1992 was a very big year in the history of the relationship between the FDA and the pharmaceutical industry. That year, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing the FDA to charge pharmaceutical companies hundreds of thousands of dollars per drug for the drug approval process. (The total amount collected by the FDA from user fees for FY 2000 was approximately $137.7 million.) In a recent interview, Jerry Avorn, M.D., of Harvard Medical School and Ken Kaitin, M.D., of Tufts, indicated that "There is no question that there was a change in the culture of the FDA after the User Fee Act…. According to colleagues in the FDA, there is a sense now that the [pharmaceutical] industry is the client, effectively paying their salary, and that they need to do things that industry is comfortable with…. [Since 1992], the assumption is that every new drug application should be accepted unless there's something in the application that demands that it should be rejected." The interviewer, Dick Gordon, then asked, "So in 1992 did the FDA shift from working on behalf of the American people to working on behalf of the pharmaceutical industry?" "Well, that's what a lot of people who work at the FDA will tell you," was the response from the guests, as they cited drugs like dexfenfluramine (Redux) that were taken off the market within a year and that probably should never have been approved in the first place.

Sources:

• http://www.theconnection.org/shows/2005/02/20050216_b_main.asp


• http://www.bio.org/reg/pdufa/