As Drug Shortages Linger, Attention Turns to TPN Crisis
This article was originally published in The Gold Sheet
The good news is that the number of new drug shortages went down in 2012; the bad news is that the total number of drugs in active shortages is increasing while growing capacity problems are being reported – and shortages of injectable nutrition drugs are especially acute. An FDA economist proposes that rewarding manufacturers for quality may help to alleviate the shortage crisis.
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How FDA, health care providers, and Pfizer and other drug makers are responding to a shortage of emergency medicines from the fragile, overstressed US sterile injectables sector.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
FDA also should more fully explore using alternatives to on-site inspections the pandemic prevents it from conducting, said Mary Denigan-Macauley, director of GAO’s health care office.