The aphorism “No good deed goes unpunished” has its counterpart when applied to business, “No good innovation can remain unscathed by the FDA.” To wit: last week the Food and Drug Administration all but ordered the company 23andMe to shut down. Their crime? They have the unmitigated gall to market their Personal Genome Services without having received prior “marketing clearance or approval” from the FDA. Those silly saps at 23andMe forgot they have to kiss the ring of their overlords if they wish to operate a business in this country.
For those unfamiliar, 23andMe sells a $99 genetic testing service wherein a customer submits to them a saliva sample that the company then performs a variety of genetic tests on in order to reveal any potential health concerns (e.g. the presence of genes predisposing one to certain types of cancer or sensitivity to certain drugs, etc.). The tests can also reveal hereditary information to provide one with possible ancestry background as well. All of this is wrapped up in a pretty slick website (that actually works!) that allows the customer to explore his or her results. They’ve basically turned something rather dull and boring (medical testing) into an exciting process of discovery that is actually affordable. With that said, the processes and testing they employ are all well vetted industry standard type testing procedures. They are simply taking existing technology and repackaging it into an easy to understand and affordable package in order to make it available to a much wider cross segment of society.
So what is the FDA’s beef with them? It’s basically semantics. You see, when either the FDA or EPA gets involved with business then all common sense goes out the window. Water becomes an insecticide and aspirin a dangerous drug. A fanciful example will help illustrate: screwdrivers are used to turn screws, and so they can be sold to turn screws, no problem. But if you now decide a screwdriver can also be used to poke holes in things or to act as a tool to pry something open and you wish to market it as a “device for poking holes or prying”, then you are now guilty of selling a “mislabeled and misbranded” product because you have not engaged ABC federal agency to plead for approval of this new application of existing technology. You will need to submit studies and analysis demonstrating that the screwdriver can indeed do these things.
That’s basically the hole 23andMe has fallen into. The FDA is concerned that they are marketing a process in a new and therefore unapproved way and they are also concerned that consumers of this service are incredibly and remarkably stupid. The FDA believes that if someone gets a false positive from one of 23andMe’s PGA tests that naturally that someone will simply take immediate and drastic actions without any kind of follow up testing or consultation with their physician. If a woman finds she has the breast cancer gene, well, she’ll just get a double mastectomy, no questions asked. If someone finds out they are prone to blood clots, they’ll just go out and start eating rat poison (the blood thinning agent warfarin is found in rat poison) in order to self medicate. Yes, as absurd as these concerns are, this is what the FDA is trying to protect us from. Of course never mind that 23andMe has very large and obvious warnings on their site that one should always consult with one’s physician before taking any steps based on test results.
So, at the height of concern in this country about rising medical costs a company steps up to the plate, provides a low cost non-invasive test that affords the customer the ability to proactively manage their health thereby preventing future costs. And how are they rewarded? The FDA valiantly steps in to all but put them out of business by forbidding them from marketing their product. Smart. Really smart. It is through actions such as these that the FDA has caused and will continue to cause far more pain, suffering and death then they have ever prevented.