Companion Drug/Diagnostic Pathway: A Question of Where and Who
This article was originally published in RPM Report
FDA has put a lot of thought into preparing for the drug/diagnostic companion products that presage the era of personalized medicine; but the lure of fewer controls and less development costs is tugging some of the effort off-shore. FDA is also scaring off small companies from genomic test projects and their VC investors. Is this really an opportunity that is slipping away from the US or just an opportunity only for some participants?
You may also be interested in...
An Institute of Medicine workshop on companion diagnostics suggests that regulatory standards are evolving at FDA to encourage companion diagnostic development. But almost everything else is still a challenge.
As FDA girds for the Capitol Hill phase of the user fee reauthorization push in 2012, the agency is projecting an image as a flexible problem-solver. FDA’s underlying message: the agency has sufficient authority and does not need tinkering with the legislative mandate. From the drug industry’s perspective, a continued stress on flexibility through the first nine months of the year could create a favorable climate for application reviews and for resolving lingering manufacturing issues.
FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in.