Opioid Approvals: Congress Wants US FDA Guidance On Abuse Potential
Instead of creating new mandate, legislation tells FDA to outline how risk-benefit decisions could be influenced by a product's abuse potential under existing approval authority; final opioids package expected to reach the White House soon.
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Some stakeholders in regulated industries are concerned that without a history as a public agency executive, Stephen Hahn could have an unpredictable tenure as FDA commissioner. Still, consumer health industry trade groups note regulatory topics crucial to the industry's growth and consumer safety should be clear.
Among Hahn's primary duties should be to reassure staff that he will not be making radical changes and begin working on a priority list, experts told the Pink Sheet.
Former US FDA commissioner Scott Gottlieb encouraged stakeholders at the Association for Accessible Medicine's GRxBiosims 2019 meeting to start small in scope when pushing for legislative changes, which makes it easier to build on later.