Panel Rejects FDA’s Plan to Address Opioid Risks

ACEP News
August 2010

By Cathy Dombrowski
Elsevier Global Medical News

Members of two Food and Drug Administration advisory panels pushed for mandatory prescriber training as they rejected an agency-proposed Risk Evaluation and Mitigation Strategy for long-acting opioid drugs by a 10-25 vote at a meeting on July 23.

Elements of the FDA's proposed plan include a program to educate health care professionals about prescribing these products. Under the plan, the agency would require manufacturers of these products to develop a prescriber education program that would be "designed to further train healthcare professionals on appropriate patient selection, dosing and patient monitoring when using" long-acting (LA) and extended-release (ER) opioid drugs, according to a statement issued by the FDA in June. The proposal says that the agency would encourage sponsors to partner with "an appropriate, independent third party" to develop the prescriber training program and to consider incentives such as continuing medical education credit to encourage prescribers to undergo this training.

But the FDA's proposal did not make registration of patients and prescribers in the REMS mandatory.

The proposed REMS was reviewed at a joint meeting of the Anesthetic and Life Support Drugs Committee and the Drug Safety and Risk Management Advisory Committee. The REMS--developed with input from manufacturers and groups representing health care providers, pharmacies, and patients--is "intended to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of LA and ER opioids, while maintaining patient access to these medications," according to the statement. These drugs include morphine ER, oxymorphone ER, oxycodone ER, hydromorphone ER, fentanyl transdermal patches, and methadone.

The FDA now must decide whether to switch from the voluntary education program envisioned in its REMS proposal to a mandatory approach, said Dr. John Jenkins, director of the FDA's Office of New Drugs, during a press briefing held after the meeting concluded.

According to the REMS proposal, the agency plans to monitor the program's effects "and may consider further steps if the REMS does not prove effective in curbing serious adverse outcomes resulting from inappropriate prescribing, abuse, and misuse."

During the briefing, Dr. Jenkins said that the panelists who voted against the current proposal "agreed that a REMS was needed, but they voted no because they didn't think the proposal from FDA was all that they thought was needed." The FDA has ordered mandatory training before, but those programs were much smaller. The FDA considered that option but did not propose it, he said. "We have to go back and decide if we heard anything today and yesterday that would change that initial conclusion," he added.

Some of the input for the proposed plan was provided at meetings held by the FDA, including one in December 2009, where an industry working group presented its ideas.

The proposal posted on the FDA Web site in late June states that requiring patient enrollment would be "overly burdensome" and could create a stigma for patients, ultimately affecting access to those drugs. An idea proposed at the December meeting--requiring clinicians to provide proof that they had undergone training in prescribing LA opioids in order to obtain Drug Enforcement Agency registration to prescribe these products - would require legislation and is not included in the proposal at this time, according to background information in the proposal.

Elizabeth Mechcatie contributed to this report.

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