"The Secretary shall issue such an authorization letter if the notification provides reasonable assurance of the clinical validity of such claimed uses. One or more studies published in a peer-reviewed journal... or data from unpublished studies... shall be sufficient to constitute reasonable assurance of the clinical validity of the claimed uses. ... The Secretary shall not require a laboratory or test-offering entity to include ...evidence of... clinical utility; or ...the ability of a physician, provider, or consumer to interpret a test result"
H.R.3207, The "Burgess Bill"
Late last week, Congress yielded a bumper crop of new legislation aimed at changing the IVD regulatory process. The Klobuchar bill has yielded the most attention so far and we'll try to have something thoughtful to say about it soon.
The one that really caught our eye, however, was the "Burgess Bill" that was burning up inboxes last week. Introduced on Friday, it's H.R.3207, the "Modernizing Laboratory Test Standards for Patients Act of 2011" (PDF). The bill was introduced by Rep. Michael Burgess (R-TX), who has previously expressed concern that excessive regulation is driving innovation and investment money away from the US device sector.
For what it's worth, we agree that the possibility of capital flight from the sector is a serious, important problem to address. H.R.3207 is not a serious framework for addressing it, however.
In a nutshell, the bill aims to take just about everything OIVD currently does and just have them not do it anymore. It then takes those responsibilities and nominally transfers them to CMS. It represents nothing less (or more) than the wholesale torching of 30-odd years of governing experience and a quick spackle job to cover the ashes.
More specifically, the bill aims to accomplish this by:
- Amending the FD&C Act to re-define "device" such that it no longer applies to LDTs or DTC "DNA Tests"
- Greatly expanding the definition of LDTs and broadly defining "DNA Tests" such that just about any reasonably complex IVD could qualify somehow
- Defining a premarket notification process that assures clearance to pretty much anyone who can figure out how to staple a journal article to their application form (quoted above)
A lot of people are champing at the bit to pull FDA back from evaluating clinical utility. We, too, believe this is a reasonable conversation we should be having.
If you're going to attempt to achieve this outcome, however, moving LDT governance to the one entity that is unambiguously charged with evaluating clinical utility is just dumb. After all, CMS is not just sitting on their hands here... they recently allowed their national contractor to announce a policy that denies coverage for most LDTs. In anticipation that they will be taking on more responsibilty, CMS is already playing hardball behind the scenes. Handing them the reins will simply speed the metamorphosis. CMS and FDA are both part of HHS, so we'd wager CMS could even trasfer in many of the exact same people currently doing this job at OIVD.
There are a lot of potential benefits to having members of Congress put focus, thought, and attention to streamlining the regulatory burdens faced by IVDs and LDTs. Unfortunately, "thoughtful" doesn't appear to describe what is going on here. It's clear that Republicans are test driving FDA "reform" legislation as a campaign issue and Speaker Boehner has repeatedly chosen to associate himself with Pathway Genomics CEO Jim Plante.
We work with a lot of LDT companies who operate high-quality labs that produce rigorous, well-supported results for patients. There are a number of things that FDA can and should do to provide a more predictable and direct pathway to market for tests that truly can advance the state of medicine. Accommodating high-quality lab tests will require some adjustments to our regulatory standards and policies, but it is insulting to assume that LDTs can't live up to real standards at all. That's the kind of impression you might get from listening to the worst of the industry, not the best.
Whatever we do next, we should take care to insist on maintaining high scientific standards. High standards are what make the US market the place that most companies in and out of the US still want to sell into. It's shocking that this point even needs to be made, but also shocking to see a serious industry group like AdvaMed proactively applaud efforts like the Burgess Bill.
Pathway Genomics neither needs nor deserves to have the entire Federal regulatory apparatus re-arranged to suit them. If we allow them to become the standard by which the rest of our industry is measured, we truly will be in trouble.