Since January 1994, northern Illinois has experienced a significant increase in litigation, which has been directly related to the lack of FDA approval of pedicle screw devices, and the adverse media attention to the FDA's actions. These activities coupled with those of the Public Citizen Health Research Group's have had a chilling effect on the practice of medicine. This is unwarranted, Congress has never provided the FDA with the authority to regulate the practice of medicine; and the FDA has reiterated that it lacks the intent or ability for such regulation. Medical science continues to outpace the regulatory process, and therefore it will remain the science of medicine that determines the standard of care.