Kaine Raises Concerns About FDA Approval Of Zohydro

WASHINGTON, D.C. – Today, U.S. Senator Tim Kaine sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg expressing concern that recent FDA approval of Zohydro ER could have a negative impact on Virginia communities. Zohydro is the first drug approved by the FDA with a formulation of hydrocodone not combined with an analgesic, making it the purest form of the product.

“As you know, there has been a significant economic and public health impact due to opioid prescription drug abuse on communities throughout the Commonwealth of Virginia and the nation,” Kaine wrote. “While all prescription opioid drugs present a risk of abuse, there is particular concern about Zohydro entering the marketplace due to its formulation.”

“I understand the importance of fulfilling clinical need for new pharmaceuticals and appreciate the FDA’s commitment to patient safety, but I am concerned about the potential of this drug to have negative and unintended consequences on communities and individuals.  I believe the FDA must recognize these risks and work with communities and appropriate government agencies to develop strategies to deal with the potential consequences that could occur with the approval of this drug.”

Full text of the letter is below: 

April 9, 2014

The Honorable Margaret A. Hamburg, MD
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Dr. Hamburg:

I write today about the U.S. Food and Drug Administration’s (FDA) approval of Zohydro and potential unintended consequences of that action.

Last year, FDA approved Zohydro ER, produced by Zogenix, Inc.  It is my understanding that this was the first drug approved with a formulation of hydrocodone not combined with an analgesic, making it the purest form of the product.  The drug also does not currently include tamper resistant or deterrent technologies.  The announcement came despite the recommendation of the agency’s advisory panel the drug not be approved, and after the agency recommended that hydrocodone combination products be moved from Schedule III to the more restrictive Schedule II classification.

Health care professionals and community leaders in Virginia have expressed concern about prescription drug abuse and its impact on communities, patients, health providers, local law enforcement and the justice system.  As you know, there has been a significant economic and public health impact due to opioid prescription drug abuse on communities throughout the Commonwealth of Virginia and the nation.  While all prescription opioid drugs present a risk of abuse, there is particular concern about Zohydro entering the marketplace due to its formulation.

In order to better understand FDA’s decision I would respectfully ask that the FDA clearly provide the reasons why it went against the advice of the advisory panel in this case, particularly when the agency has made an effort to prioritize abuse deterrence in the past.

Additionally, I request more information about the following issues:

1. Please provide information about FDA’s approach to deterrent opioids, specifically its work with manufacturers of these products.
2. Due to the far-reaching potential effects of Zohydro entering the marketplace, how is the agency working with health professionals to provide appropriate clinical guidance for prescribing these drugs?
3. Has the agency been in communication with U.S. Drug Enforcement Agency about the potential impact of Zohydro, particularly in communities that already suffer from high rates of prescription drug abuse?

I understand the importance of fulfilling clinical need for new pharmaceuticals and appreciate the FDA’s commitment to patient safety, but I am concerned about the potential of this drug to have negative and unintended consequences on communities and individuals.  I believe the FDA must recognize these risks and work with communities and appropriate government agencies to develop strategies to deal with the potential consequences that could occur with the approval of this drug. 

I look forward to working with you on these issues and appreciate your attention to this matter. 

Sincerely,
Tim Kaine

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