FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
This marks significant growth since the approval of the first approved drug to be made via continuous manufacturing in July 2015, Vertex Pharmaceuticals’ cystic fibrosis drug Orkambi (lumacaftor/ivacaftor).
Fisher provided an update on FDA’s two advanced manufacturing programs, the Emerging Technologies Program (ETP) and its Advanced Manufacturing Technologies (AMT) designation program at the agency’s Regulatory Education for Industry (REdI) meeting on 20 May. He also discussed the differences between the ETP and AMT programs.
Agency officials have been advocating for the adoption of continuous manufacturing for more than a decade, arguing that this type of manufacturing allows companies to operate with lower costs and fewer defects in smaller facilities, ultimately improving the global competitiveness of US manufacturing. (RELATED: FDA officials tout progress and achievements in advanced manufacturing, Regulatory Focus 15 October 2021)
Fisher also reported that the agency has accepted 191 applications into the ETP, which was established in 2014. In 2021, the agency said it accepted over 100 advanced manufacturing proposals into the program.
Fisher reported that continuous manufacturing is the most widely accepted technology in the program, with 72 continuous manufacturing technologies accepted. The second most common technology is novel unit operations, which received 27 acceptances. Other categories include novel analytical technologies, with 25; aseptic technologies, with 24; novel container closure systems, with 13; and distributed or point of care manufacturing models, with six.
To be accepted into the program, Fisher encouraged companies to begin early in the development process, even if a drug has not yet been identified. They should follow the procedures outlined in the ETP and develop proposals that are no longer than five pages, he said. These proposals should also describe the technology and explain why it is novel or unique. Additionally, companies should clarify how the technology improves existing products. FDA will decide on these applications within 60 days.
Fisher also discussed the AMT designation program and how it differs from the ETP. The Food and Drug Omnibus Reform Act of 2022 (FDORA) mandated that the FDA create an AMT program for manufacturing methods that either incorporate novel technologies or utilize established technologies in unique ways to produce drugs of equivalent or superior quality. Additionally, the bill required the FDA to establish this program within one year of its enactment. (RELATED: Omnibus brings new advanced manufacturing programs to FDA, Regulatory Focus 11 January 2023)
Fisher said that the AMT is designed for more advanced technologies that have specific data related to their drugs. Additionally, the holder of the AMT designation may not necessarily be the applicant for the technology. Also, the ETP covers technologies that go beyond just manufacturing, including innovative dosage forms. Unlike the ATM program, engagement with the ETP can take place earlier in the drug development process. Furthermore, the AMT is an official statutory designation granted by the agency.
In addition, a technology that does not qualify for the ETP may still be eligible for the AMT program, while a technology that does not qualify for the AMT could still be eligible for the ETP, Fisher said.
