http://nyti.ms/17qJoGK
The F.D.A.'s move to tighten restrictions for prescribing painkillers is a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and patient groups.
Our division28 members James Woods and Sharon Walsh participated in this process, and there are embedded links in this article
Division 28 members do good works through the regulatory process.
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Note mention of approval of a new hydrocodone product without formulation controls to minimize abuse liability :(
"... On Friday, public health advocates who had cheered the agency's decision the day before were dismayed when the F.D.A. approved a new, high-potency painkiller despite an 11-2 vote by an expert panel of its own advisers not to do so. The panel concluded in December that the long-acting opioid, called Zohydro, could lead to the same type of abuse and addiction as OxyContin.
The F.D.A.'s move to tighten restrictions for prescribing painkillers is a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and patient groups.
Our division28 members James Woods and Sharon Walsh participated in this process, and there are embedded links in this article
Division 28 members do good works through the regulatory process.
__
Note mention of approval of a new hydrocodone product without formulation controls to minimize abuse liability :(
"... On Friday, public health advocates who had cheered the agency's decision the day before were dismayed when the F.D.A. approved a new, high-potency painkiller despite an 11-2 vote by an expert panel of its own advisers not to do so. The panel concluded in December that the long-acting opioid, called Zohydro, could lead to the same type of abuse and addiction as OxyContin.
A top F.D.A. official, Dr. Douglas Throckmorton, said Zohydro would give doctors another drug to treat long-term pain. But Representative Harold Rogers, Republican of Kentucky, said on Friday that top F.D.A. officials had recently assured him they would only approve new opioids like Zohydro if they were marketed in formulations intended to deter abuse. OxyContin is now formulated that way, but Zohydro, which is contains hydrocodone without acetaminophen, is not. Its producer, Zogenix, says it will closely monitor use of the drug.
"It is like the original OxyContin, so that is real problematical," Mr. Rogers said.
..."
Ron
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