FDA Law Blog views recent draft REMS proposal for opioid drugs in the USA

The US Food and Drug Administration recently released a draft of it class-wide opioid Risk Evaluation and Mitigation Strategy (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, to examine FDA's most recent proposed REMS for extended-release opioids, notes US law firm Hyman, Phelps & McNamara's FDA Law Blog in a review of the plans.

This draft of the FDA's opioid 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. The FDA would encourage sponsors to use a third party to develop the prescriber education (though not mandatory) and the agency would have to approve any training materials beforehand. Sponsors would have to demonstrate that prescribers have been educated through 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 it would not be mandatory. As with the prescriber education materials, these patient information sheets would also have to be approved by the FDA.