It's a question of degree. How safe and effective do we want our medical products to be? That question can't be answered, 'as safe as possible'. We must assume that if government devoted all its resources to ensuring safe medicine, we'd have safer products. But we don't do that do we?
At some point we decide the next dollar spent or regulation imposed to improve safety isn't worth the sacrifice of freedom. It's quite simple isn't it?
So I ask you again, has the FDA crossed the line in your book? The board awaits your response.