Some Pain Doctors Concerned About FDA’s Decision Not to Approve Generic OxyContin

Some pain doctors say they are concerned the Food and Drug Administration’s (FDA) decision earlier this week not to approve generic versions of the original version of OxyContin could lead to less effective drugs that are potentially addictive, NPR reports.

“Obviously, there’s a cost issue,” Lynn Webster, President of the American Academy of Pain Medicine, told NPR. “Not having generics means this type of medication is going to be more expensive.” Because OxyContin is costly, some doctors may switch to methadone or other pain medications if a patient’s insurance will not cover it, according to Webster.

The original version of OxyContin could be crushed and then snorted or injected. Its patent was set to expire on Tuesday.

The FDA also approved new labeling for a reformulated version of the drug, which will indicate it is more difficult to crush, and thus harder to abuse than the original version. OxyContin’s manufacturer, Purdue Pharma, introduced the tamper-resistant formula in 2010, which has a patent that does not expire until 2025. If generic drug makers want to develop their own versions of OxyContin, they will have to make them abuse-resistant.

Andrew Kolodny, Chief of Psychiatry at Maimonides Medical Center in New York, who studies policies on opioids, said tamper-resistant pills are not necessarily less addictive. “One of my concerns is that this new rule could set up an arms race for the pharmaceutical companies to recreate abuse-deterrent versions because they have patent protections. You’ll see marketing to prescribers that these pills are less addictive. That could potentially make things worse.”