WASHINGTON, DC – U.S. Senate Republican Leader Mitch McConnell reached out to the Commissioner of the Food and Drug Administration (FDA) today on behalf of Kentucky law enforcement and health care providers “expressing concern about generic versions of long-release opiates coming to market without the tamper-resistant technology.”
Brand name long-release opiates, such as Opana ER and Oxycontin, are particularly potent and were subject to rampant drug abuse prior to the deployment of tamper-resistant technologies. These technologies prevent addicts from destroying the time release mechanism of the extended release opiates, designed to treat severe pain, by crushing the pills in order for the user to achieve an immediate heroin-like high. However, generic versions of the same drugs lacking the tamper-resistant formulations are expected to pour into the market in early 2013. Senator McConnell heard from some of Kentucky’s top law enforcement and health care providers about their concerns, including: the Kentucky Primary Care Association, Inc., Appalachian Regional Healthcare, Inc., Norton Healthcare, KentuckyOne Health, the Kentucky Narcotic Officers’ Association (KNOA), and Operation UNITE.
Senator McConnell contacted FDA Commissioner Margaret Hamburg on their behalf to relay their concerns on the issue. In a letter to Commissioner Hamburg, Senator McConnell pressed the FDA to identify what authority the agency may have to act should they recognize this legitimate public safety concern. He also questioned if there’s precedent to remove a generic drug from the market that lacks a safety mechanism now included as a part of the brand drug. Senator McConnell also asked Commissioner Hamburg what steps can be taken for FDA approval of the same generic drugs to include the tamper-resistant formula.
“In Kentucky, the pain pill epidemic has destroyed thousands of lives and ravaged communities,” Senator McConnell said. “In my travels across the Commonwealth, I’m often told heartbreaking stories about the 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.”
Senator McConnell’s office has also worked closely with Congressman Hal Rogers on this effort. Senator McConnell added, “I appreciate the leadership of my friend, Congressman Rogers, on this issue and I applaud his efforts to combat drug abuse in Kentucky. I look forward to our continued partnership in this fight.”
Jerry Haynes, President and CEO of ARH, wrote to McConnell about the issue recently. “Our service area of Eastern Kentucky has been plagued by prescription drug abuse for many years. Painkiller addiction has destroyed the lives of numerous people and the potential release of these generics threatens to escalate the problem.”
Karen Kelly, President and CEO of Operation UNITE, wrote: “At a time when painkillers are responsible for more deaths than heroin and cocaine combined, and illegal trafficking continues to confound aggressive law enforcement efforts, we do not need to expand the playing field by flooding the market with more – and potentially just as deadly – drugs under the guise that they are cheaper.”
In addition to writing FDA Commissioner Hamburg, Senator McConnell also forwarded the letters he received from the Kentucky organizations to the FDA and asked for a prompt review and response.
