The FDA rules one controversial painkiller is off limits for generic copies.
Regulators said yesterday that generic drug makers would not be licensed to make cheap versions of OxyContin. They said the powerful narcotic was widely abused in its original form. Many people would crush the pills and then snort or inject the drug for a quick and dangerous high.
But in 2010, Purdue Pharma, the privately-held company that makes the painkiller, introduced a formulation of OxyContin that was much more difficult to tamper with. It contains a polymer that turns into a slimy mess when crushed, and cannot easily be abused.
With OxyContin at the center of a surge in drug abuse, the New York Times reports that several state attorneys general and pain treatment experts had urged the FDA to block the release of generic OxyContin. They said failing to do so would reignite street demand.
Hal Rogers, a Republican Congressman from Kentucky, called the FDA decision "a huge win" that saved the nation from what he called "another deadly wave" of abuse and overdoses.
At one point, the Centers for Disease Control and Prevention said painkiller abuse had become an epidemic that resulted in more than 36,000 deaths in 2008. Men, especially in rural areas, were considered the main abusers of OxyContin. A study out last year said the overall cost of prescription painkiller abuse topped $70 billion dollars a year, mostly from lost productivity.
The FDA ruling extends Purdue's patent protection for at least another year. That patent had been set to expire yesterday. The company's sales of Oxy totaled $2.8 billion dollars last year.
Generic drug makers Teva Pharmaceuticals (TEVA) and Impax Labs (IPXL) had applied to make copies.
Another drugmaker, Endo Health Solutions (ENDP), is hoping the FDA gives its drug Opana a similar protection. It too was reformulated from the original version.
While the FDA ruling has a seemingly obvious benefit of reducing drug abuse, it does carry a cost – literally: It means the price of Oxy for legitimate uses will not go down.
–Produced by Drew Trachtenberg
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