Over the past year, many cancer centers across the country have experienced a significant growing shortage in their chemotherapy supplies. Although such drug shortages have occurred in the past, this deficit represents 20 chemotherapy drugs, almost twice the number of previous scarcities. Additionally, many of the chemotherapy drugs in short supply this year are widely used generics, which has exacerbated the shortage’s impact among cancer care providers.
In response to growing chemotherapy drug shortages nationwide, many of which are reaching crisis proportions, the American Society of Clinical Oncology (ASCO) recently announced their support of the Preserving Access to Life-Saving Medications Act. This legislation aims to address chemotherapy drug shortages caused by regulatory and manufacturing issues and would expand the US Food and Drug Administration’s (FDA’s) authority to require manufacturers to notify the FDA of the nature and expected duration of shortages. Currently, pharmaceutical manufacturers are not legally required to cite reasons for delays or halts in production to the public or the FDA, nor are they required to provide details as to how long drug shortages are expected to last. This law would change that.
What Causes a Shortage?
Drug shortages have been historically attributed to several different causes. Some stem from pharmaceutical manufacturing issues, including noncompliance with regulatory requirements (eg, antiquated manufacturing equipment, loss of manufacturing personnel experienced in production) or the unavailability of bulk and raw materials to produce pharmaceuticals.