The Future of Pharmaceutical Waste Regulation

May 14, 2015 12:00 pm — 1:30 pm
Washington, DC (and via webinar)

An ELI Membership Seminar

Public dialogue about the management and regulation of pharmaceutical waste has progressed in fits and starts over the last decade. This discussion is particularly germane today as several local municipalities establish local unused medicine “take back” programs and EPA prepares new rulemaking on the topic.

In 2008 EPA proposed a rule to regulate pharmaceutical waste under RCRA’s Universal Waste Rule, but a deluge of negative comments convinced the agency to pull the proposal and develop a new rule from scratch. A new notice of proposed rulemaking is scheduled for June of this year, and EPA has indicated that the revised regulatory scheme will focus on hospitals, pharmacies, and other health care facilities. Meanwhile, concerns over environmental contamination and public health and safety have prompted some local governments to establish mandatory take-back programs funded by the manufacturers. The first such program was instituted by Alameda County, California, in July 2012, and challenged in court by pharmaceutical trade organizations. Eventually, the 9th Circuit found the ordinance did not violate the Constitution. Parties are now waiting to see if the Supreme Court will hear the appeal.

This dynamic area of waste regulation is fraught with questions: Is regulation of pharmaceutical waste necessary to protect human health and the environment, and is it cost effective? What should EPA’s new proposed rule look like? What would a new rule mean for government or private “take back” initiatives? What are the appropriate roles for the federal government, state and local governments, and manufacturers?  Our panel of agency officials and representatives from various stakeholder groups tackled these and other tough questions.

Julia A. Hatcher, Partner, Latham & Watkins LLP (moderator)
Scott Cassel, CEO & Founder, Product Stewardship Institute
Dave Galvin, Manager, Hazardous Waste Management Program, King County, Washington
Alan Horowitz, Vice President of Operations Compliance and Global Safety, Health & Environment, AstraZeneca Pharmaceuticals
Elise N. Paeffgen, Senior Associate, Alston & Bird LLP

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