Animal antibiotic legislation passes through committee

May 24, 2013
by WLJ

The House Energy and Commerce Committee last week approved the reauthorization of the Animal Drug User Fee Act (ADUFA), legislation that allows the Food and Drug Administration (FDA) to collect fees for certain animal drug applications.

The measure was first approved by the Subcommittee on Health on May 8, 2013, and the Senate followed, passing ADUFA reauthorization by unanimous consent.

According to the National Cattlemen’s Beef Association (NCBA), the legislation allows pharmaceutical companies to pay a user fee to FDA which is used to hire additional technical staff. By hiring additional technical staff, FDA is able to approve future animal health products without adding to the burden on taxpayers.

“Cattlemen and women rely on new and innovative animal health products and for that reason, the reauthorization of ADUFA has been one of NCBA’s key priorities this year. I am pleased to see the House Energy and Commerce Committee pass AD- UFA reauthorization yesterday by a voice vote and look for the full House to consider reauthorization shortly,” said NCBA President Scott George, a Cody, WY, dairy and beef producer.

On Aug. 14, 2008, President Bush signed the 2008 ADUFA. It was originally passed in 2003 and was set to expire on Sept. 30, 2008. The new amendments extended ADUFA until 2013.

The ADUFA reauthorization maintains the FY 08 review timeframes for key submissions, in addition to enhancements to the program. The most significant of these is the “end review amendment” process. This amendment will enable FDA to work with a drug manufacturer to make corrections to address deficiencies at the end of the review process, rather than restarting the review clock. This will improve efficiency by significantly reducing the number of submission review cycles.

In addition, this reauthorization encourages increased communications between FDA and industry, and also provides for improvements to the information technology infrastructure of animal drug review, providing a tool which enables industry to submit drug applications electronically and gives reviewers the ability to evaluate those applications online.

The original reauthorization of ADUFA was expected to generate $98 million in user fees over five years (FY 2009 – FY 2013).—Traci Eatherton, WLJ Editor