Continuous manufacturing bill clears House
The US House of Representatives on Tuesday night passed a bill, H.R. 4369, that promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing at various universities across the country.The House also passed another bill, H.R. 3635, which would make changes to the management of the Strategic National Stockpile to help the response to the current pandemic and future public health emergencies by allowing transfers of supplies to other federal departments or agencies and by temporarily authorizing the Department of Health and Human Services to award grants to states to maintain their own stockpiles during emergencies.
Continuous manufacturing
Under H.R. 4369, the centers of excellence would be tasked with working with the US Food and Drug Administration (FDA) “to craft a national framework for advanced and continuous manufacturing, including workforce development, standardization, and collaboration with manufacturers,” according to a 20 October announcement from the House Energy and Commerce Committee.
An Energy and Commerce official was optimistic on the bill’s chances of enactment. “It is fair to say that the bill has widespread bipartisan support,” noting that the bill passed by a vote of 368 to 56, with 150 Republicans voting to support the bill.
The bill, called the National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act, was introduced 6 July 2020 by Committee Chairman Rep. Frank Pallone (D-NJ) and Rep. Brett Guthrie (R-KY), ranking member of the Health Subcommittee. (RELATED: House committee advances bills on advanced manufacturing, opioids and more, Regulatory Focus, 21 July 2021)
The bill would amend the 21st Century Cures Act and authorize FDA to establish qualified universities as national centers of excellence in advanced and continuous manufacturing and authorize $100 million to support efforts to develop and implement this mode of manufacturing.
Rep. Pallone said that the House passage of the bill he sponsored "brings us one step close to expanding advanced and continuous manufacturing technology in the United States, to help improve drug quality, mitigate drug shortages, and create an environment that would encourage drug manufacturers to bring jobs back home.”
In order to receive designation, universities would have to show they have the physical and technical capacity for research and development of continuous manufacturing, have “scalable” manufacturing knowledge-sharing networks with other higher learning institutions as well as with large and small biopharmaceutical manufacturers. They would also have to demonstrate a “proven” capacity of designing new technology for use in continuous manufacturing and have “track records” in transferring knowledge.
Designated universities would need to enter into an agreement with FDA to publish a report and share data on best practices and research related to continuous manufacturing. Such institutions must also provide an annual report on their activities and develop a “roadmap” for continuous manufacturing.
Pallone said that the Rutgers University’s Center for Structured Organization Particulate System (C-SPOPS) has “playing a leading role” in advancing continuous manufacturing technology, and has used these methods in producing powder-based pharmaceutical products. The center has a full-scale continuous manufacturing production line built and works with industry to integrate continuous manufacturing into commercial production.
A similar bill was introduced in the House last year to promote continuous manufacturing but was never enacted. (RELATED: House Committee Discusses Bipartisan Bills on Orphan Exclusivity, Generic Drug Labels and More, Regulatory Focus 29 January 2020)
FDA has been encouraging the adoption of continuous manufacturing for at least a decade, and officials said that these efforts are starting to bear fruit. (RELATED: FDA officials tout progress and achievements in advanced manufacturing, Regulatory Focus 15 October 2021)
HR 4369
House Energy and Commerce announcement
Pallone statement
