On February 21, the FDA held a briefing on drug shortages. The discussion focused specifically on two cancer-related drug shortages - Doxil and Methotrexate. Speakers included a patient advocate, as well as representatives from the American Cancer Society, the American Society of Clinical Oncology, the Children’s Oncology Group, APP Pharmaceuticals, and Hospira.
Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D. emphasized that the agency is working to prevent a record number of shortages. In 2011, the FDA prevented 195 drug shortages, and has prevented 114 drug shortages since President Obama’s Executive Order last fall. This represents a six-fold increase in voluntary reports by manufacturers of potential shortages and disruptions.
The FDA continues to emphasize the agency's ability to successfully respond to drug shortages is dependent on early knowledge. We encourage members to continue reporting drug shortages to the FDA at email@example.com.
As you may recall, ASA and the co-conveners of the Drug Shortages Summit offered a series of recommendations to the FDA to combat drug shortages and presented these recommendations before a special FDA panel in September of 2011. One of these recommendations was to reallocate appropriate staffing resources within the FDA to accommodate the growing drug shortages crisis. Yesterday, Dr. Hamburg also announced that the FDA has almost tripled its staff focused on drug shortages. ASA applauds this decision.
Finally, the FDA is seeking comments on a draft guidance document for the pharmaceutical industry that encourages voluntary notification of shortages or potential disruptions in supply beyond the scope of reporting that is required existing regulation.
Read the FDA’s press release on the briefing.
Read five recommendations from the Drug Shortage Summit Regulatory and Legislative Work Group
For additional information on ASA’s advocacy work on drug shortages, click here.