By: Ralph B. DavisManaging Editor
December 28, 2012
WASHINGTON, D.C. — While most officials in the nation’s capital were consumed by negotiations over the looming fiscal cliff, two Kentucky lawmakers were sending a warning about another deadline with potentially deadly consequences.
U.S. Rep. Hal Rogers and Sen. Mitch McConnell each sounded the alarm last week over patents expiring next month on prescription narcotics such as Oxycontin and Opana. Once the patents expire, generic versions of the two drugs will be allowed on the market.
What worries the two men, however, is that the generic versions of the drugs might lack some of the safeguards the commercial versions have.
Oxycontin and Opana each have tamper-resistant coatings which, while not foolproof, are believed to deter abuse. The coatings make it more difficult for abusers to crush the pills in an attempt to bypass their extended-release mechanism.
Rogers issued a statement last Tuesday, asking the Food and Drug Administration to act before Jan. 1 to require generic manufacturers to also implement tamper-resistant coatings.
“After Oxycontin came on the market 15 years ago, a wave of overdose deaths devastated entire towns in my region of Appalachian Kentucky before spreading like wildfire to big cities and suburban communities across the country,” Rogers said. “By crushing these pain pills, abusers can experience a euphoric — but oftentimes deadly — high. But today, the FDA has an opportunity keep these crushable pills out of our children’s reach. A number of prescription medicines already on the market use tamper-resistant technologies that can cut back on abuse. No generic pill should come to market without these life-saving features.”
McConnell went a step further, calling Bill Schultz, acting general counsel for the Department of Health and Human Services, to his office last Wednesday to express his concerns in person.
“Prescription drug abuse is a significant problem in Kentucky that will be made worse by the imminent availability of these crushable pain pills and I encourage the Administration to take action immediately to avert the looming threat to Kentucky from these frequently-abused, crushable-pain pills,” McConnell told Schultz.
McConnell said he has heard concerns from law enforcement, hospitals and health clinics in Kentucky that these generic crushable drugs lack the tamper-resistant gel coating of the brand name drugs. He fears that if the new 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.