Jim Jeffords

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I thank the ranking minority member on my committee for his words. I commend him, also. We disagreed rather strongly on one issue here, but 19 out of 20 we were together and worked together, and certainly that's a pretty good average. Mr. President, I suggest the absence of a quorum.

Mr. JEFFORDS

Mr. JEFFORDS. Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. JEFFORDS. Madam President, we are nearing the end of the debate. I have no more requests for time that I am aware of. So I will make some comments and then go into a quorum call. But I want to alert Senators that if I do not have a request within the next 10 minutes, it is my intention to yield back the remainder of my time, assuming the minority would do the same thing, so that we can expedite the process and the movement of legislation through the Senate. Madam President, I suggest the absence of a quorum.

Mr. JEFFORDS. I thank the Senator from Maryland for raising this very important point. As with the 1992 law, I intend that the FDA's performance goals that have been worked out between FDA and industry in the PDUFA reauthorization be covered in a separate letter. The letter will be sent by Secretary Shalala to Chairman Bliley and me, as well as the distinguished ranking members of the House Commerce Committee, Mr. Dingell, and our committee, Mr. Kennedy. This letter is referenced in the findings section of the user fees provisions of the bill. It will spell out in detail the performance goals that FDA has agreed to meet for each of the 5 years of the reauthorized user fee law. I consider the provisions that will be in the Secretary's letter and attachment to be as mandatory as if they were in the statute itself. I expect the FDA will treat them as such just as it has with the provisions in the 1992 letter.

Mr. JEFFORDS. I thank the Senator from Maryland for a most eloquent and moving personalized statement, as well as her efforts that have gone on to improve the FDA for all of us.

Mr. JEFFORDS. Mr. President, this is, hopefully, the final moments of debate on the FDA reform bill. There is no Senator who has been of more help and assistance, not only to the committee but to her constituents, than the Senator from Maryland. Thus, I am pleased that the one who will be opening the debate today is that Senator. So I yield her such time as she may consume; and may she consume a lot of time.

Mr. JEFFORDS. Madam President, I want to thank the Senator from Indiana for bringing to the awareness of my colleagues what the other side of the story is with respect to the famous 404 provision relative to devices. I only add, as I would point out, there are some 6,000 devices approved each year, and during the period of the last 5 years around 30,000, of which there were only 5 or 6 that were found to have had problems after approval. So I want to try to get the dimensions of this problem which has really dominated our time. I thank the Senator from Indiana. Madam President, I ask unanimous consent that the statement of the managers be printed in the Record.

Mr. JEFFORDS. Mr. President, I thank the Senator for his excellent comments and praise him again for his work. Mr. President, the goal of this legislation is to ensure a strong and efficient FDA. The modernization and revitalization provision included in S. 830 makes for a better FDA--not a weaker one, as some have suggested. Like many of my colleagues, I have had the opportunity to meet with industry groups here in Washington, and with consumers, patients, and physicians--both here and at my home in Vermont. All of these interested parties have made important points about how to modernize the agency while ensuring that its stellar standards for public safety remain as strong as ever. Though the large industries regulated by FDA are by and large not present in Vermont, all of us use their products. The people and the patient advocates in Vermont have told me that more needs to be done to ensure their timely access to the best therapies available. I believe we have accomplished that with this bill. Mr. President, I yield the floor.

Mr. JEFFORDS. Mr. President, I yield such time as he may consume to the Senator from Indiana, who has been somewhat involved in this issue. I am sure he may have a few things to say. Take as long as you like.

Mr. JEFFORDS. Mr. President, I yield to the distinguished Senator from Ohio who has worked tirelessly on this bill as well as the bill we reported out of committee by unanimous agreement relative to the work force improvement. So I yield to him 6 minutes.

Mr. JEFFORDS. Mr. President, I want to take a moment to thank the Senator from New Hampshire again for the incredible amount of work he has done, and I hope we heed his advice. I yield the floor.

Mr. JEFFORDS. Mr. President, I would like to express my sincere appreciation to Senator Frist, especially for his most recent discussion. We have been concentrating on one small part of this bill--small in the sense of the number of pages or words relative to the rest of the bill, and by outlining and expressing the tremendous advancements we made in many of these areas in this bill, which has kind of gotten lost in the dialog, especially in the off-label use which has been a very contentious issue. But I think the resolution which you and Senator Mack, working with Senator Kennedy, myself and others have come up with is a tremendous step forward in preventing such things that have occurred in fen/phen and things like that, and making sure we exchange knowledge and that we work together to improve what can be improved. I deeply appreciate the comments of the Senator and all the work the Senator has put into this bill. Your expertise and your knowledge has been a reward to us and has given us confidence that we have done the right thing. You have done a fantastic job and it is deeply appreciated. I yield the floor. I see the Senator from Delaware on the floor. I would be glad to yield to him for the time that he might take.

Mr. JEFFORDS. I would be pleased to enter into such a colloquy with the distinguished Senators from Massachusetts and Arkansas.

Mr. JEFFORDS. Mr. President, before yielding to the Senator from New Hampshire I would like to say he has spent as much or more time than anyone on this legislation and has had the very difficult chore of working in this very controversial area of uniformity. It is so essential that this Nation have uniformity so that when they buy a product they can know with the assurance of the FDA that the product they are getting is one that will be safe and helpful. Many, many hours the Senator has spent working on this issue, as well as the bill generally. I praise and thank him.

Mr. JEFFORDS. I yield such time as the Senator from New Hampshire desires.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, for the Committee on Labor and Human Resources, I report favorably two nomination lists in the Public Health Service which were printed in full in the Congressional Record of September 4 and 12, 1997, and ask unanimous consent, to save the cost of reprinting on the Executive Calendar, that this nominations lie at the Secretary's desk for the information of Senators.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, the Finance Committee requests unanimous consent to conduct a hearing on Wednesday, September 24, 1997, beginning at 9 a.m., in room 106 Dirksen.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that the Committee on Foreign Relations be authorized to meet during the session of the Senate on Wednesday, September 24, 1997, at 10 a.m., to hold a hearing, and at 2:15 p.m., to hold a business meeting.

Mr. JEFFORDS. Mr. President, I ask unanimous consent on behalf of the Governmental Affairs Committee Special Investigation to meet on Wednesday, September 24, at 10 a.m., for a hearing on campaign financing issues.

Mr. JEFFORDS

Mr. JEFFORDS. Thank you, Mr. President.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, today the Senate is resuming consideration of S. 830, the FDA reform legislation. Under the consent agreement, there will be 4 hours of debate prior to a vote on final passage of the bill. Some of that debate time may be yielded back. Therefore, Senators can expect a rollcall vote on passage of S. 830 between 3:45 and 4 o'clock this afternoon. Following that vote, the Senate may begin consideration of the D.C. appropriations bill. Additional rollcall votes may occur throughout the day as the Senate considers the last of the appropriations bills. The Senate may also consider any of the available appropriations conference reports. I thank my colleagues for their attention.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I yield the Senator from New Hampshire 5 minutes.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I ask for the yeas and nays on the adoption of the committee amendment.

Mr. JEFFORDS. Mr. President, I make a point of order that a quorum is not present.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I would like to announce for information of the Senate and the public that a hearing of the Senate Committee on Labor and Human Resources will be held on Thursday, September 25, 1997, 10 a.m., in SD-430 of the Senate Dirksen Building. The subject of the hearing is Tobacco Settlement, part II. For further information, please call the committee, 202/224-5375. committee on energy and natural resources