Livestock producers know too well that new antibiotics and other animal health products are slow to come to market. Once available, new products are usually expensive and sometimes hard to obtain.
Ron Phillips, vice president, Public and Legislative Affairs, Animal Health Institute (AHI), addressed this issue at the recent American Sheep Industry Convention. He discussed the development and approval process for new drugs and explained the regulatory approval process.
The AHI is the trade association that represents companies that make animal medicines. “In human medicine, everything goes through the FDA,” said Phillips. “In the animal world, three federal agencies approve products.” The FDA approves pharmaceuticals, the USDA approves vaccines and the EPA approves externally applied pest products.
“Our goal is to work with producers to get products needed to improve the health and well-being of animals,” said Phillips. “These [products] have very specific public health benefits including food availability and food safety.”
The process begins with an idea for a drug that will benefit livestock; the finish line is an approved drug available to producers. The basis for the regulatory steps is the Federal Food, Drug and Cosmetic Act, which requires all drugs, whether for human or animal use, to be safe and effective.
“FDA has developed a number of regulations based on that law and how we implement those basic requirements,” said Phillips. “We have a series of policy guidelines and standards; the FDA issues a guidance that instructs users [producers] how to interpret the regulation in the law.” He said that the “guidance” is actually a regulation and cannot be ignored.
Early development is a discussion process that documents a particular agency is working on a drug. “There’s a lot of discussion between a sponsor and the agency before a data package is developed,” said Phillips. “It’s the process of interpreting what the regulations and guidances say.”
Next is a series of protocols, which are written agreements between the agency and the sponsor as to what will be required and how it’s going to be produced. This allows the sponsor to begin pivotal studies.
“One of the challenges in the animal drug approval process is that unlike human drugs, we have phase reviews,” said Phillips. “All the data packages that are part of the submission process can be submitted at different times. The challenge is figuring out and measuring how long it takes to get a drug approved.” He added that the phase review process takes longer for a food animal product than for companion animal products due to the critical food safety aspect.
“A few years of work is required even before we get to the data package submission stage,” said Phillips. “That’s where we run into longer timeframes for food animal or human drugs. It’s a long and expensive process – six to 12 years – for food animals. The cost can be as much as $100 million for the FDA to approve a food animal drug.”
One of the current issues, which can be a barrier to smooth approval, is the Animal Drug User Fee Act (ADUFA). “Like on the human side, we have a program at FDA where we pay, as an industry, a fee so they can hire more people to review drugs,” said Phillips. “It’s in exchange for them agreeing to performance and time goals to ensure the process is as efficient as possible. Congress has to reauthorize this every five years – this year, Congress has to authorize the fifth generation of ADUFA.” The hope is that over time, changes will increase performance and facilitate more drugs coming to market.
For cattle drugs, sponsors can usually find large feedlots willing to participate in clinical studies. It’s more of a challenge to get large groups of animals needed for studies in less consolidated animal industries that don’t have as many animals on one site.
Every drug approved for marketing must be approved for both safety and efficacy. Products must be safe for human food, for the animal, for the environment and the product itself.
U.S. producers are aware of therapies available to competitors in other markets that aren’t available to them. “There are reams of data required from sponsors to produce for the FDA,” said Phillips. “They are required to produce the same data in Europe, Australia or wherever. We need greater regulatory harmonization with the EU and the U.S., requiring the same things and accepting each other’s data to increase efficiency in developing drugs.”
As technical requirements grow and more data and animal studies are required to prove safety and efficacy, the challenge is a lack of available contractors, who Phillips said find it more profitable to work with human drug sponsors.
Another challenge is maintaining existing products. One important drug is xylazine (brand name Rompun), a widely used animal sedative. Phillips cited an article in the New York Times about xylazine being added to fentanyl. “Veterinary drugs are being used to fuel the drug problem in America,” he said. “The snap legislative reaction is to restrict the availability and put it on the DEA’s list of scheduled drugs, which would make it harder for veterinarians to access a product.”
Compounded drugs are also an issue, and Phillips said some compounded animal health products are illegal. Compounding pharmacies can make a drug that is similar or the same as a human drug more cheaply and offer it as a cheap alternative. However, the drug has not gone through the process of being proven to be safe so they can market it for a much lower price.
“Studies have shown there are a lot of sub-potent or super-potent compounds available that are a threat to animal health, especially in the horse industry,” he said, adding that there’s a need for compounded drugs because we don’t have enough approved drugs – but the process needs more oversight.
The FDA recently came out with guidance to address the compounding issue. They had delayed enforcement until April, but Phillips said addressing the issue of illegal compounding and preserving important legal compounding while addressing the illegal side is a challenge.
Phillips said 75% of animal health products have market sales of $1 million/year or less, which isn’t much incentive for a company to go through the development and approval process. “There’s also a lack of consistency throughout the world,” he said. “Some countries have drugs available that we can’t access, or the same drugs in the EU have different withdrawal times.”
Awareness of the expense and challenges involved in bringing new drugs, especially antibiotics, to market should be an incentive for livestock producers to use antibiotics and other animal health products judiciously to preserve efficacy for as long as possible.
by Sally Colby