APF Position Statement on Reformulated Oxycontin

Release Date: September 24, 2009

FDA Hearing of the Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

Esteemed Committee Members,

My name is Mary Bennett, and I am speaking on behalf of the American Pain Foundation as the Director of Grassroots Advocacy.  The American Pain Foundation is an independent, nonprofit organization serving people with pain through information, advocacy and support. Our mission is to improve the quality of life of people with pain by raising public awareness, providing practical information, promoting research and advocating to remove barriers and increase access to effective pain management. 

Pain affects more than 76.5 million Americans, and in spite of efforts to improve pain management, a tremendous range of barriers still exist.  Millions of Americans are not receiving appropriate pain care.  It is the number one reason people seek medical attention.  There are more Americans affected by pain than cancer, diabetes and heart disease combined.  Pain does not discriminate; it can and does affect a person no matter the gender, age, ethnic group or socioeconomic status.

The American Pain Foundation works with dedicated volunteer advocates all across the United States.  These advocates are people with pain, healthcare professionals and caregivers. These remarkable individuals tirelessly work in their states and across the nation to raise awareness and call attention to the urgent need for positive changes in pain policy, practice and research investment. As people with pain and those who care for them, they personally know the incredibly high cost of pain.  Their stories are powerful and many advocates say they are morally obligated to speak out and be part of breaking down the unjust barriers to pain care, so others do not have to needlessly suffer.

Whether pain is a result of a disease such as cancer, arthritis or diabetes; a car accident; or injuries sustained in combat, these advocates know how pain and the lack of pain care can make life a living hell.  Some have described their pain as a form of torture.  These advocates know how the lack of access to effective treatments has a tremendous impact on every part of one’s life and can rob a person of dignity, the ability to function and the capacity to contribute to one’s family.  Pain not only destroys individual families and their finances, but on a societal level the undertreatment of pain contributes to excessive healthcare costs and lost work productivity of approximately $100 billion every year.

The American Pain Foundation recognizes the need for a broad range of pain treatment options.  Opioid analgesics, when taken as directed, have effectively provided life-saving relief for millions of Americans with moderate to severe pain from persistent cancer and non-cancer pain.  As you consider the evidence before you, do not abandon those who benefit from around-the-clock, long-acting opioids and the new formulations which have been proven to be safe and effective, and have the potential to reduce the risk of diversion and abuse.

We share your commitment to protect public health.  We recognize the serious problem of prescription drug abuse and illegal use, and the need for strong and effective measures.  It is a complex issue within our current medical, cultural and political landscape, and we must be active participants in preventing abuse. 

A fundamental question is - should illegal and criminal activity dictate the care for others?

Should people with pain who are using medications, as directed, be victimized by illegal use and accidental overdose?  It is critically important to aggressively address prescription drug abuse and its tragic impact with effective strategies, but not at the expense of the millions of people with persistent pain, their families, their communities and larger society.  

Regulatory policies and public health strategies that curb drug abuse without undermining relief for patients in pain are possible and are in the best interest of society. The development and approval of extended release opioid medicines, which are intended to reduce the risk of abuse and diversion, is a welcomed advance.  Many people living with moderate to severe pain who could benefit from extended release opioid medicines do not have access to these medicines because far too many healthcare providers fear that these medicines might get into the wrong hands. Formulations that deter alteration may help to reduce the fear of prescribing these therapeutically valuable analgesic medications. 

As an organization dedicated to improving the quality of life of people affected by pain, we support FDA action on the favorable approval of the new formulation of long-acting opioids that will hopefully deter those who use these important medications inappropriately and allow continued availability for those in need of these medications for their therapeutic benefits.