One of the great philosophers of the last century, Yogi Berra, was once quoted as saying “It’s déjà vu all over again”. He was, of course, referring to something he observed in baseball, but the beauty of the quote is its broad application.
Take the FDA regulation of Laboratory Developed Tests (LDTs) for example. Back in the early part of the last decade, there was widespread speculation that the agency was going to finally lift the enforcement discretion on LDTs, due largely to a string of untitled letters distributed to direct-to-consumers (DTC) testing labs. For the next few years the agency drafted guidance documents, gave talks at meetings, and held public hearings. The result was, well, not much really. The main fallout was that DTC testing labs were faced with the choice of 1) having a physician order the test or 2) get FDA clearance or approval if they wanted to go DTC.
By 2016 though, the agency threw in the towel. With a new administration and the threat of legal action by LDT manufacturers, they published a white paper on the dangers of LDTs and left it to Congress to sort out any further regulation.
Since then, a few members of Congress have been slowly stirring a legislative roux called the VALID act. The goal of this legislation has been to give the agency the authority to regulate LDTs while simultaneously overhauling the regulation of in vitro diagnostics (IVDs). That legislation has been stuck in neutral for some time now, until January of this year when the NY Times published an article on non-invasive pre-natal testing (NIPT).
Cue Yogi.
That piece has had quite the affect on the VALID act. There’s renewed interest in the FDA’s regulation of LDTs, due to concern about the safety of these tests and the fact that some pregnancies have likely ended based on their results. In fact, nearly 100 Republican lawmakers penned a letter to the FDA about their oversight of these tests. Initially the agency responded with comments about how they are worried too, and Congress should really pass the VALID act if they want action.
It might have ended there, but that would have made for a lousy blog post. Instead, the agency today used one of its favorite tools, the dreaded Safety Communication. Lest you think this is just some passive - aggressive government tactic, remember what they did to ovarian cancer screening tests with a similar communication (spoiler alert, it wasn’t good).
Which brings us back to the question of will they or won’t they. There’s been a ton of speculation that the VALID act might be tacked onto MDUFA V. Enough so that a lot of LDT organizations have been lobbying Congress to separate the act from MDUFA. This, coupled with the raging debate around whether FDA should have done more or less to regulate COVID-19 LDTs, has got a lot of labs and IVD manufacturers all lathered up.
Is this latest act by the FDA another log on the LDT fire? Will Congress actually pass the VALID act now that both sides seem at least somewhat concerned about NIPT? Will the FDA be able to regulate these tests even if VALID passes?
To paraphrase Yogi Berra, there’s a 90% chance that the legislation will pass or not.
This is a really complex issue. Congress hasn’t been really interested in regulating LDTs in the past. That’s a really entwined system that they’d be trying to unravel. There’s a legitimate risk that with too heavy a hand, a lot of tests for rare diseases will disappear. Plus there has to be concern that what’s happening in the EU with IVDR might happen in the US, particularly for innovative, novel tests (as in, ‘let’s try some other market first’). On the other hand, regulation that treats IVDs separately from other medical devices would be a welcome change.
Needless to say, we’ve seen this before. Heck, I even wrote a couple of blogs at Myraqa on the topic, in which I was convinced that regulation was coming. Fortunately, I’ve never been a betting man. There is no doubt that there is fresh interest in the topic, but whether that translates to new regulation is anyone’s guess. I’m thinking no, but frankly my track record here isn’t great. Should make for an interesting summer though.
As the great Mr. Berra once said, “You can observe a lot by watching”.