AG Olens Joins States' Call For HHS To Overturn Approval Of Powerful New Drug

By: Georgia Department of Law Email
By: Georgia Department of Law Email

News Release: Georgia Department of Law

Attorney General Sam Olens joined five other state attorneys general today in calling on the U.S. Department of Health and Human Services (HHS) to overturn the recent approval of Zohydro ER.

A pure hydrocodone pill, Zohydro is five to ten times more potent than currently available products like Vicodin or Lortab and is set to hit the market this month. Also troubling, Zohydro does not contain any abuse-deterrent properties, thus allowing addicts to more easily crush, snort or inject this powerful drug.

The painkiller’s high potential for abuse prompted attorneys general from Georgia, Illinois, Indiana, Florida, Kentucky and Maine to pen a letter to HHS Secretary Kathleen Sebelius asking her to reverse the U.S. Food and Drug Administration’s (FDA) approval of the drug.

In 2012, prescription drugs played a role in at least 592 deaths in Georgia, according to the Georgia Bureau of Investigation[1] .

“The Centers for Disease Control and Prevention has already labeled the nation’s prescription drug abuse problem an epidemic,” said Olens. “Introducing another powerful drug into the market could increase the risk for abuse, overdoses and deaths. I urge Secretary Sebelius to seriously consider the concerns raised in this letter and overturn the decision of the FDA.”

The FDA approved Zohydro last October despite its own advisory committee voting 11-2 in opposition of the drug being released. In November, Olens joined 28 other state attorneys general in asking the FDA to reconsider its approval of the drug. It has been reported that Zohydro can be prescribed in pills ranging from 10 milligrams to as high as 50 milligrams and current hydrocodone products only range from 5 to 10 milligrams.

To combat abuse in Georgia, Olens advocated for oversight of pain management clinics, which have been used by narcotics traffickers as fronts for pill mills. At the urging of Olens, the General Assembly passed the Georgia Pain Management Clinic Act in 2013. This law requires that pain management clinics be licensed and regulated by the Georgia Composite Medical Board so that bad actors can be detected and honest doctors can provide legitimate pain relief to patients.

The letter is attached.


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