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Event Health FDA Reform, Pharmaceuticals

Medical Progress and the FDA: Our Future in the Balance

Saturday June 2002

MR. SLOBODIN: Good morning. My name is Alan Slobodin, and I'm senior oversight counsel with the House Energy and Commerce Committee. On behalf of the committee and the chairman of the committee, Congressman Billy Tauzin, welcome to the Manhattan Institute’s conference on the future of the FDA.

It is quite appropriate for the Energy and Commerce Committee to be hosting a conference of this sort, since we're the committee in the House with jurisdiction over the public health laws and we have recently been quite engaged on FDA issues in passing some bioterrorism-preparedness legislation. As part of that we also reauthorize the user fees in the FDA drug approval process, so there’s obviously been a lot of discussion and a lot of focus in the committee on the FDA.

There will continue to be interest in policy issues that came out of the consideration of legislation that didn't get addressed in those bills. These issues will deal with medical devices, the medical device approval system, whether or not there should be user fees, pediatric testing, drug advertising, and drug pricing.

In addition to what we're doing on the legislative side, we also have an oversight investigation subcommittee, and we've always had a history of doing comprehensive oversight and monitoring of the FDA and the public health laws. So this is of great interest to the committee, and I look forward to hearing the views and possible solutions that can be useful to the committee and Congress as we try to come up with ways to improve the FDA.

MR. GOLDBERG: Thank you, Alan. My name is Robert Goldberg. I am the director of the Manhattan Institute’s Center for Medical Progress. Our mandate is to try to establish the value of medical progress, not only in the health care system but also in its overall contribution to America and American society. If any institution in American society plays a role in medical progress, it is the Food and Drug Administration. Whether it’s a positive or a negative role is something that we may discuss here today.

Today we will hear from three people who can speak to the issues of the agency's role better than anybody that I know in the country. Before I turn the rest of the time over to them, I'll make a few introductory remarks and observations about the FDA and the state of medical progress in America, as it pertains to drug development.