Restrictive REMS Is Least Favored Path For Opioid Prescriber Education
FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.
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Additional power would allow the agency to punish 'simple' REMS violations and improve administration of risk management programs, according to a new report looking at FDA's oversight of opioids.
Appropriations bill report includes language stating that it is 'imperative' the agency take all steps necessary to require opioid prescriber training.
Commissioner Gottlieb tells opioid scientific workshop that updated REMS will also require training to be available to nurses and pharmacists; agency beginning new study on prescriber perceptions.