Why Didn’t FDA Bar Generic OxyContin?

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In a highly controversial move, the FDA last night announced it would not approve generic versions of the older form of the OxyContin painkiller over concerns that the drugs would be susceptible to abuse. The decision hands a significant victory to Purdue Pharma, because the patent on the older pill expired yesterday and several drugmakers had been hoping to launch copycat OxyContin.

The FDA move comes not long after 48 state attorneys general asked the agency to require generic drugmakers to produce tamper-resistance versions of medicines that contain opioids. Along with some pain specialists, they argued that allowing the older form of the drug to become available would lead to increased abuse, addiction and crime.

However, the agency decision is also being described as a gift for Purdue, since the drugmaker has been selling a newer, so-called tamper-resistant form of OxyContin since 2010, when shipments of the older form were halted. In fact, the agency also approved labeling yesterday that says this version is less prone to abuse through inhalation or injection. As a result, Purdue will not face any form of competition for OxyContin and some expect the drugmaker will increase prices.

“I’m happy that an easy-to-crush, generic OxyContin will be kept off the market,” says Andrew Kolodny, who chairs the psychiatry department at Maimonides Medical Center and heads Physicians for Responsible Opioid Prescribing. “But it bothers me that Purdue, the company that helped bring on an epidemic of addiction and overdose deaths, will benefit financially from this decision. It also bothers me that Purdue continues to sell MS Contin and Dilaudid without any abuse deterrence. They already own the technology, why aren’t they adding it to all of their opioids?”

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The antipathy toward Purdue stems from the track record the drugmaker had in promoting OxyContin, which was nicknamed Hillbilly Heroin. The drugmaker’s parent company said $634 million in 2007 to settle charges of misleading patients, doctors and regulators about its addictive qualities. Three Purdue execs were later excluded from dealing with federal healthcare programs and also debarred.

In reaching its decision this week, the FDA determined from studies that the newer version of OxyContin is safer and more effective than the older version. Recently, though, the FDA had denied a citizen petition filed by Purdue in which the drugmaker asked the agency to withhold approval of any generic version that lacked abuse-deterrent features. The agency did not offer comment at the time.

The FDA announcement noted that the citizen petitions and comments were also reviewed (HERE IS THE STATEMENT AND FEDERAL REGISTER NOTICE). But some noted the move contrasts with a recent decision by Canada’s Health Ministry to allow generic OxyContin on the market, since the drug was deemed safe and effectiveness (read more here). The contrasting views prompted some to question FDA reasoning about making comparisons.

“Just because drug A is supposedly safer than drug B,’ why is drug B, therefore, unsafe?” asks Arnie Friede, a former FDA associated chief counsel and former senior corporate counsel at Pfizer. “And FDA has routinely refused to use comparative safety or comparative efficacy as an explicit criterion for new drug approvals.”

“So on what basis is that now an element of determining why a drug has been withdrawn? And why in the world is a drug withdrawn for reasons of safety when the justification for the withdrawal has to do with a misuse of the drug?  Will foreseeable misuse now be an explicit element in drug approval decisions?  If so, why shouldn’t forseeable off-label prescribing similarly be an element?  FDA has explicitly disavowed that in the context of a couple of ANDA…

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