Speeches & Floor Statements

Opening Statement: Alexander: Animal Drug User Fee Legislation “Critical” to Keep Food Supply Safe, Animals Healthy

Posted on February 13, 2018

Farmers and families in Tennessee want to have access to the drugs that keep their animals and pets are healthy.

For example, I know an East Tennessee farmer who raises calves. He checks on them several times a day, and when he notices one isn’t feeling well, he pulls him aside and gives him a drug.

This farmer wants to ensure the drug he gives his sick calves is safe for the calf and for our food supply.

We know that the human medical products we use are safe because the Food and Drug Administration has approved them.

The way the farmer knows the drug he has given to his calf is safe is the same – the FDA has approved it. 

And similar to the user fee agreements this committee reauthorized last year for human medical products, this year we need to reauthorize the Animal Drug and Generic Drug User Fee Agreements.

These are agreements between the FDA and the animal drug industry to pay user fees help speed the approval of new drugs to farmers and ranchers, families, and veterinarians to keep their animals and pets safe and healthy.

These agreements are much smaller than the human drug user fee agreements – the revenue FDA receives from the animal drug user fees IS only about 3 percent of the revenue FDA receives from the human drug program – however they are still critical to keeping our animals healthy and preventing outbreaks of disease. 

There are two agreements – one for new brand animal drugs, which the FDA calls pioneer drugs, and one for generic new animal drugs.

Last year, FDA received 780 applications for new pioneer animal drugs and 240 applications for generic new animal drugs for review.

While animal drugs are used to treat almost every animal species, much of the drug development focuses on the seven major species: horses, cattle, pigs, dogs, cats, chickens, and turkeys.

These include both animals that are common family pets as well as the livestock that is our food supply.

On average, the animal drug industry spends over $30 million a year to develop new products for farm animals, and over $22 million a year for new treatments for our pets.

And according to the animal drug industry, it can take up to eight years for a drug intended for use in farm animals to be available for veterinarians and farmers, and over six years for new pet medicines.

These agreements help bring these new medicines to the veterinarians who write prescriptions for families to care for their pets and treat diseases, such as cancer or heartworm disease.

And while these agreements are important to our family pets, we also want to ensure the farmers and ranchers raising our food supply are able to treat their animals with the safe drugs they need.

Farmers often use animal drugs to prevent outbreaks of infectious disease, to treat pain, or prevent swelling of joints in animals.

Having safe and effective animal drugs is important to both the consumer – that food-producing animals are safe to eat – and the farmer or rancher – that he has a product to treat his animals and prevent outbreaks.

According to the Tennessee Department of Agriculture, the cattle and calves industry and the poultry industry are two of Tennessee’s largest agriculture sectors.

Since the last reauthorization of these agreements, the number of cattlemen in Tennessee who have been Beef Quality Assurance Certified – meaning they have proper training to administer animal drug products – has increased from about 17,000 cattlemen to 23,000.

So it is important that farmers and ranchers continue to have access to new medicines to keep their animals healthy and prevent infectious disease outbreaks.

These updated agreements have been carefully worked out between the Food and Drug Administration and animal drug industry with input from farmers and ranchers, food and feed producers, veterinarians and other stakeholders.

FDA and the manufacturers of animal drugs held eight meetings to discuss the pioneer drug agreement and six meetings on the generic drug agreement.

Our committee has held eight bipartisan staff briefings over the last three months in preparation for reauthorizing these important agreements.

I have carefully reviewed the agreements and believe they are good for FDA and good for farmers, ranchers, veterinarians, farm animals and our pets. 

Today we are going to hear from Dr. Steven Solomon, a veterinarian and the Director for the Center for Veterinary Medicine at FDA about the agreements.

One of the important goals in the updated animal drug user fee agreements is for FDA to reduce approval times in certain areas.

For example, one goal is to cut in half the time it takes for FDA to approve the combination of medicine for animal feed and water, which helps farmers and ranchers keep their herds or flocks healthy by allowing them to combine medicines together in the food they feed their to their farm animals.

These user fees are a critical funding source for FDA to do its job to expedite the review of safe and effective treatments for animals – they fund over one third of all activities related to pioneer animal drug reviews and over half of generic review activities.

If Congress does not do its job to reauthorize these critical programs, more than 115 people who work on reviewing these drugs will lose their job. 

As was the case when we reauthorized the user fees for drugs and devices for humans last year, we have a deadline. If Congress does not have a reauthorization in place by August 1, FDA will need to notify staff within 60 days of when funding is expected to terminate. 

This would lead to delays in approving new animal drugs and bringing new treatments to farmers, ranchers, veterinarians, and families.

We hope to mark these two important agreements up by the end of the month so we can move them to the floor and this committee can continue our work on other important issues. 

These agreements are essential to ensure the animal drugs on the market are safe and effective and keep farm animals and pets healthy, and help keep our food supply safe, and I look forward to quickly reauthorizing them.