FDA's Center for Device and Radiological Health (CDRH) reportedly announced that it tripled the size of its compliance staff last month from one to three. CDRH compliance staff advises the Director and other agency officials on legal, administrative, and regulatory programs and policies concerning agency compliance responsibilities relating to medical devices and radiological health activities.
According to a Gray Sheet article on September 27, Deborah Wolf, FDA Regulatory Counsel, said at a September Food and Drug Law Institute (FDLI) conference in Washington D.C. that the newly expanded CDRH staff will increase focus on advertising and promotion of medical devices, specifically targeting "off-label" claims made by medical practitioners. The article quoted Ms. Wolf as stating: "We have sent warning letters to doctors and clinics who make off-label claims . . . There are a lot of companies that have these marketing agreements where they provide the device only to a limited number of practitioners in a certain geographic area, and then either encourage or require by contract that certain uses be made of the device. . . .We're looking for those situations."
While the FDA cannot regulate the practice of medicine, it can regulate how doctors advertise and promote the use of medical devices. According to FDA, "Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement [sic]. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects."
Some previous examples of FDA warning letters regarding the off-label promotion of medical devices include stents approved for palliation of malignant strictures promoted for offlabel use in the vasculature and approved lasers promoted for offlabel use treating varicose veins.