I wrote about last week's RAPS meeting and how FDA has made it clear that IVDMIA is not dead yet. I put off writing about the other revelation from that meeting until I could get a little more perspective.
It is far too early to see how this will play out, but I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure. If what I heard last week is indicative of OIVD's new direction, they are beginning to embrace a much more conservative position on LDTs. Those of you who celebrated IVDMIA's demise can put away the champagne now, because the hangover is about to begin.
Just about everyone hates the two-track regulatory system and I've complained about it myself numerous times. FDA proposed a moderate middle ground (IVDMIA) where the least transparent LDTs would be recognized as IVDs. They were stymied in those efforts but they are not giving up. It now appears that they are abandoning compromise in favor of regulating everything outright. Virtually all LDTs might be looking like IVDs in the not-too-distant future.
LDTs have received different treatment in the past and that's probably going to continue, at least in name. What's been under discussion is how to change (or clarify) the line separating LDTs from IVDs. The direct approach (IVDMIA) involved expanding the definition of IVD to include some products that were previously held to be LDTs. Now, it appears that they intend to narrow the definition of LDTs such that many of the products that previously qualified for enforcement discretion may no longer receive it. Either approach results in LDTs being migrated to IVD regulation, but now it's less clear where the lines are going to be drawn. And it's less clear that FDA is in any mood to negotiate or be accommodating.
At last week's conference, for example, Courtney Harper stated clearly that an LDT that is contract manufactured is outside the definition of an LDT. In another comment, she asserted that LDTs should only be shown discretion if they are used in the same lab where they were developed. Being produced by the same company is no longer good enough in this scenario. This means that if a lab has two locations, an LDT developed at one lab could not be transfered to another location unless FDA clearance or approval is obtained.
If this approach holds, it could be a back door into FDA regulating everything. If you follow these comments through to their logical endpoint, the definiton of LDTs may be shrinking so small that it covers almost nothing at all. On the one hand, I'm comfortable with that: the two-track regulatory system is a blight on the industry. On the other hand, this is a very big shift and it's going to produce a lot of confusion and dislocation, particularly if it's not being uniformly enforced. I also worry about the bottleneck that will be created when an entire industry discovers that they all urgently need to have the exact same conversation with the same dozen people at OIVD.
It may be too early to see for sure where this is going, but we may end up looking back fondly on the days when IVDMIA was still on the table. It didn't look like a good deal to some of us, but I think we may all end up wishing we had signed the deal while we still had the chance.
