Counter-Intuitive Thinking To Combat Drug Shortages
Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.
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Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.
US FDA's upcoming drug shortage risk criteria will be made public and sponsors could be asked to find the vulnerable products in their portfolios.
FDA is planning series of stakeholder meetings to identify new approaches to drug shortages, with particular interest in defining “essential” drugs. Agency is also looking outside for expertise, with Boston University’s Rena Conti tapped as advisor.