American Society of Hematology

Progress Report on Drug Shortages: Doxil and Methotrexate Shortages Resolved

Published on: February 23, 2012

ASH advocacy to prevent drug shortages continues to make progress.

  • On February 16, the FDA announced that Bedford Laboratories has limited quantities available of methotrexate preservative-free 1 gram lyophilized powder for injection (NDC 55390-0143-01) and 250 mg/10 ml (NDC 55390-0034-10) with short expiry. The product will be allocated to practices and hospitals starting today. The Agency also indicated that two more manufacturers plan additional releases over the next few weeks and continuing into March, which are anticipated to meet all patient needs.
  • On February 21, the FDA held a briefing to provide an update on the Agency's progress on combating drug shortages and also made an announcement on actions taken to bolster the supply of preservative-free formulations of methotrexate and Doxil.
    • In response to the critical shortage of Doxil (doxorubicin hydrochloride liposome injection), effective immediately the FDA and Sun Pharma Global's/Caraco Pharmaceutical Laboratories Ltd. are temporarily importing Lipodox™ into the United States. To order Lipodox, contact Sun Pharma at 1-888-835-2237.
    • In response to the critical shortage of methotrexate, and in addition to FDA's work with manufacturers of the therapy, the Agency announced that it completed a prioritized review of, and approved, a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals. The FDA expects that this product through APP will become available in March and continue indefinitely.
  • On February 14, the Society sent a letter of support to Representatives Larry Buscon (D-IN) and John Carney (D-DE) who introduced bipartisan legislation (H.R. 3839, the Drug Shortage Prevention Act) that would provide expedite FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply. The Society also submitted comments to the FDA concerning its Interim Final Rule FDA to improve collection and distribution of drug shortage information.
  • The Society's key messages were most recently featured in The Wall Street Journal; MSNBC.com; and MedPage Today.

ASH applauds the actions announced by the FDA to address the shortages of methotrexate and Doxil, but cautions more needs to be done to fully combat shortages of life-saving hematologic drugs. ASH will continue to support legislative and regulatory changes that will give FDA the authority and resources it needs to effectively prevent and mitigate future drug shortages. ASH will also continue to track methotrexate and Doxil supplies closely and will notify the membership as soon as additional information is available.

Please visit the ASH Drug Update page for more details about these shortages and other hematologic drug shortages. If you have any additional questions and/or concerns about any hematologic drug shortages, please contact ASH Government Relations Manager, Stephanie Kaplan at 202-776-0544 or skaplan@hematology.org.

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