NASEM Report: FDA Should Disclose Information About Manufacturing Drugs and Devices

0

Posted on March 04, 2022 | Through Joanne S Eglovitch

To ensure resiliency in the medical supply chain, the U.S. Food and Drug Administration (FDA) should publicly disclose the locations of all manufacturing facilities that supply ingredients and parts for U.S.-approved drugs and medical devices, according to a National Academies consensus study report for Science, Technology and Medicine (NASEM).

This is one of seven recommendations in a 365-page report on building supply chain resiliency. The report acknowledges that “there is no one-size-fits-all solution to the medical supply chain problem.” The recommendations have been grouped into four categories: raising awareness, mitigating actions, preparing for potential supply chain disruptions and responding to bottlenecks.

As part of the Law on help, aid and economic security because of the coronavirus (CARES Act), the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) has been directed to investigate the root causes of medical product shortages and recommend ways to build supply chain resilience. The department commissioned NASEM to prepare the report.

Announcing the report, Victor Dzau, President of the National Academy of Medicine, said, “The more secure the supply chain for medical supplies, the more confidence people have in their ability to deliver critical medicines when they are needed most. Increasing transparency about the availability and quality of medical devices – a key aspect of this report – is a fundamental step in gaining public trust.”

Make sourcing publicly available

The report recommends that the FDA publicly disclose information about drug sourcing, manufacturing quality and quantity, and capacity for medical devices approved for sale in the United States.

“The manufacturer of a drug should be required to publicly disclose the place of manufacture, particularly the FDA Establishment Identifier (FEI), the city and country for the finished dosage form (FDF), the Active Pharmaceutical Ingredient (API, Major Excipients), and important Packaging and delivery equipment for all pharmaceutical drugs sold in the United States,” reads a summary of the report.

The same recommendation also applies to devices; Device manufacturers should publicly disclose the place of manufacture in the FEI, the city and country involved in the manufacture and final assembly of the device.

It also recommends that the FDA make its risk-based site selection model scores publicly available. The FDA uses this model when deciding which facilities to inspect next.

In addition, the FDA should work with other US government agencies to establish a public database to understand supply chain vulnerabilities and conduct supply chain resilience research.

Healthcare systems should also place orders with suppliers who demonstrate “superior quality and reliability.”

The report also recommends ASPR “optimize inventory” by creating a Strategic National Stockpile (SNS) to respond to shortages of medical supplies. In this regard, ASPR and FDA should establish “capacity buffering” to complement stockpiling efforts for critical medical products. “Government investments in capacity buffering should target all stages of the supply chain and major public health emergencies,” the summary said.

The US should also negotiate a “plurilateral” deal with the World Trade Organization (WTO) to ban export bans. Countries violating 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 task force to identify last-mile strategies to ensure there are appropriate responses to medical product shortages.

report

Notice

Summary

© 2022 Regulatory Affairs Professionals Society.


Share.

Comments are closed.