Gottlieb On Pursuing Legislative Reform: Start Small, Build Later
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.
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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.
US FDA gains $94m in new funding for international mail facilities, a priority for the commissioner, along with an increase in non-user fee dollars for agency operations.