Drug & Device News

In an entry to his blog called “Andy's Take,” Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, discussed the challenges faced by patients who have tried FDA-approved conventional medications without relief and therefore want to gain access to investigational or restricted therapies. Stated Eschenbach, “My take is that once approved treatment regimens have been exhausted, desperately ill patients should have appropriate access to any reasonable treatment that has the potential to be of benefit and yet doesn't present unjustifiable risks.” Doing this, however, has often proved difficult, if not impossible. To help consumers work through the process of gaining access to investigational and restricted medical therapies Eschenbach suggests they call the FDA's Office of Special Health Issues at 301-827-4460. There, FDA personnel are standing by to help patients navigate the system. Explained Eschenbach, “To permit such treatment use of an investigational drug, the company must first agree to make the drug available. Then, the FDA, in conjunction with the patient's treating physician, must determine, among other things that the potential benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or the condition to be treated; and that providing the investigational drug for the treatment use will not interfere with the initiation, conduct, or completion of clinical investigations that are required to support marketing approval of the investigational drug for the greatest number of patients who can benefit.”