Congress has begun the process of taking up two bills that stand to make reforms to the user fee process for innovative and generic veterinary pharmaceutical products with the stated goals of generating faster approval times for products while providing better funding sources for the US Food and Drug Administration (FDA).
The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA), are similar in nature to an omnibus user fee bill passed in 2012 known as the FDA Safety and Innovation Act (FDASIA), which provided nearly half a billion dollars in new funding to FDA in return for reforms.
But while FDASIA concentrated on human pharmaceuticals, biologics and medical devices, ADUFA and AGDUFA focus exclusively on animals of both the household and farm variety.
In a statement, Sen. Lamar Alexander (R-TN) said the bill stands to positively affect more than 17,500 beef cattle farmers in his state. But how? Faster approvals, Alexander wrote.
"Faster approvals of animal medicines will reduce farmers' costs, and these programs have reduced the average waiting time for the FDA to approve generic animal drugs by 450 days and eliminated a backlog of applications, meaning farmers get faster access to cheaper and better products. When farmers get faster access to better medicines, people are healthier."
FDA's director of the Center for Veterinary Medicine, Bernadette Dunham, agreed in testimony delivered before the HELP Committee on 27 February 2013.
"Prior to 2004, the timeliness and predictability of the new animal drug review program was a concern," Dunham said. But under ADUFAI and ADUFA II, FDA was given an infusion of industry-paid user fees in return for expedited approval benchmarks and the directive to improve its regulatory processes. Those improvements have resulted, as Alexander said, in dramatic improvements in the veterinary pharmaceutical review programs at FDA.
The ADUFA program also boasts something that its human user fee counterparts can't: It's actually met-even exceeded-its performance goals each and every year. "During the first five years of this program, the Agency was able to dramatically reduce review times from 500 days to 180 days and completely eliminate a backlog of 833 submissions within the first year," Dunham explained.
Another huge benefit seen under ADUFA II is the ability of sponsors to work with FDA to address deficiencies at the end of the review cycle, called the "end-review amendment" (ERA) process. Dunham said that process has allowed them to reduce the number of review cycles by communicating more closely with sponsors, resulting in a 90% favorable outcome rate for sponsors in the first cycle.
Dunham also noted the benefits of other regulatory improvements, including electronic submission tools and public workshops meant to communicate more closely with industry to address potential or ongoing challenges.
But what's new? Dunham explained that the programs would "further improve the review process by replacing the ERA with shorter review times for certain resubmissions and reactivations beginning in FY 2015."
"To allow time for the programming and information management system changes required to make this and other changes, we are proposing to maintain the ADUFA II ERA process and associated review performance goals for FY 2014 for most applications," she added.
Industry would also be required to submit information earlier in the development cycle to allow more time for FDA and industry to review study protocols, but FDA would also permit a more flexible approach for the submission of scientific data and information to support those protocol reviews, supposedly to make sure that doesn't increase the overall review calendar.
The fees would also increase to $23,600,000 from around $19,600,000 in 2013. She noted that the fees would "account for changes in FDA's costs related to payroll compensation and benefits," and also include an automatic inflation adjustment based on the Consumer Price Index. The base fee would also be increased to "adequately capture changes in FDA's workload during ADUFA III." An additional revenue shortfall collection mechanism would allow FDA to meet its funding needs by increasing the next year's user fees, which would then "follow in subsequent years through the final year" of authorization.
There would also be a one-time information technology fee of $2,000,000 to support upgrades to FDA's infrastructure, Dunham said. Application fees would decrease by 5%, which would be made up by proportionate increases in product fees, sponsor fees and establishment fees.
Generic drugs would see similar changes, with the agency slated to receive considerably more money. The total five-year revenue for AGDUFA I was $27,100,000. For the upcoming five years, it would be $38,950,000, which includes a one-time $850,000 fee for IT improvements.
Those fees would allow FDA to meet shorter review times for "certain reactivations and resubmissions" and allow the agency to communicate more frequently with industry through meetings and other communications.
As with ADUFA, AGDUFA would include an inflation adjustment mechanism.
Unless re-authorized, the exiting ADUFA and AGDUFA legislation will expire on midnight on 31 October 2013.