Office of the Attorney General
Attorney General Conway Calls on Sec. Sebelius to Overturn Zohydro Approval
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
“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
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
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
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.
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
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
visit the Attorney General’s Facebook
page or view videos on our YouTube