Regulatory Focus™ > News Articles > US Regulators Looking into New Prescribing Paradigm for Opioids

US Regulators Looking into New Prescribing Paradigm for Opioids

Posted 19 December 2012 | By Alexander Gaffney, RAC

US regulators are preparing to hold a meeting regarding the use of opioid drugs to treat chronic pain, and whether new restrictions on their use should be required.

In the 19 December edition of the Federal Register, the US Food and Drug Administration (FDA) said that its meeting is meant to address-using scientific data rather than anecdotal reports-ways to minimize the improper use and abuse of opioid drugs while maintaining access for those who rely on the drugs.

"Over the past several years, the Agency has received comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain," FDA explained.

Though the drugs are already subject to a class-wide Risk Evaluation and Mitigation Strategies (REMS) policy, FDA's notice hints that the agency may be willing to consider a shift in acceptable labeling strategies.

"In particular, members of the public and the regulated community have debated the presence or absence of evidence showing the safety and efficacy of these drugs as pain relievers in the various populations for whom they are prescribed," FDA wrote. Under such a proposed system, a drug might have a specific recommendation for use on its label for a cancer patient, and another for a patient suffering from chronic pain.

The meeting seeks to answer three main questions, as well as a series of sub-questions: Are patients currently diagnosed properly for pain? Do they understand and adhere to the labels of pain-treating products? Are further limits on opioid prescribing necessary?

The Federal Register notice also notes that FDA is interested in the methods used to prescribe opioids for different sources of pain, the definitions and methods used to differentiate between the severities of pain symptoms, and the differences between short- and long-term chronic pain.

Crucially for manufacturers of opioids, FDA is also looking at whether REMS-postmarketing restrictions on the prescribing, sale and use of medical products-are sufficiently restrictive in their current form. Under some of the proposed language of the meeting, FDA said it is interested in hearing whether there ought to be maximum durations for continuous treatment, how those durations might be set and whether they might differ between various diseases or conditions. Those limits could also be set on a more short-term basis in the form of a maximum daily dose.

Regulators also said they are interested in how consumers might understand and change their opioid use habits in response to different labeling. If a product were to be labeled with a statement indicating that it should only be taken in response to "severe pain," for example, would a patient experiencing moderate pain shy away from its use, or disregard the label? FDA said it's interested in data on the subject.

The meeting will be held on on 7-8 February 2013. Questions and comments may be sent to FDA by way of email ( prior to the meeting. Requests to make in-person presentations at the meeting should be entered at by 18 January 2013.

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