Accutane
Response from Patrick Zenner, President and Chief Executive Officer, Hoffman-LaRoche Inc. to Representative Stupak.
October 17, 2000
The Honorable Bart Stupak
United States House of Representatives
2348 Rayburn House Office Building
Washington, DC 20515-2201
Dear Representative Stupak:
Thank you for your October 11, 2000, letter to me expressing specific concerns relative to Accutane (isotetinoin). I wanted to respond to your letter as quickly as possible. The safe and appropriate use of prescription medicines, including Accutane, is of paramount importance to Roche.
Since the launch of Accutane in 1982, we have remained committed to carefully monitoring and helping to manage the appropriate use of accutane. We have worked closely with the Food and Drug Administration (FDA), the dermatologic community, and other health professionals to assure the safe use of this important drug. In many respects, our current risk management program for Accutane is unprecendented in the pharmaceutical industry.
We recently presented a comprehensive analysis of the psychiatric adverse events in the Accutane-treated patient population to the FDA's Dermatologic and Opthalmic Drugs Advisory committee. Although the Committee did not conclude that there is proof of a causal relationship between Accutane and psychiatric conditions, it recommended that additional study and risk management steps would be appropriate given the serious nature of this issue. We are working closely with the FDA to develop and to implement effective responses to the Advisory Committee's recommendations, as follows:
1. We will provide the FDA with a proposed Medication Guide (MedGuide) on Accutane before the end of the month. This document will include warnings of birth defects as well as a discussion of psychiatricevents consistent with the professional label.
2. At the same time, we will provide FDA with a revised informed consent form incorporating the psychiatric information in the current labeling.
3. As recognized by the FDA Advisory Committee, designing a scientifically sound approach to studying this matter raises complex methodological issues from both a scientific as well as social perspective. We are committed to working with FDA to design a feasible approach to study this issue and to fund that effort.
Patrick J. Zenner
President and Chief Executive Officer
Roche Pharmaceuticals
