Brief Background on Drug Shortages

Since the frequency of cancer drugs shortages began to significantly increase about 10 years ago, many studies and experts have weighed in on causes and possible solutions. While the issues that lead to shortages are complex and involve aging manufacturing facilities overseas and a consolidation of suppliers, I think it is fair to point out that (1) the US is impacted to a significantly greater extent than Europe, and (2) economic factors underly many of the shortages. Drug shortages primarily involve generic sterile injectables (drugs that are given intravenously) and continue to occur with many types of medicines, not just cancer drugs. Although perhaps not the primary cause, Medicare payment reform enacted in 2003 capped the amount that could be charged for IV drugs prescribed by physicians at 6% over the “average sales price,” adjusted every 6 months. In 2019, the average sales price for a vial of vincristine was about $5; thus, the economics of supplying drugs like vincristine are challenging. In Europe, a significantly higher amount is spent on generics (and a lower amount on newer drugs). The bottom line is that longterm solutions to this problem involve US Medicare regulations, economic and other policies (and are well beyond my expertise).

Call to Action

While it is clear that the immediate concern and goal is to solve the issue surrounding vincristine, I believe the community should consider advocacy steps to help prevent future shortages of life-saving cancer drugs for children. In my view, as related efforts are developed for longer term, economic policy solutions, we need to focus on solutions for today’s children with cancer. In the upcoming days and weeks, I am hopeful we can arrive at focused action items for advocacy solutions that have the goal of guaranteeing cancer drug supplies for children in the United States. 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. There undoubtedly are other ideas to consider, and we are committed to working with the community and childhood cancer advocacy groups in galvanizing these efforts.

Closing Comments

Our first priority must continue to be today’s children with cancer who need vincristine as part of their treatment. We greatly appreciate the initial efforts by the FDA and Pfizer/Hospira. As we await further information, we look to them for additional steps, such as potentially allowing importation of vincristine from other countries, that could be considered for patients currently being impacted. While we (and many others) are infuriated that this situation has occurred at all, we should do our best to have advocacy efforts stay focused on solutions. I am hopeful we can take this unacceptable crisis and move towards better answers, always keeping the interests of patients and families central to our efforts.

For any family that is currently having difficulty obtaining vincristine for their child, the FDA recommends that you contact them at drugshortages@fda.hhs.gov.

Thank you all for your support. If there are questions that I can answer, please do not hesitate to reach out; I will do my best to track down information.

Sincerely, Peter C. Adamson, M.D.
Chair, Children’s Oncology Group
Alan R. Cohen Endowed Chair in Pediatrics
Professor of Pediatrics & Pharmacology
Perelman School of Medicine, University of Pennsylvania Children's Hospital of Philadelphia

cc: Alliance for Childhood Cancer Coalition against Childhood Cancer (CAC2)

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