Gov. Shumlin, Vermont mayors urge FDA to withdraw approval of Zohydro ER

News Release — Governor’s Office
March 16, 2014

MONTPELIER – Gov. Peter Shumlin and most of the state’s mayors today called on Food and Drug Administration Commissioner Margaret Hamburg to withdraw the FDA’s approval of Zohydro ER, a drug significantly stronger than traditional hydrocodone.

“We remind you that our state, and many others, are currently battling an opiate and heroin addiction crisis, doing everything within our power to prevent and treat the dangerous disease of addiction, and strengthen laws to keep these deadly drugs – and the crimes they bring – out of our communities,” the group said in a letter to Commissioner Hamburg.

Those joining the Governor on the letter are St. Albans Mayor Liz Gamache, Montpelier Mayor John Hollar, Barre Mayor Thomas Lauzon, Rutland Mayor Christopher Louras, Newport Mayor Paul Monette, Winooski Mayor Mike O’Brien, and Burlington Mayor Miro Weinberger. The group said introducing a significantly more powerful drug like Zohydro to the market will exacerbate the already deadly crisis.

Gov. Shumlin said he understands the need for pain medications on the market, and appreciates that Zohydro might be effective for patients who cannot use other pain therapies that combine acetaminophen. That said, the Governor believes the risks of diversion and addiction from this powerful opiate outweigh the benefits.

“Through this letter, we now ask the FDA to join with Vermont and states across the country in taking every reasonable approach to require responsible medication prescription and use, to keep our families and our communities healthier,” the letter stated.

The FDA approved Zohydro ER in October 2013, despite an 11-2 recommendation against approval by the FDA’s advisory panel of experts, which cited its potential for addiction. A bill has been introduced in the U.S. Senate to force the FDA to withdraw its approval.

Following is the governor’s letter:

March 14, 2014
Commissioner Margaret Hamburg, M.D.
The Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg,

As Governor of Vermont, with the Mayors of our largest communities, we urge the FDA to reassess and withdraw its approval of Zohydro ER, a drug significantly more powerful than traditional hydrocodone opioids and therefore likely to exacerbate the drug abuse epidemic facing our state and the nation.

We remind you that our state, and many others, are currently battling an opiate and heroin addiction crisis, doing everything within our power to prevent and treat the dangerous disease of addiction, and strengthen laws to keep these sometimes deadly drugs out of our communities.

In Vermont, we have worked together – bringing to the table mayors, law enforcement, the medical and
treatment communities, schools and youth organizations, the Judiciary and Legislature, parents, and many others – to stem the growth of addiction and overdose. Through this letter, we now ask the FDA to join with states across this country in this effort by taking every reasonable step to require responsible medication prescription and use, to keep our families and our communities healthier.

While we would also consider supporting the alternative recommendation of many State Attorneys General across the country to restrict marketing and prescription of this addictive painkiller, and to require an abuse-deterrent reformulation, we strongly urge you to consider again the need for this new prescription drug altogether and to withdraw approval of Zohydro ER from the market.

Sincerely,
Peter Shumlin
Governor

St. Albans Mayor Liz Gamache
Montpelier Mayor John Hollar
Barre Mayor Thomas Lauzon
Rutland Mayor Christopher Louras
Newport Mayor Paul Monette
Winooski Mayor Mike O’Brien
Burlington Mayor Miro Weinberger

Press Release

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