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# Ways to Address GSI Shortages: Report
- URL: https://www.fdaweb.com/ways-to-address-gsi-shortages-report/
- Published: 2023-06-21T12:00:00.000Z
- Updated: 2026-09-14T18:40:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154738

A report produced by the Brookings Institution’s Hamilton Project offers a policy intervention with three components to help address shortages of generic sterile injectable (GSI) drugs. The [report](https://www.brookings.edu/wp-content/uploads/2023/06/20230621%5FES%5FTHP%5FGSI%5FReport%5FFinal.pdf?ref=fdaweb.com) says shortages of GSI drugs “compromise patient care in emergency rooms and intensive care units, in cancer treatment, and during elective surgeries.”

What makes shortages of GSI drugs unique, the report says, is that they are disproportionately triggered not by exogenous factors, such as demand shocks or natural disasters, but rather by market-driven manufacturing quality problems.

The policy changes the report recommends are:

- supporting manufacturing infrastructure upgrades;
- providing incentives to realign hospital purchasing; and
- buffering through a targeted government-funded inventory.

The authors say that market forces have led to underinvestment in GSI manufacturing infrastructure. The solution, they say, is a combination of supply-side and demand-side incentives.

A role for FDA, the report says, would be to provide information about manufacturer quality and reliability. “In our proposal, we emphasize manufacturing quality, rather than just drug shortages, because compromised products can and do make their way to patients,” the report says.

For their third proposal, the authors suggest that HHS develop a targeted buffer inventory at the national level to complement hospital efforts. “This first-in, first-out buffer inventory would serve as insurance for drugs the short supply of which would lead to dire health consequences,” they write. “The government buffer inventories we propose would also help to allocate products to locations where they are most needed in a shortage.”