The Food and Drug Administration late today approved new labeling for the painkiller OxyContin that allows Purdue Pharma to maintain its monopoly on the drug by blocking cheaper generic versions from entering the market.
The new labeling states that a reformulated version of OxyContin makes the pills harder to crush or dissolve and reduces chances of abuse. Purdue Pharma began selling the tamper resistant version in 2010, replacing the original formulation of OxyContin.
“Because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin,” the FDA said in a statement.
“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, MD, deputy director for the FDA’s Center for Drug Evaluation and Research. “While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”
OxyContin is the brand name for oxycodone, a powerful opioid painkiller that was first introduced in the U.S. in 1996. It soon became a blockbuster drug for Purdue and has reportedly generated profits in excess of $10 billion.
But it also soiled the company’s image.
In 2007, Purdue and three of its top executives plead guilty to felony criminal charges for the off-label marketing of OxyContin – falsely telling doctors it had low potential for abuse and addiction. Many anti-drug activists say the marketing of OxyContin helped spawn an epidemic of prescription drug abuse that has killed tens of thousands of people.
Purdue introduced the new tamper resistant version of OxyContin to make the pills harder for drug abusers to snort, chew, smoke or inject. Purdue’s patent on the new formula doesn’t expire until 2025, but the original one has – which potentially opened the door for generic drug companies to make their own versions of the medication that are not tamper resistant. Today’s decision eliminates that possibility.
The FDA was under growing political pressure not to allow generic versions of the painkiller.
“It is not every day that you can say one decision will save lives, but I truly believe this will,” said Rep. Bill Keating (D-MA), who is co-sponsoring the Stop the Tampering of Prescription Pills (STOPP) Act, which would require the FDA to stop generic painkillers from coming on the market unless they are tamper resistant.
“I commend the FDA and Commissioner (Margaret) Hamburg for their responsible, thoughtful decision. It is a welcome first step in an ongoing process. Since I first introduced the STOPP Act last Congress – and reintroduced it last month – I have been fighting to require these dangerous, prescription painkillers to employ abuse-deterrent technologies. That is a key component of the STOPP Act and with today’s decision, I am happy to see that the FDA has chosen to implement part of my legislation.”
Last month the National Association of Attorneys General sent a letter to the FDA saying there is “great concern” among law enforcement and public health officials that new generic painkillers that are not tamper-resistant will be abused.
Although sales of OxyContin have declined in recent years, it’s still a big moneymaker for Purdue, generating sales of over $2.6 billion annually according to Drugs.com. At $7.50 a pill, a 30-day prescription would cost patients about $225. Analysts say a cheap generic version would shave about 30% off the price.
“Purdue Pharma is pleased with the FDA’s approval of this new language for the OxyContin label, which will provide important information to healthcare professionals,” said Gary L. Stiles, MD, Senior Vice President of Research and Development at Purdue Pharma.
The company said it was working to incorporate tamper resistant technology into other opioids it produces, including oxycodone, morphine and hydrocodone bitartrate.