Brookings offers ideas on how to improve shortages of sterile injectables

Recent drug shortages have rankled the world of cancer treatment and spurred interest and even some action in Washington, DC, in the form of committee hearings, bills on Capitol Hill and new imports from China.

Richard Frank

Building off some of that progress, the Brookings Institution today released a new report seeking tweaks to federal policies to address the “persistent drug shortages.” The report was authored by Richard Frank, the director of economics studies at USC-Brookings Schaeffer Initiative for Health Policy, and Marta Wosińska, a visiting fellow at the Schaeffer Initiative.

The report notes that shortages of generic sterile injectables (GSIs) became more prominent in 2011, when 251 drugs went into shortage, 179 of them GSIs.

While the number of shortages may have dropped since then, the FDA drug shortage list in January included 77 GSIs in shortage, making up 62% of all drugs, including products such as saline and morphine as well as drugs used in treating cancer. However, manufacturing sterile drugs can be complex, the report notes, as production requires more stringent guidelines and requirements in production.

Marta Wosińska

While there have been efforts to clamp down on sterile drug shortages through legislation or manufacturers stepping in to fill the gap and produce these drugs, Brookings is proposing other routes to try and limit shortages.

First, they call to support upgrades at production sites, with funding being set aside to modernize the production in manufacturing. This includes HHS offering low-interest loans to smaller manufacturers so newer technology and upgrades can be installed. Also, more loan foreignness should be applied toward the production of GSIs that are more susceptible to being in shortage as well.

“Instead of funding a specific technology, HHS should fund proposals that show how the company would use capital investments to support a quality operation in recognition that different GSI facilities require different investments to improve operations,” the report says.

Other proposals that the report puts forth include creating incentives for hospitals to take actions that prevent shortages by sourcing from more reliable manufacturers, including giving more cGMP data and creating an index around which producers are more reliable sources.

Another proposal seeks to encourage hospitals to increase their levels of inventory on hand or to have manufacturers and wholesalers hold on to more inventory to act as a buffer in case of a shortage.

“Because the social costs of even short supply interruptions for some drugs are so significant, public intervention through a government buffer inventory is likely socially efficient. Another reason for creating a government buffer inventory is that reallocation of the product already inventoried on the hospital level is difficult during a shortage, making recovery from uneven demand or supply shocks more challenging,” the report says.

Brookings has looked at other manufacturing issues in the past. The institution hosted a panel in March to address how to shore up the supply of drugs, looking at both the advantages and the challenges in onshoring manufacturing efforts for drugs and active ingredients.

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