Update Feb 20, 2012: The U.S. Food and Drug Administration has now taken steps to increase the supply of two cancer drugs, Doxil and methotrexate. The FDA will allow a temporary importation of the drug Lipodox, a replacement for Doxil to meet patient needs in the coming weeks. The FDA also approved a new manufacturer of methotrexate. You can read the FDA press release on the actions here, and see comments from the American Cancer Society Cancer Action Network (ACS CAN) and Dr. Len Lichtenfeld, deputy chief medical officer here.
News in the New York Times that in a matter of weeks, hospitals across the country may run out of a crucial medicine to treat childhood leukemia has resurfaced the issue of drug shortages.
Last September, our advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN) came out in support of a bill that would require drug companies to give the FDA advance notification of issues that could lead to shortages, in hopes of allowing officials to prepare and respond.
In a letter to bill sponsors, Christopher W. Hansen, president of ACS CAN said:
“Advance notification to the FDA from industry about the potential suspension of drug production, an interruption in manufacturing, or other production adjustments that might lead to a shortage would put the FDA in a better position to track and manage potential drug shortages. Notification would also allow government, industry, providers and the public to more systematically analyze and understand the causes of specific drug shortages as they occur, and to develop appropriate real-time solutions that are also needed to address the ongoing acute problem that cancer patients are living with daily.”
Dr. Len Lichtenfeld, the American Cancer Society’s deputy chief medical officer and resident blogger, also testified to FDA about the drug shortage crisis and its impact on people with cancer:
“There appear to be numerous contributing factors to the shortages, and these factors may contribute differently to the shortages of particular drugs. The market system for pharmaceuticals has served patients well for many years, but we have to ask why is it failing now.
“We strongly support the efforts of the FDA and other agencies to develop a better understanding of the root causes of the current crisis. We also call on the pharmaceutical industry act expeditiously to provide the public with a full understanding of why and how this crisis has arisen.
“However, until the causes of the shortages are better understood, interim steps should be taken by the government to minimize adverse effects for patients to the maximum degree possible.
“Through administrative action, the federal government should:
- Immediately expand its collection of information on the underlying causes of the current drug shortages. Clinicians and patients need better information about shortages and better options for purchasing the drugs they need for their treatments.
- Compile available inventories of drugs that are in short supply, including where shortages exist.
- Work with interested parties as information becomes available about the causes of specific drug shortages to resolve those shortages. For example, adequate production to meet demand in the near term could be leveraged by the National Cancer Institute’s infrastructure for drug development to provide short-term supplies for individual cancer drugs.”
As Len said at the time, every day that passes without available cancer drugs means fewer lives may be saved.