On the recordMay 29, 1996
It is not only against the law, but to do it he would have to rely, we would have to rely, on our doctor who might not have read it to request it. What an insane way to go through the process. And I think the thing that is scary and should be scary for the American people is that as this off-label use is tried more frequently, a doctor might determine that the dosage is very crucial, and if other doctors are going to use that off-label use or that pharmaceutical for an off-label use, should they not have the latest information about the dosage to use and the frequency of usage, where today again that is information that pharmaceutical companies can only disseminate when a physician requests it, not when there is a peer review article that states this new information that might have been found. So in fact there are many areas, many parts of this legislation, that are crucial to the health of the American people. America has the best health care system in the world. It is unconscionable for Americans to have anything less than superior access to lifesaving drugs. I believe that by safely streamlining the drug approval process it will not only help families by lowering drug prices and keeping high paying jobs here in America, but give terminally ill patients access to lifesaving treatments. FDA reform is not radical, it is responsible. It is not senseless, it is safe.
Source
govinfo.gov




