3 mai, 2005 09:01

FDA Hearing/Dr. Michael Olding/Conflict of Interest

CHAIRMAN CHOTI: I would like to note for the record that the voting members present constitute a quorum, as required by 21 CFR Part 14.

Let me read a letter from Dr. Michael Olding, who was to be a member, a nonvoting member, on this panel. He elected not to be present and requested that the following letter be read, "Dear Dr. Choti, I would like to request the following statement to be read into the record at the time of the General and Plastic Surgery Panel meeting.

"On December 2004, I agreed to serve on this panel with great enthusiasm for its mission and with a full understanding of the commitment and the need for impartiality. Accordingly, I completed the required conflict of interest statement in January 2005, indicated that there are no conflicts.

"Subsequently, on March 21st, 2005, Medicus Pharmaceutical Corporation announced plans to merge with Inamed Corporation, a firm at issue. That merger is subject to approval by stockholders, regulatory approvals, and customary closing conditions according to the companies.

"Upon learning of the planned merger, I immediately notified the Executive Secretary of the proposed merger and that I owned a quantity of stock in Medicus.

"Initially, on April 1st, 2005, the Executive Secretary indicated that my service on the panel would not be affected by my stock holdings and the planned merger, but one business day before this meeting, on Friday, April 8th, I received a fax from Integrity Committee and Conference Management Branch informing me that due to the stock‑holding value, between 50,000 and 100,000, in a firm that is slated to merge with a firm at issue, I would be excluded from voting on the panel. It does appear that I would be allowed to 'review and discuss matters before the panel,' even though I am denied the right to vote.

"As the chronology demonstrates, the incipient conflict was created by the decision of the two companies to merge and not by any action on my part. Indeed, I made the FDA aware of the situation.

"I was fully prepared and committed to continuing my service on the panel impartially and a relatively small stock‑holding I have in the company, which until March 2005 had no interest in the outcome of our work, would have no bearing on my decision‑making process.

"I do not feel it is appropriate for me to continue my service on the panel as a partial member; that is, one without voting rights. Since the FDA has concluded that my voting may create an appearance of a conflict due to my stock holdings, I do not want my continued service as a nonvoting panel member to be suspect in any way.

"I regret having to make this decision as I possess important experience as a plastic surgeon for the panel to consider. And my departure will leave only one other professional with similar experience. But the handicap that the FDA has placed upon me because of the incipient conflict, not of my making, that arose since my appointment to the panel makes my decision necessary.

"Thank you for your consideration and understanding. And good luck to you and the panel in your important work.

Sincerely,

Michael Olding.