Got­tlieb seeks new com­par­a­tive ap­proval stan­dard for opi­oids

With just a week left be­fore he de­parts from the FDA, Com­mis­sion­er Scott Got­tlieb on Thurs­day told the Sen­ate Ap­pro­pri­a­tions Com­mit­tee that his agency is in­ter­est­ed in Con­gress cre­at­ing a new stan­dard for opi­oid ap­provals where­by those seek­ing ap­proval would be com­pared to opi­oids al­ready on the mar­ket.

“For this to work, the FDA be­lieves that there should be a pre­mar­ket demon­stra­tion that a new opi­oid is su­pe­ri­or to an al­ready-ap­proved opi­oid or opi­oid-con­tain­ing drug for the same gen­er­al in­di­ca­tion. The stan­dard should be that a new opi­oid or opi­oid-con­tain­ing drug pro­vides a sig­nif­i­cant ad­van­tage rel­a­tive to an al­ready-ap­proved opi­oid or opi­oid-con­tain­ing drug for the same gen­er­al in­di­ca­tion in terms of greater ef­fi­ca­cy or greater safe­ty,” he said.

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