US legislators in the House of Representatives this week announced the passage of a package of user fees that would enhance what the US Food and Drug Administration (FDA) collects from members of the veterinary pharmaceutical industry.
Passage of the legislation was in many ways overshadowed by the debate over and passage of another major piece of legislation that would reform security standards for the pharmaceutical industry, known as the Safeguarding America's Pharmaceuticals' Act (SAPA)of 2013. Other congressional debate has also focused on the issue of pharmaceutical compounding and whether FDA has sufficient authority with which to regulate the now-scandal-laden sector.
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 legislators must approve both versions of legislation before the end of the government's fiscal year on 31 September 2013.
Final Passage Imminent
The House's Energy and Commerce Subcommittee on Health approved the bills earlier in May 2013, with full Energy and Commerce approval occurring shortly thereafter. The 3 June 2013 vote by the full House of Representatives approved it by a 401-0 vote.
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 Senate has already approved the same exact legislation by a 390-12 vote, and the measure will now go to President Barack Obama for his signature, which he is widely expected to provide. Final passage is expected to occur by the end of June 2013 barring any last-minute delays.
S.622 - Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013