Management Challenges for FY 2011
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. Letters from the Secretary to the Chairmen of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions set forth goals and procedures that FDA will strive to meet over the five years of ADUFA II.
- 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 153 submissions during the first two years of ADUFA II (FY 2009 and FY 2010). Virtually all (151 of 153) of the requests were related to Investigational New Animal Drug (INAD) submissions. In response, ERAs were submitted for 93 percent (142 of 153) of the requests, and 88 percent (125 of 142) of the submissions with ERAs had their reviews end with a favorable outcome in only one review cycle.
- Continue development on an Electronic Submissions Tool that is scheduled to be deployed in the spring of FY 2011. This tool will transform the FDA submission process into a modern, web-friendly environment and will allow FDA to accept INAD and New Animal Drug Application (NADA) submissions from regulated industry in electronic form.
- Continue to strive for the FY 2013 goal to hold 10 public workshops on topics FDA and industry have mutually agreed upon. During FY 2010 FDA conducted three additional workshops for industry as part of its commitments under ADUFA II. Two of the workshops featured the manufacturing chemistry Quality-By-Design approach to enhance the quality and purity of marketed new animal drugs. The third workshop featured scientific exploration of bioequivalence and was co-sponsored by the American Academy of Veterinary Pharmacology and Therapeutics. This workshop addressed challenging scientific bioequivalence concepts relating to the determination of bioequivalence between new animal drugs.
- Continue to improve communications on and enhance the timeliness and predictability of foreign pre-approval inspections. During FY 2010, 10 of 19 sponsors affiliated with foreign facilities submitted annual facilities lists. Of the 10 sponsors submitting annual facilities lists, one submitted a 30-day prior notification. FDA completed 21 foreign inspections in FY 2009, with an average time of 139 days to complete the inspections. FDA completed 19 foreign inspections in FY 2010, with an average time of 106 days to complete the inspections.
- 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.