The Animal Drug and Animal Generic Drug User Fee Reauthorization Act was signed into law by President Obama June 13. According to a release from Republican Congressman Fred Upton of Michigan, the legislation creates a more efficient federal review process for new and generic animal drugs. Specifically, it reauthorizes the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act that were set to expire at the end of this fiscal year.
The user fee programs help the Food and Drug Administration (FDA) maintain timely review of new and generic animal drugs. According to the FDA, the Animal Drug User Fee Act “enables the FDA to work with a drug manufacturer to make corrections to address deficiencies at the end of the review process, rather than restarting the review clock. This will improve efficiency by significantly reducing the number of submission review cycles.”
The agency also says the act increases communications between FDA and industry, providing an information technology infrastructure that allows industry to submit drug applications electronically and reviewers the ability to evaluate those applications online. “A streamlined approval process helps Michigan employers like Zoetis and Perrigo better compete, innovate and create jobs by getting their drugs to veterinarians, livestock and poultry producers, and pet owners in a timely manner,” Upton’s release says.
The 2013 reauthorization establishes fees under the Animal Drug User Fee Act to generate in $23.6 million in fiscal year 2014 and $21.6 million every subsequent year until its scheduled expiration in 2018. Of those fees, 20 percent are set to come from application fees, 27 percent from approved drug products, 26 percent from establishments and 27 percent from drug sponsors. Fees will be subject to a yearly inflation adjustment.
The Animal Generic Drug User Fee Act will be subject to a similar fee structure, though fees are 50 percent less than its counterpart. Fiscal year 2014 fees are expected to generate $7.328 million, $6.944 million for fiscal year 2015, $7.429 million for 2016, $7.936 million for 2017 and $8.467 million for 2018. These totals reflect adjustments in revenue from abbreviated application fees, generic new animal drug sponsor fees and generic new animal drug product fees.
The Animal Drug User Fee Act was originally passed in 2003 and was reauthorized by President George W. Bush in 2008. The 2008 reauthorization was structured to generate $98 million in user fees in the past five years.