On Friday, November 22, the Food and Drug Administration sent a letter to personal genetics company 23andMe demanding that the company halt sales of its testing units on grounds that it is selling what the FDA deems “medical devices.” The case highlights the immoral system of controls and spirit of paternalism on which the FDA is founded.
The devices in question are personal, in-home units advertised as able to diagnose for genetic diseases and conditions such as coronary heart disease, diabetes, and Alzheimer’s and to warn of potential adverse drug effects. What is striking about the FDA’s action is that it does not cite any proven fallibility in 23andMe’s tests for any of these conditions. Nor does it cite dangerous actions taken by its customers based on test results. To the contrary: much of its complaint implicitly treats the tests as at least somewhat dependable.
The FDA’s primary complaint appears to rest on the notion that 23andMe’s units could potentially lead Americans to “self-manage”, making medical decisions on their own based on the information that the tests provide (such as ceasing to take prescribed drugs should the tests show a potential adverse reaction). What makes such “medical devices” or individual’s responses to them categorically different from personal thermometers or pregnancy tests, the readings of which might lead one to take any number of medically significant actions, is undefined and highlights the subjective nature of the category.
Furthermore, no concern is paid to the idea that the tests, if reliable, might lead individuals to challenge errant or incomplete medical advice. Patients are placed at the mercy of their doctors and forbidden the tools to seek knowledge of their own condition.
In an unfortunate development, 23andMe announced yesterday that has been made to temporarily shut down its health-related genetic testing services pending FDA regulatory review.
This is the nature of our regulatory state today: treating actions by private individuals guided by their own judgment in the absence of statist controls as the greatest threat to our country and using preventive law as a weapon against private companies without evidence of wrongdoing.
Companies like 23andMe provide an increasingly valuable service at a time when America’s medical sector is being ravaged by government overhaul and when Americans may soon need innovative, private medical services more than ever. That the FDA should halt its sales based on conjecture and hypothetical dangers is a testament to the weakness of its claims and the government’s continued privileging of its own power over Americans’ well being.