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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.
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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