Letter to Kathleen Sebelius, Secretary Department of Health and Human Services - Overturn Confounding FDA Decision Allowing New Super-drug to Hit Market without Protections to Prevent Abuse

Letter

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.

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