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Pharmaceuticals / Regulatory Affairs

Gottlieb Highlights FDA Efforts on Opioids in Senate Testimony

April 5, 2019

It was a lovefest for outgoing FDA Commissioner Scott Gottlieb as he testified for the last time before the Senate Committee on Appropriations on the FDA’s budget request for fiscal 2020.

Gottlieb featured the agency’s plans for tackling the opioid crisis and said any future opioid drug approvals will need a “new comparative standard.” Any a new opioid should provide “a significant advantage relative to an already approved opioid drug for the same general indication in terms of greater efficacy and safety,” he said, adding that the approval path could mesh with a breakthrough designation or with new designations.

Gottlieb noted that the FDA is requesting $55 million to continue the battle against the opioid crisis, calling it a significant focal point for the agency. He also highlighted efforts to improve opioid labeling and said the agency will require new studies that analyze a drug’s long-term safety when administered for chronic use.

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