Thursday, July 15, 2010

FDA and the DTCG company MashUp.

I know I said I would stop writing about 23andSerge. I will, but I am still going to write about what I think may go down next week in D.C. Land.

As you may know, I am a big supporter of classifying DTCG tests in certain ways

1. If the company has purported some sort of health benefits or decisions regarding medical care for a test, then it should be classified as a medical device and regulated as such. Class II or Class III

2. If a DTCG test does actually have medical implications for treatment, diagnosis or prevention, regardless of what a company says, this should be a Class III subject to premarket review.

3. If a DTCG test has nothing in the way of health implications or diagnosis, treatment or prevention it should not be considered medical.

If 3 should become item one or 2 based on new evidence, then it should be regulated as item one or 2.

What do I think should happen here with the FDA and DTCG? Well, it depends.

One has to ask first, will regulation stifle innovation?

If you ask me, most of this rhetoric is merely legal polemic. Very similar to how the Pharma companies complain about regulation. I have seen very scant evidence on the horrible effect it has on health or longevity.

In fact most of the "evidence" on regulation seem to come via law school papers and angry blog posts and twitter feeds.

But to get at the heart of this issue facing regulators we need to ask a follow up. Is innovation a good thing?

A priori I would say yes. Always? No.

I challenge anyone to prove to me that some innovation hasn't led to bad things or bad outcomes. "Magic Mineral" anyone? Or how about derivatives trading?

Assuming that not all innovation is good, we can see the role of regulation to prevent the harm of bad innovation. Is that such a bad thing? The general pubic doesn't think so. A poll in May finds that 72% of Americans trust the job the FDA does. They also are wayin favor of regulation of innovation in the space.

Now the FDA needs a litmus test for genomic innovation to define their regulation. What defines bad innovation?

I would say:

1. Potential for human harm from use of innovation.

2. Misrepresentations of expected outcomes from using innovation.

3. Lack of innovation performance of stated use.

I think in some ways, certain DTCG companies have had 2 and 3.

Number One is a potential in some peoples minds, but I have clinical examples that were presented by K.O. a year or 2 ago.

Unfortunately for the FDA, they have some lines and categories already which can create some rigidity in their guidance. And may not apply the scale I use.

But, it is just a construct. Similar to the one I presented before.

Will the FDA throw out traditional guidance here?


They will follow the construct listed here, no matter how many people rant and rave at the DC meeting. Why?

I just told you. The public wants innovation in healthcare regulated. Which leads me to my next question. What do you think congress will do?

The Sherpa Says: We have to stop ranting about how the world will end if this tiny little field with the "unproven" ability to transform medicine sans clinician has to face regulatory scrutiny. Instead, we have to ask, is this a good innovation now? How will we make it a good innovation? Can we?

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