Schumer Calls on HHS Secretary to Overturn Confounding FDA Decision Allowing New Super-Drug to Hit Market Without Protections to Prevent Abuse

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Zohydro ER, a painkiller that is 10x stronger than Vicodin, hit market this weekend without protections that prevent abusers from crushing pills and then snorting ...

New York, NY - March 3, 2014 - United States Senator Charles E. Schumer today called on the federal Department of Health and Human Services (HHS) to overturn a disastrous decision by the federal Food and Drug Administration (FDA) that allowed an ultra-powerful painkiller to enter the market this weekend in a form that can easily be abused. Despite calls from physicians, addiction experts and law enforcement officials from around the country, Zohydro ER – a pure form of the powerful painkiller hydrocodone that can contain up to ten times as much of the powerful narcotic as Vicodin – came to market over the weekend without any of the same tamper-proof protections that the less potent Vicodin or OxyContin have in place to guard against abuse. With the prescription drug abuse epidemic an ongoing problem, Schumer is calling on HHS to overrule the FDA decision that allowed Zohydro ER to hit the market without protections against prescription pill abuse, and to require that the drug be pulled until it is tamper-resistant.
 
Many painkillers on the market, particularly high strength and high dose pills like Zohydro, are required to be abuse deterrent.  The most common deterrent is engineering the pill in such a way that it turns to a gel if crushed, not a powder that can easily be snorted or turned in to a liquid for injection.  Zohydro does not have that protection, allowing an abuser to take in an exceedingly high - potentially deadly - amount of hydrocodone at one time.  The same result cannot be achieved simply by ingesting a pill, as it has time release technology that prevents all the painkilling medication from being released at once.
 
“It is baffling that at the same time policy makers and law enforcement officials are waging a war on the growing prescription drug crisis, we are essentially rolling out the welcome mat to a new, more powerful, and easily abused super-drug,” said Schumer. “Now that the FDA has allowed Zohydro ER to hit the market without protections to prevent abuse, we need Secretary Sebelius and the Department of Health and Human Services to overrule the decision and pull the drug until it is sufficiently tamper-resistant. We should not be adding fuel to the fire of this terrible epidemic.”
 
“That the FDA has approved another incredibly powerful painkiller without tamper-proof features is both disconcerting and dangerous,” said Dr. Jeffrey Reynolds, Executive Director of the Long Island Council on Alcoholism and Drug Dependence. "We are in the midst of a national opioid crisis and given our experiences with other painkillers, it's likely that Zohydro will quickly become a favorite among those who misuse and divert prescription pills, fueling even higher levels of addiction, overdose fatalities, community crime and family strife. Kudos to Senator Schumer for once again speaking out to protect public health here in New York and nationwide."
 
Zohydro ER is a pure form of the powerful painkiller hydrocodone, and it can be ten times more powerful than Vicodin, a common narcotic that combines hydrocodone and acetaminophen to reduce pain. The drug is so strong that, according to a group of experts who recently wrote a petition to the FDA on this issue, two capsules of Zohydro, if abused, could be fatal if the person taking the drug is not used to taking opioids. The group of experts also points out that if a child were to ingest just one capsule, it could easily lead to death.
 
In October of 2013 Zohydro was approved to go to market without the same tamper-proof protections aimed at curbing abuse that are in place for drugs that are far less potent, such as Vicodin and OxyContin. These protections prevent abusers from manipulating the drug in order to do such things as snort or inject it, and they have proven to play a significant role in curbing prescription drug abuse.
 
The concerns about the potential for abuse of Zohydro ER were made clear to the FDA during its initial review process. In fact, the FDA’s own Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2 against the advancement of Zohydro ER in the approval process, citing “concerns of abuse and misuse.” They specifically acknowledged that such opioids needed to adopt “tamper-resistant or abuse-deterrent formulations” before consideration for approval. In addition, Schumer also sounded alarm bells on Zohydro in January 2012 when he urged the FDA to not allow the drug on the market until its potential negative impact on the exploding prescription drug crisis could be addressed.
 
Schumer stressed that the current nature of the prescription drug abuse epidemic makes the need to pull Zohydro from the market even more urgent. According to the Substance Abuse and Mental Health Services Administration’s 2009 National Survey of Drug Use and Health, approximately 23.5 million Americans have abused hydrocodone.  According to the New York City Department of Health and Mental Hygiene, New York City alone has seen a 65 percent increase in deaths due to opioid overdose since 2005.
 
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 is closely controlled in order to guard against abuse.
 
Schumer made it clear that Secretary Sebelius, as the head of HHS, the department that oversees the FDA, has the authority to overrule FDA’s decision and require Zohydro to be removed from the market until protections to prevent abuse are added.
 
A copy of Schumer’s letter to HHS Secretary Kathleen Sebelius is below:
 
Dear Secretary Sebelius,
 
I write to urge you to overturn the Food and Drug Administration’s (FDA) approval of Zohydro Extended Release (ER), a dangerous opioid drug product.  There is a high potential for abuse of this drug in its current form, and any potential contribution to the current epidemic of prescription drug abuse is irresponsible.
 
As you know, Zohydro ER is a pure form of the powerful painkiller hydrocodone that can be ten times more powerful than Vicodin, a common narcotic that combines hydrocodone and acetaminophen to reduce pain. As approved, this drug is not required to meet the tamper-proof protections that are in place for drugs that are far less potent such as Vicodin and OxyContin. Additionally, the FDA’s own Anesthetic and Analgesic Drug Products Advisory Committee, which voted 11-2 against the advancement of Zohydro ER in the approval process, cited “concerns of abuse and misuse” and acknowledged that such opioids needed to adopt “tamper-resistant or abuse-deterrent formulations” before consideration for approval.
 
The rate of prescription drug abuse has consistently risen over the past several years.  According to the Substance Abuse and Mental Health Services Administration’s 2009 National Survey of Drug Use and Health, approximately 23.5 million Americans have abused hydrocodone.  According to the New York City Department of Health and Mental Hygiene, New York City alone has seen a 65 percent increase in deaths due to opioid overdose since 2005.
 
This week, on February 27, 2014, the Drug Enforcement Administration (DEA) announced its proposal to reschedule hydrocodone from Schedule III to Schedule II upon recommendation from the FDA. It is inexcusable that a product with more potency and without abuse deterrent technologies has been approved for production.  These technologies, which prevent abusers from manipulating the drug in order to do such things as snort or inject it, are used in prescription drugs such as oxycodone, and play a significant role in curbing prescription drug abuse. Given our country’s national problems with prescription drug abuse, it is reckless for the FDA to approve a hydrocodone bitartrate product that does not contain abuse-deterrent technology.  Doing so negatively contributes to the increased prevalence of addiction and death across the country.
 
I urge you to override the FDA’s approval of Zohydro ER and work quickly to stop it from being sold to consumers.  It is essential that we stop yet another dangerous drug from playing a role in our country’s national drug epidemic, and that we also begin to incorporate abuse-deterrent technologies into all dangerous opioids as new drugs are introduced to the market.
 
Sincerely,
Charles E. Schumer
U.S. Senator
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