The US Food and Drug Administration (FDA) is preparing for two meetings on both branded and generic veterinary pharmaceutical products, part of the impending renewal of two user fee acts meant to fund the agency's reviews and other regulatory activities in return for more accountability.
The two user fee bills-the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act(AGDUFA)-act in much the same way as those for human prescription drug products, medical devices and biological drugs. Each year, FDA assesses on manufacturers a fee for all facilities owned by the companies, as well as a fee for all applications and submissions submitted to the agency. In return, FDA puts that funding toward hiring new staff to review applications and manufacturing sites more quickly, as well as target deadlines by which products should have an approval decision.
Early iterations of the current user fee structures were first passed in the 1990s, and by 2003 both FDA and industry found the framework appealing enough to put it into place for new veterinary products. Since ADUFA's passage in 2003, the application review process for approving animal drugs has decreased in time by 30%, FDA wrote in a Federal Register posting.
In 2008, Congress renewed ADUFA and put into law AGDUFA, which operates much like the former.
Both acts-contained within the same 2008 legislation-will be up for renewal in 2013, and FDA is calling on industry, the public and other stakeholders to weigh in on some of its proposed recommendations on how to shore up both programs and make them stronger.
Proposed Changes to AGDUFA
On the generic side, FDA has two recommendations: an enhanced premarket review process and a significant increase in fees.
Over the five-year period between 2008 and 2013, FDA said its target revenue is $27.1 million. For the next five-year period, FDA says it wants to increase fees to $38.1 million-an increase of more than 40%. In addition, FDA says it is looking for a one-time assessment of $850,000 to fund information technology improvements. Those fees will be divvied up within FDA in new ways as well. Application fees will fund 25%--$9.5 million-of the total amount, down from 30% the previous cycle. The percentage for sponsor fees and product fees will assume that difference, both rising from 35% to 37.5%, respectively.
"The purpose of changing the fee distribution is to increase the revenue stream stability and reduce application fee costs," FDA explained.
The agency's other proposed change on the generic animal drug side of the act deals with what it refers to as "work queue procedures" and other process changes, including the timing of meetings, the review of applications, the review of trial protocols and amended submissions. FDA now says it hopes to "review and act on" 90% of generic (JINAD) and abbreviated (ANADA) applications within 270 days after the date of submission, with a number of provisional caveats applying (sufficient information, non-administrative applications, etc).
FDA also said it will develop two new guidance documents for chemistry, manufacturing and controls (CMC) considerations for Generic Investigational New Animal Drug (JINAD) submissions by the end of the 2014 fiscal year as well as a question-based review process for bioequivalence submissions by the end of the 2016 fiscal year.
Proposed Changes to ADUFA
For innovative or new animal drug products seeking approval through the ADUFA pathway, FDA also seeks to make a number of changes to the way in which it reviews those products as well. Under ADUFA I, FDA introduced the practice of an end-review amendment (ERA) process, which "allows FDA reviewers to work with the drug sponsor to amend certain pending submissions," FDA explained. Instead of a sponsor needing to submit an entirely new application to address deficiencies, FDA would work with the sponsor to make changes. The procedure succeeded in increasing the number of one-cycle reviews for FDA, but agency officials noted that "certain challenges associated with the process restricted its full utilization." Namely, the entire procedure is actually unnecessary. In its stead, FDA wants to institute new rules to allow for shorter resubmission and reactivation reviews.
Like the process for generic animal drugs, FDA also proposed certain deadlines by which it would have to have 90% of products approved. Within 180 days, for instance, 90% of all non-administrative new animal drug applications (NADAs) would need to be cleared through the agency's review process. After an FDA finding, sponsors will then have a set amount of time-between 120 and 135 days for NADA sponsors-to reactivate their submission and address deficiencies. The post-review timeframes envisioned by FDA will come to replace the ERA process, it said.
Supplemental applications will be dealt with in a similar manner, but on a 120-day target timeframe.
As with AGDUFA, FDA is proposing a significant percentage increase in fees. Its statutory revenue request for the 2013-2017 fiscal period will be $23.6 million-a 54.6% increase over the 2008-2013 period's $15.26 million. A one-time funding request for IT purposes of $2 million is also proposed. A new mechanism to make up for funding shortfalls by increasing fees would also be put into the proposed legislation, according to FDA's Federal Register posting.
Both meetings will take place on 18 December 2012 at FDA's Metro Park North Campus in Rockville, MD, but comments may also be posted on either of FDA's Federal Register postings in the federal docket (ADUFA) (AGDUFA).