Hepatitis C: FDA public meeting on peginterferon plus ribavirin, Nov. 14.

On November 14 the Antiviral Drugs Advisory Committee will review the application by Hoffmann-La Roche for approval of peginterferon alfa-2a combined with ribavirin. The meeting will include time for public comment, and comments can also be submitted in writing. If you want to address the committee you need to notify the staff before November 6 and submit a brief written statement about your presentation. Written statements to the Committee should be submitted by November 6.

The meeting will be held November 14, 2002, from 8:30 a.m. to 4 p.m. at the Holiday Inn, Versailles Ballroom, 8120 Wisconsin Avenue, Bethesda, MD. This location is near Washington D.C. and easily reachable by the Red Line subway.

More information is available from the FDA Advisory Committee Information Line, 1-800-741-8138 or 301-443-0572. You will be asked to enter a code; the code for the Antiviral Advisory Committee is 12531.

Comment

We have heard that peginterferon will be approved as a single drug soon, maybe this week. The Advisory Committee will consider the combination with ribavirin. Our understanding is that Roche plans to sell its peginterferon alone as well.

FDA advisory committee meetings are often the best place to learn in-depth information about a new drug before it is approved. They are not called for every new drug application, only for those that present new, difficult, or particularly important issues. Usually a transcript and a summary appear later on the FDA Web site.

The FDA is not required to follow the recommendations of its advisory committees, but it almost always does.