FDA Explores Animal Drug Options for Screwworm Treatment

Efforts Continue to Support Safe Treatment of NWS Cases

The U.S. Food and Drug Administration (FDA) currently has no approved animal drugs to treat or prevent New World Screwworm (NWS) in animals. However, the FDA’s Center for Veterinary Medicine (CVM) is working closely with the USDA, state partners, and international regulators to develop effective solutions.

The NWS is a serious threat to livestock, wildlife, and even pets. It requires safe and effective treatments, especially for food-producing animals. The CVM’s main role is to review data submitted by drug makers to ensure animal health and food safety.

CVM is also partnering with the Environmental Protection Agency (EPA), which regulates certain over-the-counter antiparasitic and insecticide products, to better understand available prevention tools.

Several regulatory pathways can be used to make drugs available quickly, including full FDA approval, supplemental approval, conditional approval, emergency use authorization, and extra-label use. The best option depends on factors such as the drug’s approval status and which animals it treats.

In urgent situations, emergency use or extra-label use may be the fastest way to help animals. Veterinarians are allowed to prescribe FDA-approved drugs for off-label use if they have a valid relationship with their clients and follow existing laws.

CVM is also looking at long-term safety and effectiveness, and the potential for drug resistance. The agency encourages drug companies to submit research and explore possible approval routes.