FDA to Industry: Let’s Increase the Availability of Safe, Effective Animal Drugs

April 15, 2015 — 

Just as drugs for people benefit from FDA review to ensure their safety, effectiveness and quality, so do drugs for animals. [Source: FDA Voice, April 8, 2015 By: Martine Hartogensis, D.V.M.]

Unfortunately, this fact is ignored by some companies that sell unapproved animal drugs. By bypassing the FDA’s drug approval process, these firms potentially put the health of animals—and people—at risk. That’s why the FDA is working to get these products off the market.

There are different pathways to FDA approval and legal marketing of an animal drug product, but each pathway requires a drug company to expend both time and financial resources to generate the appropriate scientific evidence to support the approval. Companies that bypass the FDA drug approval process may be endangering the animals given unapproved drugs and people who either handle the unapproved drugs or eat food from animals treated with them. In addition, those who market unapproved drugs have an unfair competitive edge, and might prompt others to also break the law in order to compete in the marketplace. This slippery slope leads to a diminished supply of animal drugs that have been reviewed by the FDA for safety and effectiveness.

FDA’s rigorous review process also makes certain that the manufacturing process preserves the drug’s strength, quality and purity, and ensures that it has been consistently produced from batch to batch. FDA also requires that the product labeling is truthful and complete.

In some circumstances, the unapproved drug may be the only one of its kind available. In these cases, FDA often works with the company to develop the evidence that the product is safe and effective. Making innovative, FDA-approved animal medications legally marketable is an important part of FDA’s mission to protect the public health.

But while being helpful, FDA is also stepping up efforts to combat illegal animal drug sales, both on the ground and online.

We’ve recently issued warning letters to several marketers, distributors and manufacturers of unapproved animal drugs and expect to issue more in the coming year. Our enforcement actions could include seizures of violative products and/or injunctions against manufacturers and distributors of unapproved animal drugs. We also continue to regularly update the agency’s web page on unapproved animal drugs with information for veterinarians and industry.

We’ll continue to do all we can to make the animal drug approval process as straightforward and efficient as possible. But we need industry to do its part, so that we can continue to make more safe and effective drugs available to veterinarians, animal producers and pet owners.

Martine Hartogensis, D.V.M., is Deputy Director, Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine