At the January 8-9, 2015 FDA public meeting on the agency’s proposal to regulate a portion of lab developed tests (LDTs), there was much debate regarding whether FDA has jurisdiction over IVDs made at clinical laboratories. Not coincidentally, on January 7, the day before the meeting, the American Clinical Laboratory Association released a white paper developed for the Association by a couple of prominent constitutional law scholars. The paper outlined the arguments at a high level against FDA jurisdiction over lab developed tests generally. But with all due respect to the authors as well as the speakers at the FDA public meeting, the discussion to date is taking place at such a high level that I do not find it particularly helpful. Mostly the discussions merely stake out the positions held by interested parties. They don’t advance the collective understanding of the issues.
In connection with the public meeting, I developed five questions which help me think through the legal issues. I’d like to share those questions, in an effort to drive the discussion to a more granular level where differences can be more effectively debated and resolved. In addition, as with any lawyer, I’m drawn to precedent, so I’d like to share how FDA has tackled similar issues before. At the end of this post, based on precedent but also my conclusion that both sides are overstating their legal positions, I offer a path forward down the middle-of-the-road.
5 Questions That Frame FDA Authority Over IVDs Made at Labs
In posing these questions, I start with the most basic and simple and then move closer and closer to the current facts. In each case, I’ll also give you what I think the answer is.