Animal Drugs for New World Screwworm

By Abbey Canon

Currently, there are no animal drugs approved by the FDA for the treatment or prevention of NWS myiasis in animals. FDA CVM is working with drug sponsors, federal and state partners, and international regulators to understand options for U.S. veterinarians to treat NWS effectively and safely. The agency has multiple regulatory pathways under which it could review and authorize animal drugs for NWS.

To learn more about FDA’s pathways, see: FDA Regulation of Animal Drugs.

Frequently Asked Questions (FAQs)

1. What role does the FDA’s Center for Veterinary Medicine play in the preparedness and response efforts for NWS?CVM’s role is to review data and information submitted by animal drug sponsors to support the safe and effective use of drugs to treat or prevent NWS myiasis in animals, including food-producing animals, companion animals, and wildlife.  CVM is working in collaboration with the USDA, which is spearheading the nationwide response to NWS, on developing prevention and treatment strategies for NWS myiasis in animals. Additionally, CVM is coordinating with the Environmental Protection Agency (EPA), which regulates subsets of certain over-the-counter topical antiparasitic products and insecticides as pesticides, to understand potential EPA-regulated products that may be part of a prevention and treatment strategy.
2. What mechanisms are available to provide for the use of drugs to prevent or treat NWS myiasis in animals?  FDA approval, supplemental approval, conditional approval, extra-label use and emergency use authorization are all mechanisms by which animal drugs could be made available for use to prevent or treat NWS myiasis. The appropriate mechanism(s) for each drug would depend on factors such as current U.S. approval status, which animal species the drug treats, and data and information submitted for FDA review by a sponsor. It is likely that multiple regulatory mechanisms will be needed to ensure that there are appropriate options available to meet the needs of veterinarians, animal producers and pet owners.For example, FDA approval or supplemental approval are typical mechanisms by which animal drugs can be reviewed and brought to market. However, the time needed for sponsors to generate the necessary data in support of drug applications, and for FDA to review these applications, may not be compatible with the urgent nature of the NWS public health threat. Therefore, these typical approval mechanisms alone may not meet all needs. For more detail regarding some of these mechanisms, see: FDA Regulation of Animal Drugs.