Business and Economics

Indiana AG Wants Approval of New Drug Overturned

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March 26, 2014 – Indiana’s Attorney General Greg Zoeller has joined the attorneys general of five other states in calling for the U.S. Department of Health and Human Services (HHS) to overturn the recent approval of Zohydro ER.

According to a press release from Zoeller’s office, Zohydro is a pure hydrocodone pill 5 to 10 times more potent than currently available products like Vicodin or Lortab.

Zoeller and the attorneys general of Illinois, Florida, Georgia, Kentucky and Maine penned a letter to HHS Secretary Kathleen Sebelius asking that the U.S. Food and Drug Administration (FDA) reverse its approval of the drug. They say the painkiller has a high potential for abuse.

“Zohydro does not contain any abuse-deterrent properties, which means there is a high potential for users to crush, snort or inject this powerful drug,” Zoeller said. “Without the appropriate safeguards, the release of this drug could fuel the nation’s prescription drug abuse epidemic and undermine the progress made by so many. I join my colleagues in calling on the U.S. Department of Health and Human Services to use its regulatory authority and overturn the FDA’s decision.”

Zohydro was approved last October, despite an 11 – 2 vote against the approval by the FDA’s own advisory committee. Following the approval,  Zoeller joined 28 other state attorneys general in asking the FDA to reconsider. Reports indicate that Zohydro could 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.

According to the Indiana State Department of Health, in 2011 prescription drugs were blamed for the deaths of 718 Hoosiers, a nearly 10 percent increase from 2010. 

The Indiana Prescription Drug Abuse Prevention Task Force was established in 2013 to combat what many say is a growing problem.
The Task Force is made up of state legislators, law enforcement, members of the medical community, health officials, pharmacists, state and local agencies and education providers. The group also launched a website last year, www.BitterPill.IN.gov, to educate the public on the dangers of prescription drug abuse and offer assistance to those dealing with addiction.

 

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