Wednesday, March 26, 2014

Zohydro - More Opposition

In March, the manufacturer began distributing Zohydro, a new and powerful opiod painkiller. 

In December, 29 State Attorneys General sent a letter to Dr. Hamburg, Commissioner of the Food and Drug Administration (Zohydro in the News Again). They asked that the FDA reconsider its approval of Zohydro, an opiod painkiller that is reportedly five to ten times more powerful than those already on the market. Those Attorneys General signatories were:

Pamela Bondi, Florida (R)
Jack Conway, Kentucky (D)
Tom Horne, Arizona (R)
George Jepsen, Connecticut (D)
Lenny Rapadas, Guam (NPA)
Lisa Madigan, Illinois (D)
Tom Miller, Iowa (D)
Douglas Gansler, Maryland (D)
Bill Schuettem Michigan (R)
Samuel Olens, Georgia (R)
Michael Geraghy, Alaska (R)
Dustin McDaniel, Arkansas (D)
Joseph Biden, Delaware (D)
David Louie, Hawaii (D)
Greg Zoeller, Indiana (R)
Janet Mills, Maine (D)
Martha Coakley, Massachusetts (D)
Jim Hood, Mississippi (D)
Catherine Masto, Nevada (D)
Roy Cooper, North Carolina (D)
Kathleen Kane, Pennsylvania (D)
Marty Jackley, South Dakota (R)
Brian Tarbet, Utah (R)
Robert Ferguson, Washington (D)
Joseph Foster, New Hampshire (D)
Ellen Roseblum, Oregon (D)
Peter Kilmartin, Rhode Island (D)
Robert Cooper, Tennessee (D)
William Sorrell, Vermont (D)

On March 18, 2014, New York Attorney General Eric Schneiderman (D) Wrote his own letter. He expresses similar concerns. He refers to Zohydro as "heroin in a pill," and said "It's simply irresponsible to manufacture Zohydro without abuse-deterrent formulas, and I am calling on the federal government to reverse this decision." He went on to say that Zohydro is "one of the strongest and most dangerous opiods on the market."

Meanwhile, in Washington, two Representatives are proposing a legislative correction for the FDA decision. Representatives Stephen Lynch (D) and Hal Rogers (R) have introduced "the Act to Ban Zohydro." The bill reportedly has 11 co-sponsors. There is also a similar Senate bill sponsored by Joe Manchin (D). According to the Representatives, "approving Zohydro ER without an abuse deterrent formulation puts our nation's public health at a great risk due to the high likelihood for abuse." 

They note that a prescription drug overdose death occurs in America every 16 minutes, and opiod drugs were involved in 3 of 4 drug deaths in 2010. They suggest that the approval of Zohydro by the FDA was "a giant step backwards at a critical time when prescription drug abuse has fast become a rampant problem across the nation."

So, thirty state's top law enforcement officials are asking for reconsideration of the approval. The U.S. Congress has begun efforts to legislate over the FDA decision to approve Zohydro (which approval came despite the recommendation against approval of the FDA's own advisory panel). There seems to be significant bipartisan opposition to the marketing of "heroin in a pill."

Where will this debate conclude?




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