Animal Drug User Fees

FDA tells Congress that it is meeting all performance goals

In its second performance report of the year to the US Congress, the US Food and Drug Administration (FDA) has reported that it met all of its performance goals set out in fiscal year (FY) 2004 in accordance with the Animal Drug User Fee Act (ADUFA). The report, published on the agency's website on 8 August 2006, also said that the FDA is meeting or exceeding its targets for FY 2005, and set out its plans for achieving its FY 2006 targets.

The FDA has reported that it achieved the following goals during FY 2005:

• all applications and submissions received in FY 2004 have been completed and the agency met or exceeded each of its FY 2004 ADUFA review performance goals;
• as of 30 September 2005, the FDA was meeting or exceeding each of its review timeframe goals for applications and submissions. This will be updated in the FY2006 report;
• at the time of the report's writing, the agency said it would meet its goal of recruiting 50% of additional review staff by first quarter 2006; and
• the agency has published four policy and procedure documents including;
• format and style conventions for letters;
• preparing a memorandum of conferences;
• permissible submission tracking and reporting system (STARS) action code for STARS submissions; and
• review of protocols.

At this stage only a preliminary performance assessment of FY 2005 performance is possible. Early performance data is limited, and for those with a shorter review goal, performances for submissions received early in the fiscal year are used as an early indicator.

FY 2006

The FDA must review and act on 90% of the following specific FY 2006 goals as set out by ADUFA in 2003:

• new animal drug applications (NADAs) and reactivations of NADAs received during FY 2006 to be reviewed within 230 days;
• non-manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2006 to be reviewed in 235 days;
• manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2006 to be reviewed in 140 days;
• investigational animal drug study submissions received during FY 2006 to be reviewed in 235 days;
• investigational animal drug submissions consisting of protocols, that the agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application, without substantial data submissions received during FY 2006 to be reviewed within 80 days; and
• administrative NADAs received during FY 2006 to be reviewed within 80 days.

2008 goals

ADUFA states that the FDA should have achieved the following goals by the end of the Act's authorisation period in 2008:

• review and act on 90% of complete drug applications (NADAs) and reactivations of such applications within 180 days after the submission date;
• review and act on 90% of non-manufacturing supplemental animal drug applications (i.e supplemental animal drug applications for which safety or effectiveness data are required) and reactivations of such supplemental applications within 180 days after submission date;
• review and act on 90% of manufacturing supplemental applications within 120 days after submissions date;
• review and act on 90% of investigational animal drug study submissions within 180 days after submission date;
• review and act on 90% of investigational animal drug submissions consisting of protocols, that the agency and sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug applications, without substantial data within 50 days after submission date; and
• review and act on 90% of administrative animal drug applications (NADAs submitted after all scientific decisions have been made in the investigational animal drug process, i.e prior to the submission of the NADA) within 60 days after the submission date.

The report also outlines what implementation plans the agency has for 2006 in order to meet the above performance goals.

By the end of the year it plans to have hired the remaining review staff it needs to reach the performance goals, along with project managers to guide the review process more efficiently. The agency will offer higher levels of professional development to its review scientists to maintain and develop their knowledge base.

The agency will continue to develop standard operating procedures for review processes, scientific policies for its review staff and procedures for the timely resolution of scientific issues. It is also planning to explore the possibility of new IT systems for the electronic receipt, review and standardisation of NADA submissions.

It will additionally release more guidance documents and continue its programme of staff training.

ADUFA was enacted on 18 November 2003 and authorises the FDA to collect user fees for certain applications submitted to them to support the agency in the review process. In return, the FDA agreed to meet specified performance goals for the review of certain submissions over a five-year period. The performance goals are progressive, with the agency agreeing to act on submissions within shorter time periods each new fiscal year.

References

1. FY 2005 Performance Report to Congress for the Animal Drug User Fee Act, accessed 8 August 2005, www.fda.gov/cvm/Documents/2005perfrpt.pdf