Waiting for LDT Guidance

Tuesday, April 23, 2013

Earlier this month I attended the 40th annual meeting of the Association of Medical Device Manufacturers (AMDM). For those unfamiliar with it, this meeting is a collaborative effort between FDA and industry. FDA participates in workshops on topics like how to submit a 510(k), and both industry and FDA give timely presentations on the state of medical devices during the annual meeting. There are lively discussions between regulators and manufacturers, and at the end of the meeting everyone leaves with a renewed spirit of collaboration and optimism.

This year though, the overall tenor of the meeting was one of frustration. Nearly three years after the DTC genomics dust-up sent FDA on a crusade to regulate LDTs, the state of things is not only unchanged, but if anything has become – in the opinion of many AMDM attendees – more onerous for medical device manufacturers.  This sentiment was most artfully (and humorously) presented by Bradley Thompson during his talk on LDT’s and their impact on the IVD industry. His advice? IVD manufacturers should stop fighting the LDTs and join them. He encouraged diagnostic companies stop “Waiting for Godot” (aka LDT guidance) and open their own reference labs. Offer LDTs on new, state-of-the-art biomarkers. And if one proves to be a big hit, you can then consider manufacturing IVD kits and submission to FDA. In other words, stop trying to play by the rules you schmuck (his words, not mine).

This paradigm shift was largely in response to FDA’s continued assertion that - while they are committed to stepping up the regulatory oversight of LDTs - their hands are tied, at least in the short-term. Oh, and by the way, the regulatory burden to IVD manufacturers just jumped with the new RTA process and the pending changes to CE IVDD. For IVD manufacturers, it’s like Christmas in April - as imagined by Tim Burton.

It’s safe to say at this point that no one is happy. FDA is tired of saying that LDT guidance is drafted but tied up in legal and Congressional red-tape. IVD manufacturers are tired of having to play on a field that slants decidedly uphill for them, but slopes downward for the LDT providers. Heck, even I am sick of blogging on this topic.

The one thing that is missing from the discussion is a solution that everyone feels good about. During his presentation, Mr. Thompson suggested that, since all tests are run in labs regulated under CLIA, maybe we should remove FDA from the device regulating business altogether. But even LDT providers think this is a bad idea, although for obvious reasons they can’t really articulate why (hint: if you acknowledge the value FDA adds, it’s harder to say “except for LDTs”).

Which brings us back to Mr. Thompson’s argument for IVD companies to open a LDT shop in their backyard. This is not a new idea. When I was at Chiron 15 years ago we did it as a way to generate revenue on novel tests while simultaneously pursuing FDA approval. But in those days, the brass ring was always a distributed test, with the LDT used as a stop-gap. Now, in the face of a growing regulatory burden and an uneven competitive landscape, the distributed test is looking less and less desirable. Add to that a political environment where it will probably take a major health crisis like the drug compounding scandal to change the course of LDT regulation, and it’s hard to fault IVD manufacturers for at least thinking about altering their current business model.


Tags: CDRH, IVD, LDTs, Politics

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