Gottlieb's Priority For Proposed Opioid Money Is Mail Facilities
US FDA commissioner says primary use of proposed budget boost would be border security; budget documents state that special opioid epidemic funding also would support regulatory science and diagnostic development.
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The US FDA and the US customs office have agreed to team up and establish an expanded scientific presence at International Mail Facility locations deemed “high risk” ports of entry to deter illegal opioids and counterfeit drugs from entering US borders.
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.
Energy & Commerce's Republican and Democrat leadership ask FDA Commissioner Scott Gottlieb about work by the agency's Office of Criminal Investigations focused on opioid drugs, the office's staffing and its priorities. They note FDA's FY2018 appropriation included $94m for its work in international mail facilities.