Breaking: Congress to Investigate DTC Genetic Testing

The United States House of Representatives Committee on Energy and Commerce today launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to three prominent DTC companies: 23andMe, Pathway Genomics and Navigenics. Here is the announcement from the Committee:

Today Chairman Henry A. Waxman, Ranking Member Joe Barton, Subcommittee Chairman Bart Stupak, and Subcommittee Ranking Member Michael C. Burgess sent letters to 23andMe, Inc., Navigenics, and Pathway Genomics Corporation in light of recent reports that at least one of the companies is seeking to sell personal genetic testing kits in retail locations, despite concern from the scientific community regarding the accuracy of test results.

The Committee is requesting information from the companies on several aspects of the tests: How the companies analyze test results to determine consumers’ risk for any conditions, diseases, drug responses, and adverse reactions; the ability of the companies’ genetic testing products to accurately identify any genetic risks; and the companies’ policies for the collection, storage, and processing of individual genetic samples collected from consumers.

Signed by the Chairman and Ranking Member of both the full Committee (Henry Waxman and Joe Barton) and its Subcommitee on Oversight and Investigations (Bart Stupak and Michael Burgess), the three letters (23andMe, Pathway Genomics, Navigenics) appear to be substantively identical.

The Committee appears to be interested in gathering information. Lots and lots of information. The letters are impressively broad in their scope, which is unsurprising given that this is the first publicly reported Congressional investigation into the current generation of DTC genetic testing companies. (A previous investigation into several companies offering nutrigenetic testing culminated in this GAO report to Congress.) The Committee is seeking the following information for each DTC company:

(1) description of available tests, including which conditions, diseases, drug responses, etc. are tested;

(2) policies with respect to the involvement or availability of genetic counselors and/or physicians in conjunction with its tests;

(3) scientific support for the accuracy of its tests (including proficiency testing) and validity of its reported associations;

(4) policies for processing and use of DNA samples, including privacy protections and third party use; and

(5) compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA) and FDA regulations.

The DTC genetic testing landscape has certainly shifted dramatically. This time last week, Walgreens and CVS were still planning to offer DTC genetic tests from Pathway Genomics on drugstore shelves nationwide. Since then, first the FDA and now Congress have launched investigations into DTC genetic testing.

As for what happens next, that’s anybody’s guess. The FDA, in its letter last week to Pathway, gave the company until May 25th to demonstrate that it has proper FDA approval or to explain why such approval is not necessary. Congress is proving slightly more generous, giving the three companies until June 4th to respond to its information request. Rest assured that nobody at any DTC genetic testing company, including those not currently targeted by either the FDA or Congress, of which there are plenty, is going to be getting much sleep over the next few weeks.

The Genomics Law Report will have more on this story, and the future of DTC genetic testing and regulation, as developments occur.