In response to Dan Vorhaus, Of Drugstores and Devices: Parsing the FDA’s Evolving DTC “Policy”

Perhaps Pathway has been targeted for regulatory enforcement not because of a particular of “substance”, but because of a particular of enforcement itself: it is easier to physically enforce containment than it is to ideologically enforce cooperation.

I do believe that location is relevant to FDA enforcement because American federal government agencies police the “location” of the geographic United States and not the substance of ideas as universal abstractions.

However, I do agree that I think that the “discretion of enforcement” has been crudely applied. I too would prefer that this “regulatory discussion” began with an official publication describing enforcement policy rather than a quote in the popular press.

But, perhaps the attitude of many people is that while they too prefer a “regulatory discussion,” they do not deign themselves to participate in “block faction conflicts.” In that case, enforcement is not about “substance”: who started what in medical genomics. It’s all about “location”: expedient slum clearance without lame excuses and backtalk from the denizens of DTC Genomics.

Indeed: how do you host a good faith, civilized conversation about “genomics in public health” with the sort of rabble who sells Tay-Sachs, BRCA, and drug metabolism diagnostics as “Not for diagnostic use” from a blimp over booze with celebrities; who call themselves “revolutionaries” and you “the evil empire” and then publicly mock your inaction to stop them?

I disagree with Steven Murphy that the regulatory agencies should have been included in the first place. I think that the FDA should have never have been engaged at all.

Ideally, people would be trusted to order their own medical tests reasonably, and medical test providers would be trusted to govern themselves sincerely. But no. A certain cabal and their trashy scheme to “seize the future of entrepreneurship” has ruined this future for everybody.

So, I think that Pathway has been selected for FDA enforcement not because of any particular about Pathway’s genetic test itself, but because Pathway was a vulnerable target in an already targeted domain, and it’s easier to start with a one easy win as precedence for future enforcement policy than it is to try to police all possible targets simultaneously.

Aside: Isn’t this what Fancy School is for? You go to Fancy School to learn how to act civilized, and in exchange, you are given the power and the discretion to operate in society beyond what is otherwise tolerated. You don’t actually have to be civilized. (That’s for sucker overachieving middle class types who try too hard and don’t know better.) You just have to not flaunt yourselves in public and embarrass everybody.

This sounds like a fair deal to me: in exchange for not insulting everybody with your trashy “non-medical” Tay-Sachs, BRCA Breast Cancer, and drug metabolism medical tests which you push on the public as a goofy toys while you play T-Shirt Che Guevara, you don’t have to suffer the indignity of arbitrary FDA beat cop interrogations for whichever of your hoodies happen to be most conveniently “available” and then having to list your home address, driver’s license, and the contact information of your “current or most recent employer” for “future reference.”

(But Andrew, 23andMe and Pathway are completely different companies!)

Yah. Uh huh. Yah. Wrong neighborhood. Cops don’t care. You all look the same. Name, address, license and registration? Sign here, please.