Is the FDA moving to quickly to approve new drugs?
DR. MICHAEL FRIEDMAN: The average review time is a little over one year, but for the products that you’ve just been describing, for example, for Duract, that product required 27 months, two and a third years for review, and there was a study period of clinical trials of about a decade from 1984 to 1994. So I think it’s fair to say that that period of time is fairly substantial and the 2,400 patients who received the product were part of a very careful analysis and evaluation. ELIZABETH FARNSWORTH: Dr. Sidney Wolfe, do you think the FDA is moving too quickly? DR. SIDNEY WOLFE, Public Citizen: For certain categories of drugs, like drugs for cancer and AIDS and life-threatening illnesses, we applaud the idea that the FDA is moving rapidly. Most drugs don’t fall into that category, and in the last couple of years the FDA has broken two records. They’ve approved a record number of drugs, 92 drugs in 1996 and ’97, more than ever in any two-year period, and a record number of drugs has been f
