Regulatory Focus™ > News Articles > Obama Signs New FDA User Fee Bill for Veterinary Pharmaceuticals Into Law

Obama Signs New FDA User Fee Bill for Veterinary Pharmaceuticals Into Law

Posted 14 June 2013 | By Alexander Gaffney, RAC 

US President Barack Obama has signed into law a new piece of legislation that is set to increase the amount of funding given to the US Food and Drug Administration (FDA) by the veterinary pharmaceutical industry in the hopes of speeding up review and clearance times for product applications.

Background

The legislation, known as the Animal Drug and Animal Generic Drug User Fee Reauthorization Act (ADAGDUFRA), is an amalgamation of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA), both of which have already been law for several years.

The bills are, like their human prescription drug and medical device counterparts, a mechanism by which the veterinary pharmaceutical industry can fund the activities of FDA. In return for enhanced user fees, FDA is then in turn able to hire more review staff and make improvements to its infrastructure, allowing it to-in theory-approve products more quickly, saving companies money by reducing the time it takes to make a return on their investment in research and development.

"The AGDUFA program has been a success story at FDA, and this legislation will create new performance enhancements that will allow for a more predictable approval process for generic animal drugs," explained Rep. Cory Gardner (R-CO) in a statement in April 2013.

"This bill will also help companies that develop and manufacture animal drugs by providing predictable timelines," Gardner added in a June 2013 statement. "It will also help them to benefit from a more stable review process, so they can make decisions about where to invest research dollars."

User fees for all human prescription drug, medical device and biological products were either reauthorized or authorized for the first time in July 2012 in a sprawling piece of FDA reform legislation known as the FDA Safety and Innovation Act. Unlike its human user fee counterparts, however, ADUFA and AGDUFA are on a separate reauthorization schedule, and were due to expire on 31 September 2013.

Final Passage

The full Senate approved the bill on 8 May 2013, with full passage in the House of Representatives occurring on 3 June 2013. The legislation passed both houses of Congress by overwhelming margins (Senate, unanimous; House, 390-12), and the president had widely been expected to pass ADAGDUFRA into law.

House of Representatives approved the legislation by a 401-0 vote on 3 June 2013, with full Senate approval occurring in May 2013.

The White House announced in a statement that Obama had signed the bill into law on Thursday, 13 June 2013, thereby directing FDA to begin the rulemaking process to bring its provisions into effect.

ADAGDUFRA Basics

ADUFA is expected to take in $23,600,000 in FY2014, and $21,600,000 every year thereafter until it expires in 2018. Of those fees, 20% are set to come from application fees, 27% from approved drug products, 26% from establishments and 27% from sponsors. Fees will be subject to a yearly inflation adjustment.

AGDUFA will be subject to a similar fee structure, though considerably smaller in scale. FY2014 fees will be $7,328,000, $6,944,000 for FY 2015, $7,429,000 for 2016, $7,936,000 for 2017 and $8,467,000 for 2018. 

FDA's Commitment letter to industry, which details many obligations above and beyond the legislation, may be found here.


Animal Drug and Animal Generic Drug User Fee Reauthorization Act


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