Fresh strategies for grappling with the chronic, and at times critical, shortages of cancer drugs that have frustrated the oncology community for the past decade are likely to help alleviate supply problems, oncology and pharmaceutical leaders say. Yet they predict that forging significant and lasting improvements will be difficult due to the complexity of the issues underlying the shortages.
Bolstered by new legislation that takes effect in October, the FDA will gain resources to evaluate generic drug candidates and more clout to monitor supplies. The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have endorsed the changes.
Nevertheless, the Food and Drug Administration Safety and Innovation Act was enacted amid much disagreement among government officials, oncology leaders, pharmaceutical executives, and political figures about the causes for shortages.
Figure 1. National Drug Shortages
January 2001 to June 30, 2012
Each column represents the number of new shortages identified during that year.
University of Utah Drug Information Service. Reprinted with permission.
Reasons variously cited in the oncology sphere include manufacturing problems, quality issues, Medicare pricing rules, regulatory logjams, and the overall economic dynamic of producing cancer drugs, particularly sterile injectables.
Whatever the causes, however, experts agree that the shortages have spawned problems in cancer care: insufficient supplies for treating patients, a deficit of materials for clinical trials, borrowing and hoarding among medical institutions, the sale of counterfeit drugs, and a gray market for medications in limited supply.
Defining a Dangerous Quandary
While shortages of prescription drugs have posed problems for more than a decade, the numbers grew substantially from 2007 through 2011, according to the University of Utah Drug Information Service (Figure 1
). These shortages have affected various therapeutic areas (Figure 2
), but the US Government Accountability Office noted that the number of oncology drugs experiencing supply deficits has risen significantly since 2009.1
Michael P. Link, MD
As of early June, 22 cancer therapies had been in short supply during the previous two years, including preservative-free methotrexate, which has contributed to a 90% cure rate in children with acute lymphoblastic leukemia (ALL), said Michael P. Link, MD, service chief of Pediatric Hematology- Oncology at the Lucile Packard Children’s Hospital at Stanford in Palo Alto, California. The immediate past president of ASCO spoke during a press conference about drug shortages during the organization’s 48th Annual Meeting.
“The crisis has been particularly bad in cancer care,” agreed Richard L. Schilsky, MD, professor of Medicine and Hematology/Oncology section chief at the University of Chicago in Illinois, and chairman of the ASCO Government Relations Committee, during the June press conference. “It creates uncertainty, anxiety, and higher out-of-pocket costs for patients, and difficulty in planning for physicians.”
Link added that the crisis has hit community oncologists especially hard since they usually don’t have pharmacy staff to help them secure drugs that are in scarce supply.
Richard L. Schilsky, MD
At the height of the drug shortage at the University of Chicago, Schilsky recalls receiving a weekly e-mail asking doctors to make “painful” decisions about which patients should receive certain chemotherapy treatments.