Accutane
Response from Representative Bart Stupak to Dr. Russell Ellison, V.P. Medical Affairs, Roche Laboratories.
October 11, 2000
Russell H. Ellison, M.D.
Vice President, Medical Affairs
Roche Pharmaceuticals
340 Kingsland Street
Nutley, NJ 07110-1199
Dear Dr. Ellison:
Thank you for your letter offering to meet with me to discuss your company's views regardings its analysis of adverse events prepared for the Food and Drug Administration's (FDA) advisory committee meeting. I appreciate your willingness to discuss this issue and the sympathy you expressed regarding the loss of my son.
Today, I along with seven other members of Congress wrote to Patrick Zenner, President and CEO of Hoffman-LaRoche, presenting specific recommendations Roche and the FDA should take regarding Accutane (Isotretinoin). I have enclosed a copy of the letter for your information.
I do not believe it would be appropriate to meet, until Mr. Zenner responds to the recommendations made by the Members of Congress that signed the letter. After we have received a response to our recommendations, it may be appropriate for all the co-signers of the letter to meet with representatives of Hoffman-LaRoche. I believe this process will allow for the most constructive discussions of future actions regarding the information and marketing of Accutane.
Once again, I look forward to the prompt reply of Mr. Zenner to our letter.
Sincerely,
BART STUPAK
Member of Congress
