By CELESTE BAUMGARTNER

Ohio Correspondent

WASHINGTON, D.C. — The American Veterinary Medical Assoc. (AVMA) was pleased President Donald Trump recently signed the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (House Resolution 5554), which reauthorizes for five years U.S. Food and Drug Administration (FDA) user fee programs for branded and generic animal drugs.

The legislation also amends FDA animal drug programs regarding electronic submission of applications, drug labeling, conditional approval of drugs, agency guidance on investigational design, food additives and pet food.

“This legislation is an amendment reauthorization of FDA’s abilities to collect user fees from animal drug and animal generic drug user fees from the drug’s sponsors when they submit applications for review by FDA,” explained Lauren Stump DVM, AVMA's assistant director of Government Relations.

”These fees, coupled with annual appropriations, support FDA’s animal review process and ultimately improve veterinary access to FDA-approved drugs. We have very few drugs that are labeled safe and effective for use in veterinary medicine.”

The passage of this amendment enables FDA to review those new animal drug applications by providing it with resources which it can use to hire staff or otherwise support that review process, Stump said.

“FDA’s safety and efficacy standards are the gold standard in veterinary medicine,” she added, “so we were happy to see that ability reauthorized, and it was a pretty tight timeline; we were pleased with that getting across the finish line.”

AVMA was also glad to see a piece added to this legislation that allows a process called conditional approval. That would be approval for uses in major species for studies that are difficult or might take a long time to perform or might involve rare diseases, if researchers have trouble finding enough subjects to use, Stump said.

“That incentivizes new and innovative products for conditions that prove particularly difficult to study in certain species,” she explained.

The American Feed Industry Assoc. (AFIA) was also happy Trump signed the amendment, especially with the inclusion of Section 306. This relates to food additives intended for use in animal food.

The animal feed and ingredient review and approval process within the FDA is lengthy and expensive for ingredient companies, said John Stewart, AFIA manager of government affairs.

“Our research shows that it takes on average three to five years for an ingredient to be approved in this process; companies lose on average $1.5 (million) to $2 million per year per product in that process. Companies have lost close to $10 million just in that process,” he said.

“It is important for our ingredient companies because it brings some clarity and some guidelines to be able to get this product into the review process, and then quickly have a response as to the safety of this product.”

The good news for farmers is the more ingredients there are on the market, he noted, the more options they have for feeding their animals and more alternatives to different components, whether it is to treat an illness or to supplement an animal.

“It just provides more resources and opportunities, and obviously it increases competition in the marketplace, which is good for everybody,” Stewart said.