Political Quotes

“This company is not engaged in promoting unapproved uses for this biopsy needle. And U.S. Surgical categorically denies any association with any materials produced by others where this might have occurred. The FDA has approved the breast biopsy needle. The FDA has approved it twice, in fact, only for breast biopsies. Accordingly, U.S. Surgical does not promote the device or market the device for tumor removal. It is aware now that articles and videos do exist which discuss other uses of the devices. It is very common, and completely legal, for physicians to explore other possible uses of both drugs and devices as part of the practice of medicine. But the suggestion somehow that the company is now actively promoting this device for something other than diagnostic purposes, with all due respect, is just not true. And the question that we should be asking here--a very important question--is, if this obviously illegal practice is occurring, if U.S. Surgical is actively promoting this product for an off-label use, why hasn't the FDA gone after the company? Now, clearly, if it were true, the FDA, with all the force of law would go out and pursue them vehemently. Promotion of a device for unapproved uses is one of the most egregious violations a company can commit. Surely if this were the case, and evidence of it were so readily available, FDA would have acted. But there has been no FDA action, because there has been no violation.”