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#COVID19 has clearly shown how any significant global disruption can threaten patient access to critical drugs. With advanced manufacturing, we can reduce our dependence on foreign sources of APIs, strengthen manufacturing in the US, and ensure redundancy in drug supply.
The US pharmaceutical sector has increasingly moved out of the country since the late 1990s based on economic factors. Companies in the US could not compete using current technology against countries with lower labor costs & fewer environmental regulation. https://go.usa.gov/xvHed
FDA has been advocating for modernization of drug manufacturing since the early 2000s. Advanced pharmaceutical manufacturing covers a range of technologies that are widely used in other industries, such as automotive and aerospace. https://go.usa.gov/xvHeB
Advanced manufacturing may include continuous manufacturing or use of automation and digitization. These techniques result in smaller facilities, less environmental impact and the need for a smaller, highly skilled workforce – all factors that make production in the US feasible.
Several companies have already established facilities that can make pharmaceutical or biological products in a continuous end-to-end process, while using less solvents, producing less CO2, consuming less energy, using less paper, and yet can be much more productive.
Today, there are five companies using continuous manufacturing to make seven approved products – six finished dosage forms and one API. These examples show that drug manufacturing in the US is quite feasible using advanced technologies.
FDA is working hard to assure a robust and reliable drug supply for the US. It is important both to reestablish the pharmaceutical manufacturing sector in the US and also help bring about a high-quality resilient drug supply for all the world's citizens.
