Pharmaceutical and Sharps Safe Disposal Education Initiative has been offered as an alternative to the County’s proposal. Our coordinated approach and ongoing meetings with Supervisors has led to the County’s delaying further action from a planned early-Feb. hearing to March 29.

While all eyes are focused on Los Angeles County’s draft ordinance on drug and sharp takeback, CLSA has also implemented a 58-County monitoring system where we track local take back efforts, and other life science concerns, as they occur. Currently, CLSA is engaged in additional local take back efforts in the Counties of Santa Barbara, Sonoma and Mendocino.

At the state level, CLSA and industry groups are seeking to establish a comprehensive state approach (AB 45-Mullin) through a curbside Household Hazardous Waste (HHW) retrieval program that would alleviate the concern of this possible patchwork of County initiatives. AB 45 passed the Assembly and is on its way to the State Senate. We believe furthering consumer education and advancing local government implementation of these already successful residential programs would increase compliance with the State’s goals of diverting HHW from the waste stream, ensure consumer convenience and enhance participation rates without mandates at the local government level.

Takeback issues have also begun to percolate at the federal level. A coalition of extended producer responsibility proponents sent a letter to Dr. Stephen Ostroff, M.D., Acting Commissioner of the U.S. Food & Drug Administration (FDA), urging FDA to end its recommendation that certain medications may be disposed of by flushing. It instead encourages FDA to work with the Environmental Protection Agency (EPA), Drug Enforcement Agency (DEA), and the White House Office of National Drug Control Policy (ONDCP) to create a policy based on a single national disposal system, such as using secure take-back programs.  More than 100 individuals and groups signed the letter, including state and local elected officials, county governments, water agencies, schools of pharmacy, and various environmental coalitions and activist organizations. Indeed, shortly following on this letter has come news that federal take-back legislation to “create a non-profit, private corporation known as the National Pharmaceutical Stewardship Organization, financed by pharmaceutical producers and responsible for establishing comprehensive drug take-back programs in every state” is soon to be introduced.

As the takeback issue further elevates to the federal level, and increasingly involves other biomedical household waste (such as sharps and batteries), CLSA will continue to monitor and work with our coalition partners and other stakeholders to ensure FDA remains the authority on medication disposal, and that biomedical household waste disposal policies are science-based and do not place undue burdens on industry.

CLSA continues its commitment to advocate at each level of government on the adverse effects mandatory, wholly industry-funded take-back proposals will have on the life sciences innovation ecosystem.