Chicago, IL—Drug shortages in cancer care remain a threat significant enough to warrant pending US legislation, though the frequency of these shortages appears to be on the decline. A panel that was convened at ASCO 2012 addressed the impact of drug shortages on cancer treatment and proposed resolutions.
Legislation that is currently being debated in Congress aims to tackle drug shortages directly. Supporting the need for legislation, experts note that the availability of many drugs remains unpredictable. “We never know when a drug will go out of supply, which creates tremendous uncertainty and anxiety on the part of patients,” and makes planning difficult for physicians, said Richard L. Schilsky, MD, Chair, ASCO Government Relations Committee, and Section Chief of Hematology/Oncology, Department of Medicine, University of Chicago. “Patient care is threatened as a result of such drug shortages,” he commented.
In addition, 22 oncology therapies either are or have been in short supply in the past 2 years, adds Michael Link, MD, ASCO outgoing president and Chief of the Division of Pediatric Hematology/Oncology, Stanford University School of Medicine, Palo Alto, CA.
Specific cancer therapies in limited supply or nearly impossible to obtain include nitrogen mustard, cisplatin, and paclitaxel, as well as fluorouracil. According to a spokesperson from the US Food and Drug Administration (FDA), 12 cancer drugs are currently on the FDA’s list of medicines in short supply, but most issues are being addressed.
According to Dr Link, 4 months ago oncology practices were down to a 2-week supply of methotrexate to treat childhood leukemia, which is reportedly 90% curable when drugs are available. “That crisis was averted with stopgap measures we had in place,” said Dr Link.
According to Dr Link, the shortage even extends to drugs used to alleviate discomfort associated with anticancer therapy, such as sodium bicarbonate, which can accompany methotrexate, or leucovorin, used with 5-fluorouracil.
The proposed legislation calls on pharmaceutical manufacturers to keep US regulators abreast of unanticipated drug supply issues. Draft laws reintroduce user fees for brand-name pharmaceuticals to cover the cost of new medicine assessments by the FDA; for the first time, the legislation also builds in fees for generic drug manufacturers, as well as for potential manufacturers of biosimilars.
The addition of generic-drug user fees would generate approximately $1.5 billion in federal funding within several years, Dr Schilsky said. The funding could help reduce review times for New Drug Applications for generic drugs, trimming the current lead time of 30 months to 10 months or less. This represents a huge step forward in recruiting new manufacturers to get drugs on the market, Dr Schilsky said.
The downside is that the legislation is not expected to include provisions to levy cash penalties on manufacturers that fail to notify the agency of pending shortages. Dr Schilsky adds that there are concerns that “If there are no teeth in that legislation, some companies may decide not to report as required.”
Pending the passage of legislation, the FDA is seeking notification from drug companies if they expect a shortage, a policy that thus far has led to positive outcomes, according to Sandra Kweder, MD, Deputy Director of the FDA’s Office of New Drugs.
“Prevention of drug shortages at FDA is absolutely a priority—one of our number 1 priorities here, as well as in Congress and in the White House,” Dr Kweder said. We can engage with companies quickly if we know about them, to prevent shortages from occurring.” In 2012 alone, advance notification has prevented at least 50 drug shortages, although not all shortages are oncology-specific. Since October 2011, 150 drug shortages have been prevented, she said.
The majority of drug shortages in general are a direct result of manufacturing and drug quality problems, according to Dr Kweder. A single facility closing because of quality issues can lead to dozens of shortages. And quality issues are often related to sterility. For example, particles of glass or metal shavings may be found in vials.