U.S. FDA Delays Opioid REMS Until 2011

Saturday, August 14, 2010

U.S. FDA Delays Opioid REMS Until 2011

FDA LogoAccording to an exclusive report in Medscape Medical News, the U.S. Food and Drug Administration (FDA) will not unveil its risk evaluation and mitigation strategies (REMS) for opioid analgesics until 2011. This announcement comes shortly after the FDA’s advisory committee rejected initial plans late last month and all indications are that opioid REMS, when finally implemented, could dramatically change the prescribing of opioids for the millions of Americans who benefit from these pain relievers.

In the Medscape report [available here], Karen Mahoney, from the FDA’s Center for Drug Evaluation and Research, says: “FDA is currently reviewing the input from the advisory committee and the public. We have not yet made any final decisions on the REMS program. Once final decisions are made, FDA will communicate these requirements to the manufacturers, and they will have up to 120 days to submit a program for FDA’s review and approval.”

The FDA had previously extended the period for public comments on its docket — titled “Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting; Reopening of Comment Period REMS” — until October 19, 2010. If the FDA waits until the docket is closed before finalizing new recommendations, plus the four months for industry to respond, it could easily be spring or early summer of 2011 before new opioid-REMS programs are put into action.

At least two issues were behind the advisory committee’s overwhelming rejection of the FDA’s REMS plan, which could drastically change the landscape of opioid analgesic prescribing in the U.S.:

    • First, the FDA had proposed that the opioid REMS include only extended-release (ER) or long-acting (LA) opioid analgesics (Schedule II); whereas, the committee seemed eager for wider coverage that would include ALL opioid pain relievers. While this seems to make good sense, since all opioid formulations have been implicated in problems of abuse, diversion, overdose, and addiction, some prescribers might shun even briefly prescribing weak, short-acting opioids for acute pain if there are added requirements (and hassles) when doing so. On the other hand, having REMS only for ER/LA opioids might lead to the inappropriate prescribing of less restricted but less effective short-acting opioids for chronic pain.


  • Secondly, there is widespread agreement that healthcare providers need more training in effective and safe opioid prescribing; however, there is considerable debate as to whether such education should be voluntary or mandatory. Many of the advisory committee members stressed that this education should be a requirement of DEA (U.S. Drug Enforcement Administration) licensing to prescribe opioid analgesics. However, there are two concerns with this: (a) such involvement by the DEA would require Congressional approval (which could take a great deal of time to accomplish, if ever), and (b) there is a fear that many otherwise eligible healthcare providers would opt out of prescribing opioids entirely rather than invest the time and expense of acquiring the added, mandatory training. This could significantly diminish access to essential pain-care medications for large numbers of patients.

It appeared to us that the FDA had come up with a sensible opioid-REMS plan, at least as a beginning, and they were put in a difficult position by their own advisory committee [as we discussed here]. At this time, the FDA’s future direction is unknown but it seems there are many potential pitfalls that might change the course of medical practice in America and put millions of patients with pain in jeopardy of unwarranted suffering. Other opinions are welcomed — comment below.