White House plans pharma supply chain security push

The Joe Biden administration is worried about the security of the US medicines supply chain, and is taking steps to tackle weaknesses in the system.

A new White House report on US supply chains published this week says there is a need to boost domestic production of generic drugs to reduce reliance on overseas suppliers, make the supply chain for active pharmaceutical ingredients (APIs) and other raw materials more secure and resilient, and introduce early warning systems for shortages.

It also calls for more R&D on manufacturing technologies, improved quality management processes, and better use of data to improve oversight of the supply chain.

It says that as of March 2021, 52 per cent of all FDA-registered finished dose form (FDF) manufacturing facilities were located outside the US, along with 73 per cent of all FDA-registered API plants, and there is "little transparency into the origins of API within generic drugs."

That highlights "the critical importance of a resilient US healthcare manufacturing sector," according to the report, which says the sector needs to build "quality, diversification and redundancy."

The publication is one of the objectives of an executive order from the Biden administration in February which said more resilient supply chains are needed across all industrial sectors to make it possible to handle threats such as the pandemic.

The COVID-19 crisis has thrown the threats to supply not stark relief, according to acting FDA commissioner Janet Woodcock, who pointed to the widespread shortages in protective personal equipment last year, which were compounded by counterfeiters flooding the market with knock-off copies.

"Year after year we see shortages of medicines and medical supplies like saline," she added. "Pharmaceutical supply chains are essential for the national and health security and economic prosperity of the US, yet the COVID-19 pandemic revealed just how vulnerable the supply chain is in this country."

COVID-19 meanwhile is only the latest threat to affect the sector, as the US's reliance on overseas suppliers – particularly of APIs – hit the headlines a few years back when contaminated heparin produced in China resulted in dozens of fatalities.

"China and India are estimated to control substantial parts of the supply chain where there have been issues with shortages due to a range of disruptions that have impacted supply as well as quality and safety," says the report.

The Department of Health and Human Services (HHS), which oversees the FDA and other key government agencies overseeing the supply of medicines and other healthcare products, is due to issue its own report in response to the order next year.

"HHS will work with the private sector and Congress to implement the recommendations and develop a strategy to facilitate adoption of novel methods for commercial production of pharmaceuticals and biologics," it said in a statement on the new report.