The FDA and Cancer Treatments

Riley Drake, Editor in Chief
April 11, 2012
Filed under News and Features

Recent shortages of two cancer drugs, preservative-free methotrexate and Doxil, have threatened the lives and health of patients whose lives depend on these drugs (The Guardian).  The first drug, preservative-free methotrexate, is vital to the treatment of children with leukemia, specifically, acute lymphoblastic leukemia (New York Times).  The FDA has taken considerable measures to alleviate this shortage, including the release a batch of methotrexate produced just before the manufacturer was shut down over serious quality problems (The Guardian).  The second, Doxil, is required in the treatment of patients with ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma (Buisnessworld).  To alleviate this shortage, the FDA has taken an unprecedented move, partnering with an Indian company, Sun Pharma Global FZE, in the manufacturing and importation of Doxil substitute Lipodox (Economic Times).  Though these arrangements are temporary, they are all part of a larger effort of the FDA to prevent drug shortages before they begin to effect patients. This endeavor has been largely aided by the willingness of domestic pharmaceutical companies in contacting the FDA as they anticipate a shortage arising (The Gaurdian).  The US is experiencing a domestic shortage of 283 drugs.  Because of this, drugs that are in “short supply” are regulated, and patients who require the drug are given priority access if they are in the middle of a treatment course, though often denied permission to begin a treatment cycle (Thought Catalog).