2011-06-30

In the past year, shortages of drugs used to treat patients with hematologic malignancies, including leukemia and lymphoma, have become critical and life-threatening. ASH members have reported severe shortages of BiCNU (Carmustine), Bleomycin injection, Cytarabine (ARA-C), Daunorubicin, Leucovorin, and Thiotepa. ASH has taken several steps to resolve these drug shortages, including alerting and working with the Food & Drug Administration and Congress. The following is an update on the status of hematologic drug shortages, how ASH has responded to drug shortages, and resources for physicians dealing with shortages.

Status of Hematologic Drug Shortages (updated: 6/30/11) 

ASH has been notified that the BICNU (Carmustine) injection shortage is resolved; manufacturers of Cytarabine and Bleomycin are able to distribute small amounts of the therapies although supplies are still limited; the Daunorubicin shortage continues, and the FDA is working with overseas suppliers of Thiotepa and Leucovorin to temporarily import the drugs into the U.S. For more information regarding these drugs, please refer to the chart below.

ASH Responds to Drug Shortages 

ASH has taken the following steps to provide our membership and patients they serve with the most up-to-date information to assist them during this critical time while working with policymakers on possible solutions:

1. Contacted specific drug companies to obtain information about the drugs in short supply, specifically what is causing the delays and when the drugs will become available. Information about specific drug shortages will be posted to the ASH website as it becomes available.
2. Alerted the Food and Drug Administration (FDA) to the hematology/oncology drug shortages and requested an official response to the matter.
3. Worked with Senator Amy Klobuchar's office regarding S. 296, The Preserving Access to Life-Saving Medications Act, legislation that would provide the Food and Drug Administration (FDA) with tools to help address and prevent future medication shortages. In addition, ASH also worked with Representative Diana DeGette’s office prior to the recent introduction of similar legislation in the House of Representatives, but not identical to S. 296, H.R. 2245, The Preserving Access to Life-Saving Medications Act. Unlike the Senate bill, H.R. 2245 requires notification of shortages of all biological products, sets specific fines for non-compliance with reporting requirements, and authorizes a General Accountability Office study to examine the causes behind drug shortages.
4. Notified congressional committees of the problem and requested a hearing on this issue.
5. Developed an advocacy campaign to encourage congressional support of S. 296. ASH encourages all physicians to use the ASH Advocacy Center to contact their Senators about this issue and its impact on patients. Additionally, ASH has created a special patient advocacy campaign that physicians can share with patients. Through the campaign, patients can contact their Senators with a letter that they can personalize about how the drug shortage problem has affected them.

Additional Resources:

• For more information on drug shortages, visit the FDA drug shortage webpage.
• To report a drug shortage to FDA e-mail drugshortages@fda.hhs.gov.
• To report concerns about drug price gouging due to shortages, contact FDA’s Office of Criminal Investigations.
• If you have a question regarding a patient who requires a drug that is in short supply, please utilize the ASH Consult a Colleague program.
• Watch a recent ABC News report on this issue.
• Read a recent Los Angeles Times article 
• Read a recent Wall Street Journal article 
• Read a recent Washington Post article 
• Read a recent Op-Ed in the Washington Post 
• Read a recent WTOP.com article 

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