Drug Shortages: Is "Buy American" One Solution?
Moving more manufacturing to the US could help increase supply chain reliability, which could prevent or blunt shortages, an industry representative argues.
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The US FDA commissioner’s call for the agency or someone else to watch supply chains and anticipate problems sounds a lot like a generics industry idea from 2011.
HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.
Industry groups suggest that the drug shortage crisis needs to be addressed by changing the economic model for reimbursement, while US FDA can help by making it easier for manufacturers to use “standby” facilities as needed to bridge supply gaps and by providing generic drug manufacturers with more notice on when applications will be approved.