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Attorney General Conway Calls on Sec. Sebelius to Overturn Zohydro Approval

Wednesday, 03 26, 2014

Allison Gardner Martin
Communications Director
502-696-5651 (office)

Kentucky Attorney General Jack Conway joined five other state attorneys general today in calling on the U.S. Department of Health and Human Services to overturn the recent approval of Zohydro ER.

“We do not want to see the great strides we have made in Kentucky combating prescription drug abuse reversed,” General Conway said.  “For decades, we have fought the disastrous effects of the illegal marketing of the drug OxyContin.  Zohydro ER has the potential to exacerbate the prescription pill epidemic, and the FDA’s decision to approve the drug doesn’t make sense.”

A pure hydrocodone pill, Zohydro is five to 10 times more potent than currently available products like Vicodin or Lortab and is set to hit the market this month.  The painkiller’s high potential for abuse is what prompted attorneys general from Kentucky, Florida, Indiana, Illinois, Georgia and Maine to send a letter to Sec. Kathleen Sebelius asking her to reverse the U.S. Food and Drug Administration’s (FDA) approval of Zohydro.  A copy of the letter may be viewed at http://goo.gl/UeYsNU.

In October, the FDA approved Zohydro ER against the recommendation of its advisory panel, which voted 11-2 in opposition because of the drug’s high potential for misuse and its lack of an abuse-deterrent formulation.  Additionally, one day before approving Zohydro ER, the FDA recommended reclassifying all hydrocodone products to Schedule II controlled substances because of the abuse potential.  Zohydro ER is the first hydrocodone-only opioid narcotic, which is more potent than traditional hydrocodone products that are usually manufactured in a formulation with other non-narcotic analgesics.

“Prescription pill abuse has devastated families across Kentucky,” General Conway said.  “The approval of this very potent drug is troubling because, unlike extended-release opioids containing abuse-deterrent properties, there is nothing that would prevent someone from easily crushing or injecting Zohydro ER to get high.  The decision is especially concerning given that the FDA’s own advisory panel voted against the drug’s approval.”

In a letter to the commissioner of the FDA last December, General Conway and a bipartisan coalition of 28 other attorneys general asked the FDA to reconsider its approval of Zohydro ER.  It also requested that the drug be manufactured with an abuse-proof formula. 

General Conway and Florida Attorney General Pamela Bondi co-chair the National Association of Attorneys General Substance Abuse Committee.

Prescription Drug Diversion Efforts

Attorney General Conway launched Kentucky’s first and only statewide Prescription Drug Abuse Prevention Task Force in August of 2009.  The task force has been involved in more than 450 prescription drug diversion investigations, including Operation Flamingo Road, the state’s largest prescription drug bust that resulted in the arrest of more than 500 people.

General Conway also worked closely with Governor Beshear, House Speaker Stumbo, Senate President Stivers and other lawmakers to win passage of landmark legislation in 2012 to prevent the abuse and diversion of prescription pills in the Commonwealth.  Since passage of HB 1, overdose deaths in Kentucky declined for the first time in a decade and more than half of the state’s pain management clinics have closed their doors.

In January 2014, General Conway announced that more than $32 million recovered in settlements with two pharmaceutical companies is being used throughout Kentucky to expand substance abuse treatment, including opiate addictions.  The settlement funds will create a new treatment center for adults, treatment scholarships, a grant program for new juvenile treatment beds and/or centers, and expanded services for juveniles.

In addition to the work being done here in the Commonwealth, Attorney General Conway reached across party lines to work with Attorney General Pam Bondi in Florida to ensure that her state implemented an electronic prescription drug monitoring system similar to Kentucky’s KASPER system.  Together they have worked to shut down the pill pipeline between Florida and Kentucky and to see that all 50 states have prescription drug monitoring programs in place and that all of the programs can share data across state lines. 

Keep Kentucky Kids Safe

In 2010, General Conway launched the Keep Kentucky Kids Safe initiative with the Kentucky Justice Cabinet and its Office of Drug Control Policy, Kentucky Pharmacists Association, National Association of Drug Diversion Investigators (NADDI), Operation UNITE and concerned parents. Since its launch, Attorney General Conway and his partners have warned approximately 40,000 students, parents and teachers about the dangers of prescription drug abuse. 

A recent survey has found that the percentage of Kentucky teens misusing prescription drugs has dropped dramatically over the past four years.  According to the 2012 Kentucky Incentives for Prevention School Survey, the use of prescription drugs among students without a doctor’s order has decreased steadily among sixth-, eighth-, 10th- and 12th-graders since 2004.  The declines have been the most significant since 2008, when the Office of the Attorney General, along with state lawmakers and other agencies across the Commonwealth, began intensifying efforts to fight prescription drug abuse.

As part of the Keep Kentucky Kids Safe program, students are encouraged to participate in an annual statewide video PSA contest created to raise awareness about the risks of prescription drug abuse.

You can follow Attorney General Conway on Twitter @kyoag, visit the Attorney General’s Facebook page or view videos on our YouTube channel.