Over-Legislating On Opioids? US FDA May Get New Authorities And Unwanted Tasks
In the face of the overwhelming opioid abuse epidemic, it is hard to argue against doing more. But, at least when it comes to some of the FDA-related bills pending, there is a good argument that Congress is in danger of over-legislating.
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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.
Opioid Bills Could Enhance US FDA Approval, Withdrawal Authority
House opioid package includes ability to deny or withdraw products because of abuse potential, but new Senate package does not, setting up potential conference battle.
US House Committee Requests Proof Of FDA Progress Seizing Opioids In International Mail
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.