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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Exceeds All ADUFA Goals in First Year of User Fees

FDA Veterinarian Newsletter March/April 2005 Volume XX, No II

The Food and Drug Administration (FDA) exceeded all of its performance goals mandated by the Animal Drug User Fee Act (ADUFA), according to FDA’s March 17 report to Congress.

Congress passed ADUFA to make sure that FDA and its Center for Veterinary Medicine (CVM) had the resources necessary for timely drug reviews. Congress passed ADUFA in 2003 and the appropriations act required to permit FDA to implement the act in 2004. ADUFA mentions the performance goals by reference. FDA and the regulated industry agreed to the goals, and FDA articulated them in a letter to Congress. Performance is measured by a number of goals, including whether CVM’s review of drug applications and submissions are completed by the deadlines that FDA specified in the letter to Congress. In addition, ADUFA requires FDA to publish an annual performance report. The report CVM released in March, “FY 2004 Performance Report to the Congress for the Animal Drug User Fee Act,” covers submissions for FY 2004. (Information about the report and a link directly to it are available at http://www.fda.gov/cvm/ADUFAFY041.htm.)

Performance is determined by the total number of FDA review-days from receipt to completion of an application or submission. CVM must complete the review of 90 percent of the eligible applications or submissions within a specified time frame. For example, in 2004, CVM was required to complete a review of 90 percent of New Animal Drug Applications (NADA) within 295 days. CVM met or exceeded all the review time frames referenced by ADUFA for FY 2004 for applications and submissions that had been acted on as of September 30, 2004. Some applications and submissions received in FY 2004 are pending review and action. They had not reached their deadlines by the end of FY 2004, and are still within ADUFA time frames. FY 2004 performance will be updated in FY 2005 to reflect these pending actions and presented in future reports to Congress.; The time frames to meet the performance goals shorten for each of the five years covered by the current legislation. For instance, the NADA review goal will shorten to 180 days for FY 2008, the last year of the current legislation, from the current 295-day goal. Another of the goals referenced in ADUFA was for FDA to complete 50 percent of its anticipated hiring for review positions by the end of FY 2005.

According to the FY 2004 report, “FDA has made substantial progress in recruiting for its review staff and will meet its goal” of increasing the review staff. For FY 2005, CVM said, it will offer its reviewers higher levels of professional development so they can stay current with the science. CVM will also offer training of the review staff to improve the knowledge base of the institution. Still another goal was to complete the review within 24 months of any pending applications or submission received by FDA prior to October 1, 2003. CVM completed review of all 833 pending submissions within 12 months, more than 12 months ahead of the deadline. CVM issued two guidance documents in FY 2004 to help the animal drug industry understand how the user fee law applied to it. The first one, published in March 2004, explained the user fees and fee waivers. The second, published first as a draft in September 2004, answered most of the industry’s questions about user fees. That guidance document was published as final guidance in February 2005.

Definition of action on submission

According to the report, CVM has completed a review of an application or submission when it has made a decision and issued an action letter. A decision does not mean approval. The action letter could mean that the drug is approved or an investigational new animal drug application is complete, or it could explain the deficiencies in the application or investigational drug submission. CVM also has the option under certain circumstances to refuse to file or review an application or submission. If within 30 days CVM reviewers can determine that an application is insufficient on its face or of unacceptable quality for review under current regulations, CVM can refused to file the application. If within 60 days CVM reviewers determine that an investigational new animal drug application is deficient according to requirements specified in the regulations, CVM can refuse to review the submission.

Applications or submissions that CVM decides are not good enough for review are not considered part of the “cohort” of applications that must be reviewed by the established time frames. CVM will report the refusals in its annual report.

Generic approvals unaffected

ADUFA requires that the time frames for the review of Abbreviated New Animal Drug Applications for generic drugs will not increase as a result of ADUFA. CVM established the baseline for length of time for generic drug review based on the time such reviews took in FY 2001-2003. When compared against the established time frame, review times in 2004 did not increase for completed sentinel submissions, the report said. CVM reviews generic applications and submissions in a queue that is separate from pioneer applications, supplements, and submissions. CVM has to the extent practical separated staff and functions to provide for the separate queues.