WASHINGTON, DC -- Northern New England's House Delegation sent a letter to the FDA today voicing concern about its approval of Zohydro, a powerful new painkiller which is ten times more potent than Vicodin. The FDA's decision came despite an 11-2 recommendation against approval by the Administration's panel of experts because of Zohydro's likelihood to be abused.
The letter, sent by Representatives Carol Shea-Porter (NH-01), Annie Kuster (NH-02), Mike Michaud (ME-02), Chellie Pingree (ME-01), and Peter Welch (VT-00), notes that prescription painkiller abuse has been a factor in Northern New England's heroin epidemic, and that the Attorneys General of New Hampshire, Vermont, and Maine have all protested the FDA decision because of Zohydro's high potential for addiction.
"It is FDA's mandate to protect the public health," the delegation wrote. "As Northern New England faces one of the worst public health threats of our time, we urge you to use your authority to ensure that this highly abusable form of Zohydro does not further complicate the crisis that the Centers for Disease Control and Prevention classifies as a 'growing epidemic.'"
Zohydro's manufacturer has not yet finished development of an abuse-deterrent formulation. As the letter notes, unlike similar drugs on the market like OxyContin, which has a tamper-resistant formulation, potential abusers could easily crush and snort, chew, or inject Zohydro.
A report released just last week by the New Hampshire Department of Health and Human Services notes that heroin use "is reaching epidemic proportions in New Hampshire and across the country."
Letter to FDA Commissioner Margaret Hamburg: March 11, 2014
Commissioner Margaret Hamburg, M.D.
The Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Commissioner Hamburg:
We write to express our concerns about Zohydro ER (hydrocodone bitartrate extended-release capsules), which the Food and Drug Administration (FDA) approved in October 2013. That decision was made despite an 11-2 recommendation against approval by FDA's advisory panel of experts.
The expert panel cited as its main objection Zohydro's great potential for abuse and addiction. This finding is of great concern to us, as over the past years our home states in Northern New England have struggled with epidemic levels of opiate abuse.
A report released just last week by the New Hampshire Department of Health and Human Services notes that heroin use "is reaching epidemic proportions in New Hampshire and across the country," and that "the increase may be due in part to individuals who have become addicted to prescription opioid pain medication switching to heroin."
FDA's Center for Drug Evaluation and Research has acknowledged that tamper-resistant formulations deter prescription drug abuse. But unlike similar drugs on the market, Zohydro is not tamper- resistant, meaning potential abusers could easily crush and snort, chew, or inject it. A similar narcotic, OxyContin, was introduced in a tamper-resistant formulation in 2010, after its original formulation allowed widespread abuse.
FDA sent a strong anti-abuse message with its 2013 refusal to allow generic versions of original, non-tamper-resistant OxyContin. That progress would be harmed by allowing another powerful opioid with great potential for abuse, Zohydro, to enter the market.
In November 2013, Zohydro's manufacturer, Zogenix, Inc., announced that it will partner with Altus Formulation Inc. to develop a tamper-resistant version of the drug. We urge FDA to consider the recent call of the Attorneys General from our states and 25 others to reconsider its approval. We also respectfully request that you provide an explanation of FDA's regulatory plans to deter abuse if it does not agree to withdraw approval.
It is FDA's mandate to protect the public health. As Northern New England faces one of the worst public health threats of our time, we urge you to use your authority to ensure that this highly abusable form of Zohydro does not further complicate the crisis that the Centers for Disease Control and Prevention classifies as a "growing epidemic."
Ann McLane Kuster
Members of Congress