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New Class of Drugs Seeking Approval Are Pure Form of Highly Addictive Hydrocodone; Schumer Calls on FDA Not To Allow Drugs On Market Until Serious & Numerous Questions Are Answered

At A Time When Prescription Drug Abuse of Painkillers is an Epidemic, Allowing Drugs Far More Dangerous Than Oxycontin or Vicodin To Enter Market Could Create Huge Problems

In Letter to FDA Schumer Urges Agency to Proceed With Extreme Caution; Even If FDA Finds Drug Is Needed In A Few Extreme Cases, Asks FDA To Greatly Limit Ability To Be Prescribed And Used


United States Senator Charles E. Schumer revealed today that a series of new and highly potent prescription narcotics, which can be ten times as strong as the pain reliever Vicodin, are seeking approval from the Food and Drug Administration (FDA) for introduction to the marketplace. In the face of an epidemic of prescription drug abuse and its related crime, and the immediate aftermath of five deaths on Long Island directly related to pharmacy robberies, Schumer is calling on the FDA to move extremely cautiously in approving these new super-drugs and not allow them on the market until serious questions are answered about the potential impact their introduction could have on the already exploding prescription drug crisis.


“It’s tremendously concerning that at the same time policy makers and law enforcement professionals are waging a war on the growing prescription drug crisis, new and more powerful super-drugs could well be on their way, flooding the market,” said Schumer. “The FDA needs to grab the reins and slow down the stampede to introduce these powerful narcotics. We’re facing a public health crisis and that needs to be the major consideration before any of these powerful drugs hit pharmacies.”


There are at least four drug manufacturers that are currently conducting research on pure-form hydrocodone pain relievers, with at least one that has publicly announced that it will seek FDA approval to begin marketing their drug in 2013. Pure hydrocodone has never been approved for sale in the United States and if the FDA grants approval for the drug manufacturers to introduce these new narcotics into the market, they will become the most powerful prescription pain relievers available in the country.


Schumer noted that while there are many patients, some with terminal and painful diseases, that need access to strong prescription pain relievers, it is important to ensure that access to these types of narcotics are closely controlled. He went on to note that while we shouldn’t interfere with scientific outcomes, the FDA must consider and research all the implications for approval of these drugs, including whether they will further exacerbate the prescription drug crisis.


Hydrocodone, one of the active ingredients in Vicodin, is considered an opioid, because of its chemical similarities to opium-based drugs like heroin. Hydrocodone is the second most abused medicine in the nation, only behind oxycodone, known popularly as Oxycontin. Currently available hydrocodone-based narcotics like Vicodin contain aspirin or acetaminophen.  News reports state the new super-drugs currently in testing remove the aspirin and acetaminophen additives, leaving pure hydrocodone, with a significantly heightened potency that is time-released in the body once ingested. Drug manufacturers reportedly argue that pure hydrocodone is a better option for patients because of the side effects that acetaminophen and aspirin can have on the human liver.


Each of the companies currently testing the new pain killers are at different stages of development. Zogenix, a San Diego based company, announced publicly that it is planning to file an application for approval for its super-drug, Zohydro, in the early part of 2012 and have it on the market by 2013. The company has reportedly been meeting with the FDA to finalize its application.


In a letter to FDA Commissioner Margaret Hamburg today, Schumer raised significant concerns over the plans to introduce these drugs to market and urged the agency to proceed with extreme caution. Specifically, he called on the agency to use its authority to determine whether the potential for abuse and misuse of these new super-drugs should prohibit their introduction to market. Schumer went further and urged the agency to use its statutory authority to make any possible approval contingent on manufacturers adopting any and all technological advances to prevent abuse. He noted that over the past few years, efforts made to make pain relievers “tamper-proof” have largely failed. He also called for the FDA to consider requiring tracking technology, already used for Oxycontin bottles, to assist law enforcement. 


“There are more questions than answers about the introduction of these new super-drugs to the market,” continued Schumer. “Before we go rushing to provide even more potent and addictive pain killers to the market, the FDA needs to make a strong and compelling case as to their necessity and examine the implications on the prescription drug crisis plaguing in this country.”


January 8, 2011


Dear Commissioner Hamburg:


I write today to bring to your attention recent public reports of drug manufacturers developing and seeking FDA approval for a pure hydrocodone product, which some have called ten times as strong as the pain reliever Vicodin.  


In the wake of a recent tragedy in Long Island, New York and countless other violent incidents nationally that are related to prescription drug abuse, I have obvious concerns about how this new drug could contribute to the growing epidemic of prescription drug abuse and its resultant crime, and I urge your agency to proceed with great caution before allowing these powerful narcotics to enter the market. The prescription drug abuse problem in America, particularly for opioid pain relievers, has grown dramatically over the last decade and now opioids are at the center of a public health crisis of addiction, misuse, abuse, overdose and death. 


As you may know, this past weekend an off-duty federal Alcohol, Tobacco, Firearms and Explosive agent, John Capano, was fatally shot while attempting to intervene in a robbery of a pharmacy in Seaford, Long Island. Tragically, this is not the first death related to pharmacy robbery. Just this past June, four people were murdered while a prescription drug addict was robbing a pharmacy in nearby Medford, Long Island.


According to the Drug Enforcement Administration, oxycodone is now the most abused drug in the United States, with hydrocodone second. As the agency conducts the drug approval process for this new drug, it is essential that the potential for abuse is a robust part of the FDA’s premarket and postmarket review. As I understand it, according to 21 U.S.C. 811(b), the FDA is required to assess a drug product’s potential for abuse and misuse during the approval process and if a potential for abuse exists, the product’s sponsor is required to provide FDA with all data pertinent to abuse of the drug, a proposal for scheduling under the Controlled Substances Act (CSA) and data on overdoses (21 CFR 314.50(d)(5)(vii)). The CSA also requires notification of the DEA if a “new-drug application is submitted for any drug having a stimulant, depressant, or hallucinogenic effect on the central nervous system,” because it would then appear that the drug had abuse potential (21 U.S.C. §811(f)). I urge the FDA to undertake the most rigorous review and risk management to prevent another Oxycontin from becoming available. 


If any of these pure hydrocodone drugs are approved, it is critical to undertake robust postmarket surveillance of the new drug, including monitoring of marketing, advertisements, sales, and diversion to ensure the safety of the public and particularly, pharmacists and patients. In addition, approval should be contingent on manufacturers adopting any and all technological advances to prevent abuse. In the past few years, efforts to make pain relievers “tamper-proof” have largely failed, but the Administration’s 2011 Prescription Drug Abuse Prevention Plan proposes collaboration by the National Institute on Drug Abuse (NIDA), FDA and others to advance abuse-deterrent formulations. It is essential that this work is initiated and a solution is found.  Lastly, the FDA should examine the appropriateness of requiring radiofrequency identification technology (RFID) tracking for each bottle which could assist law enforcement. 


While I am pleased that FDA recognizes the crisis of prescription drug abuse and has taken several important steps, such as the now required risk evaluation and mitigation strategy (REMS) for the class of long-acting and extended-release opioid products and the proposed Blueprint for Prescriber Continuing Education, I am sure you would agree that more must be done to combat this epidemic. I ask that your agency respond to my staff with answers to the following questions: First, why has the agency not established a REMS for short-acting opioids, which have just abuse potential as long-acting? Second, has your agency previously weighed the risk and benefits of an opioid with this level of potency and potential lessening of side effects? Third, does FDA have access to all the appropriate tools to measure the potential for abuse? Last, when does FDA expect to publish a Medication Guide on opioids? According to your website, the guide was expected June of 2011.


I, like you, believe that any policy must strike a balance so that patients who are suffering have access to potent medications, but I am very concerned that not enough is currently being done to truly tackle this crisis and prevent prescription drugs from getting in the wrong hands. I urge the FDA to explore every possible avenue to require manufacturers of these drugs to employ technology to prevent abuse and to use the REMS to ensure maximum postmarket surveillance.


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