FDA Announces Steps to Ease Cancer Drug Shortages

FDA Announces Steps to Ease Cancer Drug Shortages

Article date: February 21, 2012

By Stacy Simon

The US Food and Drug Administration (FDA) said Tuesday that it is taking steps to increase the supply of 2 cancer drugs on its drug shortage list: liposomal doxorubicin (Doxil) and methotrexate.

The FDA approved a new supplier of preservative-free methotrexate, which has already begun shipping it to hospitals and treatment centers. This is in addition to an emergency supply of the drug that was released last week. Preservative-free methotrexate is used to treat a form of childhood leukemia as well as several other cancers.

And the FDA is temporarily allowing the drug Lipodox to be imported into the US as an alternative to Doxil. Doxil is used to treat several types of cancer, including Kaposi sarcoma, multiple myeloma, and ovarian cancer.

“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 J. Leonard Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, who attended the FDA’s announcement. “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’s actions are part of a response to President Obama’s executive order last October to help prevent drug shortages by toughening requirements for drug makers to report potential manufacturing delays that might lead to shortages. Pending legislation in Congress would strengthen the FDA’s authority to enforce the requirements. The American Cancer Society's advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), announced its support of this bill last September.

FDA Commissioner Margaret A. Hamburg, MD, said in a prepared statement released today, “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 of his administration. 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.”

The FDA said 114 shortages have been prevented since the executive order. Among its steps to ease the drug shortage problem, the FDA has increased its drug shortage program staff and is implementing a drug shortage tracking database. In addition, the FDA has issued draft guidelines to provide more information for manufacturers on mandatory and voluntary notifications about delays and disruptions in supplies.

Over the past several years, reports of drug shortages in the US have increased. There are currently hundreds of drugs on the list, and they include a couple of dozen cancer drugs. In some cases, cancer patients and their families have been unable to obtain necessary drugs. In other cases, patients have been forced to pay exorbitant prices through the emerging “grey market,” where drugs in short supply are sold legally at a reported cost of up to 650% of the original price.

Reviewed by: Members of the ACS Medical Content Staff