FDA denies production of generic OxyContin

Bret Bevens, PDT Sports Writer

April 18, 2013

Frank Lewis

PDT Staff Writer

Ohio Attorney General Mike DeWine, who came to Portsmouth on several occasions to supervise the closing of pain clinics, said Thursday that he was pleased by the U.S. Food and Drug Administration’s (FDA) decision to deny generic production of the pain medication OxyContin. In an effort to curb prescription painkiller abuse, the Food and Drug Administration is banning generic versions of the original OxyContin formula.

“The FDA has determined that the benefits of original OxyContin no longer outweigh its risks,” the agency said in a statement.

DeWine was one of 48 state and territorial attorneys general who sent a letter to the FDA last month urging them to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper-and-abuse-resistant versions of their products.

In 2010, the FDA approved a reformulated version of the original OxyContin tablets, making the painkillers much more difficult to abuse by those addicted to the pain medication. Current generic formulations of the drug do not have the abuse deterrent properties.

“Today’s OxyContin tablet is much harder to crush and dissolve, making it difficult for drug abusers to snort or inject the painkillers,” DeWine said. “Had the FDA approved the generic formulations, we would have been back at square one in our fight against prescription drug abuse.”

In December of 2011, DeWine arrived early in the morning at Greater Medical Advance on Ohio River Road in Wheelersburg, the last pain clinic in Scioto County, where Scioto County Sheriff Marty V. Donini had a locksmith open the door. DeWine praised those involved in the raid, but also cautioned area residents. DeWine said the closing of the facility did not mean there are not still problems with illegal distribution of prescription drugs in Scioto County.

“We’ve come a long long way,” DeWine said. “This has been a joint effort of the (Ohio) Pharmacy Board, which took the lead in this investigation, and did a great job. They worked directly with BCI&I (Bureau of Criminal Identification and Investigation) under my jurisdiction, and our special prosecutors are handling the case, along with the Scioto County Prosecuting Attorney. So it has been a great joint effort and progress is being made.”

The original formula was set to go into generic access on Tuesday, but the FDA’s ruling changes all that.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in 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.”

Fatal drug overdoses are now the leading cause of death due to unintentional injury in the United States, exceeding even motor vehicle deaths, according to the U.S. Centers for Disease Control and Prevention.

Unintentional drug overdoses kill an average of four Ohioans each day.

Upon taking office in 2011, Attorney General DeWine made the fight against prescription drug abuse a priority. In that time, those with the Attorney General’s Office have been involved in the permanent license revocation of more than two dozen doctors and pharmacists who improperly prescribed prescription medication, the conviction of more than a dozen doctors, pharmacists, traffickers and associates, and the seizure of more than $1.67 million worth of prescription pills.

DeWine also partnered with the Ohio Department of Health and the Drug Free Action Alliance to provide free prescription drug collection bins to law enforcement agencies across the state as part of the Ohio Prescription Drug Drop Box Program.

A list of prescription drug drop box locations is available on the Ohio Attorney General’s website. Locally, boxes are located at the Scioto County Sheriff’s Office and the Portsmouth Police Department.

OxyContin was first approved in 1995. The drug became attractive to abusers who crushed it to snort, or melted and injected it. OxyContin tablets have a time-release formula that delivers the drug over a 12-hour period. But when a pill is crushed, the entire dose is immediately absorbed into the bloodstream.

Purdue Pharma, the producer of OxyContin, stopped selling the original formula to pharmacies in August 2010 after reformulating the pills to make them crush-resistant.

The FDA has approved new labeling for the drug that makes it clear the pills are more difficult to abuse. Any generic version of OxyContin that is submitted for approval should be based on this formula, the FDA says.

Prescription painkillers have killed more Americans than heroin and cocaine combined, according to the Centers for Disease Control and Prevention. Approximately 12 million Americans over the age of 12 reported using prescription painkillers recreationally in 2010. According to the CDC, enough were prescribed that year to medicate every American adult around the clock for a month. Early in 2012 the Ohio Department of Alcohol and Drug Addiction Services (ODADAS), based on OARRS (Ohio Automated Rx Reporting System) data, showed that nearly 1.5 million fewer opiates were dispensed in Scioto County in 2011. According to ODADAS, in 2010 there were 9,713,494 opiates dispensed in Scioto County. The data showed that in 2011 there were 8,234,516, which represents a decrease of 1,478,978 or 20 percent.

In May 2007, Purdue Pharma settled a lawsuit that alleged the company used promotional materials that contained misleading or inaccurate data and downplayed the addiction risks of OxyContin, according to Fortune. The company paid a $600.5 million fine and three of the company’s top executives pleaded guilty to a misdemeanor count of misbranding.

In December, the White House Office of National Drug Control Policy sent an alert to law enforcement, particularly along the Canadian border, warning 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 in the United States.

Going forward, the FDA will continue “to encourage the development of abuse-deterrent formulations of opioids,” the agency said. “(We believe) that such products will help reduce prescription drug abuse. At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics.”

Frank Lewis may be reached at 740-353-3101, ext. 252, or at flewis@civitasmedia.com. For breaking news, follow Frank on Twitter @FrankLewisPDT.