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Experts Consider FDA OxyContin Decision


  12:17:17 pm, by MedBen5   , 244 words,  
Categories: News, Prescription

Experts Consider FDA OxyContin Decision

Experts are weighing in on the announcement by the Food and Drug Administration earlier this week that drugmakers cannot produce generic versions of OxyContin, NPR reports. Because Purdue Pharma replaced its original version in 2010 with a more tamper-proof alternative, the drugmakers’ patient was extended to 2025 – meaning the popular painkiller will remain pricey for the next decade.

“Not having generics means this type of medication is going to be more expensive,” says Lynn Webster, president of the American Academy of Pain Medicine. She adds that with the lack of a cheaper alternative, doctors may switch to methadone or less costly options.

It would be “disastrous” to market generic OxyContin without making it abuse-resistant, Webster says. “There should be no opioids on the market that don’t have some abuse-deterrent formulation.”

“The issue is really about the generic and the availability issue,” says Dr. Joe Ross, an assistant professor at the Yale School of Medicine who studies drug and device safety. “Why do they essentially get a patent extension when they had an unsafe drug on the market for many years? Why would the FDA reward them?”

“One of my concerns is that this new rule could set up an arms race for the pharmaceutical companies to create abuse-deterrent versions because they have patent protection,” Andrew Kolodny, head of psychiatry at Maimonides Medical Center in New York, told NPR. “You’ll see marketing to prescribers that these pills are less addictive. That could potentially make things worse.”

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