Maurice Hinchey: “I am glad that the FDA Amendments Act that we are discussing here this evening addresses a number of the problems that…”

“I am glad that the FDA Amendments Act that we are discussing here this evening addresses a number of the problems that we have confronted over the course of the last number of years. These problems include giving the agency enhanced authority on post-market drug safety and developing a strengthened system for oversight of direct-to-consumer advertising. That is a very good move in the right direction. However, I am deeply disappointed that this bill neglects to sufficiently address a number of other major issues that are jeopardizing the trustworthiness of the Food and Drug Administration, the agency that is supposed to represent the gold standard for consumer protection in America. First, the FDA Amendments Act reauthorizes the Prescription Drug User Fee Act through which drug companies provide funding to the FDA for its drug safety approval and oversight activities. So, in other words, what we have is the regulated industry paying money to the agency that judges the worthiness of the industry's products and how they put those products on the market.”