Friday, January 17, 2003

CHAIRMAN KASS: Good morning. We're still missing a couple of members who I trust will be along shortly, but since one never knows for sure, I think we have a quorum and our guests are ready. I think we should proceed.

The session that we start now on biotechnology, public policy, the role of the Food and Drug Administration is a session in our ongoing inquiry under the heading of public policy and regulation of biomedical technologies.

To remind everyone of the context, our interest in this is in part stimulated by a concern voiced already at the first meeting by Frank Fukuyama calling attention to the fact that with respect to the large ethical and social questions of concern to this council we may be lacking appropriate regulatory institutions, whether professional or governmental whose responsibility it might be to pay attention to these matters.

And Frank has encouraged us from the start to think beyond the scope of our own survival here as an advisory council to see if there is any help that we could offer with a view to more long term and perhaps more permanent mechanisms for paying attention to these matters, perhaps even with a view to guidelines and regulation.

Second, we have seen through our project Beyond Therapy that we are dealing with novel biomedical technologies that perhaps more than many things in the past have uses that go beyond the concern with the treatment of disease and the alleviation of suffering both with respect to so-called enhancements and satisfaction of client and consumer desires, but also questions of social control, and we'll talk about that in the next session this morning.

Third, the cloning report that this council issued called for a review of what is going on in the whole area where reproductive technologies, embryo and developmental biology research and genetic knowledge come together, what is known on the street as reprogenetics. We've tried to avoid that term here, and everyone on the council was -- the emphases were different in the report -- but everyone thought we should at least be looking into what is actually going on in this area and also to look at who is or is not responsible for monitoring and oversight.

In previous meetings we've had a discussion of the role of IRBs and their capacity to handle some of these kinds of questions. At the March meeting we hope to have some representatives from the assisted reproduction technology field to talk about their efforts at professional self-regulation and to find out a bit more about what's going on.

Today at least we've come to a discussion of the one institution and the one government agency that is most clearly at the center of efforts to, on the one hand, facilitate the development of new and useful and beneficial biological and pharmacological agents, and also charged with the protection of the public against the possible untoward effects of these things.

And to help us explore both the legal authority, the decisional processes, the institutional culture, and the competency of the Food and Drug Administration to monitor and regulate the things of special interest to us, we are very fortunate to have two people whose experience and expertise and interest is very beneficial to us.

Richard Merrill, who is the Daniel Kaplan Professor of Law and the Sullivan & Cromwell Research Professor at the University of Virginia's School of Law, and who from 1975 to 1977 was the Chief Counsel at the Food and Drug Administration.

And Jim Benson, who wore many hats at the Food and Drug Administration, beginning as Deputy Director of the Center for Devices and Radiological Health; then was Deputy and then Acting Commissioner at FDA; and since leaving the FDA has worked as the Executive Vice President of Technology and Regulatory Affairs at Medical Technology Association.

Professor Merrill will speak first, talking primarily about the legal authority of the FDA to regulate in this area, and Jim Benson will speak second to talk more about, I think, the institutional culture and competence.

I think we'll proceed with one talk, have some beginning discussion, the second, some beginning discussion, and have some time at the end for discussion of both presentations and this whole matter.

So without further ado, welcome to both of our guests. Thank you very much for joining us and for giving us the benefit of your knowledge and wisdom. Professor Merrill.