In a major policy move, the Food and Drug Administration has decided that it will not approve generic versions of the powerful, and frequently addictive, narcotic OxyContin, the painkiller that symbolized a decade-long epidemic of prescription drug abuse. This decision will probably result in higher prices for the original medication, and represents a victory for the drug’s manufacturer, Purdue Pharma.
This decision was covered well in an article in the New York Times recently. Here are excerpts:
Some state attorneys general and pain treatment experts had also urged the F.D.A. to block the release of generic versions of OxyContin, arguing that failing to do so would feed street demand for strong narcotics. But the decision is also likely to result in higher prices for OxyContin, a time-release form of a narcotic called oxycodone, because it will not face generic competition.
The decision by the F.D.A. came on the day when the patent for the original version of OxyContin was set to expire. That would have allowed generic producers to introduce their own version of the formulation. F.D.A. officials said that several producers had applications to sell a generic form of OxyContin pending before the agency.
As part of Tuesday’s decision, the F.D.A. also said it had approved a label for the new version of OxyContin stating that it was less prone to abuse through inhaling or injecting it.
The decision is the first time that the agency has allowed a manufacturer to state that a narcotic drug has tamper-resistant properties, said an agency official, Dr. Douglas C. Throckmorton.
Dr. Throckmorton said the F.D.A. had looked at data from several studies, some of it underwritten by Purdue Pharma, in arriving at its decision. He said that while the data was not perfect, the agency had concluded that it was enough to show that the new version of OxyContin was safer, in its abuse resistance, than the original version.
As a result, the efficacy of that original version — and by extension the efficacy of any generic version of it — no longer outweighed its risks, since the therapeutic value of older and new versions of the drug were the same, he added.
Along with Purdue Pharma, the manufacturer of another long-acting narcotic painkiller, Endo Pharmaceuticals, has also petitioned the F.D.A. seeking a similar claim of abuse resistance for a newer version of one of its drugs, Opana. If that claim proves successful, generic versions of the original form of Opana would also be barred.
At time of introduction in late 2010, the price of the new version of OxyContin was about $6 per 40 milligram tablet, the same then as the price that was not tamper resistant. Since then, the price of the new version has risen to about $6.80 for a tablet of that strength. Opana costs about the same amount for a pill of the same painkilling strength.
When the F.D.A. approved the original formulation of OxyContin in 1995, the agency allowed its maker to claim that the drug’s time-release formulation was “believed to reduce” its potential to be abused. That contention proved disastrously wrong.
