FDA… Today, Not Enough Regulation. Tomorrow, Too Much.

Implications: Expect a window of opportunity in a wild west of genetic testing before abuse and a federal over-reaction.

Analysis:  It's a case-book example.   The world of genetic testing is a fast-moving technology, unfettered by a regulatory structure. Some tests will be life-saving. Some may lead to a market for preventive medications that don't exist today. And others will simply be junk-science, playing off people's fears. Those hawking the worst of these tests may actually endanger consumers by prompting them to take inappropriate interventions.   So what will happen?  As technology continues to develop, we will see a mix of useful and less than useful tests. Rarely have regulators been able to finesse a scheme to appropriately handle the intricate differences between valuable tests and junk science.   Testing the outer limits of this technology, perhaps a smaller insurance company will attempt to take genetic tests into account when setting rates. No, they won't be so bold as to charge a higher rate to those at risk of a disease but rather they may offer lower rates to those who can show they do not have a genetic predisposition to various (expensive) diseases. Why not?  It's okay to ask if prospective clients smoke. Medical check-ups are permitted. How is a genetic test any different, they'll ask. Medical privacy groups will have a field day.   Or maybe we'll see a high profile case where someone took drastic (and tragic) steps in response to a meaningless test result.   One way or another, regulators and legislators will eventually be in a race to outdo each other in an effort protect consumers," and if history is any guide, instead of a gentle tap, the regulators will rush in with sledge-hammers.   Right now, we are in the wild-west phase. Everything goes. The sooner some push the limits, the sooner all will have to deal with over-burdensome regulations.   Larger, more established firms (or those bought by them), will be best equipped to thrive in a highly regulated environment. The cowboys who are riding high now won't survive the eventual regulatory onslaught.