While Walgreens may have voluntarily chosen not to sell home genetic testing kits in the face of an FDA investigation, its action has brought attention to the entire for-profit testing industry, and others may not have the luxury to quietly shut down on their own. A congressional committee is looking into the business, and could end up regulating the industry.
Wired News spliced the details:
The House’s Committee on Energy and Commerce sent requests to the CEOs of 23andme, Navigenics and Pathway Genomics for a wide array of information about the companies’ services.
The letters, co-signed by Henry Waxman (D-California), Joe Barton (R-Texas), Bart Stupak (D-Michigan), and Michael Burgess (R-Texas), ask for all documents dating from January 1, 2007 to the present.
First, the committee wants “a chart listing the conditions, diseases, consumer drug responses, and adverse reactions” for which the companies’ test and “all policy documents, training manuals, or written guidance” about their counseling policies. They also requested all documents related to how the companies identify the risk to consumers based on their genomic profiles, and how they process and use individual DNA samples.
Add it all up and the documents could be the starting point for a wide-ranging investigation, if the committee decides to go down that road.
As of now, neither the committee nor the FDA are making any statements about long-term plans, but as Wired points out, “they’ve had a relatively free ride from regulators, which appears to be ending.”