Hi, I’m Pete! I’m an approved animal drug. What’s that mean, you ask? Good question! Well, first, it means that I’ve gone through the Food and Drug Administration’s (FDA's) approval process for a drug for animals. And second, it means FDA found me to be safe and effective when you follow the instructions on my label.
When I say I’m “safe,” I mean that I’m safe:
- for the animal, and
- for the people who give me to the animal.
If I’m a drug for a food-producing animal, and that animal is treated with me, then food products made by that animal are safe for people to eat. Chickens, cows, and pigs are food-producing animals because they give us eggs, milk, and meat to eat.
When I say I’m “effective,” I mean that I work the way I’m supposed to in the animal.
Want to learn how an animal drug gets approved?
Let’s Get Started!
Working hard in his laboratory, a chemist (a scientist who studies how chemicals work together) has an idea about a new drug. His idea leads him to discover ME! The chemist thinks that I may be a good drug to help make dogs less painful and more comfortable after they have surgery.
The chemist tells his boss at the drug company about me. The boss thinks I’m a good idea, and so people from all over the company work together to help get me through FDA's approval process for an animal drug.
First, the drug company's researchers do some small tests, called "pilot studies," with me in the laboratory. (No, there’s no flying in the lab.) These tests help the company's researchers learn a lot of basic information about me.
I do well in the small tests. So, a group of people from the company visits the Center for Veterinary Medicine (CVM) to talk about how to get me approved by FDA. (CVM is the part of FDA that approves new drugs for animals.)
During the visit, the drug company and CVM talk about what information is needed to get me approved. For example, they talk about how many and what kind of tests will be needed. CVM needs to see that I am safe in dogs and that I really do make them less painful and more comfortable after surgery.
After our visit with CVM, the drug company starts planning and carrying out the tests we discussed.
All the tests involve ME—YIPPEE!
You know, when a high school senior wants to go to college, he sends his dream school a college application and (hopefully) gets accepted. Well, in my case, the drug company sends CVM a New Animal Drug Application (NADA) to get me approved.
The high school senior's college application tells his story, including information about his grades and after-school activities (like if he’s the co-captain of the varsity wrestling team, the lead trombone player in the marching band, or an Eagle Scout). In my case, the NADA tells my story, including all the information the drug company knows about me and how well I work in dogs.
Think of the NADA application as a very big book about ME – my favorite subject! Because there’s so much information in the application, CVM spends months reading it, and then writes a big book report (called a Veterinary Medical Review) about what the center learned. How long did it take you to write your last book report?
The last step in the approval process is for CVM to decide if the information in my application shows that I’m safe to use in dogs and will make them less painful and more comfortable after they have surgery. CVM decides yes, so I’m approved – HIP HIP HOORAY!
CVM decides to approve me because:
- I’m safe and work like I’m supposed to in dogs when the instructions on my label are followed,
- my label tells the truth about me, and
- I can be made the same from batch to batch (like a recipe for chocolate chip cookies – as long as you follow the recipe, your cookies will taste the same each time you make them).
Whew! I’ve made it through CVM's approval process for an animal drug! Some animal drugs aren’t so lucky. CVM doesn’t approve some drugs because they aren’t safe, don’t work the way they’re supposed to, or can’t be made the same from batch to batch.
Now I can tell everyone that I’m an FDA-approved animal drug! The drug company can now make and sell me to veterinarians. The veterinarians can then use me to help dogs feel better after their surgeries.
Even though I’m now approved, CVM will keep checking up on me to make sure I still:
- am safe,
- work well, and
- can be made the same from batch to batch.