James M. Jeffords: “To inflame this issue into being one of false information and filing of misleading information is totally incorrect. The…”

“To inflame this issue into being one of false information and filing of misleading information is totally incorrect. The issue here is not that. The issue here, on each of these medical devices, is whether or not they must file every conceivable, possible use that FDA thinks might be made of it. FDA should focus rather on the use that it is intended for or any other use that the manufacturers know it will be intended for. There is nothing involving false or misleading information. That, of course, is under the control of the FDA and that would be a serious matter with the FDA. It could, and should deny approval of a device where a manufacturer deliberately files false and misleading information. Let us set the record straight. Manufacturers cannot file false and misleading language. To raise that as the issue is to really differ from what the important issue is, and that is how long do Americans have to wait to get access to important, new medical devices. In Europe it takes much less time and it is much more expeditiously handled. We can have the same kind of treatment here while ensuring that they are safe and effective for their intended use. For any device that is intended for a particular use and it is known by doctors to be effective for another use, that's fine. That is the practice of medicine. Doctors sometimes find other, valuable uses for medical devices.”