NASEM report: FDA should disclose drug and device manufacturing information


Posted on March 04, 2022 | By Joanne S. Eglovitch

To ensure the resilience of the medical supply chain, the United States Food and Drug Administration (FDA) should publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and devices medical drugs approved in the United States, according to a consensus study report of the National Academies of Science, Engineering, and Medicine (NASEM).

It’s one of seven recommendations in a 365-page report on building supply chain resilience. The report acknowledges that “there is no single ‘silver bullet’ for the medical product supply chain problem”. The recommendations were divided into four categories: raising awareness, mitigating measures, preparing for possible supply chain disruptions, and responding to shortages.

As a member of Coronavirus Aid, Relief and Economic Security Act (CARES Act), the Office of the Assistant Secretary for Preparedness and Response (ASPR) of the Department of Health and Human Services has been tasked with exploring the root causes of medical product shortages and recommending ways to strengthen supply chain resilience. The ministry contracted with NASEM to develop the report.

In announcing According to the report, Victor Dzau, president of the National Academy of Medicine, “the more secure the supply chain for medical products, the more people will have confidence in its ability to deliver essential medicines when they need them most. need. Increasing transparency about the availability and quality of medical products – a major aspect of this report – is a fundamental step in gaining public trust.

Make procurement accessible to the public

The report recommends that the FDA publicly disclose information about drug supply, manufacturing quality and volume, and capacity of medical products approved for sale in the United States.

“The manufacturer of a pharmaceutical drug should be required to publicly disclose the place of manufacture, in particular the FDA Establishment Identifier (FEI), city and country for the finished dosage form (FDF), pharmaceutical ingredient active (API, main 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 must publicly disclose the FEI manufacturing location, city and country involved in the manufacture and final assembly of the device.

It also recommends that the FDA make the results of its risk-based site selection model public. The FDA uses this model to decide which facilities to inspect next.

Additionally, the FDA should, in cooperation with other US government agencies, establish a public database to understand supply chain vulnerabilities and conduct research on supply chain resilience.

Health systems should also award contracts to vendors that possess “superior quality and reliability.”

The report also recommends that the ASPR “optimize the inventory” by creating a strategic national stock (SNS) to respond to shortages of medical products. In this regard, the ASPR and FDA should establish “buffer capacity” to supplement efforts to store critical medical products. “Government investments in buffer capacity should target all stages of the supply chain and major public health emergencies,” the summary states.

The United States is also expected to negotiate a “plurilateral” treaty with the World Trade Organization (WTO) to ban export bans. Countries that violate the agreement would be subject to sanctions.

The report also recommends that the ASPR, in conjunction with the Centers for Disease Control and Prevention (CDC), convene a task force to identify “last mile” strategies to ensure that there are adequate responses to the shortages of medical products.




© 2022 Society of Regulatory Affairs Professionals.


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