The FDA Stifles the Advance of Modern Molecular Medicine

We are at a turning point in medicine. Knowledge of the individual's genetic makeup will soon allow molecular medicine to reach deep inside each of us to cure most of the maladies that afflict us—and perhaps even slow the rate at which we age. First we will learn to understand each person's genome; then we will learn to craft treatments tailored to his or her genetic constitution.
But it may not be so easy—and not for purely scientific reasons. Consider 23andMe, a commercial enterprise launched in 2006 that was merely looking to inform Americans about their potential genetic vulnerability to certain diseases. Regulators from the Food and Drug Administration have dropped the hammer on the company, citing baseless fears that its customers will do something dangerously stupid in reaction to the information that the tests provide. The FDA's regulatory labyrinth is not only slow to digest the science behind the genetic testing involved in 23andMe. It also can't quite figure out what to do with the proliferation of molecular biomarkers that can predict treatment efficacy more quickly than the conventional clinical trials the agency relies upon.

http://reason.com/archives/2013/12/08/how-the-fda-stifles-the-advance-of-moder