Animal Drug User Fee Act reauthorization proceeds quickly through Congress

After markup of the Animal Drug User Fee Act (ADUFA) reauthorization by the U.S. Senate Health, Education, Labor and Pensions Committee, Allison Cooke, National Cattlemen’s Beef Association  (NCBA) Government Affairs executive director, is optimistic the bill will move forward through Congress at a relatively fast pace.

“ADUFA is a program that is in place to allow for user fees to pay for employees at the Food and Drug Administration (FDA) to make sure we get animal drugs that our producers use every day pushed through and verified for safety and efficacy,” Cooke explained in a recent edition of “Beltway Beef,” NCBA’s official podcast. “This program ensures producers can turn around and use those drugs to keep animals safe and healthy.”

She added, “It’s an important program we have to reauthorize every five years.”

Markup

In about five minutes on Feb. 28, the committee marked up and approved ADUFA, and Cooke said, “We’re glad to see the committee pushed this through very quickly.”

Ed Frank, NCBA communications director, noted that, despite political differences from committee members, the bill was efficiently moved.

“Elizabeth Warren and Orrin Hatch were both in the room, and the bill still sped through on a 22-1 vote,” he said.

Cooke added, “Members on opposite sides of the political spectrum came together in agreement that makes sure we verify animal drugs and FDA does the job they are given. This is important to everyone who is eating beef.”

She also said the effort was very bipartisan, which is necessary to overcome the diverse backgrounds of the committee.

Passage

The bill must move through a full Senate approval, which looks promising, given the ease of passage out of committee, and early discussion with members of the House of Representatives, who must also pass the bill, are also positive.

“The committee on the House side is ready to get moving,” Cooke said. “They’re ready to see something from the Senate, also hoping it was a clean bill, and I think that’s what they’re going to receive.” 

Cooke further emphasized, “We need to get something done before the August recess because Sept. 30 is our deadline.”

“NCBA’s goal was to push through a straight reauthorization to the bill without a lot of extras added in or amendments offered,” Cooke said. “I think what we saw in  this approval was a committee that the agreement that the important thing is that ADUFA is approved in time so that animal drugs continue to be verified by FDA.” 

Background

ADUFA was first authorized in 2004 when the Federal Food, Drug and Cosmetic Act authorized FDA to begin collecting fees for application of certain animal drugs to support testing and verification that new drugs are safe and effective for animals and post no risk to the public. 

According to FDA, “These additional resources support FDA’s responsibility and enhance the timeliness and predictability of application review for sustained performance.” 

The bill was reauthorized in 2008 by President George Bush and in 2013 by President Barack Obama, extending the program through Sept. 30, 2018. 

In addition to maintaining the current authorization, 2013’s reauthorization reviewed timeframes to further reduce timeframes for specific segments of FDA’s review. Changes were also made to allow FDA to adjust fees to account for inflation and add enhancements to technical considerations in the bill. 

“The reauthorization of ADUFA for Fiscal Years 2014-18 were targeted to generate $114 million in user fees over five years,” FDA said.

Saige Albert is managing editor of the Wyoming Livestock Roundup and can be reached at saige@wylr.net.