The Food and Drug Administration on Thursday outlined the agency’s plans for weighing submissions for new opioid approvals, following criticism that the agency has been too lax in giving the green light to powerful new painkillers and calls for it to halt the approval of new opioids.
In a draft guidance, the agency said that it planned to start comparing the safety and effectiveness of opioid medications up for approval against those of painkillers — both opioids and other types — already on the market. If the guidelines are finalized, the FDA will also start considering the broader public health consequences of approving a drug, including whether its features make it more likely to be accidentally taken by children, for example, or if they mean it’s less likely to be misused.
Comments and suggestions can be made on the draft for the next 60 days.
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