Jim Jeffords

Mr. JEFFORDS

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. JEFFORDS. I suggest the absence of a quorum.

Mr. JEFFORDS. I yield to the Senator from Indiana 10 minutes.

Mr. JEFFORDS. My colleague from Rhode Island is a welcome addition to the Labor Committee. He has been active and has made some good suggestions for improving this legislation, but this is not one of them. This amendment sounds like simple good Government but in fact would gut the provision and 20 years of effective medical device regulation. Mr. President, I yield 15 minutes to the Senator from Connecticut.

Mr. JEFFORDS. Mr. President, I would defer to the Senator from Illinois, and I reserve my time.

Mr. JEFFORDS. Mr. President, the Senator's amendment at best duplicates the third-party conflict-of-interest protections in the bill and at worst unnecessarily constrains the agency. The ranking minority member, Senator Kennedy, and the FDA join me in opposing this amendment. Section 204 of the bill provides a full statutory directive to the agency adopt measures within 180 days of enactment to prevent conflicts of interest that may be involved with both an individual reviewer and with the reviewing organization. As with Senator Durbin, this was a critical concern for members of the committee. Section 204 provides full discretion to the agency to develop appropriate standards. The agency will not be limited in any way in developing these guidelines. In fact, the agency has already developed extensive conflict-of-interest guidelines as part of its existing third-party program, including protections from situations such as if the third party or any of its personnel involved in 510(k) reviews has any ownership or other financial interest in any medical device, device manufacturer, or distributor. The Senator's concerns have caused us to reexamine the important issue of preventing conflicts of interest. We commend him for doing so, but I urge a no vote.

Mr. JEFFORDS. I ask for the yeas and nays.

Mr. JEFFORDS. Mr. President, the Senate is not in order.

Mr. JEFFORDS. Mr. President, I disagree entirely with the statement made by the Senator from Illinois. The Senator's amendment strikes the agreement reached on these provisions among the bill's sponsors, the FDA, and Senator Kennedy. The FDA should have the discretion to decide when it makes sense to require device tracking or surveillance for a product. Current law requires tracking for certain product types and gives the FDA discretion to require tracking for other products. It is simply not necessary for every current and future device in the mandatory category to be subject to the tracking requirement. This provision allows FDA affirmatively to indicate which products in the mandatory category should be subject to tracking. FDA may use its discretion to add new products to the list of products which must be tracked, or put a product back on the list for tracking if evidence indicates the need. The FDA is overburdened. We want to free them up to do the things that need to be done. The FDA has publicly stated that it is unnecessary for all devices in the mandatory category--postmark and surveillance category--to be subject to its postapproval evaluation. I urge defeat of the amendment.

Mr. JEFFORDS. I ask for the yeas and nays.

Mr. JEFFORDS. Let me try to remove some of the confusion that I think must exist. Certainly the Senator from Massachusetts most eloquently has expressed his feelings, but his feelings and the law are not necessarily the same. I point out, first of all, that false statements, all these kinds of problems, are certainly reachable. Let us get back to where we are. Let us remove first a couple of the things that have been invoked here in the discussion. Fen/phen, for instance. Fen/phen deals with drugs, not with devices. So do not get that confused with this particular situation here. In addition to that, I point out that because of the off-label use of drugs, this committee appropriately put in place a system which would have probably even prevented fen/phen but at least would have made it possible for the FDA to intervene through the knowledge that they might not have had. So I want to take that completely out. That just raises insecurities in people which is inappropriate under this legislation. Second, with respect to the debate on devices, I think it is important that we take a look at what we are talking about here. Devices are different from drugs. Devices have to do with things which are implanted in you or are used like the neck collar, whatever else, which do require approval. There are two ways to approve these matters. One is the PMA, the premarketing approval. The amendment that they are asking for would require not only the premarketing analysis but would move the same kinds of standards which are in the premarketing approval process over to the 510(k) process. Why is that? First of all, the premarket approval is the one which requires all the clinical trials and tests and which makes it very clear as to whether a device is going to create a threat. Let us put that into dimension here. Just in the 510(k) process, there were over 5,000 a year. Over the last 6 years that has been about 30,000 devices. There have only been five or six that have created any problem which required mandatory recall. So that evidence is with respect to two points: First, these are rare things and, second, there is the present ability to handle those situations. So by putting in these words ``false and misleading,'' you take this device basically and move it back in under the premarketing approval process because, if you have to approve everything, if you have the duty of going out and inquiring among doctors, ``Are you using this device which has already been approved?'' and you say, ``I have something which is substantially equivalent to be used for that purpose,'' they would have the burden of going out among the doctors and finding out what the practice of medicine is and whether their device was being used for something other than what it was approved for under the premarketing approval process. That means a huge increase in costs to each of these companies that are trying to get something on the market to compete with the one that is already on the market. This creates huge delays. And for what reason? For no real purpose because it is only going to be used for that use intended unless somebody decides to use it otherwise. So I think we have to remember here there is authority under the law for those people who abuse the process. But one of the purposes of the 510(k) was to reduce the time so that competition can get out there with a better device and bring the costs down because there would be no longer a monopoly in that situation. The second purpose is to relieve the FDA from having to recheck and reexamine a device which is substantially or equivalent to the one that has already been studied and require the FDA to go out and examine all the doctors, all those kinds of things and create a huge burden on the FDA. So our purpose here in the bill is to make sure that we have an efficient, effective FDA with adequate resources to do their job. So I want to make it clear as to what the discussion is supposed to be about. I also remind you that the 510(k) process only applies to those devices which are not life threatening, so they are not the devices that would do the kind of horrendous things that the Senator from Massachusetts has alluded to. I yield to the Senator from Connecticut.

Mr. JEFFORDS. I ask unanimous consent that we be allowed to proceed until 12:40.

Mr. JEFFORDS. I yield 5 minutes to the Senator from Indiana.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, this morning the Senate is immediately resuming consideration of S. 830, the FDA reform legislation. In a moment we will begin two consecutive rollcall votes on or in relation to the pending amendments offered by Senator Durbin. Following those votes, additional amendments are expected and therefore rollcall votes will occur throughout the day. Under the consent agreement there are 5 hours remaining for debate prior to a vote on the pending substitute amendment. I hope that once the debate time has expired, the Senate will be able to proceed to a vote and then passage of this important legislation. The majority leader has also stated that this week the Senate will consider the D.C. appropriations bill and any appropriations conference reports that become available. I yield the floor.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, as we close debate on this issue, I want to say if I listened to this and didn't understand the law and the protections in it, I would go home and be depressed that I was backing such legislation. However, knowing the law and knowing the process, I still come away totally opposed to this amendment. First of all, let's take a look. We have had about 36,000 devices approved over the past 6 years. Out of that, there would have been six recalls. So this is not an issue that is something which has proved to be a failure in the law. Second, what we are dealing with here is the definition of false and misleading. Actually, the regulations cover the important aspects of it. But false and misleading means if you knew or should have known. They want to get into the practice of medicine. They want to say if this person has this device, and it is the same as the device with the premarket approval, they should be looking around and deciding and finding out all the possible and conceivable uses out there, and then they could be required to run clinical trials on all these. The purpose of the 510(k) process is to allow something that is identically the same, having gone through all this, not to have to go through it again. This would send fear through the device industry because it may know it is impossible to get anything improved again without expending thousands and thousands of dollars and waiting 2 or 3 years. That is totally unnecessary. The law fully protects the consumer now. This is totally unnecessary and will increase the cost to consumers and decrease the availability of devices to them in a timely manner. That is why I am opposed to it. It has been greatly overexaggerated as to what kind of problem is created here. Mr. President, I move to table the amendment.

Mr. JEFFORDS. Mr. President, I move to table the amendment. Mr. President, I ask for the yeas and nays.

Mr. JEFFORDS. I have a unanimous-consent request, Mr. President.

Mr. JEFFORDS. Mr. President, I ask unanimous consent that following debate and disposition of the Harkin amendment, Senator Murray be recognized for 5 minutes to offer her amendment No. 1161, and that following her remarks, her amendment be agreed to. I further ask unanimous consent that the following amendments be called up, considered en bloc and agreed to: A Jeffords amendment No. 1174; a Jeffords amendment No. 1175; a Kennedy amendment No. 1152; a Wellstone amendment No. 1156, and Senator DeWine's amendment No. 1136, as modified in the amendment I send to the desk.

Mr. JEFFORDS. There are no nongermane amendments in the unanimous- consent request.

Mr. JEFFORDS

Mr. JEFFORDS. Madam President, first, let me very briefly review where we are. There has been considerable debate up to this point. I think it is important for me as the chairman of the committee to remind people as to where we are. We have before us a 152-page bill, which is the first real overhaul of the Federal Food, Drug and Cosmetic Act in the last 30 years. We have taken little tweaks here and there, but it has not been thoroughly reviewed and brought into the modern world. Out of that 152 pages, we are now spending most of the time debating on 2 or 3 pages. That is why the minority ranking member has praised the bill, but then picked on one--basically, we are here because of one provision, which is 404. On some standards, we cannot agree on the precise wording. So everybody agrees on almost all of this bill. The amendment that is being offered by the Senator from Illinois does get into a very, very important area, and we do not disagree with that. We praise him for having given us the opportunity to review, to restudy, and determine as to whether or not the provision he is striking with his amendment and replacing is necessary or appropriate. We have concluded--I say ``we'' because I am sure that Senator Kennedy joins me in this statement--that we adequately take care of the conflict of interest in this bill. Let me go through what his amendment attempts to do and what the bill provides. First of all, the Senator's amendment, at best, duplicates the third-party provision that we have in the bill now and, at worst, it unnecessarily constrains the agency. Section 204, conflict of interest protections, which is being stricken and replaced, provides a full statutory directive to the agency to prevent conflicts of interest that may be involved with both an individual reviewer and with the reviewing organization. As with Senator Durbin, this was a critical concern for members of the committee. Section 204(b) reads: Within 180 days after the date of enactment of this section, the Secretary shall adopt methods of accreditation that ensure that entities or individuals who conduct reviews and make recommendations under this section are . . . free of conflicts of interest. Section 204 provides full discretion to the agency to develop appropriate standards. The agency will not be limited in any way in developing these guidelines. We believe the FDA is the one that can best understand what will be effective in this regard. The agency has already developed extensive conflict of interest guidelines as a part of its existing third-party program. The notice of April 3rd, 1996, has almost a full page of Federal Register type laying out the standards, including restrictions if ``the third party, or any of its personnel, involved in 510(k) reviews has any ownership, or other financial interest, in medical device, device manufacturer, or distributor.'' That is a quote from the wording. The agency has not identified any difficulties in the implementation of the conflict of interest guidelines, and it has expressed no concern about the conflict of interest provisions, as drafted. We have reviewed the FDA standards that appeared in the Federal Register on Wednesday, April 3, 1996, at page 14794, and believe that they adequately and appropriately address the problems which we are reviewing here. The agency's strict guidelines resulted in the elimination of 30 of the 37 applicants that originally sought accreditation. That means, obviously, that the FDA policy is effective, and it has outlined and again recognized--as the Senator from Illinois is aware--that there are problems that must be protected against. And we agree with him on that. The Durbin amendment attempts to set standards but in fact may constrain the agency. In fact, the standards cited are reportedly outdated and do not reflect recent revision. This may explain why in the second part of the amendment Senator Durbin effectively gives the agency discretion to craft appropriate guidelines. Section 204 provides a full statutory directive to the agency to prevent conflicts of interest that may be involved with both an individual reviewer and the reviewing organization. Therefore, it appears to us that the amendment, although well-intended, may even make it more complicated than necessary, and that we will end up perhaps with a less effective system than is already contained in the bill. Madam President, I ask, if we yield back time, what happens to that time? May we be advised on that?

Mr. JEFFORDS. If at the end of the time we, for instance, end up instead of using an hour on the Durbin amendment using half an hour, does that time fall into the same category as the last half-hour of this unanimous consent? So we have an hour in that last part of the unanimous-consent request.

Mr. JEFFORDS. I understand the Senator from Georgia has time, and I ask if he would yield me 5 minutes.

Mr. JEFFORDS. Madam President, I believe I understand the ruling of the Chair. I appreciate that.

Mr. JEFFORDS. Mr. President, I again commend the Senator from Illinois for focusing on some of the most critical problems that we have with respect to devices. However, I would only point out that the bill as is at this time is subject to a bipartisan agreement with full concurrence of FDA. At this time I ask unanimous consent that Senator Collins be recognized for up to 10 minutes as if in morning business and that upon completion of her remarks the Senate return to the consideration of S. 830 and the Durbin amendment.

Mr. JEFFORDS

Mr. JEFFORDS. Mr. President, I announce on behalf of the majority leader that today the Senate will resume consideration of S. 830, the FDA reform bill, with Senator Kennedy being recognized until the hour of 10:30 a.m. for debate only. Under the previous consent, at 10:30 a.m. Senator Durbin will be recognized to debate his two amendments. Further, at 12 noon the Senate will proceed to a period of morning business, with Senator Coverdell or his designee being recognized for 90 minutes from 12 noon until 1:30 p.m., and Senator Daschle, or his designee being recognized for 90 minutes, from 1:30 p.m. to 3 p.m. As previously announced, there will be no rollcall votes during today's session of the Senate. Also as announced, the next rollcall votes will occur on Tuesday, September 23, at 9:30 a.m., on Senator Durbin's amendments to S. 830, the FDA reform bill. I thank my colleagues for their attention.