FDA commissioner Scott Gottlieb says the agency plans to take a broader effort to help the drug industry to convert to more innovative and efficient manufacturing technologies. Advanced manufacturing, which includes continuous manufacturing and 3D printing, provide promising opportunities to improve the market for drugs and biologics, he said in a 7/13 online post.
“The bottom line is this: Drug makers won’t switch to these systems until we create a clear path toward their adoption, and provide more regulatory certainty that changing over to a new manufacturing system won’t be an obstacle to either new or generic drug approvals,” Gottlieb writes. “The FDA recognizes that it’ll require additional investment in policies and programs that’ll provide regulatory clarity to enable these new methods to be more quickly and widely adopted. To achieve these goals, the president’s fiscal year 2019 budget dedicates $58 million to accelerate the development of the regulatory and scientific architecture needed to progress this technology.”
Meaningful adoption, Gottlieb continues, will not occur without supporting regulatory science and a collaborative regulatory environment. “To drive adoption, the FDA will need to establish clear principles for how these new platforms will be evaluated and approved,” he says. “We need to invest in the regulatory science to develop policies to support these innovations. That includes, for example, the development of analytical tools for monitoring these continuous systems. While much of this scientific work will be done outside the agency (typically through public and private partnerships) the basic regulatory principles need to be defined by the FDA.”
Gottlieb says continuous manufacturing technologies could save 30% ($60 billion) in manufacturing costs. This estimate does not include the savings from potential future technologies. “One example of promising investment in these technologies is recent efforts by General Electric to ‘launch prefabricated manufacturing units for producing virus-based gene and cell therapies, novel anti-cancer treatments and vaccines.’ Innovations like these could make it more feasible for small, innovative biotech companies to enter the market and compete against larger pharmaceutical companies, especially for gene and cell-based cancers. This could provide a broader array of innovation, and infuse more competition into these promising therapeutic areas.”