US launches review of pharma ingredient supply chain

The US Bureau of Industry and Security (BIS) has launched an investigation into the security of the US active pharmaceutical ingredient (API) supply chain as part of an effort to identify any vulnerabilities.

The review – which will see hundreds of API manufacturers, distributors, suppliers and customers surveyed – is designed to identify "the supply chain network that underpins US pharmaceutical manufacturing capabilities," according to the BIS, a unit of the Department of Commerce.

The overall aim is to allow the federal government to more accurately plan and develop funding strategies to help ensure the availability and security of the API supply chain and to raise awareness of current limited domestic manufacturing capabilities, among other potential issues, it said.

"Ensuring the health and competitiveness of the API industry is vital to US public health security," said Assistant Secretary of Commerce for Export Administration Thea Rozman Kendler (pictured top).

"When completed, the API assessment will provide the US government with valuable insights needed to safeguard the supply of essential medicines upon which millions of Americans depend."

In 2021, the Biden administration published a report on the US supply chain that concluded there was a need to boost domestic production of generic drugs to reduce reliance on overseas suppliers, make the supply chain for APIs and other raw materials more secure and resilient, and introduce early warning systems for shortages.

The following year, the US Pharmacopoeia (USP) concluded that while 72 per cent of API facilities supplying the US market were located overseas in 2019, the reliance on overseas imports had grown by 2021, with just 10 per cent of APIs made in the US.

Last year, the Coalition for a Prosperous America (CPA) – a national non-profit organisation representing domestic producers across many sectors and industries of the US economy – claimed that growing dependence on overseas suppliers was impacting supply chain resilience and contributing to shortages downstream in finished products.

A public version of the assessment report – with de-identified data – will be published on the BIS website by the summer of 2025, according to the agency.