Concern over generic painkillers mounts
POSTED: Sunday, December 16, 2012 - 1:00am
UPDATED: Sunday, December 16, 2012 - 1:04am
CNN — The White House Office of National Drug Control Policy recently sent an alert to law enforcement, particularly along the Canadian border, warning them that Canada had approved non-abuse resistant generic versions of oxycodone, the active ingredient in OxyContin, Percocet and about 40 other painkillers.
"ONDCP expects companies will begin offering these generics without the abuse-resistant features in Canadian pharmacies within the next month," according to the alert.
The letter warned of the potential for these generics to show up here in the United States, where they are no longer available.
Prescription painkillers have killed more Americans than heroin and cocaine combined. That's according to the Centers for Disease Control and Prevention (CDC), which says the United States is in the throes of a public health epidemic fueled by highly addictive prescription painkiller overdoses.
Approximately 12 million Americans aged 12 and older reported using prescription painkillers recreationally in 2010, according to the CDC. In fact, enough were prescribed to medicate every American adult around the clock for a month.
Deaths have skyrocketed during the past decade. In 2009, about a half a million people visited emergency rooms as a result of abusing or misusing prescription opioids like Vicodin (hydrocodone); OxyContin (oxycodone), Opana (oxymorphone) and methadone, the CDC found.
The drugs were attractive to abusers who would crush them to snort or melt and then inject them. Oxycontin had a time-release formula that delivered the drug over a 12 hour period. But when crushed, the entire dose was immediately absorbed into the bloodstream.
Pharmaceutical companies like Purdue Pharma, maker of Oxycontin, and Endo Health Solutions, which makes Opana, support efforts to reduce abuse. In 2010 Purdue pulled the original Oxycontin off the shelf in the United States and Canada and reformulated the pills, making them crush-resistant. Opana was also reformulated.
In the early months of 2013, generic versions of two of these pain killers - Opana and Oxycontin - could become available.
While the much-talked-about fiscal cliff could have dire consequences, they are "not as grave as the consequences of inaction over the next three weeks on this issue of powerful pain relievers coming to market without abuse-deterrent features," said Michael Barnes, executive director of the Center for Lawful Access and Abuse deterrents, or CLADD.
"This issue is a life or death matter. Without congressional action between now and December 31st, kids will die from overdose. That's much worse than the economic consequences of tax increases and spending cuts. Congress has to act."
Barnes supports the STOPP Act, Stop Tampering of Prescription Pills, a bill introduced in Congress this summer by Rep. Bill Keating, D- Massachusetts, and Rep. Hal Rogers, R-Kentucky. STOPP would give the FDA authority to require medications with oxycodone and hydrocodone be made tamper-resistant.
"We have the ability to prevent deaths and that's what makes this issue so compelling," Keating told CNN. "Its not a theory. It's not research. We're urging the FDA to take action and show leadership. Canada has made their decision on how to deal with it. I think if we make a decision to go with tamper-resist requirements it's going to pressure them to do the same thing."
"The impacts of these generics would not only be downright disastrous for the law enforcement and health communities, but would also jeopardize the costly, painstaking gains we're already made in our fight against this scourge -- shutting down pain clinics, sending rogue doctors to jail, and standing up interoperable state-based Rx monitoring." Rogers said in an opinion piece last month. "FDA must use its power to prevent these crushable generics from turning up in the hands of children."
Pharma recently released a statement saying they support passage of STOPP. They've called on the FDA to issue guidance to manufacturers on the use of abuse-deterrent technologies in opioids now in development or under FDA review, saying in part, "unless FDA rules on these petitions soon we believe that non-abuse-deterrent or non-tamper-resistant generic versions of those products will be able to come to market under current FDA processes for approval of generic products."
FDA spokeswoman Morgan Liscinsky told CNN she could not comment on the issue because of a pending lawsuit by Endo to block approval of the generics as well as a number of citizen petitions.
"The FDA understands how important it is to give guidance and appropriate support regarding the development of abuse-deterrent formulations of opioids and also recognizes the important role that generic drugs play in our healthcare system," Linscinsky said. "As an example of our ongoing work, the agency is currently in the process of developing a guidance on the issue of abuse deterrent formulations."
The agency expects to have a draft completed early next year.