QUESTIONS MOST OFTEN ASKED ABOUT ANIMAL DRUGS
JUST WHAT IS AN APPROVED ANIMAL DRUG?
For a drug to be approved it has to go through the FDA’s drug approval process. During this process, the FDA reviews information submitted by the drug company about the animal drug. When the information meets the requirements for approval, the agency approves the animal drug. Approval from the FDA means the drug is safe and effective when it’s used according to the label. An FDA approval also ensures that the drug’s strength, quality, and purity are consistent from batch to batch, and that the drug’s label is truthful, complete, and not misleading.
WHAT IT THE APPROVAL PROCESS?
THE APPROVAL PROCESS FOR AN ANIMAL DRUG IS A COLLABORATIVE EFFORT BETWEEN THE DRUG COMPANY AND FDA. HERE ARE THE STEPS OF THE APPROVAL PROCESS:
- The drug company collects information about the safety and effectiveness of a new animal drug. The company may need to conduct studies to get this information. For any studies that are performed, the company analyzes the results.
- Based on the collected information, the drug company decides if there is enough proof that the drug meets the requirements for approval. Then the company must prove that the drug is safe and effective for a specific use in a specific animal species. When the drug is for food-producing animals ( like cows and chickens ), the company must also prove that it’s safe for people to eat food from treated animals, such as meat, milk, and eggs.
- If the drug company decides the drug meets the requirements for approval, the company submits a New Animal Drug Application to the FDA. For a generic animal drug, it’s called an Abbreviated New Animal Drug Application. The application includes all the information about the drug and the proposed label.
- A team of FDA personnel, including veterinarians, animal scientists, biostatisticians, chemists, microbiologist, pharmacologists, and toxicologists, reviews the application. If the agency’s tream agrees with the company’s conclusion that the drug is safe and effective when it’s used according to the proposed label, FDA approves the drug and the drug company can legally sell it.
WHAT ARE THE BENEFITS OF FDA’s DRUG APPROVAL PROCESS?
The benefit of the FDA drug approval process is the assurance that an approved animal drug is safe, effective, and of high-quality. The drug company has shown that the drug is safe and effective in a specific animal species when when used according to the label. The label is written specifically for that species and includes all necessary information to use the drug safely and effectively and the risks associated with the drug. The drug company has also shown that the manufacturing process consistently produces a high-quality drug.
Another benefit of the drug approval process is FDA’s continued monitoring of approved animal drugs after they’re on the market. Sometimes, the agency’s post-approval monitoring uncovers safely and effectiveness issues that were unknown at the time of approval. The FDA also continures to monitor the drug’s labeling, the drug’s manufacturing process, and the company’s marketing communications related to the drug to make sure the information is truthful and not misleading.
ARE APPROVED ANIMAL DRUGS THE ONLY DRUGS THAT CAN BE LEGALLY USED IN ANIMALS?
Besides approved animal drugs, there are two other categories of legally marketed animal drugs that can be used in animals, depending on the situation. These two categories are:
- Conditionally approved animal drugs. This is available only for some animal drugs for use in a minor species or in a major species under special circumstances.
- Indexed animal drugs. This is available only for drugs for certain species.
The FDA classifies horses, dogs, cats, cattle, pigs, chickens, and turkeys as the seven major species. All other animals, such as sheep, goats, and hamsters, are considered minor species.
CONDITIONAL APPROVAL
A conditionally approved animal drug has gone through FDA’s drug approval process except the drug has not yet met the effectiveness standard for full approval. The FDA’s conditional approval means that when used according to the label, the drug is safe and has a “reasonable expectation of effectiveness.”
The conditional approval is valid for one year. The drug company can ask the FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. During the 5-year period, the drug company can legally sell the animal drug while collecting the remaining effectiveness data. This early marketing is good for two reasons: first, the drug is available sooner to be used in animals that may benefit from it; and second, the company can recoup some of the investment costs while completing the full approval.
After collecting the remaining effectiveness data, the company submits an application to the FDA for full approval. The agency reviews the application and, if appropriate, fully approves the drug.
CAN DRUGS USED BY PEOPLE BY LEGALLY USED IN ANIMALS?
The answer is Yes. Veterinarians can legally prescribe an approved human drug in animals in certain circumstances. This is called extra-label use.
SO WHAT DOES EXTRA-LABEL USE REALLY MEAN?
Extra-label use means using an approved human or animal drug in a way what isn’t listed on the drug’s label. It is sometimes called off-label because the use isn’t listed on the label.
In 1994, Congress passed a law that allows veterinarians to prescribe approved human and animal drugs for extra-label uses in animals under specified conditions.
WHERE CAN I FIND INFORMATION ABOUT A DRUG MY VETERINARIAN PRESCRIBED FOR MY PET?
ASK YOU VETERINARIAN
Asking your veterinarian is your best resource for information about a drug that has been prescribed for your pet.
LOOK UP THE DRUG IN ANIMAL DRUGS @ FDA
Animals Drugs @ FDA ( https://animaldrugsatfda.fda.gov/adafda/views/#/search ) is an online database that includes most FDA-approved and conditionally approved animal drugs. You can search this database in several ways, such as by the drug’s proprietary name ( also known as the trade name or brand name ) or active ingredient.
READ THE CLIENT INFORMATION SHEET
Some approved animal drugs have a Client Information Sheet written specifically for pet owners in a user-friendly, question-and-answer format. The handout gives you detailed information about your pet’s medication and the side effects it can cause, helping you to use the medication as safely and effectively as possible for your pet. You can also get a Client Information Sheet from your veterinarian.
Not all approved animal drugs have Client Information Sheets available. Generally, they’re written for medications where the pet owner is involved which is important for safe and effective use.
READ THE DRUG’S FREEDOM OF INFORMATION SUMMARY
Every approved, conditionally approved, and indexed animal drug has a Freedom of Information ( FOI ) Summary. This summary is a public document describing the safety and effectiveness information that supports the agency’s decision to approve, conditionally approve, or index ( indexing is for what are considered minor animals, not dogs ) the drug. The document includes summaries of studies that were done and explains the basis for the agency’s decision.
I CAN’T FIND THE INFORMATION ABOUT A DRUG IN ANIMALS DRUGS @ FDA, WHY?
There are several reasons why you might not find a certain drug in Animal Drugs @ FDA:
- You misspelled the drug’s proprietary name or active ingredient. Make sure you carefully check the spelling.
- It’s a drug for people, not animals. Check Drugs @ FDA.
- The drug isn’t approved in the United States
- The drug is an indexed animal drug. Check the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.
HOW DO I REPORT A BAD REACTION TO A DRUG PRESCRIBED FOR MY DOG
The FDA encourages pet owners to work with their veterinarian to report problems with any animal drug. These problems can include undesired side effects associated with a drug, and product defects. Adverse events also include a lack of effectiveness ( the drug doesn’t do what it’s supposed to do ) and unfavorable reactions in people who handle the drug. Product defects are problems such as defective packaging or the drug has an abnormal appearance.
When you report undesired side effects and product defects with animal drugs, you help the FDA more easily identify and correct problems.
HOW DOES THE FDA GET AN UNSAFE OR INEFFECTIVE ANIMAL DRUG OFF THE MARKET?
Under federal law, the FDA has the authority to remove an approved, conditionally approved, or indexed animal drug from the market if the agency later finds the drug to be unsafe or ineffective.
The agency follows specific regulations and policies for removing an approved animal drug from the market. In most cases when the FDA withdraws the approval for an animal drug, it’s at the request of the drug company because the company no longer manufactures or markets the drug.
If the FDA finds that a conditionally approved drug is unsafe, the agency can deny the company’s request for an annual renewal. ( Remember, a conditional approval is valid for only one year. To legally sell the drug after one year, the drug company must ask the FDA for a renewal. The company can receive up to four annual renewals, for a total of five years of conditional approval. ) Under certain conditions, the agency can also remove a conditionally approved animal drug from the market outside of the annual renewal process.
When the FDA finds that an indexed animal drug is unsafe or ineffective, the agency removes the drug from the Index and the drug company can no longer legally sell it.
ARE GENERIC ANIMAL DRUGS AS SAFE AND EFFECTIVE AS THE BRAND NAME ANIMAL DRUGS?
Yes. The FDA requires a generic drug to have the same quality, performance, and intended uses as the already-approved brand name drug. The generic drug must be bioequivalent to the approved brand name drug. What this means is, the generic drug is absorbed by and performs to the same way in the animal’s body as the brand name drug.
The FDA also requires that the generic drug be manufactured under the same strict manufacturing standards as the brand name drug. The manufacturing process for the generic drug must consistently produce a product that is equivalent to the brand name animal drug in identity, strength, purity, and quality.
WHAT ARE THE DIFFERENCES BETWEEN AND OVER-THE-COUNTER ANIMAL DRUG, A PRESCRIPTION ANIMAL DRUG, AND A VETERINARY FEED DIRECTIVE ANIMAL DRUG?
One difference between these three categories of animal drugs is whether the FDA has determined that veterinary oversight is required for the safe and effective use of the drug. If the agency determines that adequate “directions for use” can be written on the drug’s label in such a way that a non-veterinarian can use the drug safely and effectively, then the drug company can market the animal drug as over-the-counter (OTC). If not, then the drug company must market the animal drug as either prescription (Rx) or veterinary feed directive (VFD).
VFD and Rx drugs both require veterinary oversight to be used safely and effectively. The main difference between these two categories of animal drug is whether the drug is used in or on animal feed. When the drug is for use in or on animal feed (a medicated feed), the FDA approves it as a VFD drug. When the drug is not for use in or on animal feed, the FDA approves it as a prescription drug. Federal law makes it clear that VFD drugs are not prescription drugs. A VFD drug requires veterinary oversight without invoking state pharmacy laws for a prescription drug that are unworkable for medicated feed.
A prescription animal drug can be dispensed only by or on the lawful written order of a licensed veterinarian and must have the following statement on the label:
“Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
A VFD is written order issued by a licensed veterinarian in the course of the veterinarians professional practice that authorizes the client (the owner or other animal caretaker) to obtain and use a VFD drug in or on animal feed. A VFD animal drug must have the following statement on the label:
“Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.”
IS IT SAFE TO GIVE MY DOG A PAIN RELIEVER FOR PEOPLE, SUCH AS ASPIRIN, IBUPROFEN, NAPROXEN, OR ACETAMINOPHEN?
It’s a common reaction when you see your dog in pain to think about giving her or him over-the-counter pain reliever for people. But a pain reliever for people isn’t a good alternative to a pain reliever approved for animals.
Even if data show that a non-steroidal anti-inflammatory drug (NSAID), like aspirin, ibuprofen, and naproxen, is safe and effective in people, the drug may not be safe and effective in dogs because the drug may:
- Last longer
- Be absorbed faster by the stomach and small intestine
- Reach higher blood levels
These differences may lead to toxic effects in drugs, such as stomach problems as well as liver and kidney damage.
Acetaminophen (brand name Tylenol) is not an NSAID and doesn’t have much anti-inflammatory activity. Acetaminophen is Fatal to Cats.
Even if your dog seems to be in pain, don’t give him or her anything in your medicine cabinet until you talk to your veterinarian.
MY VETERINARIAN HAS TO EXAMINE MY DOG BEFORE PRESCRIBING A DRUG, WHY?
Many states have laws governing the practice of veterinary medicine, and these laws may require a veterinarian to have a valid relationship with both the patient and the client before the vet can prescribe a drug for an animal. Depending on the state, such a relationship may include a physical examination. Your veterinarian is the best person to determine which drug is best for your dog’s condition and to make sure it’s used appropriately.
SHARPS: NEEDLES AND SYRINGES
Some pets need a medication that requires you to use “sharps” at home. “Sharps” are medical devices with sharp points or edges that can puncture or cut skin, such as needles and syringes. For example, insulin — a medication used to treat diabetes in dogs and cats — is injected under the skin using a small insulin syringe that has a needle.
For more information about how to safely dispose of used sharps, please see:
- Sefely Using Sharps (Needles and Syringes) at Home, at Work and on Travel (/safely-uning-sharps-needles-and-syringes-home-work-and-travel)
- Sharps Disposal Containers (/medical-devices/safely-using-sharps-needles-and-syringes-home-work-and-travel/sharps-disposal-containers)
HOW THE FDA EVALUATES THE IMPACT OF AN ANIMAL DRUG ON THE ENVIRONMENT
Under the National Environmental Policy Act, FDA must consider how the environment will be affected if the agency approves, or indexes an animal drug. To do this, the agency requires how much drug is expected to get into the environment and its potential environmental effects.
When the FDA determines that the drug will not significantly impact the environment based on the information in the EA, the agency writes what’s called a “Finding of No Significant Impact.” If the FDA determines that the drug will significantly impact the environment, the agency writes an Environmental Impact Statement.
A drug company can ask the FDA for a “categorical exclusion,” or “CE” for short. A CE means that the drug falls into a legally-defined category that’s unlikely to affect the environment. If the agency grants a CE, the company doesn’t have to prepare an EA.
- A drug for companion animals, like cats and dogs. Because a drug for companion animals is given to one animal at a time (as opposed to a herd or flock of animals), not much of the drug is likely to get into the environment.
- A slight change to an already-approved animal drug if the change will not increase how much drug is used or how much will get into the environment.
