Letter to Margaret Hamburg, Commissioner of the Food and Drug Administration - Zohydro ER

Letter

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."

Sincerely,

Carol Shea-Porter
Member of Congress

Ann McLane Kuster
Member of Congress

Mike Michaud
Member of Congress

Chellie Pingree
Member of Congress

Peter Welch
Member of Congress