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ASAM submits comments to FDA on the REMS Blueprint and Mandatory Prescriber Education

July 10, 2017

ASAM submitted comment letters to the Food and Drug Administration (FDA) with recommendations regarding its proposed Blueprint for the extended-release, long-acting (ER/LA) Opioid Risk Evaluation and Mitigation Strategy (REMS) training as well as whether such training should be mandatory for all ER/LA opioid prescribers.


The first letter regarding the Blueprint recommends FDA include immediate-release (IR) opioids as part of the training, incorporate recommendations from the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, and include a module on substance use disorder screening and treatment. Shortly after ASAM's comments were submitted, the FDA announced that it would require manufacturers of IR opioids to provide prescriber education as well.


The second letter regarding mandatory prescriber education reiterated ASAM's long-standing position that mandatory education on all controlled substances should be tied to a prescriber's Drug Enforcement Agency (DEA) registration. It recommended FDA not use its authority to mandate the ER/LA REMS training as ASAM views this approach too narrow and inflexible to meet various prescribers' learning needs.