Pharma’s Cutting Edge

Will post some stories that happened while I was away from the office. This first one is from Randall Willis at DDN, who reports that the EMEA and FDA will jointly review and comment upon Voluntary Genomic Data Submissions (VGDS). This is fairly big news that received virtually no media attention, perhaps because observers have become accustomed to collaboration between FDA and EMEA via the ICH process. But this is different. ICH provides a framework for submission of regulatory documents. It does not provide for joint agency review and commentary, as does this VGDS initiative. Willis raises the issue of creation of a superagency, with VGDS as a first step. I don’t see broader review and commentary collaboration becoming the norm anytime soon, given legislative inertia on both sides. But I like this relatively innocuous collaboration as a test of how collaboration might look sometime in the distant future.