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Cooper calls on FDA to make generic pain pills safer

Release date: 3/11/2013

Leads push by state AGs for tamper and abuse resistant
 prescription drugs

Raleigh: Generic versions of popular pain relievers must be made harder to abuse, Attorney General Roy Cooper and 47 other state attorneys general told federal officials in a letter sent today.
 
“Fighting prescription drug abuse requires strong law enforcement, more prevention efforts, and better treatment for addicts. Drug companies need to do their part as well by making their pills harder to abuse,” Cooper said.
 
Prescription drug abuse is on the rise in North Carolina and across the country, and prescription pain relievers are among the most commonly abused drugs. The letter encourages the U.S. Food and Drug Administration (FDA) to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper-resistant versions of their products.  Without those standards, Cooper and others in law enforcement fear that generic versions of pain pills that are easy to abuse could flood the market. 
 
Name-brand versions of painkillers such as OxyContin have made it more difficult to get high from their drugs, for example by making it harder to crush pills which abusers do in order to inject or snort the drug. But the patent on OxyContin is set to expire later this year, and generic versions of the drug expected to come on the market may not have anti-abuse features unless the FDA requires it.
 
“In our states, nonmedical users are shifting away from the new tamper-resistant formulations to non-tamper-resistant formulations of other opioids as well as to illegal drugs.  There is great concern in our law enforcement community that many non-tamper-resistant products are available for abuse when only a few products have been formulated with tamper-resistant features,” Cooper and the other attorneys general wrote.
 
Cooper and Alabama Attorney General Luther Strange led the effort to get state attorneys general to write to the FDA about the problem.
 
When abused or used incorrectly, prescription drugs can be deadly. Fatal drug overdoses are now the leading cause of death due to unintentional injury in the U. S. exceeding even motor vehicle deaths, according the U.S. Centers for Disease Control. Approximately 1,000 people died from overdoses on prescription drugs last year in North Carolina alone. 
 
If generic drug companies are able to make versions of popular painkillers without the abuse and tamper resistant features, law enforcement is concerned that overdose deaths could climb even higher.



Media contact:  Noelle Talley (919) 716-6413