NASEM report: FDA should disclose drug and device manufacturing information

Regulatory NewsRegulatory News | 04 March 2022 |  By 

To ensure resiliency in the medical supply chain, the US Food and Drug Administration (FDA) should publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and medical devices approved in the US, according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).
This is one of seven recommendations in a 365-page report on building supply chain resiliency. The report acknowledges “there is no single ‘silver bullet’ for the medical product supply chain problem.” Recommendations were in four categories: raising awareness, mitigation measures, preparing for potential supply chain disruptions and responding to shortages.
As part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) was directed to explore the root causes of medical product shortages and recommend ways to build resiliency into the supply chain. The department contracted with NASEM to develop the report.
In announcing the report Victor Dzau, president of the National Academy of Medicine said “the more secure the medical product supply chain is, the more trust people will have in its ability to deliver essential medicines when they’re needed most. Increasing transparency about the availability and quality of medical products – a major aspect of this report – is a fundamental step in earning the public’s trust and confidence.”
Make sourcing publicly available
The report recommends FDA publicly disclose information on drug sourcing, manufacturing quality and volume, and capacity for medical products approved for sale in the US.
“The manufacturer for a pharmaceutical drug should be required to publicly disclose the manufacturing location, in particular the FDA Establishment Identifier (FEI), the city, and the country for the finished dosage form (FDF), active pharmaceutical ingredient (API, major excipients, and major packaging and delivery devices for all pharmaceutical drugs sold in the United States,” said a report summary.
The same recommendation also applies to devices; device manufacturers should publicly disclose the manufacturing location in the FEI, the city and the country involved in the device’s manufacturing and final assembly.
It also recommends FDA make its risk-based site selection model scores publicly available. FDA uses this model in deciding which facilities to inspect next.
Additionally, FDA should, in cooperation with other US government agencies, set up a public database to understand the vulnerabilities of the supply chain, and conduct research on supply chain resilience.
Health systems should also award contracts to suppliers that possess “superior quality and reliability.”
The report also recommends ASPR “optimize inventory” by creating a Strategic National Stockpile (SNS) to respond to medical product shortages. Related to this, ASPR and FDA should set up “capacity buffering” to complement stockpiling efforts for critical medical products. “Government investments in capacity buffering should be aimed at all stages of the supply chain and at major public health emergencies,” said the summary.
The US should also negotiate a “plurilateral” treaty with the World Trade Organization (WTO) to prohibit export bans. Countries that violate the agreement would be subject to sanctions.
The report also recommends that ASPR, in collaboration with the Centers for Disease Control and Prevention (CDC) convene a working group to identify “last mile” strategies to ensure there are adequate responses to medical product shortages.


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