Razib Khan One-stop-shopping for all of my content

April 7, 2017

Direct-to-consumer genomics, it’s back on!

Filed under: 23andMe,DTC,Genetics,Personal genomics — Razib Khan @ 8:11 am

The past three and a half years, and arguably longer, there has been something of a dark night passing over direct to consumer (DTC) personal genomics. The regulatory issues have been unclear to unfavorable. If you have read this blog you know 23andMe‘s saga with the Food and Drug Administration.

It looks like 2017 DTC is finally turning a regulatory corner, with some clarity and freedom to operate, FDA Opens Genetic Floodgates with 23andMe Decision:

Today, the U.S. Food and Drug Administration told gene-testing company 23andMe that it will be allowed to directly tell consumers whether their DNA puts them at higher risk for 10 different diseases, including late-onset Alzheimer’s disease and Parkinson’s.

The decision to allow these direct-to-consumer tests is a big vindication for 23andMe, which in 2013 was forced to cease marketing such results after the FDA said they could be inaccurate and risky to consumers, and that they required regulatory approval.

I still agree with my assessment in 2013, this won’t mean anything in the long run. DTC is here to stay, and if the decentralization of medical testing and services don’t happen in the USA, they’ll happen elsewhere, and at some point medical tourism will get cheap enough that any restrictions in this nation won’t be of relevance. But, this particular decision alters the timeline in the grand scheme of things, and matters a great deal for specific players.

It’s on!

March 13, 2011

DTC testing, mailing addresses, contact information, etc.

Filed under: DTC,FDA,Genetics,Genomics,Jeffrey Shuren,Personal genomics — Razib Khan @ 12:10 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 ...

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