The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.
Issue link: https://lifescienceleadermag.epubxp.com/i/183291
EDITOR'S NOTE A Drug Take-Back Programs – Coming To A Municipality Near You BRAND OCTOBER 2013 EDITORIAL DIRECTOR: Dan Schell (814) 897-9000, Ext. 284 dan.schell@lifescienceleader.com CHIEF EDITOR: Rob Wright (814) 897-9000, Ext. 140 rob.wright@lifescienceconnect.com VP OF PUBLISHING: Jon Howland (814) 897-9000, Ext. 203 jon.howland@lifescienceleader.com PUBLISHER, CLINICAL & CONTRACT RESEARCH: Sean Hoffman (724) 940-7557, Ext. 165 sean.hoffman@lifescienceleader.com ASSOC. PUBLISHER/BIOPHARM & LAB: Shannon Primavere (814) 897-7700, Ext. 279 shannon.primavere@lifescienceleader.com PUBLISHER/OUTSOURCING: Cory Coleman (814) 897-7700, Ext. 108 cory.coleman@lifescienceleader.com GROUP PUBLISHER/OUTSOURCING: Ray Sherman (814) 897-7700, Ext. 335 ray.sherman@lifescienceleader.com BUSINESS DEV. MGR.: Mike Barbalaci (814) 897-7700, Ext. 218 mike.barbalaci@lifescienceleader.com SR. ACCOUNT EXECUTIVE: Scott Moren (814) 897-7700, Ext. 118 scott.moren@lifescienceleader.com PRODUCTION DIRECTOR: Lynn Netkowicz (814) 897-9000, Ext. 205 lynn.netkowicz@jamesonpublishing.com DIRECTOR OF AUDIENCE DEV.: Mindy Fadden (814) 897-9000, Ext. 208 mindy.fadden@jamesonpublishing.com Life Science Leader 5340 Fryling Rd., Suite 300 Erie, PA 16510-4672 Telephone: (814) 897-7700 ● Fax: (814) 899-4648 LIFE SCIENCE LEADER (ISSN: 21610800) Vol. 5, No. 10 is published monthly by VertMarkets at Knowledge Park, 5340 Fryling Road, Suite 300, Erie, PA 16510-4672. Phone (814) 897-9000, Fax (814) 899-5580. Periodical postage paid at Erie, PA 16510 and additional mailing offices. Copyright 2013 by Peterson Partnership. All rights reserved. Print PP. Printed in the USA. SUBSCRIPTION RATES for qualified readers in the U.S. $0. For non-qualified readers in the U.S. and all other countries $97 for one year. If your mailing address is outside the U.S. or Canada, you can receive the magazine digitally if you provide a valid email address. POSTMASTER: Send address corrections (Form 3579) to Life Science Leader, Knowledge Park, 5340 Fryling Road, Suite 300, Erie, PA 16510-4672. The drug industry is already the primary funder of the FDA's operational budget through the payment of user fees. The FDA's proposed 2014 budget, a whopping $4.7 billion, includes a proposed increase of $821 million, 94 percent of which is to be funded by drug companies. While some believe self-funded regulatory agencies to be a good thing, others feel it allows industry to have major leverage over FDA policy decision making. My concern — what precedent does this set for state and local governments to create similar self-funded regulatory initiatives? In July 2012, Alameda County, CA, passed an ordinance making manufacturers responsible for unwanted medicine collection. Just under one year later, California regulatory lawmakers moved forward with making the practice a statewide initiative. The idea is to prevent unused drugs from endangering children from accidental overdose, to prevent the potential of drug abuse, as well as to decrease the likelihood of these medicines getting into the waterways and environment by being flushed or thrown away. The bill (SB727) introduced by Hannah-Beth Jackson (D) would require drug companies to fund the collection, transportation, and disposal of unwanted medications from residential sources. If passed into law, the "Medical Waste: Pharmaceutical Product Stewardship Program," as it is formally called, would require pharmaceutical manufacturers selling drugs in California to launch by January 2016 either an individual or joint collection program with enough drop-off locations so residents never have to travel more than 10 miles to rid their medicine cabinets of unwanted pharmaceuticals. Further, drug companies would not only pay all operational costs, but would also pay a fee to the California Department of Public Health to finance the program's oversight and law enforcement. Finally, the law would prohibit manufacturers from passing the cost onto consumers. I understand the importance of environmental and consumer safety. However, I don't understand why the pharmaceutical industry has to create, let alone fund, an infrastructure when one already exists in the form of your friendly neighborhood pharmacy. Estimates place the number of pharmacies within the United States at 67,000, with more than half of these being located within other facilities, including grocery and department stores. California has the most pharmacies of any state (5,560). Doesn't it seem fairly reasonable that if consumers are capable of picking up prescription medications, then they would be just as capable of dropping off a few unwanted medications? Not according to U.S. District Judge Richard Seeborg. On Aug. 29, 2013, Seeborg ruled in favor of Alameda County, on a lawsuit brought forth by the pharmaceutical industry claiming the drug take-back ordinance as being unconstitutional. I fully expect industry to file an appeal. In the meantime, perhaps PhRMA, BIO and the Generic Pharmaceutical Association (GPhA) should take a page out of the battery industry's playbook and develop its own take-back initiative. A nationwide approach to taking back medications, proactively managed by the pharmaceutical and biotech industries, could prevent companies from having to embark on the daunting task of trying to fund and manage Rob Wright possible drug take-back ordinances developed rob.wright@lifescienceconnect.com by even the smallest form of local government. @RFWrightLSL 6 LifeScienceLeader.com October 2013