‘Legacy’ Drugs And Former US FDA Commissioner Gottlieb’s Legacy
A surprise move to unwind FDA’s efforts to end the marketing of unapproved drugs is in keeping with the overall sense of the top-down intervention in the agency’s policies at the end of the Trump Administration. It is also an unfortunate consequence of the embrace of drug pricing as part of FDA’s mission.
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Complaint lists host of problems with implementation of the rule that allows states to sponsor programs to import certain prescription drugs from Canada; at least six states have enacted legislation to sponsor these programs.
Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.
Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition
In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.