Notes from the National Drug Scheduling Advisory Committee teleconference meeting, December 20, 2001

A brief teleconference call meeting was held on Thursday, December 20th 2001 regarding a request from Schering Canada Inc. for Schedule III status for desloratidine. This federally unscheduled drug will be marketed under the trade name "Aerius" early in the New Year, and Schering requested that special permission be granted to expedite the scheduling process due to internal issues. It was noted that this drug would be placed, by default, in Schedule I of the national drug schedules until reviewed by NDSAC.

Ms. Wells called the meeting to order at 12:00 pm EST.

She explained the nature of the request to the Committee members and noted that the decision facing the group at this meeting was whether or not the request warranted a deviation from the standard procedures.

Prior to the meeting, NAPRA had received advice from legal counsel about a deviation from the standard procedures as follows:

"… we confirm that we have reviewed By-law No. 2 and the rules and procedures adopted pursuant to that By-law relating to the scheduling hearings carried out by NDSAC. In reviewing the By-laws and Rules, we note the following:

1. Section 4(4) provides that a drug scheduling review may be commenced at any time by NAPRA.
2. Section 7(4) of By-law No. 2 provides that NAPRA may amend the Manual at any time after receipt of the initial recommendation from NDSAC.
3. Section 5(1) which provides for the opportunity for interested parties to be heard is expressly subject to the Rules.
4. Rule 24 provides that "NDSAC may, where appropriate, dispense with, vary or supplement any of the provisions of these Rules".

Based on the foregoing, it is our opinion that NDSAC does have the authority to hold a hearing once the application for scheduling has been received and the requisite fees paid. In addition, NAPRA may immediately amend the Manual once the initial recommendation is received.

As discussed, the authority conferred on both NAPRA and NDSAC by the By-law and Rules is discretionary and as such, its use should be the exception rather than the rule. In addition, concerns may arise where this discretionary authority is exercised in circumstances which are not clearly in furtherance of NDSAC's mandate, more specifically, the public interest."

In addition, a formal submission had been received from Schering Canada Inc.

After some discussion, it was unanimously agreed that there were insufficient grounds to proceed with an expedited scheduling process. However, the Committee members did agree to meet as soon as possible prior to the previously scheduled April 19-20th 2002 meeting to review desloratidine. The Committee members present agreed to a meeting date of February 19, 2002.

The meeting was adjourned at 12:35 pm.