February 21st, 2012
01:35 PM ET
In response to President Obama's executive order to help prevent future drug shortages, the Food and Drug Administration Tuesday announced a series of steps to increase the supply of two critically needed cancer drugs: Methotrexate, a drug used to treat children with leukemia and some adult cancers, and Doxil, used to treat numerous forms of cancer from lung to ovarian. Doxil is also used in AIDS-related Kaposi's sarcoma and multiple myeloma.
"Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," said FDA Commissioner, Dr. Margaret A. Hamburg.
Doxil, at this time will be replaced by Lipodox, a drug similar to Doxil, which is expected to end the shortage and fully meet patient needs in the coming weeks until more Doxil is available.
Lipodox is manufactured overseas, and has not been approved by the FDA. The FDA's importation of Lipodox is temporary. Temporary importation of unproved foreign drugs is usually considered in rare cases when there is a critical shortage of an approved drug in the United States and the shortage cannot be resolved quickly with FDA-approved drugs. When a foreign company is identified and is able to import the needed drug, FDA evaluates the foreign-approved drug to ensure it does not pose any risk to U.S. patients.
As for methotrexate, the FDA has approved a new manufacturer of a preservative-free form of methotrexate that is expected to boost the supply. The manufacturer, APP Pharmaceuticals, expects its methotrexate product to become available next month and continue indefinitely.
The FDA also is having Hospira, a pharmaceutical delivery company, release additional supplies, resulting in 31,000 vials of new product - enough for more than one month's worth of demand. FDA is also working with other manufacturers of methotrexate, who have stepped up to increase production in order to meet patient needs.
"It's tough enough going through a serious illness, but not being able to have the drugs to treat (the illness) is devastating," said Sara Stuckey, mother of Nate Stuckey, a 6-year old cancer patient who's now being treated with methotrexate. Stuckey was an attendee at Tuesday's FDA press conference.
"The actions announced today will help to boost the supply of some of the most badly needed cancer drugs by patients across the country," said Dr. J. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society. "It is critical that the FDA ensure that the added supply of these drugs is safe and made easily available to the patients who urgently need them."
The FDA also announced it has issued draft guidance to drug industries on how to file mandatory and voluntary notifications to the FDA on possible shortages or supply disruptions of drugs, so that the FDA can act on the possible shortage as early as possible.
"It's a who, what, where, when outline on how to get the word out early to the FDA, so that no one goes without their treatments," noted Hamburg.
Since President Obama signed his executive order in October, directing action to help further prevent and reduce prescription drug shortages, the FDA claims it has prevented 114 drug shortages.
In October, the Obama administration also announced its support for bipartisan legislation that would require all prescription drug shortages to be reported to FDA and would give FDA authority to enforce these requirements. Congress has not acted on that legislation.
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