Although some research on formulation, device design, and manufacturing of MDIs with LGWP propellants was presented, questions about regulatory issues associated with the transition dominated the meeting. Kindeva’s workshop, for example, focused on regulatory issues, and Kindeva personnel also moderated and participated in a session featuring talks by, and a panel discussion with, representatives from the FDA.
In a talk titled, “FDA Perspectives on Scientific and Regulatory Considerations for MDIs Transitioning to a Low Global Warming Potential Propellant” Markham Luke and Bryan Newman from the Office of Generic Drugs (OGD) presented the agency’s current approach to the transition. Luke noted that OGD has been coordinating with other offices in the FDA and consulting with regulators in other countries to develop its approach to the problem, and he clarified that the presentation had been cleared by the agency’s legal team.
Luke described the agency’s approach to dealing with the transition, which he said was meant to avoid some of the problems of the CFC-to-HFA transition and to maintain patient access to MDIs that they need. Part of that approach is for the FDA to fund research on the LGWP propellants, and Newman described a number of those projects during the presentation.
Newman also suggested that sponsors of currently marketed brand-name inhalers transitioning to new propellants will likely need to submit new NDAs. For generic products, he said, ANDA submissions for products using the new propellants will not be possible because ANDA submissions cannot include clinical safety studies, so other types of applications such as 505(b)(2) NDAs might be necessary until the FDA has received sufficient safety data on the LGWP propellants.
In the talk that followed, former FDA Associate Director for Science in CDER/OPQ Rik Lostritto, who is now a consultant, took issue with Newman’s assertion that regulations would require the submission of new NDAs or ANDAs for transitioning MDIs, saying that that approach would lead to shortages and product withdrawals. Lostritto argued that “the prior approval supplement pathway is not only appropriate but feasible for transition to a new propellant.”
During the panel discussion and Q&A session, a number of people called for more timely communications with the FDA and greater clarity from the agency regarding what will be required for submissions. Vectura Chief Scientific Officer Geraldine Venthoye pointed out that the EMA has provided relatively clear guidance and called for greater harmonization between the FDA and EMA as soon as possible because the lack of that harmonization is creating chaos, especially for smaller companies, who need to make decisions now and could lead to product withdrawals.
