This time, the action takes place Wednesday morning, when the Senate Health Education Labor and Pensions committee examines user fees and drug safety.

Your host: Ted Kennedy, who wants to talk about his bill, which wouldn’t create a separate office to oversee safety issues. The guest list should make for interesting banter:

Andy von Eschenbach, the FDA commish;
Kim Witczak, founder of Woody Matters;
Bruce Burlington, Wyeth’s exec vp for regulatory and safety;
Diane Dorman, vp public policy, National Organization for Rare Disorders.

The FDA wants industry to pay more money in order to review more drugs, before and after approval, as well as scrutinize more ads. The higher fees, however, are drawing criticism that the agency is becoming increasingly beholden to industry. The Prescription Drug User Fee Act is up for congressional renewal, but the FDA proposal is controversial.

We know about Andy and Wyeth’s Burlington, although not a household name, has been around awhile. And NORD’s position on banning the use of experimental drugs is pretty clear. But Kim Witczak? Her husband, Woody, committeed suicide and she blames Pfizer’s Zoloft. For the past three years, she has lobbied for greater disclosure of clinical trial data and safety information. Woody Matters is a web site devoted to her cause. Articulate, informed and persistent, she is a convincing public speaker.

Andy should only be as straightforward.

[tags]Andrew von Eschenbach, FDA, Safety, Ted Kennedy, User Fees[/tags]