The FDA on Wednesday unveiled the outline of its plans to support the use of new drug manufacturing technologies, part of the agency’s commitments under the latest user fee program.
The seven-page strategy document explains what the agency plans to do in this developing space, such as optimizing CDER’s Emerging Technology Program and CBER’s Advanced Technologies Team, which can allow for advanced talks with the FDA on new technologies before they’re included in submissions.
Companies invest many millions of dollars in drug manufacturing, and the field has become more complicated and technology-driven because of the development of complex new therapies. A major regulatory barrier “to further adoption of innovative manufacturing is a lack of international harmonization in regulatory requirements,” the document says, echoing recent calls from CBER Director Peter Marks on enhanced international convergence over the next five years.
Marks is speaking later Wednesday at the PDA/FDA joint regulatory conference in Washington, DC, and a slide from his talk called for “urgent attention” to issues like quickly making new biologics to address emerging disease threats, and making biologics for tiny populations of patients affected by rare diseases.
“Even with a clear set of FDA regulatory expectations, manufacturers remain uncertain regarding regulatory acceptability,” the FDA strategy document said. “Other key barriers to the adoption of innovative manufacturing may lie outside FDA’s purview — most notably, financial and commercial considerations.”
Part of the problem, according to the document, is that there are sizable upfront investments required, and manufacturers “may not expect a sufficient long-term return on that investment, or may decline to adopt innovative manufacturing methods regardless of the regulatory landscape,” the FDA says.
The FDA’s strategy also says that the current 2017 guidance on CDER’s Emerging Technology Program will be updated by the end of 2026.
Plans are also afoot to implement the FDA’s new Advanced Manufacturing Technologies Designation Program “in a manner that reflects feedback on eligibility criteria,” the agency says in its strategy. The FDA released draft guidance on the designation program in February, and that document will likely be finalized before the end of the year, the agency said.