USP: Supply chain experts tackle supply chain resiliency

Regulatory NewsRegulatory News | 01 April 2022 |  By 

There is broad support in the White House and Congress to invest in a domestic manufacturing base for pharmaceuticals to strengthen supply chain resiliency and avoid drug shortages, said a supply chain expert speaking at a 1 April panel discussion sponsored by the US Pharmacopoeia (USP), while another official said this is a complex problem that defies easy solutions.
The panelists were asked during the meeting to share their perspectives on how to bolster the US pharmaceutical supply chain, with a focus on preparation and response steps.
Brian Tse, vice president at The Conafay Group, in responding to the moderator’s question on how policymakers are addressing supply chain resiliency, said, “Thankfully we are seeing widespread action for support” in this area.
He added that “part of the Biden’s administration’s support is they did a broader supply chain report, and they made some key recommendations” for investing in a domestic manufacturing base. Tse was formerly a project officer in the Biomedical Advanced Research & Development Authority (BARDA).
Last year, President Biden announced a plan to address US supply chain vulnerabilities, such steps include improving domestic manufacturing of critical medicines and active pharmaceutical ingredients, increasing investments in sustaining domestic supply chain, and better monitoring of supply chain disruption. (RELATED: Biden administration outlines plan to address US supply chain vulnerabilities, Regulatory Focus 8 June 2021.
Tse said these efforts are being buttressed by pending legislation in Congress, where bipartisan legislation under the America COMPETES Act of 2022, would grant $1.5 billion to establish a medical supply chain flexibility pilot program.
Need to look at bigger picture
Yet Nicolette Louissaint, senior vice president of policy and strategic planning at the Healthcare Distribution Alliance, said that other options besides onshoring need to be considered to address supply chain resilience and that this is a complex problem that needs to be addressed in a multi-layered fashion.
This point was also reinforced in the National Academies of Science, Engineering and Medicine’s (NASEM) recent report on building supply chain resiliency, she said. The report acknowledged that “there is no single ‘silver bullet’ for the medical product supply chain problem.” (RELATED: NASEM report: FDA should disclose drug and device manufacturing information, Regulatory Focus 4 March 2022).
Louissant said, “When we talk about domestic manufacturing, we have to be specific about the types of capabilities and the types of manufacturing that we have to have domestically… we have to look at the trade-offs and whether to invest in domestic capacity is truly the silver bullet.”
She added that “there is a benefit to strongly increase in domestic capacity, but it has to be strategic, and it has to be sustainable.”
USP meeting


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