Genomics industry facing risk of government regulation

by on July 22, 2010 · 5 comments

It’s been a tough week for the personal genomics testing marketplace.  First there were two long days of FDA meetings, and then today an Energy and Commerce Committee held hearings where the GAO announced the results of a “sting” operation into direct to consumer (DTC) genomics companies.   Below is the (brutal) GAO video.  As Daniel MacArthur has pointed out, today there exist both legitimate and not-so-legitimate testing firms, but the GAO has lumped them all in together, which will make it easier for pro-regulatory forces to get their hooks into the industry.  I urge you to read MacArthur’s entire analysis here, since he follows the industry closely and is saddened by the fact that:

The momentum seems to be well and truly in favour of the bureaucrats now. The prospect of increased regulation (specifically from the FDA) seemed to be enthusiastically received by the Committee today; there was explicit mention of increased money for the FDA to support such a move. The shape of this regulation is as yet unclear, but I’m now extremely pessimistic about the industry’s prospects of escaping excessive, innovation-crushing regulation in the US.

This is very bad news for those of us who wish to see personal medicine flourish.

  • http://srynas.blogspot.com/ Steve R.

    Is the US on its way to becoming a third world nation where corruption is the norm? This is a very powerful video, but it is only one example of the continuing decline in corporate ethics. For those who don't want government involvement (regulation) how can the free-market minimize this type of abuse?

    I never hear free-market advocates actually propose real solutions to this type of abuse, only the monotonous unthinking chant “no regulation”. This is a serious issue since the average person does not have the technical, monetary, organizational, and time resources to resolve this concern on an individual unfocused basis. Time to cough-up a free-market solution for restoring corporate ethics.

  • Jamyrogers

    To lump companies like 23andme, decodeme and FTDNA into the any film flam companies that are listed is tantamount to fraud in itself. Why is the fact that the companies I have mentioned are being charged with no wrong-doing and are valuable tools in knowing your personal risks due to genetic proclivity not noted? I have several autoimmune diseases and when you have one, you will always develop more. It is a relief to find I have a lower genetic risk on some I was concerned with. I have made beneficial lifestyle changes that I would not have even looked at prior. My retina DR said it was good I had those tests as most people do not think of macular issues till the loss is extensive. I am on an early intervention. program to slow it down. It is a lot better, safer and less risk than getting your information from a DRUG company trying to scare you to take a drug you do not need.

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