1 vote

The FDA's Attack on 23andMe

by Shayne Wissler

Today, the FDA sent this enforcement letter to genetic testing company, 23andMe.

In this blog post I am going to clear up some common misconceptions.

This action will hurt 23andMe.

Not necessarily.

The action will not necessarily hurt 23andMe the company, but it will certainly stifle innovation, in two ways: 1) New companies will not be given the nearly 8 year head start 23andMe had in working virtually free from FDA interference. On the contrary, any new “little guy” competitors to 23andMe that spring up can expect immediate FDA interference, which will prevent us from ever seeing most of them; businessmen will send the capital elsewhere. 2) Money and attention that would have been spent on R&D will instead be spent on clearing bureaucratic hurdles. New ideas within the company will be judged not according to their effectiveness in principle, but on their economic viability in the new bureaucratic setting.

What doesn’t kill 23andMe will make it relatively stronger by killing competition, but R&D will slow. This is how companies go from being path-breaking innovators to being stodgy. Such consequences are not the inevitable result of brilliant success on a free market — it’s what happens in America’s corporatist regime.

continue reading