Bradley Merrill Thompson Featured in Podcast Q&A, “Combo Product Human Factors Guidance Follows Multi-Year Coalition Effort”

The Gray Sheet

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Pharma & MedTech Business Intelligence’s The Gray Sheet, in a Podcast Q&A titled “Combo Product Human Factors Guidance Follows Multi-Year Coalition Effort.”

Following is an excerpt:

TGS: What are some of the key things that you have noticed in that guidance document based on the talks you've had with the agency and could you tell us if there's anything that the agency didn't include that you would like to see in a final version?

Thompson: I'm happy to. The guidance document came out only a week ago and I have not yet met with the individual members of the coalition so I can't speak for them, but I can speak personally.

As I look at it, there were some key questions that we raised that seemed to be addressed. One for example was the circumstances when a simulated human factors testing could be used in lieu of actual-use testing in the form of a clinical trial. The guidance lays out, at a fairly high level as you would expect, the rules for discerning when simulated use will be sufficient instead of actual use.

The guidance document seems to express a pretty clear preference for simulated-use testing and I think that's very important. That's an issue where we were noticing that in our opinion there were differing views at the agency, and they seemed to have coalesced in some manner around a general support for the notion that simulated human factors testing will typically be adequate unless there's really something idiosyncratic about the environment in which it is to be used or the drug itself that will go into a drug delivery system. Unless there's something idiosyncratic about that, simulated human factors studies will be adequate. So that's terrific. …