Part 3 of Five Golden Rants
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The rest of my rants are for things people actually did in 2010. This one's for something that's only been discussed behind closed doors. But if an idea is bad enough, just discussing it seriously may be all that's needed for most of its badness to take effect.
Creating a whole new bureaucracy to review LDTs
I can't get a copy of the proposed "Hatch Act" for review, but the core idea is ridiculous. From what I can gather, Hatch would propose that we disregard the incredible expertise that has been built in understanding, reviewing and regulating diagnostic products in favor of creating yet another center (Center for Advanced Diagnostics Evaluation and Research) and new set of regulations
It might seem odd that a hard-core Republican is proposing additional oversight and new regulations. It's not that confusing, though, when you consider that the obvious purpose of the new center is to reduce net oversight, not to create it. That's because Hatch seeks to establish the two-tiered system between LDTs and IVDs as a matter of law, not enforcement discretion. It's DSHEA for diagnostics.
There are many reasonable ways to address the differing requirements for LDTs and IVDs. I, for one, think it's wrong to create lower standards specifically to encourage the use of unproven, clinically unvalidated tests. These tests are sometimes sold DTC, and are even being applied to some of the most serious diseases.
When I contemplate any legislator wanting to encourage and promote that outcome, it makes me shake my head and wonder about our legislative system.
Talk about a waste of time and money. Closing the LDT gap does not require a new bureaucracy, nor does it require flinging serious disrespect at the folks at FDA and CMS that have been doing the job of keeping an eye on these products for many years. This is a serious tangent that is taking everyone’s eye off the ball at a time where we need to focus on the best way to make sure physicians and patients are getting good information about their health.
The Hatch Act is just a trial balloon so far and may never actually see the light of day. Even so, it's a safe bet Senator Hatch will find some way to stay involved in the LDT discussion now that he has figured out that ARUP and Myriad are located in Utah. I can't wait to see how this plays out in 2011.
