Animal pharmaceutical sales is a growing industry, and savvy manufacturers should take notice. Spending for pet supplies and over-the-counter medications increased 2.7% to $15.11 billion between 2016 and 2017, according to a report from the American Pet Products Association.
And the growth continues. By 2024, the animal health market is expected to exceed $36 billion. This presents an opportunity for agile manufacturers in the human-health sector whose products such as pain medications and surgical supplies could meet animals’ needs too.
Manufacturers in human health will benefit from having regulatory processes in place and an existing relationship with the Food and Drug Administration and Drug Enforcement Administration. But there are a few elements to consider before transitioning into the animal health care market.
Manufacturers should ask these four questions before making the move:
Do I Need FDA Approval to Launch a New Animal Health Product?
Short answer: No.
Long answer: Manufacturers in human health are used to heavily-regulated hoops involving trials, testing, and paperwork. Animal health products don’t have to go through the same approval process, but there are still regulations.
You’ll still need the FDA’s manufacturing registration and some amount of oversight; they will check your labeling and ingredients, for instance. But you won’t need the 510K premarket approval (the exceptions are radiation-emitting devices).
However, although you don’t need approval from the FDA to sell your product, you’ll want to go through all those hoops anyway. If an adverse event is traced back to your product, the FDA will want to see data indicating that your product has been tested and is safe for consumption and the uses it’s been marketed for. It will help you to have this information on hand should you ever need it.
Do I Need FDA Approval to Bring an Existing Product to the Animal Health Market?
Short answer: Yes.
Long answer: Here’s where it gets confusing. Even though you don’t need FDA approval to launch a new animal health product, if you have an existing product that’s being used in human health and you want to distribute it for veterinary use, you will have to get it approved for that use.
Essentially, you’ll have to do everything you did to get your product on the human health market in order to prove its application for animals. First, you’ll need to notify the FDA that you intend to sell this product for animal use. Then, you’ll need to show your animal-study data.
What Should My Clinical Trials Cover?
Many human-health products can be used for animals without changing anything about the product; this is true of many anxiety and pain medications, surgical sutures, and syringes and needles.
But your studies still need to prove that your product is applicable for animals. Your data should indicate:
- Dosage requirements — and how those change based on weight, size, sex, and age.
- Reactions in different species — that it’s safe for the animals it’s intended for.
- The effectiveness of the product — that it does what it’s intended to do.
What Regulations Do I Need to Follow to Sell My Product for Animal Use?
Labeling matters, whether you’re transitioning an existing product into the animal health market or launching something new.
You’ll submit your proposed product labels to the FDA as part of the pre-approval application, and a team comprised of veterinarians, microbiologists, and pharmacologists will review it for any discrepancies.
You’ll need to ensure that your labels are accurate and complete. The wording should be clear so that consumers do not feel misled; the FDA will check to ensure consumers have the information necessary to use the drug safely and as intended.
The FDA’s definition of “labeling” includes the following:
- The immediate container
- Package inserts
- Outer packaging
- Shipping label
- Client information sheets
Before considering an expansion into the animal health market, make sure you have the right partner to guide you through logistics, licensing, product assurance, and marketing. The right partner can serve as a consultative expert and help you prove your success in this new sector.
Contact EPiQ Animal Health to help you through the process of transitioning your human health products into the animal health sector.