The FDA and Balancing Innovation vs Regulation
The FDA just announced that it is going to regulate 23andme, which provides DNA analysis when you spit into the kit they provide for $99. The regulation requires 23andme to cease some of its operations until the lengthy FDA procedural timeline is enacted.
This FDA action sparked an interesting twitter debate in Atlanta. If the FDA can regulate 23andme, what else can they regulate? Where is the line drawn?
In addition to 23andme, here are two other areas that could potentially come under FDA scrutiny:
- Should all the new fitness devices (Jawbone Up, Fitbit, etc) be FDA regulated? They provide heart rate, body movement, and sleep information.
- Should wearable computing or augmented reality devices be regulated? They change the way we perceive things and the way we “see.” People are using Google Glass to do augmented reality in medical practice.
How far should regulation be pushed? Should clothing be regulated? Clothing can chaff our skin. Skin is the largest organ in the human body.
Regulation is important to keep people safe. It is necessary in many cases. But it is also dangerous when it cuts off interesting innovations and increases the costs to start a new business or invent a new device. Regulation favors incumbents over entrants in a market.
What are your thoughts on balancing innovation vs regulation?
Related articles
- FDA Tells 23andMe to Stop Marketing DNA Kits; 23andMe Says It’s Sorry for Being Slow
- Why the FDA is targeting genetic testing firm 23andMe: Unnecessary MRIs, mastectomies
- FDA Tells 23andMe to Halt Sales of Genetic Test – ABC News
- Our DNA, Our Selves
- FDA Halts Marketing Of 23andMe’s Genetic Test Kits
- FDA Tells Google-Backed 23andMe to Halt DNA Test Service
- FDA Tells 23andMe To Stop Selling Popular Genetic Test
From the conversation
Comments preserved from the original post.
Michael Munroe
This is the dumbest thing that I have seen the FDA do. They are a tool for someones political agenda. Given the “former” Monsanto folks on the board – I’m going to guess that it is dirty politics.
23andme is spawning a ton of research. They are a “force multiplier” for genetics-related research. Most of the folks that I know who use them, plug their results directly into their primary care physician for interpretation. All of the methods are peer-reviewed, bleeding-edge, excellent.
This looks like repression of innovation to me, and I do not like it.
I am a happy customer of 23andme. My microbiologist wife and very excellent primary care physician loved the material and find it valuable.
melonakos
In reply to an earlier comment
Well said 🙂