A new veterinary drug has just been approved by the Food & Drug Administration (FDA) called Galliprant that will be prescribed as part of the treatment protocols for canine osteoarthritis. The road to FDA approval for new drugs is a long one, with a number of important steps in the development process along the way. It's interesting to learn about those steps because as pet parents, we like to know that the medications that are given to our furry friends have been thoroughly tested and shown to be both safe and effective.
These are the steps involved in gaining FDA approval for a new veterinary medicine.
The very first step in the development of a new drug is the idea. Someone has an idea for a chemical compound that could have therapeutic effects. The idea, and any information to support it, is taken to a drug sponsor. This group will fund its development, and may be a business or even a university. If the sponsor feels the idea has merit, then they start the first phase of development; they create the compound and commence laboratory testing to see if the drug actually does what they expect it to and if it appears safe. The sponsor then submits a New Animal Drug Application to the Center for Veterinary Medicine (CVM), a subsidiary of the FDA. From there the Office of New Animal Drug Evaluation (ONADE) opens an investigation and determines what type of studies will need to be conducted for the new drug to gain approval.
With the approval of ONADE, clinical tests are performed to determine animal safety and effectiveness. A group of healthy animals is given the drug and they are carefully observed for side effects. This ensures that the drug is safe to give. Next, pets with the condition the drug is intended to treat are given the medication, again under close supervision. This part of the trials make sure the drug actually does what is expected – alleviate the condition. It's also essential that the drug is safe for people to administer; after all, veterinarians and pet parents are the ones who will be handling the drug.
When the drug has been shown to be safe and effective, the ONADE then looks into the effectiveness, safety, labeling, manufacturing, and environmental impact of the drug.
The ingredients used to manufacture the drug, the manufacturing process, the intended manufacturing facility, conditions for storage, and shelf life are all closely scrutinized. The environmental impact of the drug's use and manufacturing is also considered. For instance, if the manufacturing process produces harmful byproducts that could pollute waterways, the drug is less likely to be approved. If the drug passes each assessment by the CVM and FDA, it then becomes approved and a freedom of information (FOI) document is made available, which describes the approval process and uses for the new drug.
It's clear to see that it takes time, effort, and money to bring a new drug to market. The FDA is involved at all steps of its development, and is thorough in making sure it meets their guidelines. This means that pet parents can have confidence in the medications that are prescribed for their four-legged companions by their veterinarian.