Tag: FDA

23andMe and the FDA clearance

By Razib Khan | July 31, 2012 1:18 am

As they say, read all about it. I’m rather ambivalent. 23andMe has a business rationale to go in this direction, so I don’t begrudge them their decision. The problem, at least from a legal perspective, is that they’re providing medical advice at least implicitly. And I think this medical direction is really where the big money is in any case. There’s no angle standing on principle.

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CATEGORIZED UNDER: Bioethics
MORE ABOUT: FDA

Genetic paternalists are very patronizing

By Razib Khan | March 29, 2011 11:17 am

An comment below on my post Genetic paternalism & the F.D.A.:

I came across your inflamed post from March 9th and the more I read the more disappointed I became, especially when I read your comment “following twitter, it seems there may be a distinction between raw sequence and interpretation. it may be the latter where there are “gatekeepers.” probably for reasons of liability, public safety, etc. (ergo, FDA). i see the logic, but from a perspective of utility i don’t think that the regs will improve human well being. though that’s probably not the implicit rationale behind “interested parties.””
The distinction there is ABSOLUTELY CRUCIAL. There is a huge difference between providing your raw genomic information, and providing diagnostic interpretation.

The AMA letter http://www.ama-assn.org/resources/doc/washington/consumer-genetic-testing-letter.pdf clearly stated that it was directed to ” direct to consumer (DTC) genetic tests that make medical claims” and it is “the making of medical claims” that puts certain offerings of DTC genetic testing squarely in the FDA’s domain; uninterpreted DTC genetic test results – the raw sequence – are NOT in the FDA’s domain under current regulations. Medical claims are. And I have not heard the FDA claim that they would even try to regulate uninterpreted DTC genetic test results. Have you? (not a rhetorical question)

I found your sloppy, over-emotional post — and the unthinking overreactions by commentors, to be deeply disheartening. How can people claim to be super-smart and bellow about their right to their own information and to be better informed than 99% of MDs (sheesh there is some unsubstantiated overstatement) — how can these people lack the basic common sense, much less decency, to read carefully and think through the actual regulatory issues, before starting to self-righteously holler about being stepped on? Shame on all of you who did that.

Razib – please post an “oops I over-reacted” with respect to this entire over-heated mess that you have poured oil onto. That would show some integrity and thoughtfulness, which we need more of. We do not need more emotional over-reactions to regulatory issues. The dietary supplement people are doing just fine with that.

Before entering into a presumptuous and patronizing lecture, it would have been nice to explicitly admit some conflict of interest here (some MDs arguing for control over this industry did in earlier comments). The IP originates from Joan and Sanford I. Weill Medical College and Graduate School of Medical Sciences of Cornell University. This is the internet. If you’re going to get stuffy and professorial you might want to use your real name.

CATEGORIZED UNDER: Genetics, Genomics
MORE ABOUT: FDA, Paternalism

DTC testing, mailing addresses, contact information, etc.

By Razib Khan | March 13, 2011 1:10 pm

Chris, and others, have encouraged me to put up some contact information in regards to DTC testing and the . Here is what Chris has gathered….

The Center for Devices and Radiological Health (CDRH) is the division of the FDA that would be responsible for DTC genetic testing. And Office of In Vitro Diagnostic Device Evaluation and Safety (OVID) is the relevant CDRH office. The CDRH director is Jeffrey Shuren. OVID’s director is Alberto Gutierrez, and OVID’s personalized medicine staff are headed by Elizabeth Mansfield. Use the following to contact FDA staff:
• list of CDRH personnel
• contact info search form.

Dr. Jeffrey Shuren
Director, CDRH
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-5900
Fax 301-847-8510
jeff.shuren@fda.hhs.gov

Nancy Stade
Deputy Director for Policy, CDRH
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-5900
Fax 301-847-8510
nancy.stade@fda.hhs.gov

Alberto Gutierrez
Director of OVID
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone 301-796-5453
Fax 301-847-8515
alberto.gutierrez@fda.hhs.gov

Elizabeth Mansfield
Director of Personalized Medicine
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone 301-796-4664
elizabeth.mansfield@fda.hhs.gov

The Commissioner of the Food and Drug Administration is Dr. Margaret Hamburg. She’s probably busy, but her chief of staff is Molly Muldoon. There is a list of the commissioner’s closest staff here and an address search form here.

Dr. Margaret Hamburg
Commissioner of the FDA
White Oak Office Building 1
10903 New Hampshire Avenue
Silver Spring MD 20993
margaret.hamburg@fda.hhs.gov

Molly Muldoon
Chief of Staff, FDA
White Oak Office Building 1
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-9691
molly.muldoon@fda.hhs.gov

More at Chris’ post.

CATEGORIZED UNDER: Genetics, Genomics

Your genes, your rights – FDA's Jeffrey Shuren misleading testimony under oath

By Razib Khan | March 9, 2011 12:05 pm

Over the past few days I’ve been very disturbed…and angry. The reason is that I’ve been reading Misha Angrist and Dr. Daniel MacArthur. First, watch this video:

In the very near future you may be forced to go through a “professional” to get access to your genetic information. Professionals who will be well paid to “interpret” a complex morass of statistical data which they barely comprehend. Let’s be real here: someone who regularly reads this blog (or Dr. Daniel MacArthur or Misha’s blog) knows much more about genomics than 99% of medical doctors. And yet someone reading this blog does not have the guild certification in the eyes of the government to “appropriately” understand their own genetic information. Someone reading this blog will have to pay, either out of pocket, or through insurance, someone else for access to their own information. Let me repeat: the government and professional guilds which exist to defend the financial interests of their members are proposing that they arbitrate what you can know about your genome. A friend with a background in genomics emailed me today: “If they succeed in ramming this through, then you will not be able to access your own damn genome without a doctor standing over your shoulder.” That is my fear. Is it your fear? Do you care?

In the medium term this is all irrelevant. Sequencing will be so cheap that it will be impossible for the government and well-connected self-interested parties to prevent you from gaining access to your own genetic information. Until then, they will slow progress and the potential utility of this business. Additionally, this sector will flee the United States and go offshore, where regulatory regimes are not so strict. BGI should give glowing letters of thanks to Jeffrey Shuren and the A.M.A.! This is a power play where big organizations, the government, corporations, and professional guilds, are attempting to squelch the freedom of the consumer to further their own interests, and also strangle a nascent economic sector of start-ups as a side effect.

You are so much more than your genes. So much more than that 3 billion base pairs. But they are a start, a beginning, and how dare the government question your right to know the basic genetic building blocks of who you are. This is the same government which attempted to construct a database of genetic information on foreign leaders. We know very well then who they think should have access to this data. The Very Serious People with a great deal of Power. People with “clearance,” and “expertise,” have a right to know more about your own DNA sequence than you do.

What can you do? What can we do? Can we affect change? I don’t know, I can’t predict the future. But this is what I’m going to do.

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CATEGORIZED UNDER: Genetics, Genomics
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This blog is about evolution, genetics, genomics and their interstices. Please beware that comments are aggressively moderated. Uncivil or churlish comments will likely get you banned immediately, so make any contribution count!
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