Responding to the drug shortage crisis affecting several aspects of health including oncology, the FDA convened a panel on Monday to discuss solutions.
According to the FDA, in 2010 a full 178 drug shortages were reported last year--a figure already topped thus far in 2011.
According to Edward Cox, the Agency's coordinator of the drug shortage program, the problems are coming from several directions:
-- Over half of the shortages are related to problems of quality and/or manufacturing issues;
-- Over twenty percent of them are a result of delays and capacity issues;
-- Discontinuations were responsible for over ten percent
-- Five percent were related to raw material issues.
Several panelists offered underlying reasons for the shortages, such as a lack of financial incentive; market contraction from both manufacturers and buyers; and the vulnerabilities of the manufacturing process itself.
Acknowledging the complexity of the problem, the panel envisions:
-- Regulatory changes;
-- Manufacturing changes;
-- Methods to prevent drug hoarding.
Among other suggestions one panelist urged the FDA to develop and implement a National Critical Medicines Stockpile.
The American Cancer Society's deputy chief medical officer, Len Lichtenfeld MD, was quoted as saying, "The federal government should expand its collection of information on the underlying causes of drug shortages. Professionals need better information about shortages and available options.
"When you talk to a physician who says, 'I cannot get cytarabine to treat leukemia and there is no substitute,' that's not acceptable," said Lichtenfeld. "We must pull together to find effective solutions."
Congress weighed in on the crisis last week, with members introducing a bill that would require drug manufacturers to notify the FDA of pending shortages.
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