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Attorney General Conway Asks FDA to Reconsider Decision to Approve Zohydro ER

Wednesday, 12 11, 2013

Daniel Kemp
Deputy Communications Director
502-696-5659 (office)

Attorney General Jack Conway today announced that he and 28 state attorneys general from across the country, in a bipartisan effort, have asked the commissioner of the U.S. Food and Drug Administration (FDA) to reconsider its recent decision to approve the high-dose narcotic painkiller Zohydro ER.

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 reported to be five to 10 times 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, General Conway and the bipartisan coalition of attorneys general ask that if the FDA will not reconsider its approval of Zohydro ER, then it should set a rigorous timeline for the drug's reformulation to require abuse-deterrent properties.

"We do not want to see the great strides we have made in Kentucky combatting 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 given that abuse-deterrent properties are capable of being developed and required, the FDA's decision to approve the drug doesn't make sense."

The letter written to the commissioner of the FDA concerning the agency's approval of Zohydro ER is available at http://goo.gl/UybuF8 .

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

PRESCRIPTION DRUG DIVERSION EFFORTS

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 430 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 half of the state's pain management clinics have closed their doors.

Additionally, the latest report from the Substance Abuse and Mental Health Services Administration (SAMHSA) shows a decline in the non-medical use of prescription pain relievers among all age groups in the Commonwealth. Kentucky is also below the national average for prescription drug abuse, for the first time.

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. General Conway and General Bondi serve as cochairs of the National Association of Attorneys General Substance Abuse Committee.

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 more than 30,000 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 Attorney General's Office, 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 on the risks of prescription drug abuse. Additionally, high school seniors whose lives have been affected by this issue can now apply for the Sarah Shay and Michael Donta Memorial Scholarships. The scholarships were created this year to help Kentucky students who have excelled in their personal and academic lives despite seeing firsthand the devastating consequences of prescription drug abuse.

FACES OF PRESCRIPTION DRUG ABUSE

Attorney General Conway invites Kentuckians of all ages to share their stories about how prescription drug addiction has affected their families and communities through his "Faces of Prescription Drug Abuse" video series. Videos may be submitted by visiting the Attorney General's website at http://ag.ky.gov/rxabuse .