Importation, Pricing Policies Raised Concerns For US FDA's Project Orbis
Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.
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'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.
But US FDA is starting small, OCE Director Pazdur says. Program will hand-select approve high-priority oncology treatments that have to potential to change the standard of care.
Rally-style speech in Florida keeps rhetorical heat on biopharma – including a suggestion that industry may be behind impeachment – but the Administration also appears focused on promoting the idea that its drug pricing efforts have already worked.