Critics Wary of FDA’s REMS for Long-Acting Opioids

Critics Wary of FDA’s REMS for Long-Acting Opioids

April 22nd, 2011 // 1:52 pm @

With many of their proposed changes ignored, critics of the FDA’s risk evaluation and mitigation strategy (REMS) for long-acting opioids are watchfully waiting to see if an act of Congress will indeed make education mandatory for all doctors who prescribe these painkillers.

The Obama administration’s chief of drug control policy, Gil Kerlikowske, expressed utmost confidence on Tuesday that a bill to amend the Controlled Substances Act and make education requisite would be passed, but would not give details about when it might be introduced, or by whom.

“It’s a good first step,” said Jane Ballantyne, MD, a pain specialist at the University of Washington, who was on the advisory committee that rejected the original REMS. “What they said they’ll do next would be far more useful. But I wouldn’t pretend to fully understand the ways of Washington.”

In the meantime, education for opioid-prescribing physicians — who are chronically short on time — will remain voluntary, and will be produced by the drugmakers.

Critics have expressed concern about the source of the education. Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, told MedPage Today that even if education was necessary in order to obtain a DEA license, it would still originate with the drugmakers.

Ballantyne said that other physician organizations would be fully capable of developing such continuing medical education (CME) programs, and may have less of a conflict of interest in doing so.

Others are worried that having mandated education would shortchange doctors in other ways.

Andrew Kolodny, MD, chair of the psychiatry department at Maimonides Medical Center in Brooklyn, N.Y., said that it might lead to watered-down courses, since prescribers — even those who rarely write scripts for opioids — won’t be able to opt out. Kolodny theorizes that pharmaceutical manufacturers may go easy on the courses to make sure they’re not too onerous for all physicians to meet the requirement.

The requisite training, then, probably won’t even come close to that required for buprenorphine (Suboxone), an addiction treatment which involves an eight-hour course before being licensed to prescribe. That, Kolodny says, has contributed to deterring a lot of doctors from treating addicted patients with the drug.

Drugmakers “don’t want any kind of system that would limit access” to their product, he said.

Yet specialists say there is much to learn when it comes to using opioids to treat pain. Ballantyne said not all patients do well on these drugs, and there are questions about their effectiveness for long-term, noncancer chronic pain. In these areas, education — as well as more research — would make a difference.

On the other hand, many drug companies and pain organizations appear satisfied with the new REMS, saying it balances the risk of abuse with the need to appropriately treat patients with legitimate pain.

In a statement, the American Pain Foundation said “curbing abuse and misuse without limiting access to pain care for millions who require and deserve it is critical and necessary in any safety plan.”

Purdue Pharma, maker of the extended-release oxycodone product OxyContin, said in a statement that it “has supported the FDA’s efforts to develop a class-wide REMS for extended-release and long-acting opioid analgesics.”

Herb Neuman, MD, chief medical officer at Covidien, maker of Exalgo, an extended-release hydromorphone product, said his company looks forward to developing the education because it will foster new partnerships with CME companies, from whom drug companies have historically had to maintain an arm’s length.

“We hope this will provide a pathway forward” to more efficient dialog between drugmakers and CME providers, Neuman said.

There are currently separate REMS in place for OxyContin and Exalgo, which will be supplanted when the final, unifying draft is out in early 2012.

Another criticism is that the REMS doesn’t cover short-acting drugs, such as hydrocodone (Vicodin). Just today, a report from IMS Health found that the generic combination of hydrocodone and acetaminophen was the most widely prescribed drug in the country in 2010, blowing the runner-up — a statin — out of the water by nearly 40 million filled prescriptions (131 million versus 94 million).

It has held that top spot since 2003, according to additional data from the company.

“This will just encourage people to prescribe short-acting drugs when it may be more appropriate to prescribe long-acting ones,” Ballantyne said.

Ballantyne recently left the University of Pennsylvania for the University of Washington because of the state’s active campaigns to quash prescription painkiller abuse.

The state is the only one to pass a law, which will go into effect in June, that will require doctors to consult with pain specialists if patients aren’t responding to higher doses of opioids — typically those exceeding 120 mg per day.

Gary Franklin, MD, MPH, medical director of the state’s department of Labor and Industries, who was instrumental in getting that legislation passed, said dosing restrictions would be a powerful tool to curb abuse and addiction problems, since escalating doses are a pathway to addiction, as they increase tolerance and dependence.

“There’s just not enough focus on dosing,” he said, “and there won’t be in drug-company-sponsored education.”

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