NCL's Comments to the FDA, DEA about OxyContin

August 16, 2001 

Dr. Bernard L. Schwetz
Acting Principal Deputy Commissioner
Food and Drug Administration
5600 Fishers Lane, Room 1471 (HF-1)
Rockville, MD 20857

Dear Commissioner Schwetz:

            The National Consumers League is very concerned about the growing number of deaths associated with the illegal and inappropriate use of prescription drugs, particularly opioids.  NCL commends the Food and Drug Administration for strengthening the labeling of OxyContin, the opioid painkiller that has been the subject of so much attention recently.  At the same time, we urge FDA and the Drug Enforcement Administration to consider the situation carefully.  It is critical that any regulatory measures taken to reduce abuse and diversion of OxyContin not interfere with the legitimate use of this effective drug.  A delicate balance must be struck between preventing abuse of a powerful opioid and ensuring that individuals suffering from debilitating pain have access to a drug that offers prolonged relief.

            NCL is a nonprofit consumer advocacy organization founded in 1899 to represent consumers in the marketplace and the workplace.  NCL has been a major participant in the regulatory, legislative and public policy arena on food, drug and health concerns throughout the century.  In addition, NCL provides information and educational materials to consumers so that they can make wise healthcare decisions, including safe and effective use of pharmaceuticals. 

            NCL believe sthat FDA’s decision to require a “black box warning” and a more detailed “Indications and Usage” section on the OxyContin label is justified.  The black box warning will prominently remind physicians, pharmacists, and patients that OxyContin contains a powerful opioid with potential for abuse and addiction.  The expanded Indications and Usage section will help limit overprescription by identifying situations in which the drug is not indicated.  NCL also commends FDA for its plan to publish a draft guidance document on labeling of opioid analgesics in general.  We agree that FDA should develop guidelines for labeling of all opioid painkillers, not just OxyContin.

            Efforts to prevent abuse of OxyContin must be strong, aggressive, and transparent but should not have the unintended effect of making opioids, including OxyContin, unavailable to persons with persistent, debilitating pain such as individuals with cancer, multiple sclerosis, and severe osteoarthritis or back pain.  As FDA has stated, “opioids are a very important part of the medical armamentarium for the management of pain.”  OxyContin is an especially important part of that arsenal because it provides continuous relief from prolonged or chronic medium to severe pain.

            According to press reports, DEA has asked OxyContin’s manufacturer, Purdue Pharma LP, to restrict writing of OxyContin prescriptions to pain specialists.  The DEA reportedly is also considering efforts to limit the supply of OxyContin as well as the number of pharmacies that carry the drug.  These actions under consideration are aimed, in part, to reduce opportunities for product theft.  Such strictures would make OxyContin unavailable to many of those who need it.  While NCL leaves the medical judgments as to the appropriateness of this particular medication to prescribing physicians in appropriate circumstances, limiting prescribing of OxyContin to pain specialists would put the drug beyond the reach of many people who need it.  Similarly, restricting the supply of OxyContin or the number of pharmacies that stock it for nonmedical reasons can only prevent those who legitimately need this drug from receiving it.

            The DEA and local law enforcement agencies must aggressively utilize the law enforcement tools at their disposal, such as prescription monitoring programs, as well as their statutory and regulatory authority to impose physical security requirements on controlled substances handlers.  Diverters, overprescribers, and thieves should be prosecuted to the full extent of the law.  If additional law enforcement tools are needed, they should be directed at the diverters and abusers of OxyContin by, for example,  strengthening the penalties for illegal activities.

            It would be indefensible, however, to take measures that would have the effect of denying pain patients a safe and effective therapy where DEA already has ample statutory and regulatory authority to oversee the physical security of controlled substances.  NCL hopes that the DEA will avoid sweeping measures that would harm legitimate pain patients.  NCL also hopes that the DEA will be sensitive to the chilling effect that its statements and actions may have on the legitimate use of OxyContin and other opioids.  Many caring and honest physicians who prescribe opioid painkillers already must worry about peer review, state disciplinary action, and legal prosecution for overprescribing.  With the intense media coverage of OxyContin abuse, it is likely that some physicians are already afraid to prescribe opioids even when they are indicated.

            NCL believes that both FDA and DEA must not override legitimate medical judgment when combating abuse of a pharmaceutical.  We encourage both agencies to give the measures that have already been adopted time to take effect.  We also understand that Purdue is in the process of reformulating OxyContin in such a way that the oxycondone it contains will not be effective when the pills are crushed or chewed, and this reformulation may make illicit use of the drug impossible.  NCL hopes that FDA and DEA will continue to take into account the interests of the millions of legitimate users of Oxycontin when it makes important decisions concerning this drug.

Very truly yours,

LINDA F. GOLODNER
President

CC:  Dr. Cynthia McCormick, Director,
Anesthetics, Critical Care, and Addiction
Drug Products Division, FDA

The Honorable Asa Hutchinson, Administrator
Drug Enforcement Administration
Department of Justice
Tenth and Constitution Avenue, N. W.
Washington, DC 20530

For more information, write the National Consumers League at 1701 K Street, N.W., Suite 1200, Washington, DC 20007; 202-835-3323, info@nclnet.org

The National Consumers League, founded in 1899, is America's pioneer consumer organization. NCL's three-pronged approach of research, education and advocacy has made it an effective representative and source of information for consumers and workers. NCL is a private, nonprofit organization representing the consumer on marketplace and workplace issues.