TO ALL NYSSA MEMBERS

When Troyen A. Brennan, M.D., Aetna's chief medical officer, announced that he would delay their policy regarding the use of monitored anesthesia care for screening endoscopy until 2009, he cited the following reasons:

New medical devices, as well as new sedatives, are expected on the market during the late summer, and are in review with the FDA now. They are designed to provide a patient experience that is very similar, or perhaps better, than MAC, but can be managed exclusively by the GI endoscopist performing the screening procedure. Both would eliminate the significant expense of having a second physician attending during a routine screening service for a healthy patient.

The new sedative to which Dr. Brennan refers is fospropofol. Some trials with this new sedative have questioned its safety and even resulted in halting the trials.

There will be a meeting to discuss new drug application (NDA) 22-244, fospropofol disodium injection (35 milligrams/milliliter) (proposed tradename Aquavan), MGI Pharma, Inc. for the proposed indication of sedation in adult patients undergoing diagnostic or therapeutic procedures.

http://edocket.access.gpo.gov/2008/E8-6193.htm

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before April 23, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 15, 2008. Time allotted for each presentation may be limited.