A.G. Schneiderman And I-Stop Allies Call On The Federal Government To Rescind FDA Approval Of Dangerous Opioid Zohydro Er

So-Called “Heroin In A Pill” Can Be Crushed, Chewed, Injected, And Snorted As It Lacks Basic Abuse-Deterrent Qualities

Schneiderman: Zohydro Will Exacerbate Opioid Abuse

NEW YORK – Attorney General Eric T. Schneiderman today called on the United States Department of Health and Human Services (HHS) to overturn the Food and Drug Administration’s (FDA) approval of Zohydro Extended Release (Zohydro ER). The Attorney General also issued an open letter to medical professionals highlighting the potential public safety risks posed by Zohydro ER and reminding them that the drug is subject to the restrictions outlined in New York’s historic Internet System for Tracking Over Prescribing Act (I-STOP) legislation, signed into law in 2012.

“It’s simply irresponsible to manufacture Zohydro without abuse-deterrent formulas, and I am calling on the federal government to reverse this decision,” Attorney General Schneiderman said. “Releasing Zohydro ER without adequate safety precautions threatens the progress that law enforcement and our medical community continue to make in reining in our prescription drug abuse problem. This progress was significantly aided by the passage of New York’s important I-STOP law. This country cannot ignore the powerful lessons learned from the massive and unparalleled increase in prescription and illicit drug abuse resulting from ‘crushable’ OxyContin and other prescription opioids – but this approval of Zohydro ER by the FDA does exactly that. ”

Zogenix, Inc. recently began shipping the new opioid-based pain reliever under the brand name Zohydro ER to pharmacies in New York and across the United States. Zohydro ER has been dubbed by some as “heroin in a pill” and is one of the strongest and most dangerous opioids on the market. The drug, hydrocodone bitartrate, was approved by the FDA despite overwhelming opposition by its own advisory panel in an 11-2 vote. This approval was also strongly opposed by elected officials, law enforcement agency heads, addiction specialists and other medical personnel, who expressed grave concerns about Zohydro ER. The pill lacks basic abuse-deterrent properties that prevent abusers from crushing and then chewing, injecting, or snorting the drug.

New York State has been a leader in addressing the prescription drug abuse crisis in innovative ways. The Attorney General’s Internet System for Tracking Over Prescribing Act (I-STOP) legislation, signed into law in 2012, established New York as the first state in the nation to mandate that physicians consult a real-time database – where pharmacists report every prescription they fill for a schedule II, III, IV, or V narcotic – to check a patient’s history before prescribing one of these powerful drugs. I-STOP mandated the rescheduling of hydrocodone to Schedule II, which ended automatic refills for this highly abused drug. The law also made New York the first state in the nation to mandate eventual universal e-prescribing.

I-STOP has been credited with helping reduce prescription drug abuse by addressing the problems of doctor shopping and the use of stolen or falsified prescriptions. In just a few months, more than 45,000 prescribers conducted approximately 2.4 million searches in the database. In the first three days of operation, these searches identified more than 200 instances of apparent doctor-shopping. With the help of the medical community, the State of New York has made substantial progress in mitigating the problems associated with opioid drug abuse.

On average, 100 Americans die every day from prescription drug overdoses, and three out of four of those deaths can be attributed to opioids, according to the federal Centers for Disease Control and Prevention (CDC). Opioid-related deaths have increased by 313 percent between 1999 and 2010, which corresponds with a 300 percent increase in opioid prescriptions written by doctors between 1999 and 2008, according to data from the Office of National Drug Control Policy and the CDC. A Substance Abuse and Mental Health Services Administration survey found that average monthly use of illicit prescription pills is exceeded only by use of marijuana, and that 55 percent of individuals who obtain and use illicit prescription pills receive them from friends or relatives for free.

“Within days of winning a decision to reclassify how addictive Hydrocodone painkillers are prescribed, by moving the drug to Schedule II to protect against abuse, the FDA approves Zohydro, a much more potent and potentially dangerous drug when misused,” said U.S. Representative Brian Higgins (NY-26)a member of the Congressional Caucus on Prescription Drug Abuse and an original cosponsor of the Act to Ban Zohydro, bipartisan legislation recently introduced in the House of Representatives. “The FDA seems to be taking one step forward and two steps backward on the fight against the prescription drug epidemic.”

New York State Senator Kemp Hannon (R-Nassau), “The FDA’s approval of Zohydro ER is a puzzling public policy move, especially after they announced another opioid going generic would only be approved if it was in a tamper-resistant mode. We’re already battling a severe drug addiction epidemic exacerbated by the over-prescribing of opioids, and this will only make a bad situation worse. I commend the Attorney General for calling on the Department of Health and Human Services to overturn the FDA’s approval.”

New York State Senator Tim Kennedy (D-Buffalo) said, “In the months since the I-STOP legislation was signed into law and fully implemented, it has already proven to be a critically important tool to address the prescription drug epidemic in communities across New York State. Still, we must work to combat the skyrocketing number of overdoses, robberies, suicides and murders connected to prescription drug abuse. The approval of Zohydro without basic abuse safeguards and deterrents will only further the prescription drug problem, and I am proud to stand with Attorney General Schneiderman as he calls on the federal government to rescind FDA approval of this dangerous opioid.”

New York State Senator Andrew Lanza (R-Staten Island) said, “New York must continue to take strides forward in reducing prescription drug addiction stemming from opioid abuse. I-STOP and abuse safeguards in opioid pills hinders the misuse of prescription drugs.”

New York State Assembly Member Michael Cusick (D-Staten Island) said,  "With the enactment of the I-STOP law to curb prescription drug abuse, the FDA’s approval of Zohydro Extended Release is illogical. This is a drug that has the potential to follow the same path as Hydrocodone, OxyContin and other opioid drugs that created the increase in abuse and overdoses that have skyrocketed in the past several years. In Staten Island the opioid problem is one of the worst in all of New York State. Introducing another highly addictive narcotic will only add to the problem. I strongly urge the US Department of Health and Human Services to overturn the FDA’s approval of Zohydro Extended Release.”

New York State Assembly Member Sean Ryan (D-Buffalo) said, "New York has made great strides in recent years to deal with the epidemic of prescription drug abuse, most notably by passing I-STOP into law, and I thank the Attorney General for his dedication to this important issue. Many experts, including the FDA's own scientific advisory panel have said that Zohydro will only make the problem of addiction worse. The advisory panel voted overwhelmingly against the approval of Zohydro, yet the FDA still approved this powerful narcotic, which is likely to increase the severity and scope of prescription drug addiction. I join with Attorney General Schneiderman in calling upon Secretary Sebelius to overturn this dangerous decision."

Suffolk County District Attorney Thomas Spota said, “The diversion and over-prescribing of pain medication is a public health crisis and the FDA has ignored this emergency by approving this medication for the marketplace.  This is the wrong approach at the wrong time by a federal agency responsible for protecting our safety.”

Nassau County District Attorney and Co-Chair of Nassau County’s Heroin Prevention Task Force Kathleen Rice said, “It’s just common sense that any drug this powerful and addictive be made as difficult to abuse as possible.  In communities across the country, the abuse of prescription drugs has led to too many tragedies and regulators should act out of an abundance of caution to prevent more.”  

Dr. Andrew Kolodny, President of Physicians for Responsible Opioid Prescribing and Chief Medical Officer of Phoenix House headquartered in Manhattan, New York, said, "The Attorney General is correct. When we’re in the midst of a severe epidemic of opioid addiction and overdose deaths caused by over-prescribing, the last thing we need is a new, high-dose opioid painkiller. The FDA needs to reverse its approval of Zohydro. And it needs to follow the recommendation of its advisory committee, which voted 11-2 to keep it off the market.”

Dr. Jeffrey Reynolds, Executive Director of the Long Island Council on Alcoholism and Drug Dependence, said, “This approval has the potential to wreak havoc on our communities, and I join Attorney General Schneiderman in asking that it be reversed. We need to ensure doctors and pharmacists can better treat our patients and be part of the solution to our prescription drug crisis, not add fuel to a growing crisis.”

Avi Israel, an anti-prescription drug abuse advocate and founder of Save the Michaels of the World, said, "We should be adding more protections to these powerful prescription drugs, rather than repeating painful lessons of the past. Zohydro is basically pure synthetic heroin and comes in pills as large as 50 milligrams. Releasing a highly addictive and powerful drug without safety precautions will have deadly consequences."

The Attorney General Schneiderman’s letter to Health and Human Services Secretary Kathleen Sebelius is available here. An open letter to medical professionals is below.

 

LETTER TO MEDICAL COMMUNITY

 

March 17, 2014

This open letter is addressed to physicians, pharmacists, and other medical professionals who prescribe or dispense medications containing hydrocodone in the State of New York.

Zogenix, Inc. recently began shipping a new opioid-based pain reliever under the brand name Zohydro ER to pharmacies in New York and across the United States. This drug, hydrocodone bitartrate, was approved by the United States Food and Drug Administration despite opposition by its own advisory panel, elected officials, law enforcement, addiction specialists, and medical personnel who expressed grave concerns about the lack of abuse protections. The release of Zohydro ER threatens to exacerbate our state’s prescription drug addiction problem and promote the use of illegal drugs, particularly opiate derivatives such as heroin, that often dovetail with painkiller abuse.

My office has strongly urged the FDA  to ensure that addictive opioids are sold with abuse-deterrent properties. As approved, the pill lacks the appropriate safeguards that prevent addicts and abusers from crushing and then chewing, injecting, or snorting the drug.

New York has been a leader in fighting the abuse of prescription drugs. Our historic Internet System for Tracking Over Prescribing Act (I-STOP) legislation was signed into law on August 27, 2012. This law made New York the first state in the nation to ensure every prescription for a controlled substance is tracked in a real-time database accessed by both prescribers and pharmacists. I-STOP also mandated the rescheduling of hydrocodone to Schedule II under Section 3306 of the New York State Public Health Law. I-STOP has been credited with helping reduce prescription drug abuse by, among other things, addressing the problems of doctor shopping and the use of stolen or falsified prescription pads.

The linchpin to any real reduction in prescription drug abuse is the dedication and concern of New York’s medical community. Your cooperation in safely administering prescription opioids in our state reduces instances of illegal diversion and ultimately saves lives.

Thank you for your dedication to your patients and to the promotion of public health in our state.

Sincerely,

Eric T. Schneiderman
New York State Attorney General

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