James M. Jeffords: “this legislation is the result of a well-considered process to consult with all points of view and to benefit from the…”

“this legislation is the result of a well-considered process to consult with all points of view and to benefit from the expertise needed to craft legislation on this complex matter. The substitute before us today stands on the shoulders of four hearings and a committee markup of a comprehensive Food and Drug Administration reform bill in the 104th Congress. This year we held two more hearings, taking testimony from Food and Drug Administration, industry experts, physicians, and consumer groups--and I emphasize ``and consumer groups.'' Staff held dozens of meetings with Food and Drug Administration, experts and patient groups, discussing in detail every issue of this bill. The negotiation process with Food and Drug Administration, and the minority started in the drafting phase of the bill and continued up to and right through the markup, and has continued right up to this moment. This has been a process marked by openness and consultation. The philosophy of this bill is to codify recent efforts of the self-reform of the Food and Drug Administration, and a great deal of that is self-reform which we are codifying, and to provide the Food and Drug Administration with the tools to do even better in certain areas. We recognize that Congress cannot micromanage an agency like the Food and Drug Administration, nor do we want to. But we must set realistic performance goals to ensure the public is protected and well served and that the industry is fairly treated.”