Congressional legislators have nearly cleared a new piece of legislation that would reauthorize the US Food and Drug Administration (FDA) to collect and spend user fees to facilitate and expedite the approval of innovative and generic veterinary pharmaceuticals.
The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA), are, like their human prescription drug and medical device counterparts, a mechanism by which the veterinary pharmaceutical industry can fund the activities of the US Food and Drug Administration (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.
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 legislators must approve both versions of legislation before the end of the government's fiscal year on 31 September 2013.
A Clear Path Forward
That process now appears to be far ahead of schedule, with both the House of Representatives' Subcommittee on Health and the full Senate voting unanimously on 8 May 2013 to approve the marked-up versions of the legislation, first released in April 2013.
The original drafts were relatively simple in their approach to user fees. 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.
The bill was passed without any amendments in the Senate, where both ADUFA and AGDUFA are contained within S.622, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act (ADAGDUFA)of 2013.
The House version of the bill appears to be nearly identical, having fended off an amendment to the bill that would have permitted a veterinary drug to be re-imported to the Virgin Islands. That version still needs to be voted on by the full Energy and Commerce Committee and the full House of Representatives. If passed by both, it would then need to be reconciled with the Senate's version of the bill, after which time it would need to be voted on again by both the House and Senate before being signed into law by the president.
Based on the current rate of speed, it now appears likely the ADAGDUFA bill will be signed into law by or during June 2013.