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August 2008
Vol. 18 No. 8
IDSA Advocacy Update: Animal Drug Legislation Passes

Congress this month passed legislation requiring drug manufacturers to report to the Food and Drug Administration (FDA) the quantities of antibiotics sold for use in food animals. IDSA was a primary supporter of the provision, found in the Animal Drug User Fee Amendments of 2008.  The provision provides an important step toward better understanding the amounts of antibiotics used in food animals, with the end goal of limiting any negative impacts of such use on human health.

Other advocacy efforts include:

  • The Society asked the FDA to clarify whether the Orphan Drug (OD) Act or a parallel regulatory framework would be an appropriate mechanism to spur research and development of antibacterial therapies and related diagnostics and vaccines for drug-resistant infections.  Previous conflicting comments from FDA officials have caused confusion for policymakers trying to address the problems outlined in IDSA’s 2004 “Bad Bugs, No Drugs” report.
  • IDSA issued a press release opposing the Environmental Protection Agency’s decision to permit the State of Michigan to spray the state’s apple orchards with gentamicin. The Society said this decision risks undermining the value of this important antibiotic to treat blood infections in newborns and other serious human infections.

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