EDITOR'S NOTE
A LIFE SCIENCE CONNEC T BRAND
What Is The Solution
To Drug Shortages?
DECEMBER 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
ACCOUNT EXECUTIVE,
PACKAGING & SERIALIZATION: Evan LagacŽ
(814) 897-7700, Ext. 119
evan.lagace@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. 12 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.
6
LifeScienceLeader.com
When I interviewed David Meeker, M.D., CEO of Genzyme
for the October 2012 cover feature article, the focus was
on how the company was helping Sanofi to break free from
the blockbuster model. However, during our conversation,
Dr. Meeker shared that one of the most difficult lessons
learned in his career was failing a patient community by not being able to provide an
adequate drug supply. This lesson involved Genzyme receiving FDA warning letters
necessitating a shutdown of its Alston, MA, site in 2009. The result was a severe drug
shortage for two life-sustaining rare-disease medications. When the article went live
on the Life Science Leader digital edition, I tweeted about it. This resulted in one of
my Twitter followers replying to the tweet — focusing not on the article but instead
on Genzyme's failure.
Having worked in the industry for nearly 20 years, I am of the opinion, and perhaps
naively so, that companies strive to invent life-sustaining drugs in order to help
patients while, of course, making a profit. I do not believe Genzyme's failure to
have been deliberate. That being said, the shortage not only damaged a company's
reputation but also resulted in litigation and, most importantly, preventable
patient pain and suffering. When I worked at Organon Pharmaceuticals, in 2004
we experienced a drug shortage for the neuromuscular-blocking agent Zemuron
(rocuronium) — resulting from a manufacturing problem. The frustration on the part
of the hospital sales team responsible for Zemuron was equal to that of clinicians
clamoring for a resolution to the shortage. Nearly 10 years later, drug shortages seem
to be getting worse. A recent New York Times editorial notes that as of July 31, 2013,
302 drugs were in short supply — up from 211 a year earlier. According to the article's
authors, the drug shortage is not the result of numerous manufacturing issues but of
something far more sinister.
In 1987, Congress enacted the Medicare anti-kickback "safe harbor," which exempted
buying groups from criminal prosecution for accepting vendor kickbacks. A study in
the fall 2011 issue of the Journal of Contemporary Health Law and Policy found that
group-purchasing organization kickbacks inflated supply costs by at least $30 billion
annually. Because these giant purchasing organizations control the procurement of
up to $300 billion in drugs, devices, and supplies annually for some 5,000 healthcare
facilities, it can be difficult to distinguish how these activities differ from those of a
cartel. The Government Accountability Office (GAO) is investigating the role of group
purchasing organizations in the drug shortages with a report expected in 2014.
In the meantime, if you want to learn more about some of the causes of drug
shortages and possible solutions, check out Cliff Mintz's article on page 44. Some
might argue the solution to rising drug shortages is not as simplistic as reigning in
healthcare GPOs (group purchasing organizations). The fact that most of the problem
involves cheap sterile injectables sold
through hospital-purchasing organization
contracts, we need to realize — if it walks
like a cartel, quacks like a cartel, looks like a
cartel — it's a cartel. And the best way to deal
Rob Wright
with a cartel is not by enabling its activity
rob.wright@lifescienceconnect.com
through government legislation.
@RFWrightLSL
December 2013