Shortage crisis drives temporary importation, quick OK of cancer drugs
This article was originally published in Scrip
Executive Summary
With the drumbeat growing ever louder about the problem of patients unable to access critical life-saving drugs, FDA Commissioner Dr Margaret Hamburg used her regulatory authority to temporarily permit Indian drug maker Sun Pharma to import its ovarian cancer and multiple myeloma medicine Lipodox (doxorubicin hydrochloride liposome injection) into the US, even though the product is not approved for marketing by the agency, to fill the shortage of Janssen Products' Doxil, which contains the same active ingredient.