By Yvonne Limpens, Managing Human Factors Specialist at Emergo by UL
While the time to market for generic inhalers is much shorter compared to novel inhalers because there is no requirement for generic product manufacturers to repeat clinical research on ingredients or dosage forms already approved for safety and effectiveness, one aspect often overlooked during generic inhaler development is assessing the US FDA’s human factors (HF) requirements associated with the Abbreviated New Drug Application (ANDA) process. In January 2017, the FDA’s Center for Drug Evaluation and Research (CDER) released a draft guidance document reflecting these requirements.
It is important to consider the HF implications and considerations for the use of an off-the-shelf generic inhaler early in the development process, ideally before selecting the device. In the remainder of this article, the author will discuss the FDA’s HF requirements set forth in their ANDA guidance for drug-device combination products and their implications.
Regulatory imperative
The guidance states that when developing a generic combination product, such as an oral or nasal inhaler, manufacturers “should carefully consider the design of the user interface (UI) of a proposed generic combination product and seek to minimize differences from the UI for the reference listed drug (RLD).” The goal of aligning the proposed generic product’s UI with that of the RLD product is to help ensure that a patient can switch from using the RLD product to the generic product without additional training or explanation from a healthcare provider (HCP), noting that once approved, the generic product may be substituted for the RLD product without HCP or patient notification or approval.
The FDA expects manufacturers to follow the process and conduct the activities reflected in the guidance to generate evidence and justify that the generic product, like inhalers, can be substituted for the RLD product without leading to an increase in use errors associated with the potential for harm or comprised medical care, including under- or overdose. Specifically, the guidance calls upon manufacturers to conduct threshold analyses to compare the proposed generic and RLD product designs. Additionally, they suggest potentially following up with a comparative use human factors (CUHF) study.
