Pharmacy Times

STATES PRESSURE FDA FOR GENERIC INSULIN

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Mississippi Gov Haley Barbour is leading a group of officials from 11 states in a drive to secure marketing approval for a cost-saving generic version of insulin. Patients and taxpayers spend $3.3 billion a year on insulin to treat diabetes, and access to generic insulin could reduce those costs by $1 billion or more annually. Much of those savings would accrue to financially pressed state Medicaid programs, which currently spend $500 million annually on insulin.

The holdup is at the FDA, where officials have failed to follow through on promises made 6 years ago to issue guidelines for the approval of generic insulin and generic human growth hormone.

Barbour and 10 other state governors from across the country are putting political pressure on the FDA to clear a path for the introduction of generic insulin products. "To have a lower-cost solution for our very large diabetic population is in the interest of the state and the interest of these people," Barbour said. The governors are seeking FDA guidelines explaining the testing and documentation that would be required for the approval of insulin, a step that generic drug manufacturers consider a prerequisite to submitting applications for insulin products.