Guest Editorial: FDA's Risk Evaluation and Mitigation Strategies Program
by Mark Collen
 The Food and Drug Administration’s new and
evolving Risk Evaluation and Mitigation Strategies (REMS) program may be the greatest
threat to pain care in decades. The under-treatment of chronic pain is already a public
health issue1 and, if the FDA is not careful, the situation will become
critical. Chronic pain impacts the lives of 100 million Americans2 and costs
the United States economy an estimated $100 billion per year.3 The human cost
of under-treatment is incalculable.
The Food and Drug Administration Amendments Act (FDAAA) of 2007 gave the FDA authority
to require pharmaceutical companies to provide and implement risk management strategies
(REMS) for their medications to ensure benefits outweigh risks.4 In February,
2009, the FDA sent letters to pharmaceutical companies informing them of the need to
create REMS for long-acting and extended-release opioid pain medication.4 The
process has been ongoing with meetings over the past year between the FDA, sponsors
(pharmaceutical companies), and stakeholders (patient, physician, and pharmacist
organizations/ associations).5
On December 4, 2009, the Industry Working Group (IWG), which represents 22
pharmaceutical companies, met with the FDA Opioid REMS Steering Committee in a public
forum.6 The meeting was recorded and is available to view online at
http://connectlive.com/events/fda120409/fda-120409-archive.asx. The approximately 3.5 hour
video provides insight into the fluidity of the process and the views and concerns of
sponsors, stakeholders and the FDA.
At the beginning of the video, it was stated by FDA’s John K. Jenkins, MD,
Director, Office of New Drugs that opioid REMS are being required as a result of
increasing adverse opioid outcomes. Four specific adverse outcomes were later
identified—abuse, misuse, addiction, and fatal overdose. Sidney Schnoll, MD, PhD, who
represents the IWG and was one of many speakers, informed the FDA panel that according to
government statistics7 the rate of nonmedical use of prescription pain killers
had leveled off between 2002 and 2008. FDA members expressed sur-prise and were unaware of
these statistics and requested more information. In addi-tion, Dr. Schnoll pointed out
there were multiple definitions of “abuse,” “misuse,”
“addiction” and “overdose” and that defi-nitions must first be agreed
upon in order to accurately collect and interpret data.
Please refer to the March 2010 issue for the complete text. In the event you need to order a back issue, please click here.
— March 2010
The full article is now available as a PDF and may be
purchased for $5 and downloaded immediately:
|