Chuck Grassley: “I urge my colleagues to keep in mind the public's interest. Both bills contain provisions that attempt to address some…”

“I urge my colleagues to keep in mind the public's interest. Both bills contain provisions that attempt to address some of the problems that have been plaguing the FDA over the past 3 years. Some of these issues are better addressed by the Senate bill and others by the House bill. I am going to spend the next few minutes to comment on what the bills don't do and point out some of the provisions that I believe are important to improving drug safety at the FDA that will benefit all Americans. Two months ago, I offered amendment No. 1039 to S. 1082, because I believed--and still believe--that S. 1082 does not address a fundamental problem at the Food and Drug Administration--the lack of equality between the preapproval and postapproval offices of the agency, the Office of New Drugs and the Office of Surveillance and Epidemiology, respectively. The Office of New Drugs approves drugs for the market, while the Office of Surveillance and Epidemiology monitors and assesses the safety of the drugs once they are on the market.”