Holly Fernandez Lynch, Associate Professor of Medical Ethics at University of Pennsylvania School of Medicine, shared a post on LinkedIn:
“So much going on right now but for those of you who care about FDA,
Patti Zettler, Steven Joffe, Rachel Sachs, Reshma Ramachandran and I have a 2 part commentary in Health Affairs Forefront on the new plausible mechanism pathway. Part 1 is below, Part 2 will come tomorrow.
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 1)
The gist is that we think the program has great promise for truly individualized therapeutics that otherwise lack a clear pathway to approval, like the genetic editor developed for Baby KJ at CHOP or ASOs like Milasen. But there are many open questions about how it will work in practice and how it could be extended in worrisome ways. We’re also quite concerned about the process. Publishing the outline of this pathway in NEJM first rather than at least as FDA draft guidance is problematic. Hopefully the promised guidance will be forthcoming soon.”
More posts featuring Holly Fernandez Lynch.