In the U.S., pets are often considered family members. It’s no surprise then that pet owners want their pets to be as healthy as possible.
Much like in human healthcare, a huge industry has arisen in pet care, with an enormous range of supplements, foods, and other products, all claiming to help pets feel better. When deciding whether to purchase a new animal health product, there is one phrase that indicates the product has been tested and evaluated more than others: “FDA-approved.”
Much like human medications, FDA-approved pet medications have undergone a rigorous evaluation process including veterinary clinical studies, and the FDA has reviewed and determined them to be safe and effective. In this article, we explore the FDA approval process for pet medications in detail. To learn more, visit the FDA website here.
Background: Aren’t All Pet Medications FDA Approved?
In the U.S., almost all systemic animal medications — that is, those that enter the animal’s bloodstream — are regulated and approved by the FDA. Animal vaccines, however, are regulated by the U.S. Department of Agriculture (USDA), and some topical products, such as flea and tick treatments, are regulated by the Environmental Protection Agency (EPA). For the most part, any systemic medications must be approved by FDA before they can legally be sold in the U.S.
Because the bar to achieve FDA approval is high, the path is long and costly. From start to finish, it typically takes many years, and often costs millions of dollars.
The FDA Approval Process for Animal Medications
When an animal treatment is FDA-approved, a pet owner be confident that it safe and effective. That’s because an investigational veterinary medication must undergo these five rigorous steps to gain approval before it can be sold in the U.S.
Step 1: Conception and pilot studies
All new animal medications start as an idea with the investigational medication’s sponsor. Anyone with the inclination and funds can be a medication sponsor. Sponsors are often scientific research groups, and universities, but most commonly, they are pharmaceutical companies.
Once a sponsor identifies a compound which they consider promising, preliminary or “pilot” studies will be conducted to learn more about its effectiveness. If the results are positive, the sponsor will contact the FDA office in charge of approving and monitoring new animal medications — The Center for Veterinary Medicine (FDA-CVM) — to officially start the medication approval process.
Step 2: Contacting CVM
Once the sponsor contacts the FDA-CVM, an Investigational New Animal Drug (INAD) file for the medication will be opened. The sponsor and the FDA-CVM will then meet to discuss the path forward. The FDA will outline the number and types of studies required for approval, and the design that each study should take.
During this discussion, the sponsor will indicate which of three different types of applications the company plans to pursue:
- Approved New Animal Drug application (NADA): Used to seek approval of an entirely new animal medication.
- Abbreviated NADA (ANADA): Used to seek approval of a generic version of an already-approved animal medication.
- Conditionally Approved (CNADA): For a CNADA, the sponsor must demonstrate a “reasonable expectation of effectiveness.” This designation is used to help ensure that innovative health treatments are available for pets when there is a critical, unmet need. The CNADA allows the sponsor to market the drug for up to 5 years, while effectiveness data is collected to potentially meet the requirements for full FDA approval.
The vast majority of potential new animal medications are submitted under the NADA application. For brevity, the next steps shown below are for a companion animal (pet) NADA application.
Step 3: Doing the work
Since every investigational medication is different, each will have its own requirements for approval. Not all of the following steps will need to be completed in every case, but In general, the sponsor will need to establish:
A. The dosage regimen
The dosage is the amount of medication the animal will be administered. The sponsor must explain:
- The dosage form – Such as a pill, a liquid, or injectable
- The frequency – How often it will be administered
- The duration – How long it will be administered
- The route of administration – How it will be administered (such as injected, swallowed, or applied topically)
B. The investigational medication’s safety
One of the most critical things the sponsor must do is prove that the test medication is safe. To do this, the sponsor is required to conduct a target animal safety study, which evaluates the medication’s effects in a small number of animals.
C. The test medication’s effectiveness
The sponsor must also prove that the investigational medication will do what it promises to do. This can be done with a field study, in which pets are given the investigational medication under normal or “field” conditions (i.e., at home or in a veterinarian’s office). The final field studies are often referred to as pivotal studies.
D. The test medication’s manufacturing details
NADA applications also include a section called Chemistry, Manufacturing, and Controls, in which the sponsor must describe the test medication’s manufacturing details, including:
- Which ingredients will be used to make the medication
- Where the ingredients will be sourced
- Where the medication will be manufactured
- How the medication will be manufactured
- How the medication will be packaged
- Under what conditions the medication should be stored
- How long the medication can be stored before it expires
E. Any additional information
In this section of the NADA application, called “All Other Information,” the sponsor can submit any miscellaneous information pertaining to the test medication’s safety, efficacy, and usage. This can include any non-U.S. experience, whether the investigational medication has been approved in a country outside the U.S., as well as any published scientific literature.
F. Labeling information
The FDA-CVM also works to ensure that any information on the medication’s packaging is truthful, complete, and accurate. The sponsor must therefore describe all information that will appear on:
- The medication’s immediate container – Such as a vial, bottle, or syringe
- The package insert – A sheet of paper included with the medication, generally written for veterinarians
- The outer packaging – Usually a box containing several vials, bottles, etc.
- Client information sheet – A document written primarily for pet owners, detailing information about the medication and its potential adverse effects
- Shipping label – Yes, the FDA-CVM is so thorough that even the shipping label is also subject to review
At this point, at long last, the sponsor is ready to submit the NADA application for potential approval.
Step 4: Review and approval
NADA applications are reviewed by an FDA-CVM team that includes veterinarians, animal scientists, biostatisticians, chemists, microbiologists, pharmacologists, and toxicologists. They carefully study the data for evidence that the investigational medication is safe; that it is effective when used according to its label instructions; and that is manufactured safely and with consistency.
If the initial review team decides that the investigational medication meets FDA-CVM standards, the application will pass to another FDA-CVM review division, which will determine how the new medication should be classified. New animal medications can be classified as:
- Over-the-counter (OTC) medication
- A prescription (Rx) medication, which veterinarians must prescribe
Finally, the NADA application will be sent to the Director of the FDA-CVM. If the Director agrees that the investigational medication should be approved, a notice of approval will be published in the Federal Register. The sponsor can then legally sell the new medication to veterinarians and/or pet owners everywhere.
With such a lengthy and disciplined review process, there’s no guarantee that the medication will receive approval. Submissions are denied for various reasons, most often because the FDA-CVM did not find the medication to be as effective as claimed.
Step 5: FDA post-market safety monitoring
Another important aspect of the FDA’s role for both human and animal medications which few people know about, is post-market assessment and monitoring. The FDA-CVM doesn’t just approve new medications, it also continues to assess the product’s safety and efficacy as it is administered to patients. Pharmaceutical companies are required to report any complaints they receive about a medication to the FDA-CVM, and the agency often requires additional instructions or cautions to be added to the product label. Importantly, if the FDA deems there’s a significant risk to patients, it can issue a recall order at any time.
The FDA-CVM also conducts routine inspections of pharmaceutical manufacturing facilities, including those that are located outside the U.S. Inspections may be announced or unannounced, and help ensure that manufacturing facilities are using the correct equipment and methods to consistently produce high-quality, safe medications.
FDA-approval represents the highest standard in pet treatments
As you can see, any medication — human or animal — that has FDA approval has undergone an incredibly thorough assessment and determined to be safe and effective. Consumers can be assured that FDA-approved medications will do what they claim they will do, and that the majority of any adverse effects are known.
About Visionaire Research & Education
For over 20 years, Visionaire Research & Education has helped veterinary medication sponsors bring new treatments to market. Our number one priority is helping dogs, cats, and horses — and their owners — experience a better quality of life through innovative treatments and solutions. The pivotal studies that we support can be a great way to gain access to quality diagnostics and veterinary care — and investigational therapies that often aren’t available anywhere else — all at no cost. If you have questions about the work we do, please feel free to contact us.