STATES PRESSURE FDA FOR GENERIC INSULIN

Pharmacy Times, Volume 0, 0

Mississippi Gov Haley Barbour is leadinga group of officials from 11 states in adrive to secure marketing approval for acost-saving generic version of insulin.Patients and taxpayers spend $3.3 billiona year on insulin to treat diabetes, andaccess to generic insulin could reducethose costs by $1 billion or more annually.Much of those savings would accrue tofinancially pressed state Medicaid programs,which currently spend $500 millionannually on insulin.

The holdup is at the FDA, where officialshave failed to follow through onpromises made 6 years ago to issueguidelines for the approval of genericinsulin and generic human growth hormone.

Barbour and 10 other state governorsfrom across the country are putting politicalpressure on the FDA to clear a pathfor the introduction of generic insulinproducts. "To have a lower-cost solutionfor our very large diabetic population is inthe interest of the state and the interestof these people," Barbour said. The governorsare seeking FDA guidelines explaining the testing and documentationthat would be required for the approval of insulin, a step that generic drug manufacturersconsider a prerequisite to submitting applications for insulin products.