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FDA places ban on generic versions of OxyContin

The prescription medicine OxyContin is displayed August 21, 2001 at a Walgreens drugstore in Brookline, MA.
The prescription medicine OxyContin is displayed August 21, 2001 at a Walgreens drugstore in Brookline, MA.
Darren McCollester/Getty Images

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The Food and Drug Administration has prohibited the production of generic versions of OxyContin, a time-release painkiller that had been widely abused by crushing to induce a quick and powerful high. 

The ruling came down Tuesday, the same day that the patent on the drug was set to expire. 

"Basically the FDA took the position that the versions of OxyContin that would have been generically produced were far too prone to abuse, and that the risks of those drugs outweighed the therapeutic benefit of the abuse resistant form of OxyContin," said Barry Meier, business reporter for the New York Times and author of Pain Killer: A "Wonder" Drug's Trail of Addiction and Death.

The drug's manufacturer, Purdue Pharma, stands to win big from the ruling as no other competitors will be able to enter the marketplace with cheaper versions. 

"They set a big precedent from the standpoint that they do incentivize companies to switch to tamper resistant versions of these widely used drugs," said Meier. "The companies that are able to do that and other companies seeking to do that can essentially develop monopoly positions, if you will, for their particular drug."

In 2010, Purdue Pharma released a new formulation of the drug which made it less prone to abuse. The original version of the drug, approved back in 1995, could easily be crushed and snorted or injected. The new version would change state if the user attempted to tamper with its intended pill form. 

"The original version of OxyContin which would have been the same as the generic versions of OxyContin can be easily crushed," said Meier. "In the newer version of OxyContin … if you tried to tamper with the drug by crushing it, it turns into a sort of a gummy gooey mass, so it can't be injected with a hypodermic needle or inhaled." 

The FDA has also approved a new label for OxyContin bottles that touts the drug's new tamper-resistant properties. 

"It marks the first time that the FDA has given a manufacture label that states that the drug is tamper resistant or less prone to abuse,"said Meier. "According to what FDA officials said yesterday, this will be the first of what they hope to be many new formulations of narcotic pain killers that will be less abuse prone."