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Statement by: Terrance
W. Woodworth 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. |
