FDA Orders a Company to Shutdown: And What Exactly is the Consumer Benefit?

Last week, the FDA ordered the popular genetic testing startup 23andMe to shutdown. The FDA sent a letter to the company, saying they should stop marketing their popular kits immediately, as it hadn’t been completely cleared or approved by them. The worry, according to the FDA, is that some consumers might use the results from the genetic tests to self-treat, or the possibility for false positives for certain diseases or genetic traits.

23andMe, for those who aren’t familiar, allows consumers to test their DNA to get results on if they’re carrying certain hereditary diseases, if they’re at risk for genetic problems, and alerts you of them so you can work with your doctor to treat or prepare for any health concerns. The tests are administered in your own home, by yourself—you simply spit into a repository, seal it up, and mail it off. You have your results in a matter of weeks. And the cost? A paltry $99, a small price to pay for many who want to be prepared for any health concerns they should be prepared for as they grow older.

As often happens with fast moving, innovative products, the government has finally caught up to 23andMe. The government feels the need to regulate this innovative new product and service, as they fear consumers can’t make decisions on their own. Of course, as Reason’s Ronald Bailey points out, there isn’t a single instance of a consumer being harmed from this testing kit. What really happens is that these kits allow a dialog to start between a patient and their doctor, and more testing to commence to make sure the initial tests are correct.

The FDA has a history of regulating and keeping products out of the marketplace that could be helpful to consumers. In fact, there’s a movie in theaters now, Dallas Buyers Club, which chronicles a man’s fight to bring life saving AIDS drugs to consumers, and the FDA’s fight to stop him. In the film, a man brought drugs that were being safely used and saving lives in other countries to the United States. There’s also been a movement underway for years for the FDA to approve cancer drugs faster—there are many drugs languishing in testing trials that could be brought to market faster that could save thousands of lives. Bart Madden chronicles many of these cases in his book Free to Choose Medicine.

There, of course, may be a compelling need to have the FDA involved in some drug testing and keeping consumers safe, but at some point, adults should be left to make their own decisions. In the case of 23andMe, there’s no immediate harm that could come from using the service. As with any product, consumers should be trusted to use products wisely. We’re on the brink of some exciting developments in the life sciences field, and the last thing entrepreneurs and innovators need is the regulatory hand of the government involved.

Zack Christenson writes on digital tech issues for the American Consumer Institute Center for Citizen Research. 

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