Manufacturers of long-acting/extended-release opioids must develop a blueprint for physician education in pain management with their products, but otherwise will be involved only at arms’ length in the doctor training portion of the Risk Evaluation and Mitigation Strategies.

Once FDA approves the blueprint, the agency will post it on the FDA website. There, continuing education providers can “access it as part of the approved REMS and turn it into actual training materials without further involvement by the application holders,” according to the agency.

Sponsors are to submit their proposed REMS to FDA by Aug. 17, but a view of what they will look like can be gleaned from FDA answers to the Industry Working Group’s questions for clarification of FDA’s proposal (see related story, Also see "Opioid Class-Wide REMS May Launch Without Element To Monitor Prescribing" - Pink Sheet, 8 August, 2011.).

The continuing medical education blueprint is to contain key messages and concepts, expanding on the outline attached to the REMS notification letter, the agency told IWG during a May 16 meeting between the two. FDA will review the blueprint to ensure it contains needed information and does not include promotional material.

CME providers are to consult the blueprint and develop content for training courses “in their own way,” according to minutes of the meeting.

Conversations with the Accreditation Council for Continuing Medical Education indicate this approach would work, the agency noted.

An independent auditor will evaluate how well the CME materials reflect the blueprint and whether the training is free of promotional content.

FDA’s focus on the independence of the training follows Center for Drug Evaluation and Research Director Janet Woodcock's statements earlier this year that drug companies would not interact with individual prescribers as part of the process (Also see "Does Mandatory Opioid Prescriber Education Go Far Enough? Congress Might Say No" - Pink Sheet, 25 April, 2011.).

Multiple Training Modules

The agency expects the training to consist of modules – a general section, followed by modules for specific products.

Information about a drug substance or product group, such as toxicities, can be introduced in the general section, FDA explained, but more specific information for each product is to be provided in the later modules.

This is intended to give providers a general understanding of issues at the start and provide a basis for more drug-specific information in the later sections of the course.

FDA stressed that the training is to be a package, with providers learning about all the drugs, whether or not they prescribe them.

The agency expects the training to take “at least a couple of hours,” but said the length of time will depend on the course developed by the continuing education providers.

Whether the time commitment to participate in all the modules will deter physician participation in training remains to be seen.

Physicians’ time constraints were among the reasons cited by an advisory panel for opposing a voluntary approach to prescriber education (Also see "If Opioid REMS Mandates Prescriber Training, Firms May Ask DEA For Help" - Pink Sheet, 2 August, 2010.).

The mechanism for putting the training in place will be requests for proposals for accredited CME providers to develop the training courses. Selected proposals will be eligible for unrestricted grants from the sponsor group under letters of agreement.

The federal government would chip in to help pay for training if Congress were to adopt a bill introduced June 3 by Rep. Mary Bono Mack, R-Calif., and co-sponsored by Appropriations Committee Chairman Hal Rogers, R-Ky..

That measure, H.R. 2119, would require training as a prerequisite to prescribing drugs under the Controlled Substances Act and includes $4 million per year in fiscal years 2012 and 2013 to support training.

A bill from Rep. Jay Rockefeller, D-W.Va., aimed at curbing methodone use also includes a requirement for physician training in opioids and pain management. S. 507 does not provide funding for training.

A shift to mandatory training under the Controlled Substances Act is envisioned under the Obama Administration’s plan to curb prescription drug abuse (Also see "DEA-Mandated Opioid Training Allows Dispensing To Be Unencumbered By REMS" - Pink Sheet, 2 May, 2011.).

Monitoring Physician Participation

Until that occurs, physician education is voluntary and information on individual practitioners’ participation is unnecessary. However, FDA said it wants to know the number of unique providers taking the course and not just an overall number of participants, some of whom may be repeat students.

A drawback to that, industry noted, is it will require unique identifiers for a database that can store personal information securely and is operated by a third party.

FDA suggested that companies consult with the accreditation bodies and CME providers on how the information can be collected, as well as on establishing realistic goals for how many physicians can be trained through an “aggressive” CME program. Collecting the information could be part of the RFP, the agency noted.

By Cathy Dombrowski

FDA's CME Expectations For Opioid Prescribers Keep Sponsors At A Distance

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