Generics pose new threat in addiction fight

Published on NewsOK Modified: December 16, 2012 at 10:41 am •  Published: December 16, 2012

Gov. Steve Beshear has touted the new law's impact in efforts to reverse the state's status as a "prescription playground." He has pointed to a big drop in the amount of painkillers being prescribed and the closure of 10 pain management clinics.

The law has not impeded the ability of patients to obtain medications for "legitimate pain," the governor has said.

Pain relievers such as OxyContin and Opana ER feature extended-release formulations designed to give long-lasting effects. The problem is that when crushed, those drugs deliver hours' worth of pain relief in a matter of seconds when injected or snorted, said state Attorney General Jack Conway. He's among officials who fear an influx of easily crushable generic pain medication will result in more overdose deaths.

The FDA hasn't ruled on whether the abuse-deterrent features should be required on the generic versions.

McConnell, in a recent letter to FDA Commissioner Margaret Hamburg, asked if there's a precedent for removing a generic drug from the market that lacks a safety mechanism included as part of the brand-name drug.

The senator also asked what steps could be taken for FDA approval of the same generic drugs to include tamper-resistant formulation.

The agency was preparing a response to McConnell's letter, said FDA spokeswoman Morgan Liscinsky. She said the agency also is reviewing citizen's petitions asking it to require abuse-deterrent forms of such opioid pain relievers when those features are available.

"The FDA understands how important it is to give guidance and appropriate support regarding the development of abuse-deterrent formulations of opioids, and also recognizes the important role that generic drugs play in our health-care system," she said in an email.

Johnson, the eastern Kentucky sheriff, said the FDA "needs to take the bull by the horns" to avoid the influx of crushable generics.

"We can arrest drug addicts all day long, but that's not solving the problem," he said.

Rogers, who wields considerable influence as chairman of the House Appropriations Committee, is a leading sponsor of federal legislation that would require most pain drugs to adopt abuse-deterring safeguards.

The congressman said inaction by FDA will shrivel demand for more expensive pain medication featuring abuse safeguards, in favor of cheaper generics that are easily crushable.

The result, he said, is "we will be right back where we were 10 years ago with pharmacy robberies, drive thru pain clinics, orphaned children and overcrowded emergency rooms. The clock is ticking and this health crisis has a partial solution, but failure to intervene by FDA will mean it has failed its basic mission."