FDA's Opioid Programs: After Training, What's The Next Step?

When US FDA Commissioner Scott Gottlieb testifies at an Oct. 5 Senate Health, Education, Labor and Pensions Committee hearing on the federal response to the opioid crisis, he'll be able to point to a number of new agency initiatives aimed at reducing death and addiction from misuse of the products. A question that will be left unasked – and one that neither Gottlieb nor any other stakeholder can answer – is how long will FDA have to let these programs work before more drastic action is demanded?

Last week, FDA announced that it was expanding the Risk Evaluation and Mitigation Strategy (REMS) that have covered extended-release and long-acting opioids to immediate-release (IR) products as well. Now training now will be "made available" to prescribers of IR formulations, under the theory that education can prompt a reduction in prescriptions, which can cut abuse