Pediatric Oncology Drug Shortages: A Multifaceted Problem

• oncology drug shortages

The consensus statement by Unguru et al¹ concerning national shortages of therapies used to treat children with cancer accomplishes 2 important tasks: it highlights a serious public health threat and proposes steps to address the problem. The working group (WG) has outlined 6 recommendations. All are constructive approaches and, in the case of the recommendations that are within US Food and Drug Administration’s (FDA’s) purview, the FDA has already taken steps to implement actions.

The first recommendation (Support Current and Develop Innovative Measures to Prevent Drug Shortages) might be perceived as primarily in the FDA’s purview. Addressing the complex issue of drug shortages continues to be a high priority for the FDA. On October 31, 2013, the FDA released a strategic plan to improve the agency’s response to imminent or existing shortages and to identify longer-term approaches for addressing the underlying causes of drug shortages.² This plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting …

Address correspondence to Dianne Murphy, MD, FAAP, Food and Drug Administration, Office of Pediatric Therapeutics, Office of the Commissioner, 10903 New Hampshire Ave, WO32-5150, Silver Spring, MD 20993. E-mail: dianne.murphy{at}fda.hhs.gov