02.13.18

Senator Murray Working Toward Bipartisan Reauthorization of Animal Drug User Fee Agreements

Senator Murray: Congress can build on bipartisan track record of reauthorization “if we keep our focus on ensuring the health and safety of our families and animals.”

 

Senate and House health committee leaders recently released a discussion draft to reauthorize the Food and Drug Administration’s animal drug and generic animal drug user fee agreements

 

***WATCH SEN. MURRAY’S OPENING REMARKS HERE***

 

(Washington, D.C.) – Today, Senator Patty Murray (D-WA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, spoke at a hearing about reauthorizing the Food and Drug Administration’s (FDA) animal drug and generic animal drug user fee agreements. In her remarks Senator Murray spoke about the historically bipartisan support behind these agreements and their importance in maintaining the health of our animals, our food supply, and our families. Last week Senator Murray joined Chairman Alexander and House health committee leaders in releasing a discussion draft of legislation on this issue.

 

The text of the discussion draft can be found here.

 

A summary of the discussion draft can be found here.

 

Key excerpts of Senator Murray’s remarks:

 

“…the development of drugs for animals presents a unique set of challenges and considerations. One challenge is the sheer set of different health needs we might use drugs for, from treating illnesses that might harm people or the animals to preventing them. Another is the sheer number of different animals we care for—from those that are commonly pets like dogs, cats, and horses, to animals we commonly rely on for our food supply like chickens, cows, turkeys, and pigs, to minor species that aren’t common, but are so important to their owners or may be critically important to protecting public health. And finally, we must make sure the drugs approved are not only safe for the animals, but also safe for the people who may consume their meat and the environment around them.”

 

“The animal drug user fee agreements help the FDA maintain needed resources and manage this important task which affects our lives, and our families, in so many ways. Some of these ways are obvious and personal. When we go to the vet with a furry family member who has an injured paw or a runny nose, we want to know they are getting treatment that is safe and effective. Some are less obvious, but no less important. We want our farmers and livestock producers to know that the products they use are humane for their animals and safe for their consumers. And we want to know how the drugs we give animals impact the larger environment so that we aren’t creating dangerous and unintended negative consequences.”

 

“As we work to reauthorize this important legislation, I’m optimistic that the new agreements can bring more collaboration and communication to the drug development process by bringing regulators and sponsors together earlier to clarify expectations. Congress has historically reauthorized ADUFA with bipartisan support. I believe we can build on that track record if we keep our focus on ensuring the health and safety of our families and animals.”

 

 

Video of Sen. Murray’s remarks available HERE.

  

Full text below of Sen. Murray’s remarks:

 

“Thank you Mr. Chairman, and thank you Dr. Solomon for joining us today.

 

“As we begin our work to reauthorize the Food and Drug Administration’s animal drug and animal generic drug user fees, I’m optimistic we can do this with the same bipartisan spirit we brought to this important issue the last time the Animal Drug User Fees Amendments, or ADUFA, were up for reauthorization—and the same bipartisan spirit we brought to this issue last year when we passed the FDA Reauthorization Act and reauthorized the user fees for prescription drugs, medical devices, generic drugs, and biosimilars.

 

“The FDA has a critical role in protecting public health and ensuring the safety of the food, drugs, and devices families in my home state of Washington and across the country depend on. Part of that role is to ensure that our nation’s animal population is healthy. But the development of drugs for animals presents a unique set of challenges and considerations.

 

“One challenge is the sheer set of different health needs we might use drugs for, from treating illnesses that might harm people or the animals to preventing them.

 

“Another is the sheer number of different animals we care for—from those that are commonly pets like dogs, cats, and horses, to animals we commonly rely on for our food supply like chickens, cows, turkeys, and pigs, to minor species that aren’t common, but are so important to their owners or may be critically important to protecting public health. 

“And finally, we must make sure the drugs approved are not only safe for the animals, but also safe for the people who may consume their meat and the environment around them.

 

“The animal drug user fee agreements help the FDA maintain needed resources and manage this important task which affects our lives, and our families, in so many ways.

 

“Some of these ways are obvious and personal. When we go to the vet with a furry family member who has an injured paw or a runny nose, we want to know they are getting treatment that is safe and effective.

 

“Some are less obvious, but no less important. We want our farmers and livestock producers to know that the products they use are humane for their animals and safe for their consumers. And we want to know how the drugs we give animals impact the larger environment so that we aren’t creating dangerous and unintended negative consequences.

 

“An important example of this is the work the FDA does to ensure antibiotics are being used judiciously in animals to avoid creating new resistant strains of bacteria that can harm our families.  

 

“I’m pleased that the FDA continues to collect antibiotic sales data and has taken valuable steps to drive down use of antibiotics in our food animals.  I hope to hear more from Dr. Solomon about how we can continue to better understand how antibiotics are being used in our food supply chain through collaboration with the Department of Agriculture.

 

“As we work to reauthorize this important legislation, I’m optimistic that the new agreements can bring more collaboration and communication to the drug development process by bringing regulators and sponsors together earlier to clarify expectations.

 

“Congress has historically reauthorized ADUFA with bipartisan support. I believe we can build on that track record if we keep our focus on ensuring the health and safety of our families and animals. I’m confident the insight from our witness today and the stakeholders offering comments to our bipartisan discussion draft released last week will help us do that.

 

“I’m looking forward to your testimony Dr. Solomon. Thank you Mr. Chairman.”

 

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