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The Good News: F.D.A. Shoots Down OxyContin Generics The Bad News: Pharma Co. Hikes Price on Naloxone

Home / Naloxone / The Good News: F.D.A. Shoots Down OxyContin Generics The Bad News: Pharma Co. Hikes Price on Naloxone

The Good News: F.D.A. Shoots Down OxyContin Generics The Bad News: Pharma Co. Hikes Price on Naloxone

The Food and Drug Administration refused to approve generic versions of OxyContin, which is very good news. Experts agree that this will help stop the epidemic of prescription pill abuse, and the news indicates that the F.D.A. is doing what it can to help.opiates.jpg

Purdue Pharma gets a bad name as the manufacturer of the painkiller that “symbolized a decade-long epidemic of prescription drug abuse,” according to The New York Times. However, the company started manufacturing a different version in 2010 that was “less prone to tampering.” (It turned to jelly when people tried to crush it for snorting or injecting.)

Purdue Pharma’s patent was expiring when this ruling came down, which is why this was such good news. It means that the companies that want to manufacture generic versions of the drug won’t be able to contribute to the drug abuse epidemic. If they want to sell the drug at all, these companies will have to come up with formulations that are more difficult to tamper with, like Purdue Pharma did.

A Medpage “breaking news” email noted that there are new labeling requirements for the drug; specifically, that it “has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route.” This effectively thwarts companies hoping to sell generics that don’t comply

The bad news for people who really need OxyContin for medicinal purposes is that the price of OxyCodone has risen since 2010.  However, if other manufacturers come up with tamper-proof generics, that could keep a lid on prices and even help reduce them.

Endo Pharmaceuticals has also requested that the F.D.A not approve generics for their Opana, another narcotic pain killer of similar “painkilling strength.” This company, too, has come up with a formulation that is harder to tamper with.

However, the article raises the question about the drug manufacturers’ motives, whether they only really care about profits, saying “In court papers filed in response to a lawsuit filed by Endo, the F.D.A. described the company’s action as a ‘thinly veiled attempt to maintain its market share and block generic competition.’”

There’s other news about the price of a drug that, rather than contributes to prescription pill abuse, saves lives. I first wrote about Naloxone over a year ago. If you remember, this medication can help revive a person who overdoses on an opiate like heroin, and there are programs that dispense the drug for free. Hospira is currently the only company still manufacturing the medication, and Alternet noted that the price has skyrocketed by $1,100 since 2008.

The director of a Chicago program called the company in in 2008 to ask for a break, he was able to get a reduced price. Thankfully, Hospira is working with other nonprofits to offer more reasonable prices. Addiction writer Maia Szalavitz noted in another Alternet article that some programs have already folded. Shockingly, Hospira stands to make $20 million from the drug. Naloxone is injected and expensive to make, so there’s little incentive for other companies to jump to market it.

The F.D.A. is considering making Naloxene available over the counter (will that make it less expensive?), but nothing has happened yet. 


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