Daniel Coats

Mr. COATS

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. COATS. Mr. President, I thank the Chair and I thank the Senator from West Virginia. (The remarks of Mr. Coats pertaining to the introduction of S. 2000 are located in today's Record under ``Statements on Introduced Bills and Joint Resolutions.'')

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. COATS. I just want to introduce legislation. I can probably do it in 2 minutes.

Mr. COATS. There is no rush on this. I think we should stick with what was agreed upon.

Mr. COATS

Mr. COATS. All Members of this body remember early in this Congress we introduced and passed into law the Congressional Accountability Act which applied the various civil rights and labor laws that are currently applicable to employers and employees throughout America's workplaces, and applied this same restrictions to Members of Congress. For too long we had exempted ourselves from the laws and regulations that we had imposed on virtually every other business operation in America. There were only a couple of workplaces that were exempted: The Labor Standards Act, the Civil Rights Act of 1964, the Americans With Disability Act, and the other items that we discussed. Those institutions were the U.S. Congress and the executive branch, in particular, the White House. We remedied that, partially, for the Congress with the adoption of the Congressional Accountability Act. Now, these 11 specific items apply to Members of Congress as well as to the private sector. I think what we are learning is that some of these laws are good, some of these laws are applicable to what we do, but some of them are overly burdensome and overly restrictive and therefore need to be examined. Because they apply to us as they apply to everyone else, we feel that burden, and perhaps we can be reasonable when we examine these to determine whether or not reforms are needed. This act would apply these same provisions that now apply to Congress and virtually every other workplace in the country, to the White House. This legislation, which I send to the desk for referral, was originally cosponsored by Senator Stevens, as well as other Members including Senators Nickles, Abraham, DeWine, Coverdell, and Faircloth. Mr. President, today I send to the desk a bill designed to eliminate a dubious double standard that remains in the application of our civil rights and labor protection laws. Last year, this Congress passed the Congressional Accountability Act, requiring Congress to live under the laws it passes--and oftentimes imposes--on the rest of the Nation. Now that the Congressional Accountability Act is the law of the land, only one workplace in America remains exempt from our Nation's laws and regulations. In just one place of employment, workers do not enjoy the rights and protections afforded to all other Americans. That one place is the White House, and it's time for the White House to join the rest of the United States in living under the civil rights and labor laws governing the rest of the Nation. For decades, Congress callously exempted itself from rules and regulations it was passing for the rest of the country. Many of us had supported the Congressional Accountability Act for years, but were thwarted in our efforts. Finally, when--for the first time in 40 years--Republicans gained control of Congress, we wasted little time and passed the Congressional Accountability Act into law. I remain in strong support of the principle that Congress should not be exempt from the laws that apply to all other Americans, and because of the Congressional Accountability Act, Congress now is living under 11 different labor and civil rights laws from which it had previously exempted itself. I continue to believe that this is a simple issue of fundamentlal fairness. Congress should live under the laws it passes for everyone else. In doing so, lawmakers will learn first hand which laws work, and perhaps more often than not, which laws are overly intrusive and burdensome. These lessons also would be appropriate for the White House, since under President Clinton the Federal Register of Government regulations now totals about 65,000 pages, the largest number in more than 15 years. Despite President Clinton's stated concerns for the working men and women of this country, the White House continues to exempt itself from the laws and regulations covering the rest of the country, including Congress and all private businesses. For example, because of this privileged loophole, the White House does not have to abide by the minimum wage or the Family Medical Leave Act or the overtime requirements of the Fair Labor Standards Act or several of the other civil rights and labor laws that apply to all other Americans. I think America's labor leaders will agree with me when I say that employees of the White House should be protected by the same laws that the President approves for the rest of the country. Employees should have the same rights and protections regardless of where they work--whether the individual labors in the private sector, the Congress, and yes, even in the White House. There are some in the White House who argue that this legislation is unnecessary because the White House voluntarily complies with the spirit of many of these laws. Mr. President, I argue that voluntary compliance is not good enough. How many private sector companies are allowed to voluntarily comply with the laws of the land? The answer is zero, and the White House should not be an exception. The Congressional Accountability Act, and the proposed White House Accountability Act, give employees of these two branches of Government the same rights as any other citizen to go into a court of law and have their case heard by a jury of their peers. White House employees should not have to depend on the benevolence or arbitrary good will of a supervisor to ensure that they are not taken advantage of, sexually harassed, or otherwise dealt with in an inappropriate and possibly illegal manner. They deserve the right to be free from discrimination, the right to work in a safe and healthy work environment, the right not to be fired simply because of race, sex, disability, or age. White House workers deserve the same rights and protections that every other American enjoys in the private sector, and now in the U.S. Congress. The White House Accountability Act also would be good policy for senior management and administrators. White House policy makers and their staffs would gain a first-hand understanding of the laws they propose and enact. Perhaps the White House will find, as many in Congress have been forced to learn, that some of the laws we pass are good, some do not go far enough and need to be strengthened, or--and this is too often the case--that many of the regulations imposed on the Nation by the Federal bureaucracy in Washington are onerous and in serious need of reform. Writing in the Federalist Papers, James Madison instructed us that no branch of Government is above the law. Madison wrote, ``Congress can make no law which will not have its full operation on themselves and their friends, as well as on the great mass of society.'' Because of the Congressional Accountability Act, Federal laws and regulations now apply from our Nation's assembly lines to our Nation's general assembly. When President Clinton was inaugurated, he called the White House, ``the people's house.'' It's time he backed up that statement by letting his workers in the White House enjoy the same civil rights and labor protections enjoyed by the rest of the people in whose house they serve.

Mr. COATS

Mr. COATS. Mr. President, I send the amendment to the desk.

Mr. COATS. Mr. President, I would like to add as original cosponsors to the bill Senator Specter, Senator Baucus, and Senator McConnell.

Mr. COATS. I temporarily withdraw that request.

Mr. COATS. If the Senator will yield, I am fully aware of the perils and pitfalls of moving appropriations bills to the executive branch and having the President sign them. I know that is not directly related, although I think it is indirectly related to energy and water. I appreciate the commitment from the Senator from New Mexico in doing his very best to see if we can add this in an appropriations bill and get it accepted in conference. As I said, this is not a partisan issue. The President has already indicated that he would sign this particular provision. So this will not be a deal breaker. If I can get the commitment from the Senator from New Mexico and the Senator from Louisiana that they will fight for this effort in conference and do their best to reflect the Senate position on this, in deference to my colleagues, who I know are seeking to catch planes and wrap up the session, if there are no other votes ordered on this legislation, I will not be the one to scuttle the picnic here. So I will make that commitment to the Senator.

Mr. COATS. It has been modified from the original legislation. We have addressed some of the concerns of the exporting States and struck a balance between the timetables, in terms of their ratcheting down the exports, and we made some adjustments on the importing State side. We allow, for instance, local jurisdictions to enter into what are called host agreements. We do not upset those agreements. We don't want to breach any contractual obligations already entered into. We have added flow control language to address that particular issue, also. This is identical to what we passed in 1995 in this Congress.

Mr. COATS. Will the Senator yield?

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

Mr. COATS. Mr. President, I came to the Senate in January 1989. I was not here very long before I realized our State was facing a very difficult problem with the sudden surge of the importation of out-of- State waste. Our capacity to dispose of our own waste was quickly being filled to overflowing, and action needed to be taken. The State of Indiana Legislature has taken a number of steps to attempt to limit this flow of unwanted waste coming from other States. Yet, each one of their attempts was met by a court challenge, and a challenge that was successful in that it said we were violative of the interstate commerce clause of the Constitution. In reviewing the court opinions on that subject, we discovered the court said if the Congress specifically and affirmatively grants States the authority to regulate its flow of out-of-State waste, then it would meet constitutional muster. So, I then proceeded to offer legislation on that subject to find a solution to not only our problem but a number of importing States' problems throughout the country. That was a contentious issue at the time, and it was tied up in filibuster and a whole number of procedural delays. We persisted, and in September of 1990, a modified version of my original amendment passed the Senate by a vote of 67 to 31, as an amendment to the District of Columbia appropriations bill. It was not a partisan issue. It was a bipartisan issue--Democrats and Republicans joined together to pass this legislation. Unfortunately, in the conference on the appropriations bill in 1990 in October, just before we adjourned for the elections, that provision was stripped. That was the 101st Congress. In the 102d Congress, early on in that Congress, March of 1992, I introduced new legislation which, after some considerable debate and maneuvering, we managed to pass by an even more overwhelming vote. I was joined by the Senator from Montana in that effort. He was very helpful in allowing us to move forward on that legislation. It passed the Senate in July of 1992 by a vote of 89 to 2. We had addressed a number of the objections that were raised in the original legislation, States that had particular and peculiar problems, and we even worked with the exporting States that were putting the waste into play on an international basis, and satisfied a number of their demands. In other words, we achieved a balance, a balance between the legitimate needs of those States that found State waste overwhelming their own environmental plans to adequately dispose of their own waste to protect their environment, and we addressed the needs of the exporting States who needed some time to ratchet down their exports, out-of-State exports, and deal with their waste on an intrastate basis. That accommodation resulted, as I said, in that vote in 1992. The support from the Senator from Montana was critical to that success. Unfortunately, the House failed to act on that legislation, which brought us to the 103d Congress. In February 1993, I again introduced the interstate waste bill, and after considerable negotiations and work, we passed that bill in the Senate, the Coats-Baucus bill, in September 1994. In October, it passed the House and came to the waning days of the 103d Congress, and because of procedural reasons we needed unanimous consent to proceed with that. We moved the legislation through the House, through some very difficult negotiations, got 435 Members of the House to agree to that, and we got 99 Members of the U.S. Senate to agree. Unfortunately, we could not get that last vote. Because we needed all 100 and needed unanimous consent to proceed to the legislation, it failed. Then the 104th Congress came, and in March 1995 I reintroduced the legislation. In May, on May 16, 1995, on my birthday--I do not think it was a birthday present from the Senate to me, but it happened to fall on that particular date--the Senate passed that new legislation by a vote of 94 to 6. The House subsequently has done nothing. Now, I am hoping that Members will detect there is a pattern here, that there is a pattern that this issue is not going to go away, and that I will keep introducing that as long as I have voice to speak and the good people of Indiana choose to send me back to the U.S. Senate. This is an issue that is not only important to my State, the people who I represent, but it is important to the Nation. Given the votes that we have had here in the Senate, a lot of people are wondering, why can't we finalize this? We cannot finalize it now because the House refused to act on it for a number of reasons. We are not going to give up. The pattern is we will just keep coming back and back and back and back and back until this issue is resolved and we strike the necessary legislation and put it into law, giving States control over their own borders. The legislation before the Senate is a bipartisan effort. I am being joined this morning by Senator Levin from Michigan, another importing State. I know a number of other Senators here have a vested interest in this issue, and whether they need to come to the floor to discuss this or not, I am not sure. I am confident we can move forward. But, again, we want to make the point that this legislation is not going to go away. My effort is not going to go away. We are going to persist with this until we finalize this. This is an amendment, with due respect to the chairman and the ranking member of the Energy and Water Appropriations Subcommittee, this is an effort to try to attach it to somewhat relevant legislation so that we can get it into conference and hopefully convince the conferees that this strongly bipartisan, strongly supported effort, after literally years of intense negotiations--with importing States, exporting States, all involved; waste haulers, all involved--we have reached a reasonable agreement that ought to be enacted into law. I am offering it this morning along with my colleague from Michigan, Senator Levin. We do strike an appropriate balance. What we are offering today is exactly the same legislation that the Senate has voted on in this Congress and passed by a vote of 94 to 6. In the interests of time and in the interests of Senators who I know are trying to make plans to travel back to their States for this weekend, and to move this appropriations bill forward, I am going to limit my remarks to this, unless I need to respond to questions or opposition raised on this particular legislation. I thank the chairman for his tolerance and willingness and his support in this effort to, once again, move this legislation. I yield the floor.

Mr. COATS. Mr. President, the Senator is correct. The amendment we are offering today is identical, word-for-word, to the legislation that passed this body earlier in this session of Congress.

Mr. COATS. I yield the floor, Mr. President. I suggest the absence of a quorum.

Mr. COATS. Yes, it was. I can give you the exact date.

Mr. COATS. Mr. President, I will withhold that request at this time.

Mr. COATS. Mr. President, I ask for the yeas and nays.

Mr. COATS

Mr. COATS. Mr. President, I ask unanimous consent that Senator Robb be added as a cosponsor.

Mr. COATS. I move to lay that motion on the table. The motion to lay on the table was agreed to.

Mr. COATS

Mr. COATS. Mr. President, earlier there was discussion--not discussion, a statement on this floor--by a Senator on the Medguide. The Medguide issue is an issue that arose in the Labor and Human Resources Committee discussion of the Food and Drug Administration reform effort. Medguide is an attempt by pharmacies and pharmacists to provide consumers information relative to the drugs that are prescribed by those pharmacists. The industry has attempted in the last few years to prepare software which would allow them to prepare leaflets and information for distribution to their patients, those seeking to have their prescriptions filled at the pharmacies, which would provide those consumers with information about the impact of those drugs on their health, the dosage, what contraindications might be necessary; in other words, warnings as to what the side effects are, warnings to not mix these drugs with certain other drugs that the patient may be taking, and so forth. An example of these are--I hold these up. Here is one from Eckerd, ``RX Adviser,'' for the drug Novolin. It is easily readable. It describes the prescription number, the date on which the prescription was filled, the directions to the individual taking the prescription, and then it lists how to use this medicine. It is formatted in bold type. It has cautions and possible side effects, and it is very consumer friendly. It catches your eye. It grabs your attention. It is in different colors. Here is one from another pharmacy, CVS for Zantac, 300 milligram tablet. It again tells the prescription number, the name of the individual it is prescribed for, how to take this medication, what the uses are, side effects, precautions, notes to the consumer--very helpful information. I have a whole raft of these that are currently being distributed and handed out by pharmacies across the country. In fact, in 1995, it is estimated that nearly 65 percent of all patients received this information from their pharmacist, up from just 20 percent 3 years ago. Now, many in the industry believe we have gone beyond that point. I think that is a conservative estimate. Many believe we have already reached the 75-percent level of consumers receiving this information, which happens to be the goal set by Health and Human Services Healthy People 2000 Goal Program. So we are 4 years ahead of schedule with private industry. But now along comes the FDA saying: Oh, no. No, no, no. We do not trust the professionals to advise those taking these medicines to do a competent job to provide necessary warnings, to provide appropriate consumer information. We think this is something that the Government needs to step in and regulate. And so we, the FDA, need to make sure that these consumer information guides which are in addition to, by the way, the manufacturer's required printing of all of the compounds that go into the drug--all of us have seen those. You get your bottle of prescription drugs, and you pull out a piece of paper and you extend it out 2, 3, 4 feet and the print is so small that those of us over the age of 20 do not have the eyesight to read that. If we could read it, we would not understand what it says. And so the pharmacies have said let us boil this down into everyday common language and make sure the consumers get the right information. But the FDA says we do not trust the industry to do that; we need to make sure that we have a plan that will ensure that the information given to consumers fits our requirements. And by the way, we are going to have to approve all of these proposals of information to make sure that it is not violating anything that the FDA wants to check. And so they have put out these nice, big, thick rules and regulations called ``Prescription Drug Product Labeling, Medication Guide Requirements, Proposed Rule,'' issued on August 24, 1995. If you thought it was hard to read and understand the drug manufacturer's instructions about drugs, you ought to try reading FDA's proposed rule. On and on it goes for page after page--nearly 100 pages of fine print now that everybody is going to have to sort through, every manufacturer is going to have to sort through, adjust all of their information to the Government regulated point size of lettering, to the Government regulated headings. They are going to tell you what headings you have to use. They are going to tell you what size of type you are going to have to use. Interestingly enough, the samples that FDA puts out which follow their recommended guidelines are only about one-tenth as intelligible as the information currently being distributed to the patients when they receive their prescriptions. Typical Government bureaucratic ineptitude, mediocrity, and obfuscation that we find in Government agency after Government agency advising consumers as to how to use a product or how not to use a product. And so we bring in another Government agency to tell private industry what to do, and in telling them what to do they are going to turn a readable, consumer-friendly product into your typical Government, IRS, unintelligible form of how to do all this. Let me find this section here that describes some of the requirements: Format for Medication Guide. The medication guide shall be printed in accordance with all the following specifications: A. The letter height or type shall be no smaller than 10 points. And they point out here that one point equals 0.0138 inches. See all these people measuring with a little ruler here, is this greater than 10 times 0.0138 inches? For all sections of the medication guide except the manufacturer's name and address and revision date. Interestingly enough, they do not say how big the manufacturer's name and revision date are, probably the two most important pieces of information are not described here: B. The medication guide shall be legible and clearly presented. Well, the current industry forms are very legible and very clearly presented. But does that satisfy the FDA? Oh, no. Oh, no. It has to be printed and legible like the FDA forms that they provide as samples which, if anybody cares to look, are illegible and unintelligible. So we are going to go to the Government format for that. On and on it goes: The words ``Medication Guide'' must appear-- So forth and so on. And then here is the killer. Here is the killer. And this is why people ought to be concerned about FDA sticking its head in here where it does not need to. This medication guide has to have this verbatim statement. This medication guide has been approved by the U.S. Food and Drug Administration. And that has to appear on the bottom of every medication guide. The whole purpose for FDA reform is because you cannot get anything approved at FDA. And so instead of consumers receiving helpful information, they are going to be sitting around waiting for month after month after month after month or year after year after year for FDA to approve the guide that tells them how to use the medicine. Now, FDA says: Oh, no. We can handle this without a problem. They cannot handle anything else without a problem. Consumers not only are unable to get the medications they need because FDA takes years to approve it, now they are not even going to be able to get the information to use the medication because the FDA once again has to approve all of the information. On and on this goes with prescription after prescription as to just how these advisories should be put together. I guarantee you, anybody who has had experience with FDA, anybody who has listened to drug manufacturers or medical device manufacturers tell the horror stories about getting even the most simple of medical devices approved or even drugs that have been tested clinically approved, used for years in other countries without problem, yet cannot receive approval here in the United States, will quickly realize the problem that we are developing here. So FDA now will create a whole new bureaucracy. They will create a whole new process of making sure they approve all of the Medguide statements. Now, we took this issue up in committee, and in committee after significant discussion it was determined by a majority of members on a bipartisan basis--I believe the vote was 13 to 3. Members need to understand this is not a politically partisan debate. This is a debate between those who want to hold on to the status quo of mediocre, inept Government bungling and bureaucracy and those who think that maybe private industry has a more efficient, effective way to do it and perhaps can even protect the consumer a little more efficiently and effectively than FDA has been able to protect the consumer. We have gone through several decades now of denying effective treatment and drugs and devices to American consumers because FDA does not have the capacity to adequately and on a timely basis examine and approve or disapprove submittals of either drugs or devices that can benefit the consumer. I have a lot of manufacturers that would simply say, if they would just call us up and tell us they would disapprove it, they would not have to go through this year after year after year of inept bureaucratic bungling to determine whether or not our product is going to be allowed to be marketed in the United States. So, here we have another Big Government stride into a brand new area of regulation, regulation that currently is handled at the State level. State pharmacy boards traditionally regulate pharmacists, have the authority to regulate pharmacists. They have been providing services to the patients and consumers for a long, long time in this country. We have now an FDA that will, again, issue a regressive regulation which will stifle innovation and changes in pharmacy information. We have an FDA which will provide a one-size-fits-all, bureaucratically uniform style of type, style of heading, style of verbiage. Any of you who have to struggle through, as I do every year, trying to read the IRS instructions as to how to fill out your income tax will understand that somehow Government just cannot seem to get instructions into common, everyday language. I am afraid we will see more of that out of FDA. The most ironic thing here is that people have been pleading with FDA for more focus on their necessary items. No one is saying we ought to close down FDA. We are simply saying, can you focus more of your resources and your effort on the more essential elements of your business here? Yet now we are going to take already scarce, depleted resources and shift them and divert them from their primary focus of providing safety and efficacy for drugs and devices and protecting the Nation's food supply, to making sure that the information handed to the consumer, which is a duplicate, which is in addition to all the requirements that the drug manufacturer has to put in the medicine, consumer-friendly information--we now have to make sure this complies and gets approval from the Food and Drug Administration. I think they ought to spend more time approving drugs, more time approving devices, and less time worrying about whether this is 10-point type or 12-point type. How interesting to note that the advisories that we have examples of here are far more readable, far more presentable and far more legible than what the FDA, in their regulation, says it ought to be. The last thing a pharmacist or a pharmacy wants to do is hand its own customers something that is illegible. What they really want to do is hand them something that they can read and understand, because if they do that, they will come back. I get frustrated over this whole process, as you probably can tell. I am frustrated that we cannot proceed on meaningful FDA reform when we have such a bipartisan consensus on doing this. The vote in the Labor and Human Resources Committee was 13 to 3. We had solid support from both Democrats and Republicans on the need to do this. Yet, because FDA reform is stalled and cannot seem to work its way before the U.S. Senate, the Senator from Mississippi, whose committee has jurisdiction over the appropriations, took this portion of the proposal, which would impose some requirements and restrictions to make sure these private advisories comply with what is necessary, and incorporated that language in the agriculture appropriations bill. Suddenly we have had this big holdup here over whether or not this language ought to be here. Mr. President, my understanding is that some agreement has been reached on a watered down but hopefully still effective change in the language, which will be the subject, apparently, of a colloquy that will be coming shortly between the chairman of the committee and the Senator from Massachusetts. I hope the agreement which is reached is not one that the FDA will find another excuse not to implement, because my understanding is that the agreement is subject to the approval of the Commissioner of the FDA, who is probably the biggest problem we have at FDA right now. One of the amendments I offered in committee was to limit the terms of FDA Commissioners because I think, if there is ever an argument for term limitations, it is the current FDA Commissioner and the way that agency is being run. Hopefully, we can move forward now with something that is of great benefit to the consumers of this country--nearly 65 to 75 percent now receive these advisories--and not grind ourselves down into a bureaucratic excuse for something that does not begin to measure up to the advisories that are currently out there. When are we going to learn that all wisdom, all professionalism, does not rest in a Government agency; that industry has its own, the private sector has its own motivations for protecting the consumer? Besides, States have the ability, and State pharmacy boards have the ability, to impose some reasonable regulations on their own pharmacists and their own pharmacies. Mr. President, I wish we were debating FDA reform, because it looks like we may go another session of Congress without any meaningful reforms in a process that denies patients and consumers in this country sometimes life-saving drugs. The question is asked, what if FDA did not take this time to approve some of these medicines? The question also has to be asked, how many people have suffered, or perhaps needlessly died, because FDA was not able, on a timely basis, to approve life-saving drugs or devices? There is a backlog that is staggering at FDA. There is an ineptitude that is staggering out there. I do not trace it to the good scientists who are working there and clinicians who are working there. I trace it to an inept bureaucracy which often seems to have motivations beyond the health and safety of consumers. I think it is time we did something about it, and I am glad we are taking this one small step to benefit the consumers. I congratulate the Senator from Mississippi for working out an agreement here so we can accept this. I yield the floor.

Mr. COATS. Mr. President, I ask unanimous consent that that amendment be temporarily set aside so that I may speak on the bill in general.

Mr. COATS. Mr. President, what is the current status of the legislation?

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