Office of the Attorney General
Attorney General Conway Urges FDA to Make Generic Pain Pills Harder to Abuse

Press Release Date:  Monday, March 11, 2013  
Contact Information:  Shelley Catharine Johnson
Deputy Communications Director
502-696-5659 (office)
 


Generic versions of popular pain relievers must be made harder to abuse, Attorney General Jack Conway and 47 other state and territorial Attorneys General told federal officials in a letter sent today by the National Association of Attorneys General (NAAG). The letter encourages the U.S. Food and Drug Administration (FDA) to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper- and abuse-resistant versions of their products.

"Prescription drug abuse is an epidemic that kills more than 1,000 Kentuckians each year," said General Conway, who co-chairs NAAG's Substance Committee. "Adding new physical and chemical features to prescription opioids to deter abuse could reduce misuse of these drugs and save lives in communities across Kentucky and the nation."

Attorney General Conway, along with Alabama Attorney General Luther Strange, Florida Attorney General Pam Bondi and North Carolina Attorney General Roy Cooper, led the effort to get state Attorneys General to write to the FDA about this important issue.

"The development of tamper-resistant and abuse-deterrent opioid drug products is a valuable aid to the law enforcement, legislative and public awareness initiatives many of us have implemented in our states to combat prescription drug abuse," General Conway said.

In their letter to the FDA, the Attorneys General expressed concern that non-medical users are shifting away from the new tamper-resistant formulations to non-tamper-resistant formulations of other opioids, as well as other illegal drugs.

"There is great concern in our law enforcement community that many non-tamper-resistant products are available for abuse when only a few products have been formulated with tamper-resistant features," the Attorneys General wrote.

When abused or used incorrectly, prescription drugs can be deadly. Fatal drug overdoses are now the leading cause of death due to unintentional injury in the United States exceeding even motor vehicle deaths, according to the U.S. Centers for Disease Control and Prevention.

Kentucky is one of the most medicated states in the country, and has the sixth highest overdose rate. Last year, 220 million doses of the highly addictive painkiller hydrocodone were dispensed in the Commonwealth. That's 51 doses for every man, woman and child in the state.

Combating prescription drug abuse

To fight the epidemic of prescription drug abuse, 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 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.

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 alerted nearly 20,000 students about the dangers of prescription drug abuse.

In addition to his law enforcement and awareness efforts, General Conway 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 its passage, prescriptions for hydrocodone are down almost 20 percent and prescriptions for Opana have been almost cut in half.

Attorney General Conway's Office has also filed suit against Purdue Pharma, the manufacturers of OxyContin for misrepresenting the addictive nature of the drug. A recent federal appeals court ruling has cleared the way for the case to be heard in Pike Circuit Court.

General Conway's efforts are making a difference. 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 Kentucky. The state 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 General 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 stop shut down the pill pipeline between Florida and Kentucky and to see that all 50 states have prescription drug monitoring programs are in place and that all of the programs can share data across state lines.

Link to the AGs Letter to the FDA: http://ag.ky.gov/pdf_news/naag-fda-letter.pdf .