Bono Mack Seeks Answers About New Version Of OxyContin
Calling attention to the growing problem of prescription drug abuse and addiction among Americans young and old, Congresswoman Mary Bono Mack today urged the Food and Drug Administration (FDA) to answer questions on the proposed reformulation of the powerful prescription drug OxyContin. In a letter to FDA officials, Bono Mack emphasized the need for a version that would prevent young people from tampering with the drug to use it for non-medical purposes and asked for clarification of testing results.
"It is time drug manufacturers and the FDA take a serious look at OxyContin and find ways to prevent this powerful substance from being easily abused," said Bono Mack. "Already, one in twenty high school seniors have abused Oxy for non-medical purposes; we cannot stand by while more and more young people succumb to this drug without taking meaningful and effective steps to keep this drug from being used for the wrong reasons.
"It is my hope that the FDA will pursue the most rigorous and thorough testing and carefully examine the new formulation of Oxycontin so that our young people aren't so easily exposed to such a potentially dangerous -- and addictive substance."
Below is the text of Bono Mack's letter:
As a Member serving on the House Energy and Commerce Committee, I have closely monitored the disturbing trend of prescription drug abuse and how it is taking hold of Americans lives. I write with concern regarding the opiod analgesic oxycodone, and specifically the proposed reformulation of OxyContin.
In 2008, the Food and Drug Administration (FDA) made public documents relating to a proposal by Purdue Pharma, L.P. and their goal of reformulating the drug so that those who would seek to abuse the drug would no longer be able to alter the nature of the substance in order to render its time-release attributes ineffective. This stands as an overdue and extremely important effort, as currently people both young and old across our country have become addicted to the intense reaction they get from snorting or injecting OxyContin, as they seek its heroin-like high.
The most disturbing trends we're seeing in prescription drug abuse are the increasing rates of abuse and death among our nation's youth. In fact, just last week, the National Institute on Drug Abuse (NIDA) released their annual "Monitoring the Future Survey" which details ongoing drug use and related trends by 8th, 10th, and 12th grade students. It is extremely troubling to note that 1 in 20 high school seniors reported non-medical use of OxyContin. Given the sheer strength of this drug and its power to addict our children, our work to oversee any new formulation of this drug is crucial.
Your Agency's website notes a public meeting that was held on September 24, 2009 that had, as part of its agenda, public discussion of the new drug application (NDA) 22-272 OXYCONTIN Tablets, Purdue Pharma, L.P. The Advisory Committee conducting this effort noted the meeting was in part due to new data. Can you please provide me with any information possible related to that new data gleaned after May 5, 2008?
More importantly, a portion of the discussion the morning of September 24, 2009 was not open to the public and centered on the nature of internal steps the FDA takes in evaluating the new formulation of drugs like OxyContin.
As you know, the imperative is to produce a version of OxyContin that is not easily abused by non-medical users. To that end, please also provide me an explanation of the information you have or was provided to the FDA by Purdue Pharma, L.P. that displays the improvements sought. In particular, has the FDA already put the proposed new drug formulation through significant heat-resistance tests? If so, please explain how extensive and of what nature the tests were that have been conducted by the FDA. It has been reported that the stated goal of the new drug formulation is to decrease the potential for abuse with a new polymer, that, when heated, will create a substance not unlike plastic. The current formulation, when mixed with water, is said to also be impossible to inject.
The last thing our children and the addicts currently struggling with an addiction need is a highly-touted, heavily marketed "new" formulation that in reality delivers little new for those patients who are legitimately prescribed OxyContin. Are the chemical and structural attributes of this proposed formulation such that if an addict were to try to heat them with a lighter, that they couldn't break it down to inject? Does the same heat testing hold true for a microwave or conventional oven? Dosage levels are also important to this process; is your Agency being asked to also approve this coating for both 60 and 80 milligram doses of OxyContin?
The tragic reality of what we face is that prescription drug addicts will seek out nearly any solution to try to make OxyContin an immediate release product so that they can abuse the drug in its strongest form. I know that you recognize the challenges faced with approving any new drug application, but this new submission deserves to meet a clear standard that won't end up in the hands of drug dealers bent on making a quick dollar at the risk of contributing to the death of the hundreds who die from OxyContin overdoses each year in our country.
I care deeply about finding reasonable ways to tackle the problems of prescription drug abuse in our country and because of this urge you to carefully examine (NDA) 22-272, the new version of OxyContin being proposed. I also appreciate your prompt attention to these concerns and look forward to your responses in the coming days. Should you have any questions, feel free to contact me or Chris Foster, my Legislative Director, at (202) 225-5330.