Measures the U.S. Can Take to Bolster the Nation’s Medical Supply Chain as Per NASEM Report

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Moving manufacturing of medical supplies back to the U.S. is one of the strategies to substantiate the nation’s medical supply chain. But this strategy alone is not adequate to achieve this goal, says a report from the National Academies of Sciences, Engineering, and Medicine.

As per Ozlem Ergun, a member of NASEM’s Committee on Security of America’s Medical Product Supply Chain, while the reliance on other countries for manufacturing has several drawbacks, onshoring the entire global supply chain will be a pretty daunting logistical task, with huge costs involved. He further said this strategy could indeed increase the resiliency of the U.S. medical product supply chains, but it should only be seen as one of the resiliency strategies and not the one [and only] solution.

Announcing the NASEM’s report’s release, Ergun said that all resiliency strategies, including onshoring, must be carefully assessed through a framework so that the most cost-effective and impactful tactics can be figured out. The committee suggests that the FDA should make sourcing, drug manufacturing volume and capacity, and quality information publicly available for all approved medical products to address the problems. This will require the device makers and drug manufacturers to disclose their manufacturing locations and other data.

A public database with this information will facilitate the identification of the supply chain vulnerabilities so that steps can be taken to shore up the most vulnerable parts of the supply chain. The prediction of potential medication shortages will also become easier with the availability of this data. For all these expected benefits to take the shape of reality, Congress needs to make the necessary amendments and changes to permit the public disclosure of this information.

Now the question arises how will the health systems be affected by the availability of supply data? With supply data in hand, the health systems can deliberately incorporate quality and reliability in their contracting, buying, and inventory decisions.

Committee member W. Craig Vanderwagen suggests that the Assistant Secretary for Preparedness and Response (ASPR) could develop and manage that kind of information database. It should also fund research and development in advanced pharmaceutical manufacturing techniques to help with onshoring of the manufacturing process.

Stressing on the importance of data and evidence, Vanderwagen further said that it would be difficult to find rational approaches to respond to shortages without data and evidence.

The NASEM report also states that the ASPR and the FDA should complement stockpiling with capacity buffering strategies. These include setting a list of guaranteed ‘crisis prices’ that the government would pay for certain products under specified conditions.

The report’s authors also call for an international treaty among major exporters under the WTO that would prohibit export bans and restrictions on medical product supply chains deemed critical. Anyone violating the terms of this agreement should be subject to sanctions by other signatories of the agreement. This will prevent countries from restricting the export of critical products or components out of their borders as it will leave them quite vulnerable to the reaction by their trading partners.