White House says data is one key to improving pharma supply chain resilience
The White House 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 that directed the government to identify risks, address vulnerabilities develop a strategy to promote supply chain resilience throughout sectors.
“Pharmaceutical supply chains are essential for the national health security economic prosperity of the United States, yet the COVID-19 pandemic revealed just how vulnerable the supply chain is in this country,” said Food 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 limited international coordination.
“It will take a concerted effort over the short-, medium- long term to adequately address these 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 fostering international cooperation.
- Promoting research development to establish innovative manufacturing processes production technologies.
- Creating robust quality management maturity.
- Leveraging data.
Regarding the latter point, the report noted that “a robust surveillance system that leverages information 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 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 executive branch efforts to ensure its adequacy resilience,” it continued.
According to a press release from the agency, the U.S. Department of Health Human Services will initially commit about $60 million from the Defense Production Act appropriation in the American Rescue Plan to develop novel platform technologies 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 EHR integration, for help in the short 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 significant shortage of N95 respirators for healthcare workers masks to protect essential workers others, year after year we see shortages of medicines medical supplies like saline,” said Woodcock.
“Now is the right time to take action to keep the U.S. drug supply chain secure resilient,” she said.