The White House and several federal agencies on Tuesday released a series of policy recommendations for addressing the vulnerabilities in U.S. pharmaceutical supply chains.
The review came in response to an executive order signed by President Joe Biden in February, which directed the government to identify risks, address vulnerabilities and develop a strategy to promote supply chain resilience throughout sectors.
“Pharmaceutical supply chains are essential for the national and health security and economic prosperity of the United States, yet the COVID-19 pandemic revealed just how vulnerable the supply chain is in this country,” said Food and Drug Administration Acting Commissioner Janet Woodcock in a statement.
WHY IT MATTERS
The administration highlighted multiple drivers of supply chain vulnerability across industries, including insufficient U.S. manufacturing capacity; private market focus on short-term returns; international competitiveness; geographic concentration in global sourcing and limited international coordination.
“It will take a concerted effort over the short-, medium- and long-term to adequately address these and put U.S. supply chains on stronger footing,” read the report.
When it comes to the pharmaceutical supply chain in particular, the report’s recommendations focus on four main pillars:
- Boosting local production and fostering international cooperation
- Promoting research and development to establish innovative manufacturing processes and production technologies
- Creating robust quality management maturity
- Leveraging data
Regarding the latter point, the report noted that “a robust surveillance system that leverages information and data is a critical component of resilience in the supply chain.”
Unfortunately, key information gaps exist, making monitoring more challenging. Therefore, in the short term, the report recommends that the U.S. government encourage stakeholders to make use of commercial data sources to identify supply chain risks, while establishing a robust surveillance system over the long term.
“Empowering the FDA to collect this information will in many cases require statutory changes as well as close consultation with industry and other stakeholders,” read the report.
“But this information will enable the FDA to conduct a more comprehensive risk assessment of the U.S. pharmaceutical supply chain to support legislative and executive branch efforts to ensure its adequacy and resilience,” it continued.
According to a press release from the agency, the U.S. Department of Health and Human Services will initially commit about $60 million from the Defense Production Act appropriation in the American Rescue Plan to develop novel platform technologies and increase domestic manufacturing capacity for active pharmaceutical ingredients.
THE LARGER TREND
As Woodcock noted, the COVID-19 crisis exposed the weaknesses in the federal supply chain, with hospitals scrambling to keep medical workers properly fitted with personal protective equipment.
Several health systems turned to digital tools, particularly those geared toward analytics and EHR integration, for help in the short and medium term.
But as Hal Wolf, CEO of HIMSS (parent company of Healthcare IT News) said in an interview this past year, a revolution in supply chain management has been a long time coming.
ON THE RECORD
“Last year the American people experienced a widespread and significant shortage of N95 respirators for healthcare workers and masks to protect essential workers and others, and year after year we see shortages of medicines and medical supplies like saline,” said Woodcock.
“Now is the right time to take action to keep the U.S. drug supply chain secure and resilient,” she said.
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