External Comments and the Veterinary Drugs Directorate's Response to Comments

On September 19, 2002 , the Veterinary Drugs Directorate contacted 148 submission sponsors to seek their comments on the draft version of the Interim Policy on Outstanding Responses to Additional Data Letters (ADLs). As of May 31, 2003, there were a total of nine responses received from this external consultation. The majority of respondents support the underlining principles of this interim policy.

Following a thorough review and analysis of the feedback received, comments were categorized under six main themes.

Key Comment #1

Submission sponsors are concerned about the unknown length of time it will take to review the responses to additional data requests.

Response to #1

Efforts will be made by the applicable Divisions to expedite the review of responses to ADLs, however the length of time it takes to complete a review is dependent on the content and quality of the data submitted.

Key Comment #2

A scientific dispute mechanism should be put in place to address regulatory data requests that the sponsor believes are not warranted in order to ensure safety and/or efficacy.

Response to #2

A process is in place for sponsors to appeal a decision made by VDD. Information about this appeal process is posted on VDD's Web site.

Communication is a shared responsibility. VDD strongly encourages sponsors to provide a rationale as to why the information requested in related ADLs is not warranted.

Key Comment #3

The proposed 90-day, no extension rule is insufficient and unreasonable.

Response to #3

VDD considers the proposed 90-day timeframe sufficient for sponsors to submit outstanding responses to ADLs, especially since many responses are long outstanding. Although there may be extenuating cases where the sponsor cannot meet this deadline, the provision of an extension would be of little benefit to both the sponsors and the Directorate for reasons outlined below:

• the submissions lack essential studies/data (clinical, manufacturing or human safety) to complete the review; and/or
• the sponsor may have decided not to address the submission deficiencies.

Key Comment #4

VDD should identify ways to prevent a backlog of ADL responses in the future.

Response to #4

VDD is in the process of developing a revised set of guidelines for preparing veterinary drug submissions that will assist sponsors to prepare consistently high quality and complete submissions. In addition, revised methods and processes for handling Additional Data Letters will be defined. Draft versions of these proposals will be put forward for consultation by stakeholders prior to implementation.

Key Comment #5

Sponsors should be granted a rebate for submissions that are re-filed.

Response to #5

This policy applies only to submissions for which the applicable reviews of different components have been completed. Appropriate fees will be applied correctly in accordance with the fee regulations. Re-filed submissions will be subject to new submission evaluation fees.

Key Comment #6

It is premature for VDD to implement this Interim Policy and, furthermore, this policy will not be of benefit.

Response to #6

It is the Directorate's position that this Interim ADL Policy is needed for reasons outlined below.

• The Directorate must take steps in order to clear away existing backlog.
• The current situation has an impact on the validity of data that are currently in the review queue. For example, if a response to an ADL was received for an ADL issued five years ago, it may be difficult for VDD to conduct a proper review since the original data may no longer be valid.
• When a response to an ADL is received after a long delay, the reviewer will need to look at the original submission again to be able to properly review the additional data. This would create an additional delay to the review process.
• When the submission history is not clear (i.e., only some information was considered acceptable), more time is likely to be spent during the review by evaluators to research the history of the product/ submission.
• In light of this Interim Policy, revised methods and processes for handling ADLs are under development and will include measurements to minimize potential re-occurrence of outstanding ADLs in the future.