Breaking: Congressional Committee Requests Additional Information Regarding 23andMe Sample Swap
Nearly a month ago we reported that the House of Representatives Committee on Energy and Commerce had launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to several of the most prominent DTC companies: 23andMe, Pathway Genomics and Navigenics.
Today the Committee has followed up with another letter, this one directed to 23andMe president and co-founder Anne Wojcicki, inquiring into the circumstances surrounding the company’s recent and widely reported sample swap. The letter (pdf), which is signed by the same four Representatives (Waxman, Barton, Stupak and Burgess) requests the following:
1. All internal and external communications relating to the collection, processing, and analysis of DNA samples affected by incorrect processing, including all communications with third-party laboratories and all instructional documents detailing appropriate handling of DNA samples;
2. All internal company policies, directives, and written guidance materials relating to the company’s handling of errors in the collection, processing, and analysis of DNA samples; and
3. All documents relating to previous instances in which 23andMe customers received DNA results belonging to other persons.
As was true of the last round of Congressional letters, this appears to be a broadly worded request for all relevant information. It’s unclear to me whether the third request – for information relating to prior data mix-ups – is simply a Congressional fishing expedition or a request rooted in evidence that this is a problem 23andMe has had before.
One thing that this letter makes abundantly clear – coming as it does only a week after the 23andMe sample swap was first reported by Daniel MacArthur of Genetic Future, and just days after the FDA announced its intention to regulate several DTC genetic tests, including 23andMe’s test, as medical devices – is that DTC genetic testing has the full attention of this particular Congressional Committee.
After spending the majority of the time since its inception three years ago free from significant legislative and regulatory oversight, particularly at the federal level, the DTC genetic testing industry is now indisputably under the microscope.
Oh good grief! Can anyone tell me where in the Constitution (our asinine, overreaching and overspending) Congress gets this authority? The FDA is not even Constitutional since it has nothing to do with the 3 enumerated powers of the Federal government.
@SL
Since when does the Constitution matter? Court packing anyone??
@SL. Congress “gets” the authority from the Commerce Clause, if nothing else. Article I, Section 8, Clause 3 of the Constitution states that that the United States Congress shall have power “to regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes”. It is my personal view that Congress has used the Commerce Clause to poke its’ fingers into anything it wants when it can’t find some other (more legitimate) basis, and the Supreme Court has done its share to expand Congressional authority in this regard (especially after FDR’s threatened to “pack the court” by expanding the Supreme Court from 9 to 15 Justices.
The the first two paragraphs of the Wikpedia entry on Wickard v. Filburn (1942) should give you a great concise and accurate illustration of just how expansive Congress’ authority is.