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Schneiderman, I-STOP allies call on federal government to rescind FDA approval of Zohydro ER

by jmaloni


Tue, Mar 18th 2014 06:30 pm

So-called "heroin in a pill" can be crushed, chewed, injected, and snorted as it lacks basic abuse-deterrent qualities

Attorney General Eric T. Schneiderman today called on the U.S. Department of Health and Human Services to overturn the Food and Drug Administration's 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 the drug is subject to the restrictions outlined in New York's 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," 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 U.S. 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 has been a leader in addressing the prescription drug abuse crisis. The attorney general's I-STOP legislation, signed into law in 2012, established New York as the first state in the nation to mandate 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. 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, a member of the Congressional Caucus on Prescription Drug Abuse and an original co-sponsor 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 Sen. Tim Kennedy 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 Assembly Member Sean Ryan 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."

Schneiderman's letter to Health and Human Services Secretary Kathleen Sebelius is available here.

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