The US Food and Drug Administration has stepped in to increase the supply of critically-needed cancer drugs, specifically shortages of Johnson & Johnson’s Doxil and methotrexate, caused by manufacturing problems at Ben Venue Laboratories.
For Doxil (doxorubicin), used for ovarian cancer, AIDS-related Kaposi’s sarcoma and multiple myeloma, the FDA has okayed temporary importation of a replacement drug, namely Sun Pharmaceutical Industries’ Lipodox (also doxorubicin). The move is “expected to end the shortage and fully meet patient needs in the coming weeks”, the agency noted.
For methotrexate, “a drug that is needed for the treatment of many forms of cancer and other serious diseases”, the FDA says it has “successfully engaged many firms to assist in maintaining supplies”. First, FDA has prioritized review of and approved a preservative-free methotrexate generic manufactured by APP Pharmaceuticals which will become available in March and continue indefinitely.
Secondly, Hospira expedited release of additional supplies, resulting in 31,000 vials of new product, enough for more than one month’s worth of demand, being shipped to hundreds of US hospitals and treatment centres. The FDA is also working with Mylan and Sandoz.
FDA Commissioner Margaret Hamburg said that “a drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority”. In October, the president issued an executive order on drug shortages, and the FDA says this resulted in “a sixfold increase in voluntary notifications by industry of potential shortages”.
In 2011, there were a total of 195 drug shortages prevented and since the executive order, the agency has prevented 114 of them.
