The National Consumers League is
a national nonprofit consumer organization that has represented consumers and
workers in the marketplace for over 100 years.
NCL has been a major participant in the regulatory, legislative and
public policy arena on food, drug and health concerns throughout the century.
The League provides information and educational materials to consumers
so they can make wise health care decisions, including safe and
effective use of pharmaceuticals.
The National Consumers League
commends the Food and Drug Administration for looking at the problem of
illegal and inappropriate use of opioid analgesics.
A delicate balance must be struck, however, between the prevention of
the abuse of a powerful opioid and ensuring that individuals suffering from
debilitating chronic pain have access to drugs that offer prolonged relief.
NCL believes FDA’s decision to strengthen the labeling of OxyContin,
the opioid painkiller subject of much attention recently,
is justified. The “black
box warning” prominently reminds physicians, pharmacists and patients that
OxyContin contains a powerful opioid with potential for abuse and addiction.
The more detailed “Indication and Usage” section helps limit over
prescription by identifying situations in which the drug is not indicated.
These warnings should change any faulty prescription practices as well
as alert the physician to the potential for abuse, misuse and diversion.
Although misuse and diversion are and will continue to be potential problems for all opioids, such as OxyContin, it would be indefensible to deny pain patients a safe and effective therapy. Today, there are between 50 and 60 million Americans who suffer from chronic pain. Many of these are cancer patients. Research has show that over 40 percent of cancer patients do not receive adequate relief for their pain. The under treatment of pain affects the quality of life for millions of people - from cancer patients to those who suffer from severe osteoarthritis or back pain. OxyContin is one of the effective treatments for pain because it provides continuous relief from prolonged or chronic medium to severe pain. As the FDA has stated, “opioids are a very important part of the medical armamentarium for the management of pain.”
It is critical that any regulatory
measures taken to reduce abuse and diversion of OxyContin not interfere with the
legitimate use of this drug. For
those patients who find OxyContin is
the effective safe treatment, the drug should continue to be available. We would
encourage the FDA to continue to educate health professionals and the public on
the appropriate use of opioid pain medications.
FDA should also continue to monitor reports of abuse, misuse, and
diversion of OxyContin and other opioids, and work with other federal agencies
and drug manufacturers to help ensure that opioids remain available to
appropriate patients. We would
believe that the stronger FDA warnings for OxyContin will help ensure that the
drug is used appropriately by pain patients, and not misused. We also understand
that Purdue Pharmaceuticals, the manufacturer of OxyContin, is in the process of
reformulating the drug so that it will be much less susceptible to abuse
and addiction.
NCL hopes that FDA will continue to take into account the interests of the millions of legitimate users of OxyContin when it makes important decisions concerning this drug. Thank you for this opportunity for the National Consumers League to present our views on this important issue to the FDA.
The
National
Consumers League, founded in 1899, is America's pioneer consumer
organization. Our mission is to identify, protect, represent, and advance the
economic and social interests of consumers and workers. NCL is a private,
nonprofit membership organization. For more information, visit www.nclnet.org.
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