Law proposed in US to hasten generic drugs approval
Would provide more resources for FDA to inspect foreign facilities
New legislation has been proposed in the US that aims to expedite market approval procedures for generic drugs to reduce the country’s growing pharmaceutical drug shortage.
The Generic Drug and Biosimilar User Fee Act was introduced into the House of Representatives by Republican Representative Tim Murphy on 5 March with support from the Democrats and seeks to develop inspections for foreign pharmaceutical manufacturers that reflect domestic controls.
According to the US-based trade organisation Bulk Pharmaceuticals Task Force (BPTF), 40% of all drugs taken by Americans are imported from foreign manufacturers and 80% of their active ingredients are from abroad. It would take the US Food and Drug Administration (FDA) an estimated nine years to inspect all foreign facilities, which dramatically affects the approval time for imported generic drugs.
The bill would provide more resources for the US FDA to expedite foreign facility inspections.
‘This legislation will go a long way in safeguarding our drug supply,’ said BPTF chairwoman Patty Benson.