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) animal drug approval process. And second, it means FDA found me to be safe and effective if the instructions on my label are followed.
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, the food products made from an animal treated with me are safe for people to eat. Food-producing animals give people food. 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 I went from being an idea to an approved animal drug?
Let’s Get Started!
Working hard in his laboratory, a chemist 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 more comfortable after they have surgery.
The chemist tells his boss at the drug company about me. The company thinks I’m a good idea and helps get me through the animal drug approval process.
First, the drug company does some small tests, called pilot studies, with me in the laboratory. These tests help the company learn a lot of basic information about me.
I do really well in the small tests. The drug sponsor thinks veterinarians will want to use me to help dogs feel more comfortable after surgery. So, the company visits the Center for Veterinary Medicine (CVM) to talk about how to get me approved. 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 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 how a high school senior who wants to go to college has to send the school a college application to get accepted? Well, in my case, the drug company has to send CVM a New Animal Drug Application (NADA) to get me approved.
The college application tells the high school student’s story, including information about grades and after-school activities (like if he’s the quarterback on the football team or she’s a tuba player in the marching band). The NADA tells my story, including all the information the drug company knows about me and how I work in dogs.
Because there’s so much information in the application, CVM spends months looking at it. Think of the application as a very big book report – CVM has to read lots about one subject (ME – my favorite subject!) and then write a big book report all about ME! How long did it take you to write your last long book report?
So, the drug company has sent CVM my application with all the information about me. CVM has looked at it and has written the big book report. Now what?
The last step in the approval process is for CVM to decide if the information in my application shows that I’m safe in dogs and will make them more comfortable after they have surgery. CVM decides yes, so I’m approved – HIP HIP HOORAY!
I’m approved 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 making sure each batch of chocolate chip cookie dough will make cookies that taste the same).
Whew! I’ve made it through FDA’s animal drug approval process! Some animal drugs aren’t as lucky as me. 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 use me to help dogs feel more comfortable after their operations.
Even though I’m 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.