Omnibus brings new advanced manufacturing programs to FDA

Regulatory NewsRegulatory News | 11 January 2023 |  By 

The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing centers for excellence and an advanced manufacturing technologies designation program.
The omnibus spending bill was signed by President Biden on 27 December and authorizes $3.5 billion in budget authority for the US Food and Drug Administration (FDA) in FY 2023, a 6.5% increase compared to its 2022 budget. (RELATED: This Week at FDA: Congress passes omnibus spending bill, securing budget increase for FDA, Regulatory Focus 23 December 2022)
The spending bill may give manufacturers the boost they need to embrace advanced and continuous modes of manufacturing. FDA has encouraged the adoption of these manufacturing methods for over a decade, and claims that advanced manufacturing methods can help companies reduce costs and quality defects and can improve the global competitiveness of US manufacturing. (RELATED: FDA officials tout progress and achievements in advanced manufacturing, Regulatory Focus, 15 October 2021).
Manufacturing centers of excellence
Section 3204 of the omnibus spending bill amends the 21st Century Cures Act and authorizes FDA to award $100 million to support the implementation of advanced or continuous pharmaceutical manufacturing for companies seeking to manufacture drugs in the US. The legislation authorizes FDA to designate five institutions of higher education as a National Center of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.  
To receive such designation, institutions of higher learning must show they have the physical capacity and technical capabilities to conduct advanced research and develop and implement advanced and continuous manufacturing.
Designated institutions would have to collaborate with other colleges and universities, as well as nonprofit organizations and pharmaceutical manufacturers in developing these modes of manufacturing. It would also have to have a “proven capacity” to design and implement technologies to use in advanced and continuous manufacturing.
Designated universities must publish reports and share data with the agency on best practices on developing this mode of manufacturing.
A continuous manufacturing bill cleared the house last October 2021 but was never enacted. (RELATED: Continuous manufacturing bill clears House, Regulatory Focus 21 October 2021)
Legislation calls for advanced manufacturing technologies designations
Section 3213 of the bill requires FDA to initiate an advanced manufacturing technologies designation program for manufacturing methods that incorporate a novel technology or uses an established technology in a unique way to produce a drug of equivalent or superior drug quality. FDA must establish the program within one year of the law’s enactment.
The legislation calls on FDA to issue a report within three years describing and evaluating the program, including the types of innovative manufacturing approaches supported under the program, the number of designations awarded by FDA, the number of methods that have been granted designation requests and the number of calendar days for evaluating the technologies.
Omnibus bill


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