As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program.
With the enactment of the 2022 omnibus spending bill, the US Congress mandated FDA to establish an AMT program for manufacturing methods that incorporate a novel technology or use an established technology in a unique way to produce a drug of equivalent or superior quality.
Advanced manufacturing, which generally is the use of innovative or emerging technologies to improve the drug manufacturing process, is viewed by FDA as a “key component of the overall U.S. strategy to strengthen domestic drug manufacturing” and increase supply resilience by providing patients with quality products.
FDA is establishing this new program to designate AMTs meeting the criteria for a given “context of use” (e.g., class of products), provide enhanced interaction with sponsors developing products utilizing designated AMTs, and prioritize review of drug and biological product applications incorporating these technologies.
Eligibility, Request Criteria, and the FDA Process
Drug and biological product sponsors, contract manufacturers, and technology developers can submit AMT designation requests. Due to the expanded scope of who may be a requestor, and because designation requests are to be submitted independently of drug and biological product marketing applications, the holder of an AMT designation may be different from the drug applicant.
The AMT designation applies to manufacturing methods that incorporate a novel technology or use an established technology in a novel way to substantially improve the drug manufacturing process while maintaining equivalent, or providing superior, drug quality. Improvements include a reduction in drug development time or an increase or maintenance of supply of a life-supporting, life-sustaining, or critical importance drug or a drug that is on the drug shortage list.
When considering whether to submit an AMT designation request, note that FDA considers a novel technology to be one “that has not been used in a previously approved application and for which FDA therefore has limited assessment or inspectional experience.” Manufacturing methods that are novel, but which play a limited role in the drug manufacturing process, may not qualify for AMT designation.
Further, the guidance outlines what information to include in an AMT designation request to FDA (to be reviewed within a statutory 180-day timeframe), including a description of the manufacturing method, why it should be considered for designation, and how it meets the eligibility criteria.
Benefits of AMT Designation
Enhanced Interactions
An AMT designation allows early interaction with FDA in the form of written correspondence or meetings with requestors or drug sponsors for the development of drugs that may be manufactured using a designated AMT. Among other topics, sponsors are encouraged to discuss with FDA how the designated AMT can be used to shorten or optimize drug development.
Further, additional interaction may be available, depending on available resources, throughout drug development and application submission and review to address AMT-related topics.
Prioritized Review
FDA intends to prioritize the review of drug or biological product applications utilizing designated AMTs, aiming to give higher priority to drug sponsor interactions that discuss the use of a designated AMT “with the potential to significantly improve product quality, address known quality issues for a drug or class of drugs, or increase or maintain the supply of drugs that are currently in shortage or imminently at risk of being shortage.”
FDA also notes that the degree of prioritization afforded to an application may be impacted by whether the application has otherwise been accepted into other expedited programs (e.g., fast track or breakthrough therapy designations).
Key Takeaways
The guidance demonstrates FDA’s ongoing effort to support the use of innovative manufacturing technologies for drugs and biological products to improve product quality, address drug shortages, and increase manufacturing capacity and flexibility. Importantly, as emphasized in the guidance, drug applicants seeking to request AMT designation or adopt a designated AMT should engage early with FDA to discuss how the use of the designated AMT can facilitate efficiency and improvement to the drug manufacturing process.
Given FDA’s continued receptivity to new manufacturing technologies, drug sponsors should assess and adapt its current drug manufacturing processes to ensure that they are staying at the forefront of technological innovation to remain competitive in the pharmaceutical market.
FDA strongly recommends that requestors engage with the Center for Drug Evaluation and Research Emerging Technology Team or the Center for Biologicals Evaluation and Research Advanced Technologies Team before submitting an AMT designation request. Interested stakeholders should also comment on this draft guidance, with the comment period currently open until February 12, 2024.
In light of FDA’s growing interest in emerging manufacturing technologies, we expect the agency to provide additional guidance in the future. In particular, we expect FDA to issue guidance on its Platform Technology Designation Program shortly, which was also enacted by the 2022 omnibus spending bill. Of note, this draft guidance communicates important distinctions between the AMT Designation Program and the Platform Technology Designation Program.
While both programs aim to increase the efficiency of drug development, AMT designation requires a novel technology while the platform technology program focuses on well-understood technology that is incorporated or used by an approved drug or licensed biological product. In addition, in contrast to AMT designation, a broader range of technologies are eligible for platform technology designation (e.g., molecular structures, mechanisms of action, delivery methods).
Morgan Lewis will continue to monitor developments in the drug manufacturing space and provide updates.