A couple of weeks ago, we saw the sorry saga of the Food and Drug Administration stomping on the effort by the direct-to-consumer (DTC) genotype screening company, Pathway Genomics, to offer its tests through drugstores. Pathway had reached an agreement with Walgreens to sell its test kits over-the-counter in its 6,000 or so stores. The FDA sent a threatening letter asking Pathway to justify the unregulated sale of a "medical device" to the public, and Walgreens backed away from its deal with the company.
Now the Congressional nanny-in-chief and head of the House Energy and Commerce Committee, Rep. Henry Waxman (D-Calif.) is demanding information by June 4 from three DTC companies, Pathway Genomics, Navigenics, and 23andMe. As Bloomberg reports:
The lawmakers gave the companies until June 4 to submit documents on the ability of the tests to identify consumers' risks for illnesses. The legislators also requested information on the proficiency of the companies' lab testing, policies on consumer privacy and whether the kits comply with FDA rules.
Some purchasers of the screening tests may be dissatisfied with their experiences, but I would suggest that most are first-adopter types who recognize the current limitations of genetic screening science. The way that consumers learn about the upsides and downsides of new products is to try them out; just as the way companies learn how to improve their products is through customer feedback. As often occurs, the "I'm-from-the-government-and-I'm-here-to-help" types are eager interfere with this kind of speedy social learning.
If you've been thinking about buying a gene screening test, you might want to go ahead now before Congress and the FDA make it illegal for you to get this kind of information. Just saying.
Disclosure: I am a happy customer of 23andMe (though I really wish their test had screened for the APOE4 allele associated with a much higher risk of Alzheimer's disease). Given this news, I am going to order a new test from another company today. I own no stocks in any gene screening companies. Finally, my article on the joys of DTC gene screening and the exaggerated concerns over genetic privacy has at last been submitted to my editors at Reason who are now busy making improvements to it.