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06-06-2012 | Article

Cancer drug shortages ease, but solutions still needed


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MedWire News: Cancer drug shortages in the USA are beginning to decline, although ongoing difficulties obtaining certain chemotherapy drugs mean cancer patients are not out of the woods yet, according to the Food and Drug Administration (FDA).

In late October, the White House issued an executive order asking drug manufacturers to give the FDA an early warning of potential disruptions in the drug supply, and it appears to have worked: In 2012 alone, the FDA has taken action to prevent at least 50 shortages, according to Sandra Kweder (FDA Office of New Drugs, Rockville, Maryland).

"Early notification by manufacturers of when they are having production difficulties makes a huge difference in our ability to prevent the public from bearing the burden of drug shortages," she said at a briefing during the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois.

Although the supply chain problems are beginning to diminish, oncologists remain concerned that they may not be able to get adequate supplies of several common chemotherapeutic agents, nearly all of which are generic. The list includes 5-fluorouracil, nitrogen mustard, and the taxane paclitaxel. Ironically, although a methotrexate shortage has been resolved, sodium bicarbonate needed to deliver high-dose methotrexate is now in short supply, said ASCO president Michael Link (Stanford University, California).

W Charles Penley (Tennessee Oncology, Nashville), who is scheduled to chair ASCO's government relations committee, said at the briefing that in his own practice he has had to substitute one front-line drug for colorectal cancer for another more expensive, less well-tolerated agent.

Reasons for the shortages vary, but they are usually attributable to manufacturing problems, such as contamination of sterile injectable compounds with glass particles, metal shavings, or other impurities.

"No patient should ever be exposed to risks of those sorts," said Kweder.

The FDA has asked Congress to authorize creation of "user fees" for generic drugs that the agency says could help speed approval of generic drug review, cutting the average time from the current 2-plus years down to a relatively speedy 6-10 months.

By Neil Osterweil