More Treatments Expected for Diseases in Dogs and Cats as FDA Changes Rules
The U.S. Food and Drug Administration Center for Veterinary Medicine (FDA CVM) has announced taking steps to help increase the availability of novel treatments for rare diseases and conditions in cats and dogs, also known as "minor use" drugs.
The FDA has planned to change its rules for giving an animal drug the status of minor use anticipating that more treatments for small animals will meet the criteria. For that, the agency has increased the threshold of dogs and cats that helps an animal drug qualify as a minor use. For cats, the number increased from 120,000 to 150,000 cases annually. For dogs, the new threshold is 80,000 cases annually (up from 70,000).
As per FDA's new rules, an animal drug must be intended to treat a disease or condition in animals that meet the following criteria:
- Treats a disease or condition in what FDA considers a major species including dogs, cats, horses, cattle, swine, chickens, or turkeys.
- Treats a disease that occurs less frequently and in limited geographic areas.
- Treats a disease that occurs in less than a small number of animals per anum.
The reason for which FDA CVM is changing its rules for approval of minor use is that the overall number of dogs and cat population has increased after Covid-19. It is because more people in the U.S. have adopted pets during the pandemic. American Veterinary Medical Association (AVMA) estimates that 45% of U.S. households now have at least one dog which was 38% back in 2018.
The changes made by the FDA will be effective on December 14 while the agency will start accepting public comments from November 14. Anyone can submit comments to FDA through the details mentioned on its website.
