The FDA is going to have catch up with technology, doctors are going to have to practice letting go, the tort system is going to have to be reformed, and patients are going to step up if we're going to solve this health care crisis.
It is perfectly legal and common for physicians to prescribe medication and medical devices for "off-label" use. But the FDA prohibits manufacturers from directly promoting the unapproved use of their products.
Thanks to technological advances in microsurgery and space-age breakthroughs, people like James Hindman with Age-related Macular Degeneration have new hope from the world's tiniest telescope that's implanted into the person's eye.
At stake is whether medical devices that are put in your body, cardiac stents, heart valves, knee and hip implants, among others, will be subject to safety tests in humans before they are approved by the FDA.