“You can’t force a manufacturer to produce a particular drug against its other drugs, so this is a big problem,” said Sharona Hoffman, JD, professor of law and bioethics and codirector of the law-medicine center at Case Western Reserve University School of Law, Cleveland, Ohio. “The paper mentions creating a stockpile — this is very difficult, expensive, and requires a lot of manpower,” said Hoffman.
Possible sanctions for shortages or incentives for achieving a continual supply of drugs could be a solution, but there’s no way to force companies to manufacture specific drugs.
“The government can’t go in and dictate which drugs a company must produce. You can create lists — that’s fine — but taking that leap of asking the government to ensure supply is difficult. We have a free market; the government can’t force a business to make this or that drug,” noted Hoffman.
At the time of this article, several core chemotherapy agents frequently used in childhood cancer treatment were on the shortage list, including asparaginase, methotrexate, and etoposide.5 The shortages show no immediate signs of stopping, but there does appear to be a renewed effort to counter the shortages following an announcement in late 2018 by the US Food and Drug Administration (FDA) stating that the agency would ramp up its efforts to prevent potential shortages and resolve existing ones.6
“There are more conferences on drug shortages in Washington, D.C. now,” said Hoffman. “There [are] some health care organizations and advocacy groups that are really focusing on the issue.”
“This is a health care crisis. The government need to take a position. They already do with companies to guarantee water, electricity – why not these essential drugs? These medicines are truly part of our critical infrastructure and we need to treat them as such,” concluded Dr Unguru.
- Smith MA, Altekruse SF, Adamson PC, et al. Declining childhood and adolescent cancer mortality. Cancer. 2014;120(16):2497-2506.
- St. Jude Children’s Research Hospital. Acute lymphoblastic leukemia. https://www.stjude.org/disease/acute-lymphoblastic-leukemia-all.html. Accessed March 29, 2019.
- Unguru Y, Bernhardt MB, Berg SL, et al. Chemotherapy and supportive care agents as essential medicines for children with cancer [published online March 4, 2019]. JAMA Pediatr. doi: 10.1001/jamapediatrics.2019.0070
- Salazar EG, Bernhardt MB, Li Y, et al. The impact of chemotherapy shortages on COG and local clinical trials: A report from the children’s oncology group. Pediatr Blood Cancer. 2015;62(6):940-944.
- US Food and Drug Administration. Current and resolved drug shortages and discontinuations reported to FDA. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm. Accessed March 29, 2019.
- Gottlieb S, Woodcock J. FDA is advancing new efforts to address drug shortages. https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm626108.htm. Updated November 19, 2018. Accessed March 29, 2019.