DEA
Congressional Testimony
Statement
by:
Terrance
W. Woodworth
Deputy Director
Officer of Diversion Control
Drug Enforcement Administration
Before
the:
House Committee
on Energy and Commerce, Subcommittee on Oversight and Investigations
Date:
August 28,
2001
Note: This document
may not reflect changes made in actual delivery.
Chairman Greenwood,
other distinguished members and guests, I would like to thank you for
the opportunity to address this Subcommittee regarding OxyContin®.
Mr. Chairman, on behalf of Administrator Asa Hutchinson, I would like
to thank the Subcommittee for its interest and support in assisting the
Drug Enforcement Administration (DEA) with our mission of enforcing the
nation's drug laws.
The Controlled Substances
Act of 1970 (CSA) assigned legal authority for the regulation of controlled
substances to the DEA. The statute charges DEA with the prevention, detection,
and investigation of the diversion of controlled substances from legitimate
channels, while at the same time ensuring that adequate supplies are available
to meet legitimate domestic medical, scientific, and industrial needs.
The CSA established
five schedules into which controlled substances are classified according
to their approved medical use and abuse potential. The Food and Drug Administration
(FDA) is responsible for approving drugs for medical use and for regulating
the marketing of drugs by industry. Schedule I controlled substances have
no approved medical use in the United States and have a high potential
for abuse. Schedule II substances, including OxyContin®, are approved
for medical use and have the highest abuse potential among controlled
substances approved for medical use. Schedules III, IV and V include controlled
substances that have a currently accepted medical use and have diminishing
potential for abuse.
OxyContin® was
introduced by Purdue Pharma in 1995. It is a controlled release formulation
of the Schedule II narcotic, oxycodone, used in treating chronic moderate
to severe pain when a continuous, around-the-clock analgesic is needed
for an extended period of time. The controlled release formulation has
an important role in the management of pain where dose administration
should be limited to twice, rather than four to six times, per day. It
is currently approved in 10, 20, 40, 80 and 160 milligram strengths.
From the first full
year of sales in 1996, the number of OxyContin® prescriptions has
risen 18 fold, to approximately 5.8 million prescriptions in 2000. On
the other hand, another controlled release formulation manufactured by
Purdue Pharma containing morphine (MS-Contin) saw an approximate 20% drop
in prescriptions during that same period (from approximate sales of slightly
less than 1 million prescriptions in 1996, to less than 800,000 prescriptions
in 2000). Additionally, two other new products released in the mid 1990s
from the same manufacturer, OxyFast and OxylR, sold less than 100,000
and 400,000 prescriptions last year, respectively.
During the last
two years, DEA has noted a dramatic increase in the illicit availability
and abuse of OxyContin®. As early as 1999, DEA assisted the State
of Maine in the investigation of an organized ring of individuals who
used forged, stolen, washed and altered prescriptions to divert thousands
of dosage units of OxyContin® to abusers. While OxyContin® diversion
and abuse appears to have begun in more rural areas of the United States,
particularly Appalachia, it has now spread into urban areas. To date,
at least fourteen States have experienced increased abuse and diversion
of OxyContin®, including the State of Pennsylvania.
The appeal of OxyContin®
for abusers of controlled substances is related to the larger amounts
of active ingredient, oxycodone, in relation to other narcotic products,
and to the ability of abusers to easily compromise the controlled release
formulation. Simply crushing the tablet can negate the controlled release
effect of the drug, enabling abusers to swallow or snort the drug for
a powerful morphine-like high. The tablet can also be crushed, mixed with
water and injected.
In response to the
escalating diversion problem, DEA has embarked upon a comprehensive action
plan, focused largely on enforcement and regulatory investigations which
target key points of diversion, including unscrupulous and/or unethical
medical professionals, forged and fraudulent prescriptions, pharmacy theft,
and doctor shopping. DEA has increased efforts to gather necessary data
to better define the scope of the problem. Such data includes information
regarding OxyContin® prescriptions, deaths, emergency room mentions,
thefts, drug treatment program admissions, and forensic laboratory exhibits,
as well as investigations, arrests and administrative actions. DEA has
also written letters to each member of the National Association of Medical
Examiners requesting medical examiner/autopsy, toxicology, and crime scene
investigator reports on all deaths related to oxycodone in the years 2000
and 2001.
DEA does not intend
to restrict legitimate use of OxyContin®, nor to prevent practitioners
acting in the usual course of their medical practice from prescribing
OxyContin® for patients with legitimate medical needs. The Controlled
Substances Act and DEA regulations do not attempt to define "legitimate
medical purpose", nor do they set standards as to what constitutes
"the usual course of professional practice" - the requisite
elements of lawful prescriptions under the Controlled Substances Act and
DEA regulations. DEA relies upon the medical community to make these determinations.
In the past, OxyContin®
has been marketed and represented as having a lower abuse potential than
other opioid analgesics. One component of DEA's action plan has been to
offer FDA information on OxyContin®'s potential for abuse relative
to other opioids, to assist FDA in more accurately defining the drug's
indications for medical use. In July 2001, the FDA and Purdue Pharma reached
an agreement regarding labeling changes. The revised package insert for
OxyContin® contains a prominent "black box" warning of the
drug's abuse and diversion potential, highlighting the threat of serious
injury or death resulting from its misuse. A letter calling attention
to the labeling change is being sent by Purdue Pharma to healthcare professionals
throughout the country.
Other issues discussed
by DEA, FDA and Purdue Pharma include providing additional information
to the medical community on the proper use of OxyContin®, as well
as the feasibility of reformulating OxyContin® in order to reduce
its abuse potential. On August 8, 2001, the company announced the development
of a reformulated version of OxyContin®. Purdue Pharma estimates that
the new formulation may be marketable in three years.
DEA has initiated
meetings with the National Alliance for Model State Drug Laws, which has
been the catalyst for the establishment of state prescription monitoring
programs. Such programs provide a better mechanism to gather and evaluate
prescription data, which is essential in responding to newly developing
trends in prescription drug abuse. Existing data sources (IMS, Inc.) indicate
that the five states with the lowest number of per capita OxyContin®
prescriptions all have long standing prescription monitoring programs
in place. These five states, beginning with the fewest per capita prescriptions
for OxyContin® are California, Illinois, New York, Texas, and New
Mexico. The majority of states reporting significant abuse and diversion
issues are those without such programs. DEA has embarked on a number of
programs to collect and monitor prescription data for controlled substances.
DEA recognizes that
the best means of preventing the diversion of OxyContin® is to increase
awareness of the proper use and potential abuse of the product. DEA is
taking an active and measured approach to dealing with OxyContin®
abuse and diversion. At the same time, DEA is committed to ensuring that
the valid interests of legitimate pain patients and the health care community
that serves them are not adversely affected as a result of state, local
or federal enforcement efforts, media attention or legislative or regulatory
changes generated in response to the problems associated with OxyContin®.
Before concluding,
I would like to thank my colleagues at FDA for their cooperation in addressing
this very important issue.
Finally, Mr. Chairman,
I thank you and the members of this Subcommittee for the opportunity to
comment on this topic. I look forward to addressing any questions that
you may have at the appropriate time.
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