When Donald Trump took office a year ago, it had a rather sobering effect on the FDA. The new administration was pretty transparent about their lack of enthusiasm for regulations, which is kind of a bummer if you work for a regulatory agency like FDA. So it was no surprise that some at FDA decided to either retire or try the private sector.

One group that was likely giddy about the new direction at FDA was the Laboratory Developed Test (LDT) community. Many LDTs felt that FDA's move to enforce the device regulations in their arena would not only impact patient care, but was fell outside the FDA's jurisdiction. They publicly contested the draft guidance documents the agency published in 2014 on numerous occasions, and lobbied heavily to make the agency back down.

Once it was obvious Trump was taking over the White House, FDA quickly shifted from draft guidance to a white paper on what they'd really like to see in the way of LDT regulation should anyone be interested. And that, it would seem, was that.

Except a funny thing happened...

Once the election dust settled, there were several names buzzing around for FDA Commissioner. One was Dr Scott Gottlieb, a candidate whom many consumer groups and pro-regulation types found to be the lesser of several evils. Nevertheless, his pro-industry stance and direct ties to big pharma made some of them very nervous. But as the New York Times piece last Sunday discussed, he's been a bit of a surprise in his handling of the FDA.

Which brings me to two rather progressive decisions that CDRH made last year. One was the authorization of the Memorial Sloan Kettering (MSK) IMPACT oncology panel test. The other was the approval of the FoundationOne CDx (F1CDx), another oncology panel test. Both curiously enough are LDTs. Both are touted as addressing unmet medical needs by FDA. There's a lot of extraordinary regulatory science in these market authorizations which - if you have the intestinal fortitude to go through - can be found in the FDA Decision Summary (MSK) and Summary of Safety and Effectiveness (F1CDx) documents, respectively.

However I'd like to draw your attention to two key parts to each, which I think help to bolster my current hypothesis that FDA might be doing something innovative with LDTs. First is the MSK decision, which took a device that FDA had previously indicated was a Class III PMA and made it a Class II, albeit with more limited claims around its use. Yet that's not the most fascinating part. What's significant is how they cleared it, relying heavily on the New York State Department of Health (NYSDOH) as a third party reviewer.

Using third party reviewers was always a central tenant of the FDA's strategy on LDT regulation. NYSDOH inspections have long been considered one of the toughest hurdles for labs to clear, so it's no surprise that FDA has certified them. What is surprising is that FDA is moving ahead with one central piece of its LDT regulatory strategy, specifically reducing the regulatory burden on LDTs by using a framework they're familiar with.

Perhaps even more interesting is the F1CDx approval, which came with a simultaneous announcement of CMS coverage for the test. The latter was of course common knowledge as the F1CDx test was making its way through the agency. But what happened after approval wasn't. That's when CMS somewhat casually stated that they are proposing coverage for Medicare patients if:

the test is an FDA-approved companion in vitro diagnostic; and
the test is used in a cancer with an FDA-approved companion diagnostic indication; and
the test provides an FDA-approved report of test results to the treating physician that specifies FDA-indicated treatment options for their patient’s cancer.

Ouch.

Needless to say the LDT community isn't really thrilled with this new approach. Personally, I feel like CMS is coming to the clinical utility party that private payers have been at for years, but you can see why AMP and others believe this is another FDA land-grab. Regardless, FDA seems to be looking for novel ways to get LDTs to come test drive their new and improved regulatory process, and seem willing to use both the carrot and the stick.

Now obviously anyone that knows how the FDA regulatory submission process works gets that these applications were in the works well before Dr. Gottlieb took office. Yet he's not taking the same regulation-is-bad-very-bad approach that his peers in the Trump administration are using. Instead he seems to be pushing to get Congress to legislate LDT regulation (much like his predecessor) while moving FDA to a more "streamlined", industry friendly process. Which all feels oddly...pragmatic. How this plays out in the coming months (years) remains to be seen, but what seems clear thus far is that FDA under Dr. Gottlieb seems to be pushing more towards finding a way to (gently) regulate LDTs that we would have guessed.