Management Challenges for FY 2012: FY 2011 ADUFA Financial Report
On August 14, 2008, the President signed Public Law 110-316, the Animal Drug User Fee Amendments of 2008 (ADUFA II). ADUFA II amends and reauthorizes animal drug user fees for an additional five years, FY 2009 through FY 2013.
To continue to meet the demanding review time goals established under ADUFA II in FY 2012, FDA has or intends to take the following actions:
· Continue to provide an “End-Review Amendment” (ERA) process that enables FDA reviewers to work with the drug sponsor to amend pending submissions in order to achieve a complete review decision. FDA used the ERA process to request additional information on 167 submissions associated with the FY 2010 and FY 2011 cohort. Virtually all (166 of 167) of the requests were related to Investigational New Animal Drug (INAD) submissions. In response, ERAs were submitted to 96 percent (160 of 167) of the requests, and 91 percent (146 of 160) of the submissions with ERAs had their reviews end with a favorable outcome in only one review cycle.
· FDA released the eSubmitter electronic submission tool to the regulated animal health industry on March 11, 2011. This tool permits new animal drug sponsors to create and transmit INAD, New Animal Drug Application (NADA), Generic Investigational New Animal Drug (JINAD), Abbreviated New Animal Drug Applications (ANADA), Veterinary Master File (VMF), and General Correspondence (GC) submissions electronically to the Office of New Animal Drug Evaluation (ONADE). The eSubmitter tool is expected to reduce the cost of submission to the industry as it eliminates paper and mailing costs while permitting Center for Veterinary Medicine (CVM) scientists to review the submissions electronically in a more efficient manner. Sponsors who submit applications and submissions electronically now receive an immediate response electronically rather than waiting to receive letters in the mail. The eSubmitter tool will lead to a more efficient and effective drug approval process than was previously experienced with paper. Within 5 months of the project roll-out, over 20 firms were using the tool.
· Continue to strive to meet the goal to hold 10 public workshops on topics FDA and industry have mutually agreed upon. During FY 2011 FDA conducted three additional workshops for industry as part of its commitments under ADUFA II. The first was an eSubmitter workshop which solicited feedback from the regulated industry on (Center for Veterinary Medicine) CVM’s electronic submission tool. The second was a Manufacturing Chemistry Question-based-Review process for sterile process validation information. The third workshop was an American Academy of Veterinary Pharmacology and Therapeutics (AAVPT) Veterinary Drug Regulatory Life Cycle Course. Lastly, FDA hosted, through the American Academy of Veterinary Pharmacology and Therapeutics (AAVPT), a workshop in which industry, academia, and FDA representatives discussed novel approaches to demonstrating safety and effectiveness using pharmacokinetic/pharmacodynamic data.
· Continue to improve communications on and enhance the timeliness and predictability of foreign pre-approval inspections. During FY 2011, four of
19 sponsors affiliated with foreign facilities submitted annual facilities lists. Of the four sponsors submitting annual facilities lists, three submitted a 30-day prior notification. FDA completed 19 foreign inspections in FY 2010, with an average time of 106 days to complete the inspections. FDA completed
19 foreign inspections in FY 2011, with an average time of 142 days to complete the inspections.
· With ADUFA expiring September 30, 2013, negotiations on the reauthorization of the Animal Drug User Fee Act are currently in progress.
· Continue progress on management initiatives that include development of standard operating procedures for review processes, scientific policies for review staff, and implementation of a quality business system.
· Continue to seek qualified candidates to assure adequate staffing to help FDA meet ADUFA II review time goals.
· Continue to provide training and educational opportunities for FDA staff to enhance the knowledge base of the review organization.
FDA is committed to improving the efficiency, quality, and predictability of the new animal drug review process. We are dedicated to exploring new approaches and technologies that offer high quality and cost-effective improvements in FDA’s review of NADAs and other submissions. FDA looks forward to the continued success and significant improvements in the animal drug review process that ADUFA II helps make achievable.