FDA Releases Draft of Class-Wide Opioid REMS

By William T. Koustas –

FDA recently released a draft of it class-wide opioid REMS in preparation for an advisory committee meeting on the issue.  The Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is scheduled to meet July 22 and 23, 2010 to examine FDA’s most recent proposed REMS for extended-release opioids. 

This draft of FDA’s opioid REMS is substantially less onerous than previously discussed versions which would have required both patient and physician registries.  The draft REMS includes a medication guide, elements to assure safe use (“ETASU”) and a timetable of assessment.  The medication guide would be required to include class language as well as product specific information.  The ETASU would consist of both prescriber and patient education, but no restrictions on distribution.  The prescriber education is to be developed by the drug sponsors and would educate prescribers on patient selection and monitoring as well as counseling patients on the safe use/storage/disposal of their opioids.  FDA would encourage (though not mandate) sponsors to use a third party to develop the prescriber education and FDA would have to approve any training materials beforehand.  Sponsors would have to demonstrate that prescribers have been educated through prescriber surveys.  Patients would be educated via patient education sheets provided by sponsors to prescribers to use in their discussions with patients.  Sponsors would be required to encourage prescribers to use these materials, though FDA cannot actually mandate their use by physicians.  As with the prescriber education materials, these patient information sheets would also have to be approved by FDA. 

FDA openly considered requiring prescribers to enroll in a registration program and patients to enroll in a patient registry, but determined that the risk of prescribers and pharmacies opting out of the program, which may reduce patient access to these drugs, was outweighed by the benefits at this time.  While FDA left open the possibility of linking prescriber education with the DEA registration system, the agency acknowledged that this is outside its current authority and would require new legislation.  Further, FDA decided that enrolling the nearly 4 million patients currently using extended-release opioids on an annual basis would be too burdensome of an undertaking to make part of a class-wide REMS at this time.

The periodic assessments will likely include various metrics to measure the effectiveness of this new REMS, such as the means to measure patient and prescriber knowledge, the use of opioids for non-medical purposes, adverse events and access to care. 

Immediate release producst appear safe for now.  FDA explained that it does not think that it is wise to institute a REMS for immediate-release opioid products at the present time as data indicate a substantially higher rate of adverse outcomes associated with extended-release opioids compared to immediate-release versions.  However, in addition to these REMS, FDA noted that it intends to use its Safe Use Initiative to partner with other Federal agencies and the private sector to develop and implement non-REMS programs to reduce the abuse/misuse of opioids.