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McConnell Contacts FDA Regarding Prescription Drug Abuse and Efforts to Ensure Safety of Generic Pain Pills

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Location: Washington, DC

Continuing his efforts to help combat Kentucky's prescription drug abuse epidemic, U.S. Senate Republican Leader Mitch McConnell sent a letter to FDA Commissioner Margaret A. Hamburg, M.D., asking her to work to prevent the influx of generic opiates from coming to market that fail to incorporate technologies to reduce the likelihoods of misuse and abuse. In the letter sent today, McConnell wrote, "As I travel throughout Kentucky and meet with constituents, I continue to hear concerns about prescription drug abuse. Foremost in the minds of many of my constituents remains the FDA's approval of generic versions of extended-release opiates without requiring technologies that reduce the likelihood of misuse and abuse."

Senator McConnell has heard concerns from law enforcement, hospitals and health clinics in Kentucky that generic versions of the two most commonly-abused painkillers -- Opana and OxyContin -- lack the tamper-resistant gel coating of the brand name drugs. Without this technology, addicts crush the pills in order to achieve an immediate heroine-like high from sniffing or injecting the painkillers. If these generics come to market without the tamper resistant coating, much of the work that law enforcement and health care providers have done to stem the tide of pain pill abuse in Kentucky will be lost. Last December, Senator McConnell asked the FDA Commissioner to delay these crushable generic drugs from coming to market until a workable solution can be found.

In today's letter, Senator McConnell wrote that while he recognizes the "FDA has recently taken additional steps to provide guidance to industry on abuse-deterrent reference drugs, I believe more can be done to prevent an influx of generic opiates from coming to market that fail to incorporate technologies to reduce the likelihood of misuse and abuse." He also mentioned the fact that several law enforcement groups such as the Kentucky Narcotic Officers' Association remain "very fearful that a new wave of overdose deaths and more illegal trafficking of these drugs will occur if the generic formulation is approved."

McConnell asked Commissioner Hamburg to respond to several questions on the issue (letter attached), including if the FDA believes that the manufacturers of the new formulations of OxyContin and Opana collected the necessary data to ensure its safety to reduce the likelihood of misuse and abuse.

"I look forward to hearing from Commissioner Hamburg in response to the questions I sent her today," Senator McConnell said. "In Kentucky, the pain pill epidemic has destroyed thousands of lives and ravaged communities. I continue to hear heartbreaking stories from constituents about individuals who needlessly lost loved ones to opiate drug overdose. The problem is so acute that more Kentuckians die from drug overdose than from car accidents each year."
Note: According to the U.S. Centers for Disease Control and Prevention, drug-related deaths continue to rise.

Background on Senator McConnell's work to combat drug abuse and deaths in Kentucky

*Senator McConnell met with the Office of National Drug Control Policy (ONDCP) Director, R. Gil Kerlikowske, in Washington, D.C in February 2011.
*Senator McConnell invited Director Kerlikowske to tour Kentucky in order to get a better sense of the unique challenges posed by the drug issue in the commonwealth. The Director accepted and toured the state with members of McConnell's staff.
*Senator McConnell met with several judges from the Commonwealth representing the Kentucky Drug Court Program to hear of the positive impact of drug courts and received the All Rise Leadership Award from the National Association of Drug Court Professionals (NADCP) for his leadership in supporting innovative drug courts.
*In July 2012, on a phone call with Director Kerlikowske, Senator McConnell advocated for the inclusion of Hardin County into Appalachia HIDTA.
*In August 2012, Senator McConnell met with Director Kerlikowske to again, push for Hardin County's designation and on August 29, 2012, Director Kerlikowske announced that Hardin County had been designated as part of the Appalachia HIDTA. This designation allows the Hardin County community access to federal training, personal, and technology resources to combat drug trafficking and abuse.
*In December 2012, Senator McConnell called Food and Drug Administration (FDA) Director, Margaret Hamburg encouraging the FDA to take steps to prevent the flood of crushable generic pain pills set to come to market in early 2013.
*In December 2012, Senator McConnell met with Health and Human Services' (HHS) Acting General Counsel, Bill Schultz to stress the importance of preventing generic crushable pain pills from coming to market without tamper resistant coating in early 2013.
*On April 3, 2013, Senator McConnell contacted FDA Commissioner Margaret Hamburg to ask several questions to better understand FDA's position regarding efforts to prevent an influx of generic opiates from coming to the market to help reduce the likelihood of misuse and abuse.


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