USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed

The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of the ambiguities associated with advanced manufacturing to accelerate adoption in the pharmaceutical industry. The GAO further recommended that the US Food and Drug Administration (FDA) should set benchmarks to better measure uptake to this mode of manufacturing.

A USP official discussed both reports, as well as his perspectives on the industry’s adoption of advanced manufacturing methods, in an interview with Focus.

According to GAO, the COVID-19 pandemic revealed vulnerabilities in the medical supply chain that led to drug shortages while FDA has highlighted advanced manufacturing to boost supply chain resiliency. Yet, said GAO, “at the time of this report, few drugs had been made using advanced manufacturing.”

GAO noted that that between 2015 and last October, the agency had approved 16 applications or supplements that used advanced manufacturing technology. Yet during this same period, CDER had accepted 112 proposals for participation in its Emerging Technologies Program (ETP).

Advanced manufacturing can include novel manufacturing methods to improve process robustness, novel dosage forms, continuous manufacturing, new modeling tools for analytical testing and novel container closure systems…