FDA's Rejection Of Generic OxyContin May Have Side Effects

OxyContin's long-acting formulation makes it popular but also prone to abuse.

OxyContin's long-acting formulation makes it popular but also prone to abuse.

Banning cheaper, generic forms of a dangerous drug sounds like a worthy idea.

But the Food and Drug Administration's decision to bar generic OxyContin may also push patients towards less effective drugs without eliminating the risk of addiction, experts say.

"Obviously, there's a cost issue," says Lynn Webster, president of the American Academy of Pain Medicine. "Not having generics means this type of medication is going to be more expensive."

On Tuesday, the FDA said that it won't approve generic versions of the original formulation of OxyContin, a long-acting narcotic pain medication, which went off patent that day.

Normally, the end of the patent's life would open the door to generics. But drugmakers must now develop their own abuse-resistant versions if they want to compete for a share of the lucrative market.

In 2010, Purdue Pharma LP replaced the original OxyContin with an abuse-resistant form, in an effort to reduce deaths and overdoses caused by the powerful pain medication, which was licensed in 1995.

From 1999 to 2006, deaths involving prescription opioid painkillers more than tripled, according to the federal Centers for Disease Control and Prevention. In 1997, Purdue pleaded guilty to federal charges that it misbranded the drug by claiming that it was safer and less addictive than short-acting narcotic drugs like Vicodin and Percocet.

The new version of OxyContin includes an ingredient, a polymer, that makes it harder to crush and snort or inject to get a quick, heroin-like high.

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FDA's Rejection Of Generic OxyContin May Have Side Effects