Continuous manufacturing back in second Act

House tries again to promote advanced technology for the return of pharmaceutical manufacturing to the US in post-COVID-19 era.

The new HEROES Act legislation revives a proposal to establish national centers of excellence for continuous pharmaceutical manufacturing that had earlier made it into the US House of Representatives’ version of the CARES Act but not the final enacted CARES pandemic relief law.

The HEROES bill (HR 6800) authorizes $100 million for the centers of excellence, available until expended. That’s up from the $80 million over five years that the House had proposed for CARES.

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The centers would help with the effort, expected to accelerate in the wake of the COVID-19 pandemic, to restore pharmaceutical manufacturing capacity in the US. Because continuous methods are highly automated, they require fewer, more highly trained workers. The thinking is that US wages are too high to compete with countries like India and China in batch manufacturing.

The manufacturing proposal is just one of an array of funding and policy provisions in HR 6800 targeting the pandemic. Other provisions would, for example, eliminate cost-sharing for COVID-19 drugs and vaccines – a proposal that the Senate nixed from the CARES Act. While the House may take up HEROES within the next couple days, Senate Majority Leader Mitch McConnell has shown little enthusiasm for the legislation, saying it reflects aspirations of the House Democratic majority rather than practical needs stemming from the coronavirus pandemic. The bill would impact a number of different federal agencies, many outside health care.

The continuous manufacturing/centers of excellence proposal – first introduced in October 2019 as a freestanding measure (HR 4866) by Rep. Frank Pallone, D-NJ, and Rep. Brett Guthrie, R-KY – would amend the 21st Century Cures Act to establish the centers of excellence. Rep. Abigail Spanberger, D-Va., joined as a sponsor of HR 4866 on 12 May.

Fernando Muzzio, a Rutgers University professor who is a leading authority in the field, gave his support for the legislation in testimony at a hearing in January of the House Energy and Commerce Health Subcommittee, which Pallone chairs. Rutgers, which does a lot of research on continuous pharmaceutical manufacturing, is in Pallone’s district.

The FDA Would Solicit Requests From Universities

The bill gives the commissioner of the US Food and Drug Administration (FDA) one year after enactment to solicit and obtain requests from universities for designation as national centers of excellence for continuous pharmaceutical manufacturing.

The universities would have to show they have the physical and technical capacity for research and development of continuous manufacturing, the requisite knowledge-sharing network among industry and academia, capacity to design and demonstrate new technology, a track record for knowledge transfer, the ability to train the highly specialized workforce needed to develop and commercialize advanced manufacturing systems, and experience with technology partnerships in this area.

In part, the centers would be expected to help the FDA with technical assistance, including regulatory quality metrics guidance.

Universities would have to enter into agreements with the Health and Human Services Department to get the designation. They would have to agree to work with the FDA to publish reports, share best practices with the agency, work with industry to develop workforce and institutional roadmaps, and report annually to the FDA.

The bill provides that HHS can fund the centers through grants, contracts or cooperative agreements.

It also requires HHS to report to Congress annually about the initiative.

Within two years of designating its first center of excellence, HHS must, with consultation from the centers, report to Congress with its long-term vision for the FDA’s role in supporting continuous manufacturing. The vision should include a framework of principles for implementation and regulation and a plan for developing pertinent FDA regulations and guidance.

This article was first published on 14 May 2020 in The Pink Sheet.

Since it was first published, the House of Representatives passed the HEROES Act by a vote of 208-199.

Bowman Cox leads the Pink Sheet’s coverage of pharmaceutical manufacturing quality issues. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to drug manufacturers and their quality organizations. He can be contacted at bowman.cox@informa.com.

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