Push for FDA approval of generic insulin continues

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Experts say the cost of diabetes treatment could drop by 25% if the Food and Drug Administration approved the production and sale of generic insulin, according to a report in the New York Times.

Generic insulin would ease spending by individuals and Medicaid programs (which paid a half a trillion dollars for treatment in 2005), according to some interested parties. But some scientists and drug makers have cautioned against moving too quickly when it comes to biologics, medicines made from living organisms, which may be difficult to safely duplicate.

Makers of generic drugs have urged the FDA to follow through with the creation of guidelines for generic insulin, which in 2001 the agency said it would develop. But the agency has stalled on the issue, pondering whether it should develop guidelines for all biologics rather than individual treatments.

Last year, two prominent federal lawmakers called for the FDA to release guidelines. Eleven governors also have urged the agency to expedite approval of generic insulin.