On December 12, 2023, the Food and Drug Administration (“FDA”) issued a Draft Guidance titled the “Advanced Manufacturing Technologies Designation Program” (“AMT Draft Guidance”), which introduces a new program established by the Food and Drug Administration Omnibus Reform Act (“FDORA”) for designating specific methods for manufacturing drugs, biological products, and active pharmaceutical ingredients (“APIs”) as advanced manufacturing technologies (“AMT”).1 The goal of the program is to facilitate the development of drugs manufactured using an AMT. This Alert summarizes the new draft guidance, which details the eligibility criteria for the program, the expected content of designation requests, the designation review process, and the benefits of the program.
The AMT Draft Guidance reflects the agency’s latest effort to encourage the use of advanced manufacturing to improve manufacturing processes and increase supply chain reliability. The pharmaceutical and biotech industry, including contract development and manufacturing organizations, should pay close attention to the draft guidance and carefully consider how AMT designation may benefit their ongoing and future development programs.
Advanced Manufacturing
FDA defines “advanced manufacturing” in the AMT Draft Guidance as an “innovative pharmaceutical manufacturing technology or approach that has the potential to improve the reliability and robustness of the manufacturing process and supply chain, and increase timely access to quality medicines for the American public.”2 The AMT Draft Guidance reflects the agency’s hope that advanced manufacturing technologies (“AMTs”) will help ensure drug quality, and support a robust supply of drugs that are life-supporting, life-sustaining, of critical importance to providing health care (“Critical Drugs”), or that are in shortage.
AMT Designation Eligibility
A manufacturing method, or combination of methods, will be eligible for designation as an AMT, per the statutory eligibility criteria, if such method, or combination of methods, incorporates a novel technology, or uses an established technology in a novel way, that will substantially improve the manufacturing process for a drug while maintaining equivalent, or superior, drug quality.3 Examples of demonstrable improvements that would render a manufacturing method eligible for designation as an AMT include reducing drug development time or increasing, or maintaining, the supply of a Critical Drug or a drug on the agency’s drug shortage list.
FDA strongly recommends that those seeking an AMT designation engage with the Emerging Technology Team (“ETT”) or CBER Advanced Technologies Team (“CATT”) prior to submitting their request and notes that the manufacturing method candidate should also meet the general criteria for participating in CDER’s Emerging Technology Program4 and CBER’s Advanced Technologies Program.5 Designation determinations will be completed within 180 days of receipt of the original request.
Content of an AMT Designation Request
AMT requests are expected to include data or information showing that the manufacturing method meets the statutory criteria “in a particular context of use.”6 The depth of information in the request should match the level of risk inherent to the product and its process.7 Requests must also show the proposed AMT’s ability to improve the drug manufacturing process while maintaining drug quality or increasing a drug supply that is critical, or in shortage.8
AMT requests should include the following elements:
- A brief description of the method of manufacturing, or combination of methods, and why it should be considered for AMT designation – discussing how the method incorporates a novel technology or uses an established technique in a novel way;
- A detailed description of how the manufacturing method meets the statutory eligibility criteria;
- The context of use under which the proposed AMT will be used in drug development – including information about a model drug used to generate data submitted in the request;
- Any perceived challenges to implementation of the proposed AMT;
- A timeline for drug development that incorporates the proposed AMT – including the planned submission of any applications that would use the data and information about the proposed AMT in the same context of use, if known at the time of the submission;
- Description of any previous engagement with ETT/CATT if applicable; and
- A request for designation of an AMT that is intended for use in manufacturing an existing drug that is either a Critical Drug or is on FDA’s drug shortage list should also refer to the existing drug application and data showing that the proposed AMT will increase or maintain the supply and quality of the drug.9
The AMT Draft Guidance also provides questions and answers on key topics related to AMT Designation submissions and the program in general, such as how FDA will assess whether a technology is “novel,” considerations regarding the context of use for a particular AMT, how AMTs can be used or referenced in BLAs (”Biologics License Application”) as compared with NDAs (“New Drug Application”) or ANDAs (“Abbreviated New Drug Application”), and how the program differs from other similar programs like the Platform Technology Designation Program.
Benefits of AMT Designation
The AMT Designation Program provides an opportunity for early engagement with and feedback from FDA about development of drugs that may rely on use of the novel manufacturing method as well as the method itself.10 Agency engagement may come both in the form of meetings and written correspondence. FDA expects to prioritize interactions with applicants planning to use designated AMTs in drug development, quality improvement, supply increase or maintenance of a Critical Drug, or a drug in shortage or at imminent risk of being in shortage. The AMT Draft Guidance recognizes the possibility that a designated AMT may cease to meet the statutory eligibility criteria for designation and could lose the designation. At that point, new applications relying on the manufacturing method previously designated as an AMT would be eligible only for the standard level of FDA communication and interaction.
Conclusion: What to Expect for AMTs
FDA has long been interested in cultivating the development of advanced manufacturing technologies. With FDORA, Congress mandated that the agency take concrete action in the form of establishing a program whereby applications that depend on designated AMTs will be prioritized. We can expect to hear more from the agency as the program develops and FDA has the opportunity to take into account the types of issues that arise in evaluating AMT designation submissions. FDA is obligated under FDORA to issue final guidance regarding implementation of the AMT Designation Program before December 29, 2024, and hopefully that final guidance will provide further clarity on program eligibility criteria and the characteristics of a successful submission.11 FDA is also expected to issue guidance soon regarding a related but distinct program, the Platform Technology Designation Program. This program is also intended to increase the efficiency of drug development and manufacturing but applies to “reproducible technology that is incorporated in or utilized by an approved drug or licensed biological product.”12
The deadline for comments on the AMT Draft Guidance is February 12, 2024. Ropes and Gray will continue to monitor developments in this area. If you have any questions about this Alert or would like assistance in submitting comments to FDA or filing a request for an AMT designation, please contact any member of our FDA regulatory practice or your usual Ropes & Gray advisor.
- See 21 U.S.C. § 356l.
- FDA, “Draft Guidance for Industry: Advanced Manufacturing Technologies Designation Program” (Dec. 2023), available at https://www.fda.gov/media/174651/download (“AMT Draft Guidance”).
- Id.
- FDA, “CBER Advanced Technologies Program,” available at https://www.fda.gov/vaccines-blood-biologics/industry-biologics/cber-advanced-technologies-program.
- FDA, “How to Participate in ETP,” available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/how-participate-etp.
- AMT Draft Guidance at 4.
- Id.
- Id.
- Id. at 5.
- See AMT Draft Guidance at 3.
- 21 U.S.C. § 356l(e)(2).
- AMT Draft Guidance at 13.
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