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.
As time went by during my daughter Alexis' long thirty-three month battle, we found out that her tumor was growing. We found ourselves in Manhattan seeking to gain enrollment in what looked to be a potentially promising trial. But after preliminary tests we were told that Alexis was ineligible.
For as welcome as the new food safety programs are, the FDA is still plagued with problems. It moves at a glacial pace in the face of pressing health hazards, like its three-decade-long refusal to act on its own findings that the use of antibiotics in livestock feed threatens human health.
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.