FDA Releases New Report on Drug Shortages
The Food and Drug Administration has a new report out on the topic of drug shortages.
In light of the vincristine shortage, this report - Drug Shortages - Root Causes and Potential Solutions - is particularly timely for our community.
The report identifies several root causes for drug shortages, including regulatory challenges and a lack of market incentives. It also identifies potential solutions, including:
creating a shared understanding of the impact of drug shortages;
developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and
promoting sustainable private sector contracts to make sure there is a reliable supply of medically important drugs.
The report also outlines several planned FDA initiatives for preventing and mitigating shortages, cushioned with this word of caution: "Given the potential scale of impacts from drug shortages, and the fact that these impacts have continually been underestimated, it is likely that drug shortages will continue to persist absent major changes to this marketplace."
The FDA report specifically points to children with cancer whose treatment is too often impacted by shortages: "From 2009-2019, 9 of the 11 drugs used to treat ALL were in and out of shortage. Despite recent evidence that adding nelarabine to children's treatment regimens improves survival rates and is thus becoming the new standard of care, nelarabine has been in shortage recently, causing much anguish and grief for patients, parents, and clinicians."
Related — In a letter to the community earlier this month related to the vincristine shortage, Children’s Oncology Group Chair Peter Adamson proposed policy recommendations aimed specifically at addressing pediatric cancer drug shortages:
"Proposals that could be enacted in a reasonable time frame for today's children that merit consideration include but are not limited to (1) establishment and maintenance of a national stockpile of key cancer drugs used for the treatment of children with cancer and (2) US government purchasing contracts that provide a guaranteed buyer and may help stabilize a fragile market. ... I am hopeful that we can take this unacceptable crisis and move towards better answers, always keeping the interests of patients and families central to our efforts."
Read Dr. Adamson's full letter here.
Children’s Cancer Cause is an active part of two coalitions responding to the vincristine shortage crisis and evaluating policy solutions related to the broader issue of drug shortages. Along with the Alliance for Childhood Cancer and the Coalition Against Childhood Cancer (CAC2), Children’s Cancer Cause will continue to monitor the situation and work deliberatively toward impactful policy solutions.
Join our Kids Action Network to be on the front lines of taking action on this issue in the coming weeks. Thank you for stepping up to help ensure that every child with cancer receives every dose of their treatment on time, to give them the best fighting chance to survive and thrive.