US Pharm. 2012;37(4):44.
The FDA announced steps to ramp up the supply of key cancer drugs and augment President Obama’s Executive Order to help avoid future disruptions. In response to the shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) and declining supplies of methotrexate, the FDA took steps to increase available supply in the U.S. To alleviate the shortage of Doxil, there will be temporary importation of a replacement drug, Lipodox (doxorubicin hydrochloride liposome injection). Doxorubicin hydrochloride liposome injection is indicated for ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.
In the case of methotrexate, the agency has approved a new manufacturer of preservative-free formulation (APP Pharmaceuticals), a move that is expected to further increase supply and avoid a shortage. The FDA expedited review of the application to help address the potential shortage of methotrexate, which is indicated for many forms of cancer and other serious diseases.
In addition, the FDA issued draft guidance to industry on detailed requirements for both mandatory and voluntary notifications to the agency of issues that could result in drug shortages or supply disruptions. In 2011, 195 drug shortages were prevented. Since the implementation of the Executive Order on October 31, 2011, the FDA has prevented supply shortages of 114 drugs.
