We’ll have many months (perhaps years) in which to discuss and debate the substance of FDA’s LDT policy. Before we all rush in with guns blazing, it might be worth taking a moment to appreciate what really just happened here.
I believe that industry overplayed its hand. That matters because it looks like we’re about to double down on the same strategy.
There are very few things in life you really shouldn’t ever do, but there are some:
- Do not try to fool your banker with financial figures
- Do not challenge Eminem to a rap battle
- Do not try to out-regulate a Federal regulatory agency
Back in 2012, Congress passed FDASIA, a 140-page act re-authorizing FDA user fees and refining FDA’s mission and authority. Buried on page 138 of that document was section 1143, which stated, in essence, that FDA may not take action to regulate LDTs without providing 60 days notice to the relevant House and Senate committees and “...including in such notification the anticipated details of such action.”
The common industry belief at the time was that this requirement was an additional helping of red tape that would “...inhibit FDA’s efforts to regulate LDTs” (page 48). But what we actually did was we challenged Eminem to a rap battle.
FDA has been stymied for years on their efforts to release their draft guidance the right way. It was alleged to be stuck at the Office of the Chief Counsel, it was rumored to be stuck at OIRA, it now appears to be stuck at OMB. The regular channels have been truly gummed up. Industry lobbyists thought they were putting another bar on the door by involving Congress, but they ended up opening a window.
FDA might not ever have been cleared to issue this draft guidance… but because of FDASIA, they are required to furnish a copy of this guidance to Congress at least 60 days before it is issued.
Is this guidance likely to be issued in 60 days? Who knows… and really, what difference could it make now? We’re already talking about this picture of a theoretical document as though it’s an actual policy that requires discussion. And all that discussion just might be enough to make it an actual policy.
At a very literal level, all FDA has done here is to staple a document to another document. They have not issued a draft guidance, they’ve just given us the opportunity to talk about it enough that everyone might start acting like it’s real. But this is not the least bit real… it’s just a document stapled to a document. But that’s a staple that might change this industry.
FDA’s deft doc dump is truly a whole lot of nothing. But it’s exactly this kind of nothing that can form the basis of new regulatory policy if people don’t treat it like nothing.
Industry’s choices here are stark. If we respond to this like it’s actually something, we risk making it into something. On the other hand, if we ignore this and it gains momentum, we will feel like we’re missing the opportunity to have input or raise objections before it becomes real.
If only there were a third path, where we had the opportunity to engage FDA as though we all had a stake in setting high quality standards for established tests while leaving room for innovation in unsolved areas of need. Who knows what might happen if we actually worked together?
Maybe someday. In the meantime, I’ve got to brush up on my scales… I’ve got a big cello battle with Yo-Yo Ma coming up in a few days.