McConnell calls on FDA to address ‘pain pill epidemic’

McConnell calls on FDA to address ‘pain pill epidemic’

April 8th, 2013 // 2:20 pm @ jmpickett

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Senate Minority Leader Mitch McConnell (R-Ky.) asked the Food and Drug Administration (FDA) to ensure that generic painkillers are tamper-proof to prevent abuse.

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“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,” McConnell wrote in a letter to FDA Commissioner Margaret Hamburg on Wednesday.

McConnell asked the FDA to force manufacturers of generic versions of the two most commonly abused painkillers — Opana and OxyContin — to include the tamper-resistant gel coating used by brand-name drugs so that the pills cannot be crushed and snorted for a heroine-like high.

“As I travel throughout Kentucky and meet with constituents, I continue to hear concerns about prescription drug abuse,” McConnell said. “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.”

This month, Oxycodone will lose its patent protection. McConnell said that several law enforcement groups have told him they are concerned that overdose deaths and illegal drug trafficking will increase if generic drug manufacturers aren’t required to use the same tamper-resistant formula as the name-brand drug makers.

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“In Kentucky, the pain pill epidemic has destroyed thousands of lives and ravaged communities,” McConnell said. “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.”

McConnell asked Hamburg to respond to his questions on whether the abuse-deterrent formulas are working and why the FDA cannot force generic manufacturers to use the technology before being approved.

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