US legislators on the House of Representatives' Energy and Commerce Committee have finally released the draft versions of two bills that would serve to reauthorize industry-paid user fees for both innovative and generic veterinary medicines.
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.
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 re-authorization schedule, and legislators must approve both versions of legislation before the end of the government's fiscal year on 31 September 2013.
Could More Provisions be added?
Some industry analysts have speculated whether the bills will be passed "cleanly"-that is, without significant mark-ups or rider provisions-or if legislators might use the bills to pass a number of reform provisions that were left unfinished after the passage of FDASIA. At present, speculation has included plans to implement a national pharmaceutical track and trace plan, as well as a number of plans intended to curb the abuse of painkiller drugs.
An opinion piece authored by the Pharmaceutical Research and Manufacturers Association (PhRMA) and the Generic Pharmaceutical Association (GPhA) last week in Politico have added fuel to those rumors, as has a letter sent by Sen. Mitch McConnell (R-KY), the Senate Minority Leader and an influential power broker, to FDA requesting information regarding FDA's authority to require products to have abuse-deterrent formulations.
A Clear Slate-For Now
For now, however, both bills appear clean of any notable markups-a process that will likely start (if at all) after a 9 April 2013 hearing by the House Energy and Commerce Committee, at which FDA's Bernadette Dunham, director of the Center for Veterinary Medicine (CVM), is expected to testify.
The bills are also notably smaller than their human user fee counterparts. 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.