Point of view: MDI propellant switching in the 2020’s vs.1990’s: Commentary, perspective and recommendations

This paper focuses on the regulatory aspects of propellant switch programs for pressurized metered dose inhalers (MDIs) where products currently regulated by the United States Food and Drug Administration (FDA) are involved. Currently, several critical regulatory parameters and questions are yet to be decided upon by the FDA. There is much to be learned from the previous MDI propellant switch of the 1990’s. That earlier change was much more dramatic than the current scenario for a number of reasons.

Requiring submission of NDAs or ANDAs in support of propellant switch programs for MDI products that are already approved could lead to a number of otherwise avoidable negative public health outcomes. Instead, it is reasonable to conclude that successful propellant switch scenarios may be achievable via the prior approval supplement (PAS) pathway for both NDAs and ANDAs that are currently approved. This appears feasible within the FDA’s existing guidance and regulatory framework through the lens of science and progressive policy that can be aligned with the uniqueness of this situation.