[Congressional Record Volume 143, Number 116 (Friday, September 5, 1997)]
[Senate]
[Pages S8851-S8869]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                        1997--MOTION TO PROCEED

  The Senate continued with the consideration of motion to proceed.
  Mr. DURBIN. Mr. President, I would like to address the motion pending 
before the Senate at this time on the FDA reform bill.
  I have listened very, very closely to the statements by my colleague 
and friend, the Senator from Indiana. I note that his comments are 
heartfelt about a very important agency. The Food and Drug 
Administration is by Federal standards a small agency. The annual 
appropriations is in the range of $1 billion, and by the standards of 
Washington, DC, it might be ignored by many. But those of us who are 
familiar with the important mission of the Food and Drug 
Administration, those of us who have worked closely with that agency 
and with its Commissioners over the years, and in my particular case, 
those of us who have had the opportunity to literally fund this agency 
through the Appropriations Committee of the House, understand the 
critical importance of this agency. Though its resources and budget may 
be small by Washington standards, its responsibilities are immense. 
There is not an American living who is not touched by the work of the 
FDA. They regulate things as diverse as the radar guns used by police, 
microwave ovens used in airplanes, and virtually all of the drugs and 
medical devices for sale in the United States. We count on them every 
day. And they are an agency, as you can tell from the previous 
Senator's remarks, which is not above criticism. This is an agency 
which has a very difficult mission. On the one hand, a person who is 
ill seeking a new drug or medical device wants the FDA to issue 
approval as quickly as possible. That is a natural reaction.
  By the same token, a company with a drug or a medical device which 
they want to see approved is anxious for the FDA to give approval as 
quickly as possible. The FDA approval on a drug or medical device is 
better than any Good Housekeeping seal of approval. It is literally a 
ticket for sales, confident sales, worldwide. Once the Food and Drug 
Administration of the U.S. Federal Government gives its approval, you 
know that your medical device or your prescription drug is going to 
have an opportunity for a worldwide market because that approval means 
something.
  There is another side to this ledger. The Food and Drug 
Administration, with the pressure to approve drugs and medical devices 
by not only consumers but also by manufacturers, also has an awesome 
responsibility to make sure that those approvals are done in the right 
way, so that the American consumers know that what they purchase is 
safe and effective.
  Those are the two criteria. So the scientists and those working at 
the FDA put in long hours, days, weeks, months, sometimes years, to 
make certain that a product, before it goes on the market in the United 
States, is safe. While they are in the process of evaluating, there are 
people on the sidelines saying, what is taking so long? Why hasn't this 
agency moved to approve this drug or this medical device?
  I have been frustrated myself when people in my old congressional 
district or in my State have come forward and said, it has taken 
months, sometimes years; why don't we have the FDA's final approval? I 
am sure some of that may be associated with bureaucratic slowdown, and 
if this bill addresses

[[Page S8852]]

that, then I think it is a very important step forward. But do not 
minimize the fact that many times the evaluations by the Food and Drug 
Administration are careful reviews of clinical trials to make sure, 
before a drug or device is released in America, it is safe and 
effective. Not a single one of us would want to take a drug prescribed 
by a doctor uncertain as to whether or not it was safe. No one would 
want to do that. The Food and Drug Administration tries to give us that 
confidence.
  There has been a reference made earlier to Dr. David Kessler, the 
last Administrator of the Food and Drug Administration. The previous 
speaker obviously shares a different opinion than some about Dr. 
Kessler's performance and contribution. I think he is one of the most 
extraordinary public servants I ever had the opportunity to work with. 
The only holdover from the Bush administration, Dr. Kessler was 
reappointed by President Clinton and I think did an exceptional job. Of 
course, we are kindred spirits on the tobacco issue, but beyond that I 
think his job at the Food and Drug Administration will set an example 
that others will have to try to emulate, and they will find it 
difficult to do so. I am sorry we lost him, but he gave so many good 
years of service to the Federal Government we can be thankful he did.
  Let me also say that this is an agency which has fallen under 
criticism politically. When the Republican control of the House 
occurred after the 1994 election, I was amazed that one of the first 
lines of attack by Speaker Newt Gingrich was on the Food and Drug 
Administration. He made arguments, many of which you have heard this 
morning, that this agency was stopping those devices which would save 
lives, this agency was stopping the approval of drugs which would save 
lives. And he went on at great length about how they were going to 
dismantle the Food and Drug Administration, literally to turn out the 
lights at this agency.
  Thank God that didn't occur; saner minds prevailed, came forward and 
said that would be a serious mistake. A lot of the references to a more 
responsible approach came from the same industries that are regulated 
by the FDA. They realized that when you drop your guard, when you get 
into a no-holds-barred strategy when it comes to the approval of drugs 
and medical devices, the reputable companies will be the first to lose 
when consumer confidence is destroyed.
  Let me give you three examples of what I have seen in a short period 
of time, of the work of the Food and Drug Administration. Some of these 
are forgotten, and they should not be.
  There was a counterfeit infant formula on the market that was 
discovered by the Food and Drug Administration. It turned out that some 
group of individuals had decided to take one of the most popular brands 
of infant formula in the United States and to literally copy its label 
and to put contents in a can and sell them as if it was the product 
that it was advertised to be. In fact, it wasn't. It was a phony. 
Luckily, the FDA caught them and in catching them stopped the sale of 
this infant formula product which was grossly deficient, which if it 
had been given to infants across America could have caused serious 
health problems. The Food and Drug Administration was vigilant, caught 
them and stopped them.
  Let me make reference to one that most people remember. It was only a 
few years ago that they discovered these syringes in Diet Pepsi cans. 
Oh, every nightly newscast told us about this discovery. What did it 
mean in the wake of the AIDS crisis to find a hypodermic syringe in a 
can of soda? Well, luckily the Food and Drug Administration stepped in 
and determined that this was only an isolated example and a hoax. It 
was important for the consumers across America, but it was equally 
important for Pepsi Cola. Their stock had plummeted when this occurred. 
But the Food and Drug Administration stepped in and said this is 
something the consumers do not have to worry about. We have it under 
control. And because they have the respect of the American people, the 
product went back on the market without a problem and the stock resumed 
its climb. I think it is important for us to make sure that we talk 
about what this agency brings to us.
  I also took a trip to the State of Massachusetts, to review the Food 
and Drug Administration programs there, in particular, to review one 
particular company that was making heart catheters. Most people are 
familiar with them. Those who are not should know that they are tiny 
little threaded lines that the surgeon will insert in your body and 
then it will course through your veins to your heart, and they can 
literally take samples as well as photographs of the interior of our 
bodies--a critically important medical device. Yet, as it turns out, 
this company was making defective heart catheters that literally broke 
off inside people's bodies and then, of course, surgery was necessary 
to remove them. That is the type of thing the Food and Drug 
Administration must be constantly vigilant to watch out for and to 
protect us against.
  I could go on--and I will not--for hours about what the Food and Drug 
Administration does and how important it is when we reform this agency 
to remember their enormous responsibility to consumers across America.
  I agree with my colleague, Senator Kennedy, that there are portions 
of this bill that should be reviewed and I hope changed during the 
course of the floor debate. I think it is wrong for us to remove from 
the States the authority to review cosmetics and to put warning labels 
on them, if a State decides it is in the best interest of its citizens. 
We do not have sufficient personnel at the FDA right now in the 
Cosmetic Section to take responsibility for complete Federal oversight 
of this large industry. Senator Kennedy has made a compelling argument 
that we should allow the States to continue to have this authority, to 
put those provisions in place which will protect the health and safety 
of consumers.
  I have three amendments which I am going to offer, and I hope that 
they will be amendments approved on a bipartisan basis. One seeks to 
reverse an area of this bill which I am afraid will weaken the strong 
safety protections put in place by the Safe Medical Device Act of 1990. 
Many of us remember the tragedy resulting from the Bjork-Shiley heart 
valve failure. Extensive congressional hearings were held in the late 
1980's examining what had gone wrong and how we might prevent future 
repeats of those terrible deaths when this heart valve failed.
  In the United States alone, over 300 people died because this 
defective medical device was implanted. Worldwide, almost 1,000 people 
have died as a result of fractures in this valve once it was put in 
place. After it was concluded these heart valves were defective, over 
50 percent of the patients with these heart valves in their bodies 
could not be located. One widow testified before Congress about how her 
husband had a heart valve, suffered chest pains and the couple had no 
idea that it was because of the defective heart valve. They had not 
heard about it. They had not been notified. They lived at the time 
equidistant between two hospitals, only one of which was capable of 
performing open heart surgery. They made a mistake; they went to the 
other hospital. Her husband died. She didn't realize that he might need 
open heart surgery because the heart valve in his body was defective.
  The Safe Medical Device Act of 1990 set up a system for mandatory 
tracking of these high-risk devices so that if problems were found, the 
patients with the devices could be located and notified. That is a 
basic protection.
  There are only 17 types of devices that require mandatory tracking. 
They are all extremely high-risk medical devices--heart valves; 
pacemakers; vascular stents; jaw, shoulder, hip joint replacements; 
windpipe prostheses; breathing monitors and ventilators.
  It is hard to imagine the tracking of such high-risk devices could 
ever be made optional, and yet that is exactly what this bill does. The 
FDA has already complained that they find it extremely difficult to 
enforce this provision, and yet instead of helping them with 
enforcement, this bill weakens their ability further by making tracking 
discretionary.
  Isn't it curious that automobile manufacturers are required to have a 
tracking system so that if a safety problem is identified with your 
car's model, they know where to find you. It seems unthinkable to have 
a lower standard of consumer protection for a pacemaker or a ventilator 
as compared to a seat belt.

[[Page S8853]]

  The second aspect is surveillance. This is a key part of this Safe 
Medical Device Act which this bill undermines. The mandatory 
surveillance program of high risk medical devices is especially 
important for consumers. These surveillance programs are important for 
the early detection of potential problems with medical devices. In some 
cases the initial breakage of a device may not cause instantaneous 
harm. For example, in the case of Telectronics' heart pacemaker J 
leads, which were found to be defective in 12 percent of the patients, 
breakages did not result in harm until the next bout of heart 
arhythmia. Surveillance of these leads identified problems in some 
patients. This led to the notification of patients with these leads of 
the need to have them checked. Such early detection and correction can 
prevent a health crisis.
  Let me give you another example. Early detection, unfortunately, was 
not seen in the case of Teflon jaw implants made by Vitek in the 1980s. 
These implants, once put inside of a human being, were found to 
splinter and cause massive corrosion of jaws and skull due to the 
triggering of inflammation and other immune responses. By the time the 
patient suffered the pain, extensive damage had already been done. Many 
of these patients required complete resection and removal of their 
jaws, even some of their skulls exposing their brains.
  Donna Fennema from Ames, IA, testified here late last year at an FDA 
hearing of how she needed 30 hours of critical major medical surgery to 
rectify her splintered jaw implant. She needed a rib graft to rebuild 
her jaw on both sides. To this day, she suffers pain from both her jaw 
and her rib cage. If a surveillance program had been in place prior to 
the Vitek jaw implant defect, many of these patients would have been 
able to have the implants removed prior to the deterioration of their 
physical conditions. This terrible tragedy that we have seen is one of 
the major catalysts, along with the Bjork-Shiley heart valve, for the 
passage of mandatory surveillance and tracking of implantable high-risk 
medical devices.
  Yes, it is true that these programs of surveillance and tracking are 
burdensome to industry. Make no mistake about it. But the cost to 
society, the cost to each of us, the cost to American families of 
weakening them is far too high for us to be undermining them.
  The second issue I would like to raise is one that is very typical 
and one that I have worked on for a long time. It is the issue of 
tobacco. I am concerned that section 404 of this bill, this FDA reform 
could undermine FDA's ability to regulate tobacco. This section 
attempts to limit FDA's ability to look at anything other than the 
manufacturer's label to determine the intended use of the product and 
to determine whether the product is safe and effective for this labeled 
use.
  This section has much broader implication than just tobacco 
regulation. It provides a generally huge loophole through which device 
manufacturers can attempt to avoid FDA regulation through imaginative 
labeling. However, it is most worrisome for tobacco regulation given 
the long history of tobacco companies and their deception.
  In the early seventies when there was a ban on TV advertising of 
tobacco products, the industry devised every imaginable way to 
circumvent this ban. They would purchase bill-board space at sport's 
events which were placed in such a manner and location, that they knew 
they would be televised during the sport's event. For example, they 
would purchase billboards behind homeplate of a baseball game or near 
the scoreboard. They would purchase racing cars with advertisements 
along their sides. No stone was left unturned, looking for ways around 
the ban.
  Around the same time of the television ban on advertising of tobacco, 
the industry passed a voluntary code that none of them would use models 
that appeared to be under 21, and yet many of the models which were 
used could pass as high school students.
  All this suggests to me at least that we do not want to jeopardize 
any type of tobacco settlement with this FDA reform bill. I suggest a 
very simple and straightforward fix, and I hope that the sponsors of 
the bill will consider it. It says as follows: Nothing in this entire 
bill shall be construed to alter any authority of the Secretary to 
regulate any tobacco product or any additive or ingredient of a tobacco 
product.
  Mr. KENNEDY. Will the Senator yield on that issue?
  Mr. DURBIN. I will be happy to yield.
  Mr. KENNEDY. I welcome the Senator's focus on that particular 
provision. We had attempted to address that question, but it was done 
very unsatisfactorily. I think the Senator has raised a very important 
issue with regard to what we have done in the legislation and the power 
of the FDA to deal with tobacco in this legislation.
  We will have an opportunity to address that when we move toward the 
legislation itself, but I think it is important and one of the 
principal reasons for taking the additional time on the legislation for 
the reasons that the Senator has just identified.
  For example, I think we have heard from responsible legal authority 
that if the manufacture of tobacco products were to label them as 
``intended for smoking pleasure'' or ``intended for weight loss'' or 
``intended to be used twice weekly,'' then there is a real question 
whether FDA can get safety data on the addiction of those health 
hazards.
  We know how creative--and the Senator from Illinois knows well 
because he has been a leader in the House of Representatives and in the 
Senate with regard to the activities of the tobacco industry--how 
creative they can be in terms of packaging, so to speak, their 
intercessions with the FDA in ways that can circumvent the kind of 
protections that all of us are so concerned about, primarily with 
youth, and also as part of this whole tobacco negotiation.
  I commend the Senator for the work that he is doing and welcome the 
opportunity to join with him to try and address the actions of the 
tobacco industry in the recent budget item to circumvent the agreements 
that the tobacco industry had made with the attorneys general. That is 
another issue for another time. What it does reflect is how the 
industry is working tirelessly at every junction to try and foreclose 
the opportunity of meeting their responsibilities, either under the 
agreement or under this legislation.
  I think they undermine the authority of the FDA in their agreement, 
which they signed with the attorneys general, and that agreement should 
not pass under any circumstances unless that measure is addressed. I 
know the Senator will work with us closely in doing that.
  But the Senator has identified another potential loophole that ought 
to be addressed. I am very hopeful that we will be able to do that. I 
thank the Senator for raising this because this is another very 
important aspect, as we are being asked to rush through this 
legislation. There are only two or three Senators evidently concerned 
about this particular proposal. We have seen the fact that the 
Governors, all of the Governors, the State legislatures sent in their 
resolution and their letter saying, ``Go slow,'' in opposition to the 
legislation. As the Secretary of Health and Human Services has also 
indicated, go slow.
  I thank the Senator for his comments on these other items, but 
particularly with regard to tobacco.
  Mr. DURBIN. I thank the Senator from Massachusetts. Another item I 
would like to address on which I will be offering an amendment that I 
hope Senator Jeffords will consider is that of removing any possible 
money taint of the external review process.
  This bill expands the ability of medical device companies to purchase 
their own third-party reviewers. Given the importance to the public of 
the approval process remaining untainted by monetary influence, it is 
extremely important we ensure that there are very strict anticonflict 
of interest standards for product reviews.
  In laymen's terms, if we are going to hire companies to review 
medical devices to determine whether or not they are safe enough for 
sale in America, devices such as the heart catheter that I mentioned 
earlier, we want to make certain that the reviewers are truly 
objective; that they do not have any conflict of interest or any 
monetary gain associated with what they are doing.
  This bill, as currently drafted, has only very limited language on 
the issue of preventing conflict of interest. Senator Harkin was 
successful in adding

[[Page S8854]]

some strength to that language. His amendment which was accepted after 
the markup of this bill in committee, allows the FDA to look at the 
contractual arrangements between an outside reviewing entity and the 
company whose product is being reviewed.
  FDA employees themselves are subject to a wide range of anticonflict 
of interest legislation for obvious reasons. If you are an employee at 
FDA, if you can purchase stock in the company of the device you are 
about to approve, you are in for a windfall. We don't want that to 
occur, and we certainly don't want it to occur when we talk about 
third-party reviewers.
  Senator Feingold and I will be offering an amendment that would 
codify into law basic requirements for outside reviewers. We don't seek 
to impose all the FDA employee regulations on outside reviewers, merely 
the most appropriate. We would be happy to work with Senator Jeffords' 
staff to tailor these very basic requirements specifically to outside 
reviewers.
  Our amendment is simple. It merely asks outside reviewers not be 
allowed to have a financial interest in a company that they review. It 
further demands that no outside reviewer may receive a gift from a 
company whose product they review. To monitor and prevent such 
activities, the amendment allows FDA to require financial disclosure.
  It should be obvious to all of us why it is necessary.
  The money stakes are certainly higher with respect to getting FDA 
approval. Every day we read of how the stock market soars for a company 
whose product has just received FDA approval. For instance, on May 7 
this year, FDA announced approval for a laser system made by a company 
called Premier Laser Systems, Inc., that treats tooth decay painlessly. 
There is something we all would like to see. Within days of this 
approval, the company's stock price more than doubled, and for the 
first time since going public in 1995, Premier hit the top 10 in 
trading volume on Nasdaq, far surpassing even Microsoft 5 days in a 
row. That is what FDA approval means.
  As we farm out this responsibility to third-party reviewers, it is 
important that they make decisions that are objective and honest.
  Failure to get approval of a product can have the opposite effect. 
For example, recently an FDA panel voted 9 to 2 that FDA reject an 
approval for a heart laser made by a company known as PLC Systems. 
Trading in the stock had to be halted after this announcement. Shares 
of PLC had risen dramatically in recent weeks on the expectation of a 
more favorable result. FDA denial of approval shattered the stock's 
profitability.
  The medical device industry produces over $50 billion annually in 
sales. In fact, a recent article in the journal Medical Economics, 
entitled ``Why Medical Stocks Belong in Your Portfolio,'' the medical 
device industry was described as ``a hot market that is only getting 
hotter.''
  Not only are the money stakes high for investors, however, the stakes 
are also high for patients who have to rely on these devices.
  Reviews must be of the most stringent nature and must be carried out 
without outside corrupting influences.
  The approval of an unsafe drug or device, as I have already 
mentioned, can have a devastating impact. Surely, it is not too much to 
ask that a reviewer be prevented from accepting gifts or loans from a 
company they are reviewing and that they not be allowed to designate 
another person for acceptance of such a gift.
  Furthermore, a reviewer or their spouse or minor child should not be 
allowed to have a financial interest in a company whose product they 
are reviewing. That seems basic and fundamental. I hope Senator 
Jeffords and others on the committees would consider agreeing to the 
Durbin-Feingold amendment. The products are too important to the 
American people. I believe we should take a firm stand and specifically 
enumerate basic standards within this legislation to prevent even the 
potential for corruption of this process.
  Let me say, I was one of the five this morning who joined with 
Senator Kennedy in suggesting that this bill should be debated at 
length. I hope that some of the items that I have raised during the 
course of this debate will give Senator Jeffords and others an 
indication of my concern. But let me say also that I respect what 
Senator Jeffords and the committee has accomplished here. FDA reform is 
needed, and I think what you are setting out to do, to make it a more 
efficient process, is a very worthy goal.
  I find most of this bill to be very positive, and I am anxious to 
support it. I hope that during the course of the debate on my 
amendments and others, we can rectify what I consider to be a handful--
but only a handful--of very important items which still need to be 
debated. I hope to be able to vote for final passage of this bill, and 
I hope Senator Jeffords and others will be open to these amendments. 
They are offered in good faith, and I hope we can work together to 
resolve some of the concerns I have.
  Let me close by saying that those who are critical of the FDA often 
pine for those countries overseas where it is so easy to get approval 
for drugs and medical devices. I recommend to some of them that on 
their next trip to Mexico that they drop into a pharmacy and look at 
what is for sale on the shelves of those Mexican pharmacies. You will 
find products that are openly advertised as being cures for cancer and 
AIDS. Many countries, which have a much easier process, have little 
integrity in that process. We want to maintain that integrity to make 
sure the American consumers know that they still are getting the very 
best. I yield back my time.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, first of all, Senator Mikulski will be 
here shortly. I would like to make a few comments before I turn the 
floor over to her.
  With respect to the devices, as I pointed out earlier and I just want 
to refresh everybody's recollection, the bill that we are dealing with 
is 152 pages long. The matters on devices are two pages. The matters on 
cosmetics are four. I thank the Senator from Illinois for bringing 
attention to some possible problems with respect to ensuring, as we all 
want to ensure, that there is no conflict of interest involved with any 
of the companies that they will be dealing with.
  I point out, first of all, that the FDA has total control over the 
third parties that will be allowed for the purposes of reviewing. They 
have total control over that. There are already regulations which 
propose to correct most of the problems, although a couple others have 
been raised, and we certainly are going to seriously consider 
amendments that will take care of those problems.
  Let me go through the provisions right now on the existing 
regulations for FDA:
  Can't own a device company;
  Can't have any ownership or financial interest in any medical device 
company;
  Can't participate in the development of medical products;
  Can't be a consultant;
  Can't prepare advice for companies; and
  Fees cannot be contingent on third-party recommendation.
  In addition, I emphasize that the FDA has a list of those they have 
examined, have gone through to make sure that they are appropriate for 
the purposes of assisting--assisting--FDA in coming to conclusions on 
these devices.
  There are some protections:
  Can't obtain reviews for the same product from more than one third-
party organization;
  Can't contract for a substantial number of reviews, like more than 10 
a year, from the same review organization on different devices; and
  Can't contract for reviews from the same review organization where 
the sum of fees is substantially like $50,000 one year when the other 
organizations have the same capacity.
  So there are many protections now. Of course, we are very concerned, 
along with the Senator from Illinois, and want to make sure we have 
taken care of every possible situation.
  With respect to the legislatures and the Governors, I will point out 
that the discussion in that regard has been very limited to certain 
provisions, but I want to enter into the Record a letter

[[Page S8855]]

which came to the majority leader, Senator Lott, from Gov. Tom Carper 
from the State of Delaware, chairman of the Committee on Human 
Resources, and Gov. Tom Ridge, the vice chair of the Committee on Human 
Resources. I will read that for the Record:

       On behalf of the nation's Governors, we are writing to 
     express our support for swift passage of bipartisan FDA 
     reform and a reauthorization of the Prescription Drug User 
     Fee Act (PDUFA).
       Better health care for all Americans is a paramount 
     national goal that is strongly supported by the Governors. An 
     important component to improved health care delivery is the 
     development and approval of safe and effective new medical 
     technology. New therapies, for example, have the potential to 
     improve the lives of millions of Americans and may, in many 
     instances, reduce health care costs.
       The Governors also recognize that the competitiveness of 
     the U.S. pharmaceutical, biotechnology, and medical device 
     industries--and the hundreds of thousands of people they 
     employ in our states--is dependent on bringing products to 
     market safely and quickly. Constructive reform will improve 
     the efficiency of the approval process while continuing to 
     protect the public's health and safety.

  We have the support of the Governors. They are not going to go 
through everything. Generally, they support what we are doing. That is 
why we had an 89-to-5 vote today to move forward.
  I ask unanimous consent that the letter be printed in the Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                               National Governors Association,

                                    Washington, DC, July 25, 1997.
     Hon. Trent Lott,
     Senate Majority Leader,
     Capitol Building, Washington, DC.
       Dear Senator Lott: On behalf of the nation's Governors, we 
     are writing to express our support for swift passage of 
     bipartisan FDA reform and a reauthorization of the 
     Prescription Drug User Fee Act (PDUFA).
       Better health care for all Americans is a paramount 
     national goal that is strongly supported by the Governors. An 
     important component to improved health care delivery is the 
     development and approval of safe and effective new medical 
     technology. New therapies, for example, have the potential to 
     improve the lives of millions of Americans and may, in many 
     instances, reduce health care costs.
       The Governors also recognize that the competitiveness of 
     the U.S. pharmaceutical, biotechnology, and medical device 
     industries--and the hundreds of thousands of people they 
     employ in our states--is dependent on bringing products to 
     market safely and quickly. Constructive reform will improve 
     the efficiency of the approval process while continuing to 
     protect the public's health and safety.
       Thank you for your consideration in this important matter.
           Sincerely,
     Governor Tom Carper,
                              Chair, Committee on Human Resources.
     Governor Tom Ridge,

                         Vice Chair, Committee on Human Resources.

  Mr. JEFFORDS. With that, I see Senator Mikulski is here. I would, 
therefore, yield to her such time as she may desire.
  Ms. MIKULSKI. Mr. President, I thank the chairman for his leadership 
in bringing about not only a reform structure for FDA that preserves 
both the safety and efficacy of pharmaceuticals, biologics and other 
products that the American people utilize, but also for the fact that 
he has been able to move this legislation to the floor.
  I also extend my compliments to Senator Kennedy for his longstanding 
commitment to public health, to public safety, and at the same time 
being able to maintain the whole idea of developing jobs in our own 
country.
  Mr. President, I have been working on FDA reform for a number of 
years. I worked on FDA reform when I was a Member of the House of 
Representatives on the Energy and Commerce Committee, serving under 
then Congressman Dingell, where we embarked, on a bipartisan basis, to 
ensure consumer protection and that we did not dump our drugs that did 
not meet our standards on third world countries.
  Coming to the Senate, I joined with my colleague from Massachusetts 
and the Senator from Utah, [Mr. Hatch], in fashioning legislation 
called PDUFA, the Prescription Drug User Fee Act, which enabled a very 
important tool to go into place in which we could hire more people to 
come to FDA to examine the products that were being presented for 
evaluation, to be able to move them to clinical practice in an 
expeditious way. The leadership of Kennedy-Hatch on PDUFA has not only 
stood the test of time, but has really been shown as a test for being 
able to expedite approval processes and maintaining safety and 
efficacy.
  But it was clear that PDUFA was not enough, that more staff operating 
in an outdated regulatory framework, without a clear legislative 
framework, was deficient. That is when we began to consult with experts 
in public health, those involved in public policy related to food, 
particularly with drugs and biologics. And in the meantime, while we 
were considering all this, something came into the world which was the 
revolution in biology. We had gone from a smokestack economy to a 
cyberspace economy. We had gone through basic discoveries in science 
from the field of chemistry and physics to a whole new explosion in 
biology, which is truly revolutionizing the world, whether it is in 
genetics or other biologic materials. These offer new challenges to 
ensure their safety and efficacy, new staff and a new legislative 
framework.
  What we then said is that we needed an FDA with a new legislative 
framework and a new culture. This is then when we tried to put together 
what we called the sensible center, working with Republicans and 
Democrats alike, because we certainly never want to play politics with 
the lives of the American people to come up with it.
  Senator Kassebaum chaired the committee during this initiative. We 
took important steps forward. I say to Senator Jeffords, you have 
assumed that mantle, and I think you have improved on the original 
legislation that Senator Kassebaum had written.
  I was proud to participate for several reasons.
  One, I have the pleasure and the honor of having FDA located in 
Maryland. I cannot tell you the enthusiasm to be able to have the 
National Institutes of Health in Bethesda and FDA in Rockville, really 
looking at the life science endeavors, the ingenuity, creativity and 
scientific know-how, to come up with basic knowledge, to work 
extramurally in these wonderful institutions in Maryland, in 
Massachusetts, and Vermont, academic centers of excellence, to come up 
with fantastic new ways of saving lives and at the same time generating 
jobs.
  Through the work, then, of Secretary Shalala and the Vice President, 
we did make some improvements. But we must codify those improvements. 
So this is where we come to today. What I like about the legislation 
here is that it streamlines and updates the regulatory process for new 
products, it reauthorized that highly successful Prescription Drug User 
Fee Act, and it creates an FDA that rewards significant science and 
evaluation while protecting public health.
  Now, what is the end result of the legislation that we will pass? It 
will mean that new life-saving drugs and devices will get into clinical 
practice more quickly, and it will enable us to add products that we 
can sell around the world and, through this, save lives and generate 
jobs.
  FDA is known the world over as kind of the ``gold standard'' of the 
approval of products. We want to maintain that high standard. We want 
to maintain its global position. At the same time, we want to make sure 
that FDA can enter the 21st century. This bill gets us there. It sets 
up a new legislative and regulatory framework that reflects the latest 
scientific advancements. The framework continues FDA's strong mission 
to protect public health and safety and at the same time sets a new 
goal for FDA, enhancing public health by not impeding innovation or 
product availability through unnecessary processes that only delay the 
approval.
  We are considering a very important issue today. I would just like to 
reiterate the importance that no matter what the outcome of this bill, 
we must pass the reauthorization of the Prescription Drug User Fee Act. 
This has enabled them to hire 600 new reviewers and cut review times 
from 29 to 17 months over the last 5 years. If we fail to act, it means 
that people who have been working on behalf of the American people will 
get RIF notices because we have not been as quick to approve FDA reform 
as we have asked them to approve products that do meet the safety 
standard.
  Who benefits from this legislation? Most of all, it is the patients. 
Safe and effective new medicines will be getting to the patients early. 
It will meet the

[[Page S8856]]

performance standards in PDUFA, and we will be able to again provide 
this great opportunity for patients.
  By extending PDUFA, we can make further improvements in the drug 
approval process. Currently, PDUFA only addresses the review phase of 
the approval process. Our bill expands PDUFA to streamline the early 
drug development phase as well. This expansion will be covered in a 
separate letter. This letter is very significant in how PDUFA will 
work. The letter includes performance goals that have been worked out 
between FDA and the biological and pharmaceutical industry.
  What are the kinds of things that this will do that will help? 
Electronic submissions. It means that instead of a carload, whether it 
is UPS, IPS, or whatever, pulling up at FDA, with stacks and stacks and 
stacks of material, it can be done electronically. That not only 
reduces paperwork, but actually provides a more facile, agile way for 
the scientific reviewers to get through the data. Also, we are talking 
about meeting management, in other words, FDA meeting to discuss what 
are the appropriate protocols; reducing the response time on clinical 
holds; having written protocol agreements; predictable appeal 
processes; and reducing manufacturing supplement review times, along 
with some others.

  These are management tools, and I cannot understand why the naysayers 
are saying no to this.
  I want to make it clear that these goals that we are outlining should 
be binding on the agency. It is my intent that the letter that will 
accompany this legislation should be considered as a minimum, not a 
maximum, commitment. The agency can do better; it should by all means 
do better. The agency did a great job exceeding its commitments in the 
1992 letter along PDUFA compliance. I am sure they can do it this time.
  Updating the approval process for biotech is another critical 
component. Biotech is one of the fastest growing industries in our 
country. There are over 143 biotech companies like that in my own State 
of Maryland. They are working on AIDS, Alzheimer's, breast and ovarian 
cancer, other life-threatening infections such as whooping cough.
  I know during the NIH discussion the other day we passed additional 
money for Parkinson's. I am proud to report that there is a biotech 
firm in Maryland that also has a joint venture with brilliant 
neurological scientists from Johns Hopkins. And we anticipate either a 
cure for Parkinson's--a cure for Parkinson's--or certainly the ability 
to stretch out the ability of people to function both intellectually 
and in terms of their motor skills.
  You know what? That cure could very well come from Maryland. My gosh, 
can you understand the joy that I will have the day that I can come to 
the U.S. Senate and announce that we have found a cure for Parkinson's, 
that it is in my own home State, and that we have a pharmaceutical that 
can help people gripped by this devastating and debilitating disease?
  That is what we are here for. We do not find the cure, but we fund 
the research to look for the cure. We do not invent the product; that 
is up to the genius of our private sector working with our scientific 
community. We cannot ensure the safety and efficacy of that idea to 
make sure it is not only a dream, but also has the ability to really 
work in clinical practice in a way that enhances in patients. And that 
is the job of FDA. But our job is to fund the research and to have the 
regulatory and legislative framework to evaluate it, to get it out to 
clinical practice. That is why I am fighting for this. This is exactly 
why I am fighting for this.
  My dear father died of Alzheimer's, and it did not matter that I was 
a U.S. Senator. I watched my father die one brain cell at a time, and 
it did not matter what my job was. My father was a modest man. He did 
not want a fancy tombstone or a lot of other things, but I vowed I 
would do all I can for research in this and to help other people along 
these lines. And we can go around the Senate. Every one of us has faced 
some type of tragedy in our lives where we looked to the American 
medical and pharmaceutical, biological community to help us.
  When my mother had one of her last terrible heart attacks that was 
leading rapidly to a stroke--there is a new drug that is so 
sophisticated that it must be administered very quickly. You need 
informed consent because, even though it is approved, it is so dramatic 
that it thins the blood almost to the hemophilia level. I gave that 
approval because my mother was not conscious enough to do it.
  Guess what? That new drug approved by FDA, developed in San 
Francisco, got my mother through her medical crisis with the hands-on 
care of the Sisters of Mercy in Baltimore at Mercy Hospital. We were 
able to move that through. Mother did not have a stroke because we 
could avoid the clotting that would have precipitated it.
  Thanks to the grace of God and the ingenuity of American medicine, we 
had my mother with us 100 more days in a way that she could function at 
home, have conversations with us and her grandchildren.
  Do you think I am not for FDA? You think I am not for safety? You 
think I am not for efficacy? You bet I am. And that is what this is all 
about. It is not a battle of wills. It is not a battle over this line 
item or that line item. It is really a battle to make sure that the 
American people have from their physicians and clinical practitioners 
the best devices and products to be able to administer to save lives.
  So that is what we are all about. I do really hope that we can 
approve this FDA reform. I am glad that we invoked cloture, not because 
I want to stifle debate, but I hope that for whatever ways can be done 
to improve the bill, let us offer those amendments on the floor, let us 
have a robust debate, and then let us vote on this, because at the end 
of next week we will make sure we have had adequate staff to be able to 
deal with work at FDA and an adequate framework to save lives and 
generate jobs.
  So, Mr. President, I thank you for the time. If I seem a little 
emotional about it, you bet I am. I love FDA. I am really proud they 
are in my State. I thank God for the ingenuity of the American medical 
community. And I really look forward to moving the bill.
  I yield the floor.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. I thank the Senator from Maryland whose untiring 
efforts have enabled us to come forward here with an excellent piece of 
legislation, her undying efforts on behalf of FDA and the people of 
Maryland and the rest of the country to ensure that they are an 
effective, efficient operation and they do all that is possible and 
appropriate to protect the interests of others. There is no one I 
relied on more who has done more to bring about this bill in the shape 
that it is in and in a position where I feel confident that it can 
pass. So I thank the Senator very, very much for her effort.
  Mr. President, I know of no other Members on my side of the aisle who 
desire to speak and I do not believe there are those on the other side, 
other than Senator Kennedy.
  I make a point of order that a quorum is not present for the purpose 
of allowing other Members to notify me if they do desire to come and 
speak and we will certainly accommodate them. I will wait for at least 
5 minutes for a response.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER (Mr. Grams). The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. JEFFORDS. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. JEFFORDS. Mr. President, we have given Members time to notify us 
that they desire to speak. I have received no requests from my side or 
supporters of the bill for a presentation here. I believe the same is 
true for Senator Kennedy, but I defer to him for that.
  Mr. KENNEDY. Mr. President, there is a possibility of one speaker but 
not more than that, although I have some remarks related to the 
legislation which I will look forward to presenting.
  Mr. JEFFORDS. My present intention is to make some final remarks 
myself and then to yield back the time on behalf of the majority. It is 
my understanding, as the Senator has said,

[[Page S8857]]

that he intends to proceed for some time and perhaps have one 
additional speaker, and it is my understanding at that time that he 
will yield back his time. I am not concerned for the presentation of 
the majority because we have another 4 hours on this on Monday morning, 
I believe, so we will have ample time--just to reassure the majority--
we will have ample time on Monday to take care of any situation which 
may arise.
  Before I complete my remarks, I want to refresh people where we are, 
especially on the critical issues that have been raised by the Senator 
from Massachusetts. I understand there are concerned people, and I am 
well aware of editorials and groups who have raised issues, most of 
which I have found not to be relevant to the bill which we are 
considering. Many of those problems were related to last year's bill 
and we are assured the whole country has available to them the bill 
before us here by having it on Web pages and all. I am hopeful those 
groups who have expressed their deep concerns will review the 
legislation that is before the Senate and not make conclusions or alarm 
the public based upon provisions which were in the bill which did 
appear before this body last year but of course were not voted on.
  First, I remind everyone we voted 89-5 to proceed on this 
legislation. It is clear that the large majority of the Members here 
believe and have full confidence that any problems that may exist in 
the bill will be taken care of. I remind everyone, as I hold this bill 
up, it is 152 pages long. The areas we are concerned with are two, 
basically. One is cosmetics. That is an area of deep concern to all of 
us and the present status of things without this legislation. That is 
four pages in the bill. There are another two pages on the problems 
which some see with respect to medical devices and the approval process 
for them. The issues there have been narrowed down to very small 
issues, but they are important. I do not diminish that at all.
  With respect to the cosmetics, and that is where the most concern has 
been expressed, and rightfully so because of the present situation with 
respect to cosmetics, there is little or no assistance or help to the 
public in understanding as to whether there are problems, health 
problems, created by cosmetics. The industry itself has done a great 
deal to work within the industry to try and ensure they have adequate 
understanding of what the contents of the cosmetics are and they have 
tried to eliminate to the extent possible any potential harm to 
individuals. That has apparently been fairly successful.
  On the other hand, the present situation with respect to governmental 
influence in trying to protect the public or trying to allow people to 
determine the safety of the utilization of cosmetics, there has really 
been no effort to do this which is satisfactory to us and to the 
American public generally. The issues are raised in a way that explain 
what the present situation is and make it look like that is what the 
bill is. That is not what the bill is. The bill is trying to take care 
of the concern that the public has with the present situation of not 
being aware or officially find ways to determine whether or not 
cosmetics are harmful.
  What the bill does is to say not only should the FDA get into this 
and reassure the public on cosmetics but that they should do that with 
an eye toward uniformity so that if you buy something in Vermont it 
does not tell you one thing and you find if you buy it in California, 
something else, or other places have no warnings. You do not have any 
way to judge if the product you may be using is one that is safe.
  Now, the States have had authority to move into this area and thus to 
point out that this will somehow interfere with the States. You have to 
remember they have had this authority forever, I guess, and only one 
State has taken it upon themselves to really do anything in this area 
to try and solve the problem--not the best of ways, to determine what 
cosmetics are good or bad for your health.
  What did we do? We said, ``OK, California, fine, we will not get 
involved with preempting you with respect to your laws that are on the 
books. We will allow those laws to stand. The FDA can work around 
that.'' But on the other hand, we will tell the other States that you 
are free, too, unless the FDA has moved in on those specific products 
and has made a determination and has exercised its authority, in which 
case you would be preempted.
  Now, that leaves a narrow problem we are dealing with and is one of 
the reasons, perhaps the only reason, we are here, and that is suppose 
a State should say no, not only is that cosmetic going to cause 
possibly skin cancer, it may also cause blood poisoning, and the FDA 
only includes skin cancer. Can we not tell our people they should be 
protected against blood poisoning? We have not quite resolved that. It 
does not seem irresolvable to me or make the bill horrible because I 
have that much confidence in the FDA.
  With respect to the devices, again, that is two pages of the bill. 
With respect to that, it gets down to another problem for the industry, 
and that is, when they have a device and they say we have studied it 
and this is the intended purpose of that device and the studies have 
gone on and it shows it is effective and safe for this purpose, FDA 
says, yes, but there may be some other uses of that, so we want to do 
studies on all possible uses of that device. The industry says, well, 
wait a minute, it is being produced for this purpose, being sold for 
this purpose, intended for this purpose; we should not have to run all 
these studies on other things that somebody dreams it may be used for.
  The issue of tobacco has been raised. We were concerned, also, that 
the tobacco devices--I don't know what they might be, but obviously 
filter-type things, or whatever else, I don't know. Anyway, we were 
concerned about that. So, first of all, we asked the CRS as to whether 
or not the bill, as presently drafted, in the device areas would in any 
way allow tobacco devices to be sold out from under the bill and, 
therefore, create problems and a very serious situation in tobacco. I 
have the CRS study that was done.
  I ask unanimous consent that this be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                   Congressional Research Service,


                                      The Library of Congress,

                                Washington, DC, September 4, 1997.
     To: Senate Committee on Labor and Human Resources, Honorable 
         James M. Jeffords, Chairman.
     Attention: Jay Hawkins.
     From: American Law Division.
     Subject: Discussion of Possible Effects of Sections of S. 
         830, the ``Food and Drug Administration Modernization and 
         Accountability Act of 1997,'' On FDA's Ability to 
         Regulate Tobacco.
       This memorandum responds to your request for an examination 
     of various claims and the effect that certain provisions of 
     S. 830, the ``Food and Drug Administration Modernization and 
     Accountability Act of 1997,'' \1\ may have on FDA's current 
     authority to regulate cigarettes and smokeless tobacco 
     products. Specifically, you are concerned with provisions of 
     S. 830, as reported out of the Senate Committee on Labor and 
     Human Resources, that may interfere with FDA's ability to 
     regulate these products or have serious, unintended 
     consequences. Two memoranda by different commentators have 
     been prepared and have examined S. 830's provisions as they 
     may relate to the FDA's regulation of cigarettes and 
     tobacco.\2\ The following highlights and discusses the main 
     provisions of S. 830 that were discussed in the two memoranda 
     and concludes that it would not appear that S. 830, in its 
     current form, would interfere substantially or negatively 
     with the FDA's tobacco authority. To a certain extent, this 
     discussion is speculative considering that a hypothetical new 
     cigarette product is discussed herein and that a new product 
     application is not pending or known to be the focus of this 
     inquiry.
---------------------------------------------------------------------------
     Footnotes at end of article.
---------------------------------------------------------------------------


              relevant provisions of S. 830 and discussion

       Section 404 of the bill, as reported out of full committee, 
     would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) 
     \3\ and provides, in pertinent part:
       ``Consideration of labeling claims for product review.
       ``404(a) PREMARKET APPROVAL . . . In making the 
     determination whether to approve or deny the application, the 
     Secretary shall rely on the conditions of use included in the 
     proposed labeling as the basis for determining whether or not 
     there is a reasonable assurance of safety and effectiveness, 
     if the proposed labeling is neither false nor misleading. In 
     determining whether or not such labeling is false or 
     misleading, the Secretary shall fairly evaluate all material 
     facts pertinent to the proposed labeling.''
       ``404(b) PREMARKET NOTIFICATION . . . Whenever the 
     Secretary requests information to demonstrate that the 
     devices with differing technological characteristics are 
     substantially equivalent, the Secretary shall only request 
     information that is necessary

[[Page S8858]]

     to make a substantial equivalence determination. . . . The 
     determinations of the Secretary under this section and 
     section 513(f)(1)[Initial classification and reclassification 
     of certain devices] with respect to the intended use of a 
     device shall be based on the intended use included in the 
     proposed labeling of the device submitted in a report under 
     section 510(k) [of the Act].'' \5\
       Section 404(a) of the bill relates to agency action on an 
     application for premarket approval of a device intended for 
     human use.\6\ This section of the bill primarily relates to 
     the classification of devices, findings of substantial 
     equivalence to prior approved products, and, premarket 
     notification requirements under 510(k) of the Act. With 
     reference to 404(a) and (b) of S. 830, several concerns and 
     responses were raised in the commentators' memoranda. 
     Regarding 404(a), Mr. Westmoreland asserts that the bill may 
     limit the Secretary's ability to determine whether there is a 
     ``reasonable assurance of safety and effectiveness'' if the 
     Secretary's evaluation for approval is tied only to 
     ``conditions of the use included in the proposed labeling'' 
     of the product.\7\ This concern is raised in light of the 
     tobacco industry's history of dealing with the agency, 
     consumers, and others. The commentator notes that, 
     hypothetically, the manufacturer could develop a cigarette 
     that reduces nicotine intake levels and state on the proposed 
     labeling that the product is for occasional 
     consumption, weekend use, or once-a-week use. Under this 
     scenario and the language of 404(a), he claims that the 
     Secretary would assess safety and effectiveness only in 
     light of the proffered ``conditions of use'', when in 
     reality, addicted smokers would most likely consume many 
     more cigarettes than the occasional one or two. Under this 
     scenario, the memorandum states, ``the FDA may be required 
     to approve the product as safe (inasmuch as there are 
     probably few data about smoking once a week.) \8\
       The question is raised whether this provision would reduce 
     or negatively interfere with the FDA's authority and result 
     in the approval of a cigarette that would have the agency's 
     imprimatur of ``safe and effective'' for the conditions of 
     use listed on the label. By way of background, the FDA 
     currently regulates cigarettes as delivery devices and 
     nicotine as the drug in the device under the Act, recent 
     rulemakings and other relevant statutes. The agency has been 
     granted broad statutory and regulatory authority, as well as 
     a great degree of agency discretion, when evaluating an 
     application for approval of a device or drug, particularly in 
     light of strong public health concerns.
       Section 404(a) does appear to limit the Secretary's 
     examination to the proposed label, to a certain extent, 
     however, it provides an exception for ``false or misleading'' 
     labeling and authorizes the Secretary to ``fairly evaluate 
     all material facts pertinent to the proposed labeling.'' This 
     exception is bolstered further by other important provisions 
     of the FFDCA. The Act currently defines ``label'' to include 
     a display of written, printed, or graphic matter upon the 
     immediate container of the article and defines ``labeling'' 
     to include all labels and other written, printed or graphic 
     matter upon any article or its containers or wrappers or 
     accompanying such article.\9\ Additionally, under the 
     misbranding provisions of the Act, an article may be deemed 
     misbranded because the labeling or advertising is misleading. 
     When determining if the labeling is misleading, the Secretary 
     shall take into account, ``among other things'', not only 
     representations made or suggested by statement, word, design, 
     etc., ``but also the extent to which the labeling . . . fails 
     to reveal facts material in light of such representations or 
     material with respect to consequences which may result from 
     the use of the article to which the labeling . . . relates 
     under the conditions of use as are customary or usual.''\10\
       Additionally, section 515(d) of the Act currently 
     authorizes the agency to deny the approval of an application 
     if, ``upon the basis of the information submitted . . . and 
     any other information before [the Secretary],'' that ``based 
     on a fair evaluation of all material facts, the proposed 
     labeling is false or misleading in any particular.'' \11\ 
     Thus, even though current law does constrain the Secretary 
     to ``conditions of use on the proposed labeling'', much in 
     the same manner as S. 830, other relevant provisions grant 
     the Secretary authority and discretion to examine other 
     material facts and information when evaluating the product 
     application. This permits the agency to view different 
     facets of the product, the manner in which it is commonly 
     used, the presence of misleading or false information on 
     the label, or the absence of appropriate information.
       When viewed in the context of the agency's broad statutory 
     and discretionary authority under the FFDCA, it would appear 
     that section 404(a) of the bill would not necessarily confine 
     the FDA to look only at the label thereby compelling the 
     agency to make a favorable decision on a product like the 
     hypothetical new cigarette offered for ``occasional use.'' 
     Relying on its statutory authority and recognizing its 
     mandate to protect the public health, the agency would most 
     likely evaluate the new product for safety and effectiveness 
     by considering numerous issues it considers material. Thus, 
     the agency would not necessarily be confined to a narrow 
     reading of only the proposed labeling. Although this approach 
     may be objectionable to some, it is likely that the agency 
     would examine material issues beyond the proposed labeling, 
     particularly in light of the scientific data that indicate 
     the addictive nature of cigarettes, especially for young 
     people, and the debilitating, serious health effects of 
     cigarette ingredients and smoking. While the intent of 404(a) 
     seems to be aimed at limiting or confining the agency to a 
     certain degree and clarifying rules of procedure \12\, it 
     does not appear that this section would operate in a vacuum 
     and result in a catastrophic, unintended consequence 
     involving cigarettes or tobacco products.
       Section 404(b) of the bill focuses also on the label but 
     presents slightly different issues that involve the 
     classification of devices \13\ and the finding of 
     ``substantial equivalence'' between a new device and a device 
     already on the market, i.e., predicate device.\14\ This 
     subsection would amend section 513(i)\15\ of the Act by 
     adding new provisions relating to what types of 
     information the Secretary may request to demonstrate that 
     devices with differing aspects are ``substantially 
     equivalent'' to a product already on the market. To 
     generally explain, current law provides that any device 
     intended for human use that was not introduced into 
     interstate commerce for distribution before the date of 
     enactment is classified in class III (triggering high risk 
     controls) unless (1) the device (a) is within a type of 
     device (i) which was introduced into interstate commerce 
     before the enactment date and which is to be classified 
     under 515(b) [classification panels] or (ii) which was not 
     introduced before such date and has been classified in 
     class I or II and (b) is ``substantially equivalent'' to 
     another device within such type or (2) the Secretary, in 
     response to a petition, has classified the device as class 
     I or II. In sum, under current law all devices are class 
     I, II or III, however, the manufacturer can petition to 
     have its product placed in class I or II.
       Examining the text of section 404(b) of the bill (see 
     above), the thrust of the provision appears to be that the 
     Secretary, when requesting certain information concerning 
     substantial equivalence, must request only the amount of 
     information that is necessary to the decision and is the 
     least burdensome to the manufacturer. Among other things, 
     this provision would operate during the agency's assessment 
     of substantial equivalency and classification for controls. 
     Section 404(b) would appear to limit the Secretary's inquiry 
     concerning ``intended use'' of the device, and ultimately 
     substantial equivalency, to only information of intended use 
     that the manufacturer includes in the proposed labeling 
     (submitted in a report under 510(k) of the Act.) At the same 
     time, this provision appears to be aimed at lifting perceived 
     information and demonstration burdens borne by manufacturers.
       The question has been raised whether 404(b) is constructed 
     in such a way that it, albeit unintentionally, could limit 
     the FDA's authority to regulate cigarettes, tobacco, and 
     nicotine by limiting the agency's decision only to the 
     intended uses listed on the proposed label. Mr. Westmoreland 
     raises the concern that clever labels and such a restricted 
     authority might pave the way for cigarette products to enter 
     the market, with less stringent controls, having (apparently) 
     met the tests for safety and effectiveness. The commentator 
     states, ``Under the terms of subsection (b), the FDA would 
     not be allowed to look behind the conditions of use. 
     Consequently, a cigarette manufacturer with a clever proposed 
     statement of use may be able to force the FDA to classify or 
     reclassify the cigarette as an approved Class I or Class II 
     medical device with relatively few controls.''\16\
       Under the bill, to a certain extent, the Secretary would be 
     required to make the relevant determination based on the 
     ``intended use included in the proposed labeling.'' \17\ 
     However, the result proposed by Mr. Westmoreland may be 
     unlikely since the hypothetical product would need to have 
     the same intended uses as the predicate device upon which 
     the claims of substantial equivalence are based. Current 
     law provides that substantial equivalence means that the 
     device has the same intended use as the predicate device 
     and that the Secretary by order has found that the device 
     (i) has the same technological characteristics as the 
     predicate, or (ii) has different technological 
     characteristics and the information submitted that the 
     device is substantially equivalent to the predicate 
     contains information, including clinical data if deemed 
     necessary by the Secretary, that demonstrates that the 
     device is safe and effective as a legally marketed device 
     and does not raise different questions of safety and 
     efficacy that the predicate device.\18\
       The more likely scenario would be that based on the prongs 
     of the substantial equivalency test, the agency would not 
     find substantial equivalence to a predicate device that had 
     different characteristics or raised different questions 
     without the requisite supporting data. And, under the Act, in 
     most cases, a new or the hypothetical product would be 
     automatically classified in class II.\19\ A new type of 
     cigarette that, say, reduces nicotine levels or has a unique 
     filter, could very well have ``different technological 
     characteristics'' that would probably not give rise to a 
     finding of substantial equivalence. Thus, under this prong of 
     the substantial equivalent assessment, the agency would not 
     be overly confined in its judgement. In the context of 
     cigarette and tobacco issues, S. 830 could potentially, but 
     would not appear to affect drastically these determinations 
     by the FDA.
       The FDA's final tobacco rule and explanatory statements in 
     the Federal Register shed

[[Page S8859]]

     some light on the FDA's view of ``intended use'' for tobacco 
     products. In the ``label'' section of the rule, the FDA 
     requires that each cigarette or smokeless tobacco package 
     that is offered for sale, sold or otherwise distributed shall 
     bear the following statement: ``Nicotine-Delivery Device for 
     Persons 18 or Older.'' \20\ The explanatory statement that 
     accompanies the final rule indicates that initially, in the 
     proposed rule, the agency indicated that it would exempt 
     these products from the statement of identity and labeling 
     for intended use. However, based on comments received, FDA 
     reconsidered and concluded that it is appropriate to require 
     that the intended use statement noted above must appear on 
     the label. The FDA stated that as with all over-the-counter 
     devices, cigarettes are required to bear the common name of 
     the device followed by an accurate statement of the principal 
     intended action/s of the device. ``As over-the-counter 
     devices, cigarettes . . . are legally required to comply 
     with this provision.''\21\ To reflect the ``permitted 
     intended uses'' of these products, the agency requires the 
     statement: Nicotine Delivery Device for Person 18 or 
     Older. The agency stated further: ``The statement of 
     intended use, in essence, incorporates the statement of 
     one of the principal restrictions FDA is imposing on these 
     products.'', i.e., restrict and eliminate youth smoking.
       These agency statements tie in with what are considered 
     ``adequate directions for use'' of the products. The FDA 
     acknowledged in the final rule that it is very difficult to 
     establish adequate directions for use for cigarettes and 
     smokeless tobacco, primarily because of the inherent nature 
     of the products, their addictiveness, the numerous hazards 
     associated with their use, and because the behavior of each 
     user, e.g., depth of inhalation, duration of puff, whether 
     the filter holes are covered, length of time in mouth, 
     determines the amount of tar and nicotine delivered to the 
     user from the device. The FDA has stated:
       ``Tobacco products have a very long history of use in this 
     country, and they are one of the most readily available 
     consumer products on the market today. Consequently, the way 
     in which these products are used is common knowledge. FDA 
     believes that the public health would not be advanced by 
     requiring adequate directions for use. . . . In the agency's 
     view, the warnings mandated by the Cigarette Act and the 
     Smokeless Act satisfy this requirement. Additionally, the 
     Surgeon General's warnings provide information warning 
     against use in persons with certain conditions, i.e., 
     pregnant women.''\22\
       The FDA has chosen to regulate tobacco products as 
     ``restricted devices'' under section 520(e) of the Act and is 
     authorized to require that a device be restricted to sale, 
     distribution or use only upon the written or oral 
     authorization of a practitioner licensed by law to administer 
     or use such device or upon such other conditions as the 
     Secretary may prescribe in regulation if, because of its 
     potentiality for harmful effect or the collateral measures 
     necessary to its use, the Secretary determines that there 
     cannot otherwise be reasonable assurance of its safety and 
     effectiveness. Moreover, as a restricted device, the label of 
     the product shall bear ``appropriate statements'' of the 
     restrictions required by regulations under the noted 
     paragraph as the Secretary may prescribe.
       Returning to section 404(b), the current text would not 
     appear to obviate or reduce the agency's authority in a 
     manner that would ensure that the hypothetical cigarette 
     product (for occasional use) would reach the market with 
     little controls or by default. The agency could utilize the 
     full range of its authority, briefly discussed above, with 
     regard to the test for substantial equivalency, 
     classification or reclassification of these products, as well 
     as the enforcement and definition sections of the FFDCA. 
     Moreover, the agency has been granted additional authority 
     reserved for restricted devices under section 520.
       Section 604 of the bill as reported raises similar issues 
     regarding the Secretary's authority and discretion to 
     evaluate a product and assign its classification. Mr. 
     Westmoreland's memorandum indicates that this section, 
     operating with section 404(b) of the bill, may limit the 
     Secretary's authority and force the agency to rely only on 
     the manufacturer's statement of intended conditions of use 
     when classifying or reclassifying the product. In brief, this 
     section allows manufacturers who have a class III designation 
     to request the agency to reclassify the product to less 
     stringent control levels, e.g., class I or II. The Secretary 
     then has 60 days to respond to the request. Based on the 
     foregoing and the current provisions of the FFDCA, the view 
     expressed by the second commentator would appear to be the 
     more likely scenario. The FDA would not be limited to the 
     proposed labeling and would employ what it considers to be 
     the appropriate evaluation of safety and effectiveness for 
     class designation.
       Additionally, the concern was raised that the bill, 
     particularly section 402, may interfere with the FDA's 
     regulation of ``combination products'', e.g., a combined drug 
     and device product. This is raised in light of the fact that 
     the FDA intends to regulate, and is regulating, cigarettes 
     and smokeless tobacco products as combination products 
     whereby the nicotine is the drug and the cigarette is the 
     delivery system and device. The bill would establish a 
     procedure for the FDA when assigning the product is 
     appropriate designation, e.g., drug, device biologic, etc., 
     thereby placing it within the proper sphere or center for 
     regulation within FDA's structure. Many features of the bill 
     are currently being performed via inter-center memoranda of 
     understanding of FDA. Section 402 does not expressly state a 
     person may request the designation of combination product. 
     Further drafting attention may be merited to add that 
     clarity, however its absence would not appear to remove that 
     authority from FDA's powers. Under current law and policy, 
     the FDA is authorized to designate and regulate combination 
     products and assign the product to the appropriate center for 
     its primary regulation. More express language may be 
     desirable in order to remove any hint of ambiguity and to 
     avoid some unintended or unforeseen consequences.


                               conclusion

       Based on the foregoing analysis and the current text of S. 
     830, it appears that the bill would not interfere with or 
     lessen the agency's authority to regulate tobacco products by 
     the agency. Current provisions of statutory and regulatory 
     law upon which the FDA basis its jurisdiction to regulate 
     tobacco, would continue to be viable and would appear to 
     support the FDA's actions regarding these products. The two 
     memoranda raise valuable insights by discussing and relating 
     various sections of the law so that a more clear 
     understanding is gained. However, it is reasonable to 
     conclude that the highlighted provisions of S. 830 would not 
     appear to operate in a manner that would reduce the agency's 
     tobacco authority in a weakening manner. Although some issues 
     await judicial resolution, the explanatory statements that 
     accompanied the proposed and final tobacco rules issued by 
     the agency, as well as other subsequent analysis indicate 
     that the provisions of the law upon which the FDA bases its 
     jurisdiction, would continue to support, as least at this 
     point the FDA's regulatory actions governing cigarettes and 
     smokeless tobacco products. Notwithstanding some 
     unforeseeable circumstance, S. 830, in its current text, 
     would not appear to alter drastically that approach. Finally, 
     in addition to any drafting changes or clarifications of 
     text, further explanation of congressional intent regarding 
     these sections or the bill in its entirely may be included in 
     report language, in order to guide a legal challenge in which 
     the court might be called upon to discern the intent of the 
     law, if enacted.

                                               Diane T. Duffy,

                                             Legislative Attorney,
                                            American Law Division.

                               Footnotes

     \1\ As ordered to be reported by the full committee.
     \2\ Memorandum of Tim Westmoreland, July 23, 1997 and 
     memorandum of an unknown or undisclosed source.
     \3\ 21 U.S.C. Sec. Sec. 301 et seq.
     \4\ Emphasis added.
     \5\ In the text of S. 830 supplied to CRS, there is 
     additional handwritten language added to the end of 404(b) 
     which reads''. . . provided however that nothing in this 
     paragraph shall prohibit the Secretary from determining that 
     a device is not substantially equivalent to a predicate 
     device within the meaning of paragraph (A)(ii).'' This 
     language does not appear to be included in the reported-out 
     version of the bill, according to text in Sen. Rept. No. 105-
     43. However, I have included it here because it was included 
     in the text supplied to CRS and also because it may benefit 
     your examination of these issues.
     \6\ Section 404 proposes to amend section 515(d)(1)(A) of the 
     FFDCA.
     \7\ Westmoreland memoranda, pp. 1-3.
     \8\ Westmoreland memorandum, p. 2.
     \9\ FFDCA, section 201 [Definitions].
     \10\ Id. Regarding the ``customary and usual'' phrase, even 
     if one argued that a new cigarette product could be 
     introduced where the ``customary and usual'' use would not be 
     apparent, the agency has stated in the final tobacco rule 
     issued in the Federal Register, the tobacco products have a 
     very long history of use in this country and ``the way in 
     which these products are used is common knowledge.'' 61 Fed. 
     Reg. 44464 (Aug. 28, 1996).
     \11\ FFDCA, section 515(d)(2).
     \12\ Title IV of the bill is entitled, ``Improving Certainty 
     and Clarity of Rules.''
     \13\ Devices are classified according to risk and then 
     subject to various controls. For instance, class I trigger 
     general controls; class II products present more risk to the 
     user and are subject to tighter controls; class III present 
     the highest risk and are subject to the most stringent 
     controls on the products. The FDA stated in the final tobacco 
     rule that it would apply the general controls provisions of 
     the Act to cigarettes and smokeless tobacco, including 
     restrictions on their distribution, sale, and use under 
     section 520(e) of the Act governing restricted devices. These 
     controls will be in place while the agency's decision on 
     classification is pending. The FDA will, in a future 
     rulemaking, classify cigarettes and smokeless tobacco in 
     accordance with section 513 of the Act. ``In the meantime, 
     the general controls will apply.'' 61 Fed. Reg. 44464 (Aug. 
     28, 1996).
     \14\ In brief, the finding of substantial equivalence permits 
     the device to be marketed without going through the longer, 
     more stringent premarket approval process for new devices.
     \15\ Section 513(i) relates to substantial equivalence in 
     classification and reclassification of devices into 
     categories I, II and III. This section also references 
     section 520(l) that relates to transitional provisions for 
     devices considered as new drugs or antibiotics.
     \16\ Westmoreland memorandum, pp. 3-4; [footnote omitted].
     \17\ This hypothetical again would involve the reduced 
     nicotine cigarette that is labeled for once-a-week use or 
     occasional use.
     \18\ Act, section 513(i). The Act defines ``different 
     technological characteristics'' to mean that there is a 
     significant change in the materials, design, energy source or 
     other features of the device from those of the predicate.
     \19\ However, the agency's current classification of 
     cigarettes is class I pending a rulemaking and final 
     articulation of what class of controls these products will be 
     under.
     \20\ 61 Fed. Reg. 44617 (Aug. 28, 1996).
     \21\ 61 Fed. Reg. 44464 (Aug. 28, 1996).
     \22\ Id.; citations omitted.
  Mr. JEFFORDS. This clearly sets out that, in their opinion, it would 
appear

[[Page S8860]]

that, in its current form, our bill would not interfere or 
substantially negatively affect any of the FDA tobacco authority.
  In addition to that, just to be double and triple sure, we, in the 
bill, say it can't apply to tobacco and that the FDA has full authority 
in the tobacco area. So that is why we got the 89 to 5 vote today. Yet, 
I certainly commend the Senator from Massachusetts, and others, who 
want to make darn sure that we are really doing the job we think we are 
doing. I appreciate that and I think it is healthy. The harder that 
Senator Kennedy fights, the more the public will be aware of that, and 
I hope we have as good a vote this time.
  Mr. President, with that, on behalf of the majority, I will yield 
back the time that we have today, except that I will provide the 
Senator from Minnesota 5 minutes at his disposal, at such time as he is 
appropriately available to make a statement. I would be happy to make 
that time available for the Senator.
  Mr. GRAMS. Mr. President, I rise today in support of S. 830, the Food 
and Drug Administration Modernization and Accountability Act.
  While this legislation covers many areas under the FDA's 
jurisdiction, as chairman of the Medical Device Caucus, I want to focus 
primarily on the provisions relating to the regulation of medical 
devices.
  The medical device industry is an important asset to Minnesotans. I 
am proud to say that many of the world's leading and most innovative 
medical device companies call Minnesota home. In fact, there are over 
500 medical device manufacturers in Minnesota.
  In my State, the medical device industry has created more than 16,000 
manufacturing jobs. Minnesota ranks fifth nationally in total 
employment for medical devices--and since 1988, the number of medical 
device manufacturing jobs has grown faster in Minnesota than in the 
rest of the Nation. In 1994 alone, 53 new medical device companies were 
created in Minnesota.
  Yet, despite all the successes, there are significant hurdles the 
industry must clear in order to succeed in the increasingly competitive 
global marketplace.
  Medical device manufacturers face incredible barriers that too often 
prevent them from marketing new products, creating jobs, researching 
and developing the latest technologies, and most tragically, from 
providing U.S. patients the best medical technology in the world.
  Mr. President, it is easy for debates on reforming or modernizing the 
FDA to develop into an FDA bashing session which does nothing to 
persuade or accentuate the positive results of suggested changes made 
in the FDA reform measure, S. 830.
  I want to be very clear: The individuals charged with ensuring the 
safety of medical devices, drugs, biologics, food, and cosmetics are 
good people, trying their best to do a difficult job. The pace at which 
new technologies are introduced in the medical community is 
staggering--and at best, difficult to keep up with.
  This legislation will give the FDA the tools they need to keep pace 
with technology and ensure the safety and effectiveness of drugs, 
medical devices, food, and cosmetics well into the 21st century.
  I would like to thank the Labor and Health and Human Services 
Committee for drafting what is a well-balanced and meaningful FDA 
modernization package in addition to reauthorizing the Prescription 
Drug User Fee Act.
  The User Fee Act has proven itself as an example of how an agency and 
an industry can work together to bring highly regulated products to the 
market more quickly and more efficiently--without sacrificing safety.
  However, the regulatory burdens imposed on the medical device 
industry have had a chilling effect on the industry and its customers--
the patients. As a result of regulatory delays, device manufacturers 
are falling behind their foreign competitors or moving their production 
and development overseas.
  While approval of devices in Europe takes only 6 to 8 months, the 
same device can be caught up in the regulatory process for years here 
in the United States. What this means is that Europeans have access to 
the most up-to-date technologies while patients in the United States 
are forced to wait.
  If this continues, we will not be able to claim that the United 
States has the world's best health care for very much longer.
  Many will say we need a strong FDA. I agree. I would argue, however, 
that far too many Americans have become victims of the Government's 
bureaucracy because they were denied access to devices which have been 
available and safely used in Europe for years.
  We can no longer allow ourselves to perpetuate out-of-date rules and 
regulations which ultimately harm the patient, nor can we allow those 
same rules and regulations to force American jobs, technologies, and 
health care overseas.
  The FDA Modernization and Accountability Act is a solid piece of 
legislation which will ensure American patients' access to the most 
advanced medical devices as well as create jobs and strengthen the 
economy.
  I urge my colleagues to support this important legislation.
  Mr. President, I understand that there are no other speakers on our 
side of the aisle wishing to come to the floor and talk about the 
subject today. So, on behalf of the manager of the bill, the Senator 
from Vermont, and the majority, I yield my time and the remainder of 
the majority's time.
  Thank you.
  Mr. KENNEDY. Mr. President, I wonder if the Senator would yield for a 
question on my time?
  As I understand, Minnesota has passed a hazardous product labeling 
bill requiring warning of all products that are ignitable, corrosive, 
reactive, or toxic, and that that this legislation will effectively be 
preempted--Minnesota's passage of that particular legislation.
  I was just interested in the Senator's reaction to that. That has 
been a judgment made in Minnesota by Minnesotans and passed by their 
legislature, is now current law, and has not been grandfathered into 
this legislation. It effectively would be eliminated.
  Mr. GRAMS. I would have to defer to the author of the bill and to the 
Senator from Massachusetts. I am not aware of the details of that. I 
would have to look that up to understand it fully.
  Mr. KENNEDY. I thank the Senator. I think we had earlier comments by 
our chairman, which we welcome, about the fact that California has been 
able to be grandfathered in and they will have the protections. But 
Massachusetts, my State, is about to pass this legislation. The people 
of my State of Massachusetts are concerned about the public health of 
citizens in that State, and want to provide the protection for those 
people. The action here in this legislation, as it is prepared, will 
basically wipe out those protections.
  I have been on this floor so often and have heard that we want to get 
away from the Washington solution to these problems, that what we want 
to do is get away from this one-form-fits-all solution; what we want to 
do is let the States make judgments and decisions. And here we are 
writing legislation that is going to preempt States from taking action 
in the future. We grandfather in one State, California, but are denying 
any other State the opportunity to take action.
  I find that very difficult to understand, or to be able to accept.
  (Mr. JEFFORDS assumed the chair.)
  Mr. KENNEDY. I will give my assurance that if there is a Senator on 
the other side coming over here on the floor and wants some time, we 
will be delighted to make sure they have an opportunity to do so.
  Mr. President, again, I thank my friend and colleague from Vermont. 
We have worked long and hard on this issue, although there are areas 
where we do have differences, and I mentioned those here today. It is 
very important. It doesn't negate the point of the substantial progress 
that has been made on a wide variety of different matters, which we all 
believe will make a difference in terms of the health of the American 
people.
  Mr. President, I want to just, first of all, address and respond to 
some of the comments made by my friend from Indiana, Senator Coats, 
about the FDA, come to their defense because it was a rather blistering 
assault on the FDA. I have heard those comments made by the Senator on 
previous occasions. But as we are here on the floor of the U.S. Senate, 
I want to say a few words

[[Page S8861]]

about the FDA and where it is now. Perhaps those comments might have 
been relevant some years ago. I don't believe that they are relevant 
today.
  Out of fairness not only to the men and women that work at FDA day-in 
and day-out and toil to protect the American consumer because the 
protection for the American consumer sets an example for the rest of 
the world, and for the agency itself, and for respect for that agency, 
I would like to point out that there are few more important agencies of 
the Federal Government than the Food and Drug Administration. The FDA 
is responsible for assuring that the Nation's food supply is pure and 
healthy. The FDA provides a guarantee that the drugs and devices we 
rely on to cure and treat diseases are safe and effective. It does its 
job.
  The FDA can speed miracle drugs from the laboratory bench to the 
patients' bedside. If the agency does its job poorly, it can expose 
millions of Americans to unsafe devices and medical products and 
jeopardize our food. I think even the most zealous supporters of the 
FDA recognize that there have been troubles in the past. But we would 
also recognize there has been the sincerest effort to address those 
deficiencies in the past. To listen to some of the speeches we have 
heard on the floor today, you would think that the FDA was a regulatory 
dinosaur, mired in the past, cumbersome and bureaucratic, imposing 
unnecessary and costly regulatory burdens on industry and denying 
patients speedy access to life-saving drugs. That is a myth. Those who 
want to destroy the FDA in the service of an extreme ideological 
agenda, or in the interest of higher profits at expense of patients' 
health, would love you to believe that. But it isn't true.
  The FDA's regulatory record is the envy of the world. It sets the 
gold standards for the protection of patient health and safety. The 
agency's recent performance under the leadership of former Commissioner 
David Kessler and the Clinton administration represents a model of how 
to transform the regulatory process so that it is more flexible, 
responsive, and speedy, while maintaining the highest standards of 
patient protection. Indeed, a large number of the positive elements of 
this legislation simply codify or extend actions the agency has 
undertaken administratively.
  The landmark PDUFA reauthorization contained in this bill was 
essentially negotiated by the agency and the industry, working 
collaboratively with the bipartisan efforts here in the Senate and in 
the House of Representatives. I welcome the chance to work closely with 
Senator Hatch in the passage of this legislation to improve the review 
process.
  In recent years, in partnership with Congress and the administration, 
FDA has responded to growing criticisms of delay in approving new 
products by taking impressive steps to improve its performance. The 
PDUFA Act of 1992 was one of the most effective regulatory reforms ever 
enacted. The bill established a new partnership between the agency and 
the industry. The industry agreed to provide additional resources and 
agreed to measurable performance standards to speed the review of 
products. This was unique instance where, in receiving the additional 
funding, they established criteria to be measured by over a period of 
time and those were strict criteria and a strict challenge. Every goal 
set by the legislation has not only been met, but it has been exceeded.
  Today, the FDA is unequaled in the world in its record of getting new 
drugs quickly to market without sacrificing patient protection. In 
fact, last year, the average review times in the United States were 
twice as fast as in Europe. Fifty new drugs were approved in both the 
European Union and in the United States. In 80 percent of the cases, 
the United States approved the new drugs either first or at the same 
time as the European Union. More companies chose the United States for 
the introduction of breakthrough drugs than any other country.
  In addition, to speeding the review times, the FDA has taken far-
reaching steps to reduce unnecessary regulatory burdens on industry and 
modernize its regulatory process. More needs to be done, but these 
steps have added up to a quiet revolution in the way the FDA fulfills 
its critical mission. When PDUFA was originally passed, the device 
industry refused to agree to user fees that would give the FDA the 
additional resources and performance standards that have contributed to 
so much to the agency's outstanding record on drugs and biologics.
  I remember the negotiations. They were unsatisfactory, regrettably. 
But even in the device area, the FDA's recent achievements have been 
impressive. The so-called 510(k) applications, devices approved based 
on their substantial equivalence to a device already on the market, 
accounts for 98 percent of all the device admissions. FDA has now 
essentially eliminated its backlog. Last year, it reviewed 94 percent 
of these devices within the statutory timeframe, compared to only 40 
percent just 4 years ago.
  Even in the area of class 3 devices, where the most problems remain, 
the FDA has improved its performance substantially. According to a 
study by the General Accounting Office, median review times dropped 60 
percent between 1991 and 1996. In a recent survey of device industry 
executives reported that the business climate for the industry is in 
the best shape in the 5-year history of the survey. I introduced that 
in the Record in our markup. The industry publications are virtually 
uniform in terms of the progress that has been made and the atmosphere 
that has been created and the current very positive atmosphere. The 
sponsor of the survey attributes this favorable response in large 
measure to improvements at FDA and concludes that the agency has not 
only reduced the delays to allow new products to be introduced but, 
more importantly, has also greatly reduced executives' and investor's 
uncertainty about the timeliness of future product introductions.
  So, Mr. President, the FDA must continue to improve many of the 
provisions in this legislation. The idea that the reforms in this 
legislation must be passed at whatever cost, because the agency is 
doing a bad job, is simply incorrect.
  Now, Mr. President, I want to just return to what I consider the most 
troublesome part of our legislation. We have had very important 
discussions and representations by our colleagues and friends, the 
Senator from Rhode Island, Senator Reed and Senator Durbin, on 
particulars of the legislation, which I think need further attention. 
In my remaining time here, I would like to talk again about the whole 
issue of protection of the health and safety of the American consumer 
as it relates to cosmetic products. That is the most egregious and, I 
believe, unjustified provision in the bill, which would effectively 
cripple consumer protections by preempting State regulations on 
cosmetics.
  I note for the Record that these provisions, as I mentioned, were not 
in the chairman's mark, they were not the subject of significant 
hearings, and they have no place in the bill, whose primary purpose is 
to reauthorize the Prescription Drug User Fee Act. That is the 
principal purpose of the bill, the reauthorization of that program and 
to try and accept these adjustments, incorporate into the law some of 
the measures which have been so successful administratively by the FDA. 
And also to incorporate the great majority of the measures which have 
been included in the bill that relate to pharmaceutical products and 
device products.
  If the Congress were earnest about addressing over-the-counter drug 
and cosmetic regulation, it would have undertaken a serious and 
detailed inquiry into the regulatory structure and authorities which 
assure that consumers are adequately protected before even remotely 
contemplating the possibility of preempting active and essential State 
protections.
  The preemption of cosmetic regulation is especially outrageous and 
shows a callous disregard for the health of American men, women and 
children. Cosmetics are broadly used by Americans, far more broadly 
than prescription drugs and medical devices and biological products.
  Mr. President, I want to mention why we find ourselves where we find 
ourselves today and why this issue is of such importance. I have here 
the testimony of Commissioner Young from some years ago, 1988. It 
points out that Congress, in 1938, recognized the public health 
problems associated with cosmetics and addressed them in the laws

[[Page S8862]]

they enacted based on the science available to them. But science and 
the cosmetics industry have changed. In 1938, at most, only a few 
hundred ingredients were used to formulate cosmetics, and the industry 
was small in numbers of manufacturers that marketed products. Today, 
tens of thousands of cosmetics are in distribution, and the number of 
ingredients used has risen to an estimated 4,000 for producing a 
multitude of base formulation in equal number for compounding 
fragrances. Regulatory sciences have also progressed. When the law 
regulating cosmetics was enacted in 1938 the science was based on a 
less sophisticated concept for evaluating the safety of chemicals used 
on the skin. If you saw a reaction, you treated it; then avoid it. 
Today, science can take into account the effects produced under chronic 
long-term exposure to trace contaminants in addition to acute toxic 
effects, such as immediate skin irritations, contact allergic reaction, 
systematic reaction resulting from inhalation and ingestion. In 1938, 
the skin was considered to be an impenetrable barrier to cosmetics or 
other substances.

  As the number of ingredients and products has multiplied through 
scientific and technological innovation, our ability to measure minute 
amounts of residual contaminants and unwanted substances also has taken 
a quantum leap. At the same time science has developed more precise 
ways to assess risk, taking into account relevant factors such as use 
and exposure over a lifetime.
  (Mr. GRAMS assumed the chair.)
  Mr. KENNEDY. Mr. President, I was pointing out how the change in the 
complexity of the different products had taken place from 1938 and the 
number of products that were out there; the number of potentially 
dangerous products that were out there and the progress that had been 
made from the time when there were only a few hundred of them; back to 
1938.
  Listen to what we have now at the present time. This is according to 
the Food and Drug Administration and the studies that have been done. 
The number of cosmetic ingredients in the industry's own inventory is 
over 7,500. The industry has been adding new ingredients at a rate of 
1,000 per year for the last few years. Virtually none of these 
ingredients have been properly tested for safety. The industry's safety 
review process has reviewed only 450 of the most commonly used cosmetic 
ingredients. That is about 20 a year. At this rate, even using the 
industry's own process, it will be many years before new ingredients 
are considered for safety.
  So the sheer number of cosmetic ingredients in products makes safety 
assurance difficult. And most adverse reactions for cosmetics are 
immediate burns or irritation--long-term effects which do not show up 
for many years, such as cancer or reproductive effects are even more 
difficult to determine. They require special studies designed to 
measure this risk, while many ingredients are studied for only short-
term effects when they are added to products. Risk of cancer or 
reproductive effects are not available for the vast majority of 
cosmetic ingredients.
  Mr. President, we have been talking here this morning and this 
noontime about the authority and responsibility of different agencies. 
We have been talking about the power of the States. We have been 
talking about rules and regulations. But, when we are talking about 
health and safety, we are talking about real people.
  Let me give you the kinds of examples that we are dealing with.
  A woman from Santa Rosa--this is 1995, April 22--complained about an 
acrylic product which is for nails. She had the product applied to her 
nails. The product burned, and the cosmetician tried to remove it. 
Since the incident, six of her nails have fallen out.
  That was according to the California Department of Health Services, 
in April 22, 1995.
  Here is another one.
  On her 29th birthday, a woman from New Jersey was supposed to retire 
from the career she loved. She was a hairdresser for 11 years until a 
series of ailments, including difficulty breathing, burns in her 
sinuses and severe headaches prompted her to quit in August 1985. Her 
doctors had concluded that the beauty products she used on the job led 
to her medical problems. She had no idea what was actually in the 
products which she used in her beautician job. Lack of labeling is 
neither unusual nor illegal, although cosmetic manufacturers are 
required to list ingredients containing products sold to consumers. 
They need not do so for products sold for use only by professionals.
  Another case is Carolyn, a secretary from Rockville, MD. She arrived 
at a wedding shower and realized the permanent she had received at a 
beauty salon the day before resulted in a red swollen, face. Carolyn's 
is a case of cosmetic contact dermatitis, also known as acute allergic 
inflammation of the skin caused by contact with various substances 
found in cosmetics, including materials used by the hair stylist. This 
is a case that was reported to the FDA.
  A 33-year-old housewife consulted her dermatologist because of 
inflammation of her hands, face, and neck. She had experienced two 
similar episodes earlier in the year. After the skin properly healed, 
the physician determined through appropriate testing, that Swedish 
formula lotion had caused the adverse reaction.
  A telephone company supervisor was hospitalized after a 2-year 
history of chronic irritation of her eyelids. She received a variety of 
topical medications without relief. Her contact history revealed a long 
list of cosmetic eye drops, and multiple spray perfumes. All the 
cosmetics were removed from her hospital environment, and after her 
skin healed, patch testing showed lanolin in her creams--lanolin in her 
creams--was causing her condition.
  That is from a subcommittee hearing on health.
  The use of chemical skin peeling products caused severe injuries, 
including reports of skin burns from using a product called Peel Away. 
FDA sources said such products can penetrate the skin too deeply 
causing severe skin damages. In several cases persons have been 
hospitalized with severe burns, swelling, and pain. In one case, a 
California woman suffered seizures, shock, and second-degree burns 
after a combination of skin peel chemicals was applied to her legs by a 
beautician. Skin peeling procedures used to be carried on by plastic 
surgeons.
  However, they are now being done by nonmedical professionals, by 
beauticians and some using newly marketed preparations. Many have 
inadequate instructions. None has been approved by the FDA as being 
safe and effective. Again, an FDA consumer report.
  A letter from the CDC cited nine cases of eye infections due to 
microorganisms contained in mascara. One was a 47-year-old woman who 
developed a corneal abscess within days of scratching her eye with a 
mascara wand. The woman eventually needed a corneal transplant.
  As I understand it, it is because of the failure to be able to 
indicate that mascara needs an expiration date.
  So, Mr. President, this list goes on. I want to show what the States 
have been doing with regard to the protection for the American 
consumer. The issue now that is before the Senate on the FDA reform 
deals with the medical devices and pharmaceuticals and the extension of 
what we call the PDUFA, which will help to expedite the consideration 
of those measures.
  By and large, there is strong bipartisan agreement to those 
provisions. There are several that have been identified today that need 
further attention, but men and women of good will can work that out and 
work it out with the administration so that we can have a successful 
conclusion. But what was not considered in the original bill is the 
provisions that apply to preempting the States from giving protections 
to their consumers on the use of cosmetics. What we have recognized in 
this debate is that the Food and Drug Administration does not today 
have the authority, power, or personnel to protect the American 
consumer on the issue of these cosmetics.
  What we know overwhelmingly today is that the number of dangerous and 
toxic products and the number of carcinogens has expanded exponentially 
and is continuing to expand. All you have to do is look at the past 
record, of the numbers that have been introduced, and it is continuing 
and continuing to grow and those products are not being tested 
adequately today.

[[Page S8863]]

  So who has been protecting the American consumer? Who has been 
protecting the American public? The States have been doing it, and 
primarily California has been doing it, under the legislation which 
they have passed. How important that has been. It has not ended up with 
actions that have been taken by the State of California as the result 
of very extensive studies that products have been removed. What has 
happened is that the producers and the manufacturers have withdrawn the 
product, addressed the problem, put it back on the market, and by and 
large, if you look at the advertising, they would say the product is 
better today than it was yesterday.
  That has been the record. That has been the record. And that is why 
this is so important. Just review with me, Mr. President, the extent of 
this preemption--as I mentioned before, the extent of this preemption 
of the cosmetic industry in the States. This is the language that there 
will be the preemption for--``labeling of cosmetics shall be deemed to 
include any requirement relating to public information or any other 
form of public communication relating to the safety or effectiveness of 
a drug or cosmetic.''
  There it is in the legislation. They are effectively saying no to the 
States in providing public information or any public communication 
relating to safety. If the States are trying to protect their people 
and they develop public information on the basis of scientific studies, 
they are prohibited under this legislation. I don't know what the 
penalties are. I don't know what the civil penalties are, but they must 
be in there. They are prohibited from providing public information or 
any form of public communication relating to safety or effectiveness.
  That is what the cosmetic industry is doing in this legislation. That 
is the disdain that the cosmetic industry has for those in the States 
who are trying to protect the public. That is the arrogance that this 
industry has for legislators or Governors or attorneys general or 
medical professionals who are interested in the public.
  This is what this says. You cannot do it. You cannot provide public 
information even with regard to safety. That is arrogance. That is 
greed. That is the greed of a $20 billion industry.
  What do the States say? Well, why are you so worked up, Senator? It 
isn't just myself. Again, we have shown we have the letters from the 
Governors, the State legislators. This is not just one Senator's 
position. This happens to be the position of the Governors and the 
State legislators.
  Yes, I listened to the comments of my friend and colleague, Senator 
Jeffords, about the general statements of two of the Governors with 
regard to the health provisions on pharmaceuticals and devices, that 
is, an admirable job has been done. I think we still have areas to deal 
with. But I would certainly sign on to that. But what we are talking 
about is what we are saying to the States. The cosmetic industry is 
saying to the States you are not going to stick your nose in and 
protect the consumers there. What have they done in the past? Why are 
the other Governors worked up about it? Because of what these two 
charts demonstrate, Mr. President.
  Here we have the issue of lead which is known to cause birth defects 
and has also been found in hair dye. That is the result of State 
action, of State analysis, of various hair dyes that are out there that 
contain lead product. Initially, when there was the analysis, they 
said, well, this really isn't dangerous because it is just on the 
scalp. Then they did additional kinds of studies and found that the 
lead got into the individuals, obviously, who were using it. That lead 
was passed on to pets, children playing with pets, children ingesting 
it and when people are washing their hair day after day after day it 
causes a birth defect. Lead is one of the principal causes of mental 
retardation among children, period. We find, as a result of State 
activity, they have found it and it has been changed in many, many of 
the products--not all of them, because the cosmetic industry was able 
to get an exclusion from some participation.
  Mercury, which can cause mental retardation, has been found in 
lipstick and nail polish--lipstick and nail polish, mercury. With all 
the implications that has in terms of women's health and in terms of 
safe pregnancies, it is found in lipstick and nail polish. That was 
another study that was done in California.
  Alpha hydroxy, a known carcinogen, has been found in face creams. 
That was not done by the Food and Drug Administration. That is a result 
of State activities. There is not a physician in this country who does 
not know the dangers of lead and mercury and the alpha hydroxy to the 
American consumer, primarily women. There isn't a doctor who will not 
tell you that. Yet this legislation is saying, no more. 
This legislation is saying, no more. ``Any requirement relating to 
public information or any other form of public communication relating 
to safety or effectiveness of the drug or cosmetic''--preempted. So we 
are saying, if you find this out, we are preempting you. You are not 
going to have to tell the public.

  As a result of State regulation protecting consumers, we have seen 
that States forced the removal of reproductive toxins from lipstick and 
nail polish. That is a result of State action. You have to admire the 
resourcefulness, the innovativeness, the persistence of the leaders in 
States that have had the courage and the determination and have been 
willing to take on the cosmetic industry, the cosmetic industry that by 
its own agreement spends 70 percent of its lobbying dollars in the 
States rather than on the Federal Government. You can understand that, 
because we haven't got any power over it, so they have targeted it in 
the States. Yet you find the courage of State public health officials 
who have been willing to force the removal of reproductive toxins from 
lipstick and nail polish. They didn't take the products off the 
markets. The manufacturers took them off the market and they addressed 
those issues.
  States forced the removal of harmful lead from hair dyes and antacids 
and calcium supplements. The States forced the removal of mercury from 
suppositories. These are just examples.
  How do we know how many other dangers there are out there when we 
have an explosion of dangerous products that have been agreed to by 
Republican and Democratic leaders of the FDA over the period of years--
increasing exponentially with the dangers of toxins and carcinogens. 
The problem isn't getting less. The problem and the danger is getting 
more as every consumer understands the range of additional kinds of 
products that are out there and available to them. Nonetheless, we are 
asked on the floor of the Senate to say no to the States. We are not 
doing it at the Federal level.
  As I mentioned before, if you said, well, we are going to have a 
whole review, regulatory review, we are going back to say, OK, we will 
preempt the States but we will find out what we are going to do with 
regard to providing protection--we have had, as I mentioned earlier, 
the GAO studies that have been done 10 years ago which made a series of 
recommendations to the Congress about steps we ought to take if we are 
going to protect the public--then maybe, maybe then it makes some 
sense. But we have not done that. We have not done that. The FDA has 
been starved in resources to even fulfill its requirement for 
protection in terms of the American consumers in medical devices and 
with regard to pharmaceuticals.
  So we have a situation where we have limited, limited, limited 
authority under the FDA to protect the public for a range of these 
cosmetics. We find a record today where you are getting the explosion 
of these dangerous products, of toxins and carcinogens. Carcinogens 
cause cancer--cause cancer. We are seeing those numbers expand. We are 
finding completely inadequate policing by the cosmetics industry. We 
find the only breath of air that is out there to protect the public is 
the States. California is leading the way. Thank God, at least 
California has been grandfathered in.
  What we are saying is California is grandfathered in, but my State of 
Massachusetts, which is just about to pass a similar law, is out. We 
cannot protect people. Washington knows best. Washington is saying to 
Massachusetts, no matter how you want to protect your consumers up 
there, you can't do it because we are preempting you.
  Come on, Mr. President. This is a health issue. This is a safety 
issue.

[[Page S8864]]

 This involves primarily women, it involves children, and to some 
degree men in our society. But it involves health and safety.
  We have thousands and thousands of complaints about various products. 
I indicated earlier today--maybe I didn't--about the number of people--
there were 47,000 cosmetic-related injuries in the emergency rooms in 
American hospitals in 1987--47,000. I wonder how many today, with 
greater utilization of cosmetics, greater danger, more toxins, more 
carcinogens. These are just the emergencies. These are not the kinds of 
situations that maybe--they may be--have long festering, long lasting 
kinds of implications and have been festering for a long period of 
time.
  That is what is happening out there--47,000 cosmetic-related injuries 
in the emergency rooms. How many others where people go back to their 
doctor and do not go through the emergency room? How many others?
  We have scores, scores and scores of complaints that have come to the 
FDA, and they go down the list. Thousands of consumer complaints in 
1996 alone: Equate Baby Oil--these are complaints to the FDA--their 
complaints are eye tissue damage. Disney Kid Care Bubble Bath: 
urogenital track reactions. Nat Robins Eye Shadow Pencils: eye rash, 
burns and irritation. Flame Glow No Mistake Eyeliner Pen, black magic 
color: Rash, burns, and irritation. Incredible Lex Mascara, Eye 
Perfector, Dramatic Timing Faceneck, Covergirl Professional Advanced 
Mascara: rash and burns.
  These are the companies. You have the Disney Co., the Reckitt & 
Colman Co., Softsoap Enterprises, Great American Cosmetic. They produce 
Nat Robins eye shadow pencils.
  You have Del Laboratories, Estee Lauder eye shadow; Avon products; 
Procter & Gamble, rash and burns.
  You have Helene Curtis, Salon Selective Styling, flammable, resulting 
in thermal burns.
  You have American Pride, hair relaxer, Alberto Culver lotions, hair 
tissue damage and hair loss.
  You have Clairol, Clairol Infusion 23 Shampoo, hair loss and hair 
tissue damage;
  Del Laboratories;
  You have Products Naturistics Mango Shampoo, hair loss and damage;
  Helene Curtis, Suave Balsam and Protein Shampoo, hair loss, hair 
damage.
  Vigoral--we find hair loss and tissue damage.
  Alberto Culver Co., VO5, hot oil concentrated treatment, hair loss 
and tissue damage;
  Hydrox Laboratories, Fresh Moment Mouthwash, mouth infections--mouth 
infections;
  Carter Wallace, Arrid deodorant, bleeding and infection with 
utilization;
  Apollo Health Care, Baby Bear Lotion, pain, including itching, 
stinging, burning, and soreness.
  Mr. President, these are just some of the items. I may very well 
include the whole list in the Record on Monday. These just give an 
example of some of the leading companies.
  Some may say, these are not really accurate. We would know whether 
they are accurate if we were able to give the assurances that we had 
those in the States who were looking into this and be able to say, 
``Look, this isn't a problem.'' But now we are not going to know 
because all the States are preempted. Now we are going to find these 
reports are going to come in more and more. We will have to just 
presume that they are accurate, because the cosmetic industry will not 
let us find out whether they are or are not accurate. They will not 
permit the publication of information that is going to reflect poorly 
on either safety or effectiveness.
  Mr. President, these are just some of the items that I think form the 
compelling case for State action. I think we will on Monday go through 
some of the particular cases in more detail on the California 
situation, because I think that they have really had the soundest 
record. It isn't easy to get this kind of information, but we will go 
through it. These that I just mentioned are some of the thousands of 
consumer complaints to Government agencies. This is only for a few 
months of the year, and I have read just a very few of them. I will 
perhaps get into even more of them later on.
  Mr. President, I mentioned earlier a study by the General Accounting 
Office which reported that more than 125 ingredients used today are 
suspected of causing cancer. We have scores of cosmetic ingredients 
that can damage the nervous system, including headaches, drowsiness, 
convulsions.
  To all of those watching this program I would say, ``don't discount 
the fact that perhaps some of your ailments--headaches, drowsiness, and 
convulsions--may actually be resulting from the use of cosmetics.'' 
Don't discount that, because the record shows that cosmetics 
manufacturers are including ingredients that can cause those symptoms. 
You don't know, your State won't know, the Federal Government won't 
know, we won't be able to tell you because of the power of the cosmetic 
industry in foreclosing that kind of study and the publication of 
information about the real health implications.
  The GAO found that additional Federal authority is necessary to 
protect the public. That is the General Accounting Office. It is not 
this Senator from Massachusetts, not a Democrat, it is not a 
Republican. Here is the General Accounting Office reaching the 
conclusion, after reviewing this whole subject matter, that if you want 
to protect the public, you need greater Federal authority--we are not 
getting that today. The only authority that we have out there is at the 
State level, and this bill is taking that away.
  How much do we have to yield to the greed of this industry? How much? 
And why? Why should we do it? We patch together something that will 
take care of California because they passed their law a couple of years 
ago. But we say to the other 49 States, ``You can't, you are never 
going to be able to do it again, never be able to do it again, ever.'' 
They have been able to protect their consumers. Hopefully, they will be 
protecting the people of Massachusetts, because that is the only way we 
are going to be protected, not at the Federal level, but through their 
own leaders, legislature, and representatives. No, we are just saying 
absolutely not.
  So, Mr. President, the cosmetic industry wants the public to believe 
that no effective regulation is necessary or desirable. They are 
masters of the slick ad and expensive public relations campaign, but 
all the glamour in the world cannot obscure the facts.
  Mr. President, I just showed what the results of some of these 
actions are in terms of affecting people. I mentioned the peelaway 
product. This is a before and after appearance and complaint of the 
peelaway product. You can take a look and see what happens to people.
  These are various ingredients which have been put on an individual's 
feet. Look at the reactions to it. We are saying, no, we are not going 
to permit the States to try and do something about that kind of 
activity. And we could have had a whole series of charts up here.
  I mentioned just a few moments ago what was happening in terms of 
burns and irritations that are occurring with skin products and what is 
happening to eye tissue and what is happening with rash and burns and 
hair tissue and hair loss and mouth infections and bleeding--the list 
goes on and on.
  We could have had charts all around this room. Generally speaking, 
when you have this kind of circumstance, we would be in here debating 
what to do about it. Instead of thinking about what we are going to do 
about it, we are talking about what we are not going to do about it.
  Mr. President, here we have seen what the States have done, what the 
problems have been, what the dangers are to the American consumer in 
terms of mercury, lead, and other substances in products that everyone 
knows are dangerous and are health hazards. Here we have a problem, and 
it is getting bigger. The products that are being produced for the 
market are more dangerous. Yet, we are doing less and less and tying 
the hands of the local communities to act in our stead.
  We allow States to decide whether your bottles are going to be 
recycled or whether they are going to be buried. We permit the States 
to decide what they are going to do about licensing barbers. States 
decide and have rules and regulations and laws about pets. We have 
States that have rules and regulations about how close to the crosswalk 
you can park your car. We have regulations in the States about

[[Page S8865]]

what store hours are going to be, how late a store can be open. But 
this bill would prohibit the States from protecting consumers from 
lipsticks, hair creams and the soaps, hair dyes, mascara, and 
deodorants that can give you cancer or can catch you on fire as a 
result of flammable ingredients, or cause serious birth defects.
  Now, does that make any sense at all? Does that make any sense at 
all? When you have the most serious dangers in terms of health and 
safety, we are denying States the opportunity to do something about it, 
but we will let them go ahead and look after these other kinds of 
issues which are not related in any particular way to health and 
safety.
  It just doesn't make any sense. It makes no sense at all. The 
proponents of this provision know they couldn't pass this legislation 
if it wasn't tagged on to the Food and Drug Administration bill. They 
wouldn't dare bring this legislation out here on its own. The reason 
they tagged it on this bill is because they knew the importance of food 
and drug reform. They knew that we had to pass the extension of PDUFA, 
which is a key program to provide sufficient resources to the Food and 
Drug Administration to get the qualified people who can help expedite 
the more rapid consideration of new products, new pharmaceuticals in 
the Food and Drug Administration and has been very creatively utilized 
over there.
  So what do they do? They tag this on to that train. This legislation 
would be laughed out of this body if it came up here on its own. Why 
don't they try to bring it up on its own? We have Members in the Senate 
say, ``We don't understand, there are just one or two Senators troubled 
by this.'' All the Governors seem to be troubled by it, and you can't 
blame them. They have the fundamental responsibility for protecting 
health and safety. That has been fundamentally a responsibility at the 
State and local level. It is a fundamental responsibility that is as 
old as this country. So the Governors don't buy into this.
  The administration understands that this thing is a phony grab, a 
greedy grab for profit, because that is what it is. It will mean that 
the various cosmetic industries are not going to have to be altering or 
changing their products because you are not going to have the research 
being done or the authority in the States to bring changes that would 
make products safer. It is going to mean more profits. On the one hand, 
more profits for the cosmetic industry and much greater health threats 
in terms of safety, in terms of potential birth defects for infants, 
for various kinds of ingested products with a whole range of 
sensitivity to the body--eyes, mouth, ears, hair--and the problems of 
lips and the ingestion of various products that are dangerous.
  (Mr. COVERDELL assumed the chair.)
  Mr. KENNEDY. It just defies any logic. So, as we all know--we have 
been around here--hopefully even the newer Members understand this one, 
where you get something that is going through and can't make it on its 
own, and is added at the last or next-to-last markup with just a 
fraction of the discussion as we have had to date out here today during 
this consideration, and it is locked in.
  That cosmetic industry is just smiling. They are smiling now with the 
votes that they had down there saying, ``Well, it seems we've got 
through this hurdle.'' I am just telling you, this is a long, long 
process. And they better get used to the fact there is going to be a 
long process, because this issue is not going to go away. It is not 
going to go away today, and it is not going to go away when we talk 
about this some more on Tuesday and get more information. It is not 
going to go away on Tuesday and not going to go away in terms of the 
consideration of the legislation. It is not going to go away for a 
long, long time.
  Amazing about how a measure like this can slow something down over a 
long time so that the American people can begin to understand what is 
really at risk. I do not believe that they do. I wonder how many 
Members of this body have read through the legislation and understood 
exactly what was included in terms of the cosmetic program.
  So with this particular proposal in there, we are going to have to 
ensure that we are going to have the kind of full awareness and 
understanding, not only by our colleagues here but the American people 
as well, as to what the health implications are.
  This has important and significant health implications. We deal with 
a variety of different proposals in terms of education--the HOPE 
scholarship, the tuition credit, the work-study programs--and we debate 
those and discuss those and allocate resources to those, trying to 
decide how much we are going to provide in terms of the Head Start 
Program. Will it be 59,000 new children this year or 100,000? At the 
end of the day we may understand that our side does not win, others 
prevail on it, but we know that we have made the battle and made the 
fight, and the people that are going to be disadvantaged may be those 
children who are not going to get that benefit in terms of education. 
And that is a tragedy in terms of a mind developed.
  But here we are talking about something else that is even much more 
important. You are talking about the vital health of the American 
people and the safety of the American people. You are talking about the 
dangers to children and infants and about the birth of healthy 
children. You are talking about the dangers to children's eyes, and you 
are talking about the dangers to people who are trusting just what they 
see on the shelves of American pharmacies across the country.
  I would say that 9 out of 10 Americans who walk into any pharmacy 
this afternoon and see a product on the shelf are saying, ``Well, this 
is just sort of like my medicine or just about like the other products 
that I'm buying here. Somebody's looked at it, the Food and Drug 
Administration or somebody's looked at it, and it is safe or it 
wouldn't be out there.'' That is baloney. It is true for prescription 
drugs. And by and large it is true about over-the-counter drugs. True 
about medical devices, by and large. You can flyspeck and find 
instances, but that is true about those. We have the safest regulatory 
systems in the world. But it is not true for those products that are on 
those shelves that so many millions of people are using and have 
resulted in, in 1 year, 46,000 people going to the emergency room.
  People do not go to the emergency room unless it is serious. I do not 
know whether it is $300, $800 to go to an emergency room to get any 
kind of attention. People might go back to their doctors with good 
health insurance, go back to their dermatologists to ask them to do it, 
but how many people are going to the emergency room? Someone with a 
little burn is not going to that emergency room. Particularly if you 
are working families and have children and you do not have health 
insurance, you are not going to be going down. How many other people 
did not go and still were adversely affected? But we say, ``Oh, no, no, 
no, we're not going to do anything about that.'' Whatever was being 
done out there by the States--that is out now. You cannot go forward 
with it.
  So, Mr. President, the cosmetics industry wants the public to believe 
there is no effective regulation that is necessary or desirable. They 
are masters of the slick ad and expensive public relations campaign. 
But all the glamorous pictures in the world cannot obscure the facts. 
This is an industry that is underregulated and its products are too 
often hazardous.
  The severe reactions may be only the tip of the iceberg. Long-term 
illnesses, ranging from cancer to birth defects, may not be linked to 
their underlying cosmetic-related causes. As the GAO points out, 
``Available estimates of cosmetic-related injuries do not accurately 
reflect the extent to which consumers are exposed to toxic cosmetic 
products and ingredients. Because symptoms of chronic toxic effects may 
not occur until months or years after exposure, injury estimates 
generally account for only acute toxic effects.''
  The GAO is saying that with those 46,000 people that are going to the 
emergency room, that is only the tip of the iceberg. And Lord only 
knows, if you did not have State action in taking away the lead and the 
mercury and the other kinds of poisonous products that are cancer 
forming there would be even a much more dramatic number for it.
  Here we have the GAO effectively saying that because the symptoms of

[[Page S8866]]

chronic toxic effects may not occur until months after exposure, injury 
estimates generally account for only acute toxic effects. We see that 
in 1987 we had 46,000 of what we know now was the exponential increase 
in the danger of all these products. We can imagine the dangers that 
exist out there today.
  In light of this limited authority and even more limited resources to 
protect the public, you would think Congress would want to encourage 
States to fill the regulatory vacuum. You would think we would be out 
here asking, what can we do to help, if anything, the States that are 
trying to address protections for their consumers? What can we do with 
the Centers for Disease Control to help Massachusetts, to help Georgia, 
help North or South Carolina? What are the resources that are out there 
to assist your State legislatures, Republican and Democrat, to provide 
protection from some of these toxic or carcinogen problems?
  But, oh, no, we are not out there asking that this afternoon. We are 
out there putting more roadblocks in front of the States in their 
attempt to do so. In fact, the language is so extreme the States have 
been barred, as I mentioned, from establishing ``any requirement 
relating to public information or any other form of public 
communication relating to the safety and effectiveness of a drug or 
cosmetic.''
  So, Mr. President, the last time the Senate looked at the issue of 
cosmetic regulation was in the late 1970's. We held extensive hearings, 
and we debated the issue, and we passed a comprehensive bill that 
included additional authorities for the FDA. Today, we are considering 
a bill that resulted from no hearings, where there has been little 
debate, no expert testimony in a product area that touches the American 
public every day.
  It should be made clear to anyone that cosmetics are as deserving of 
adequate regulation as they were 20 years ago. It defies logic that our 
single action in this important consumer product area is to preempt the 
States from acting where there is wide agreement that FDA has neither 
the authority nor the resources to adequately fill the field. An 
attorney, now with Procter & Gamble, wrote in a 1996 Food and Drug Law 
Journal article that although cosmetics are regulated by the Food and 
Drug Administration, ``the agency's regulation is extremely lenient.'' 
If lenient regulation led to the chamber of horrors documented in the 
Senate hearings 20 years ago, it is difficult to imagine the impact of 
preempting the States from acting.
  The proponents of the bill will tell you their language preempts 
State safety regulations only--remember we heard that during the course 
of the day--that their language preempts safety regulations only where 
the Federal Government has acted. But the actual statutory language is 
very broad and demonstrates a different intent. The industry admits 
that the language is drafted specifically to undermine Federal judges 
that have narrowly interpreted the Federal preemption.
  For instance, if FDA sets a standard for lead in hair products, this 
bill would direct a conclusion that the lead level sets the standard 
for other, unrelated products that might have different routes of 
exposure. So we know what the industry was doing. You can talk about 
these issues in generalities, but you have to look at the specific 
language here.
  Mr. President, I have no doubt the industry will argue that any 
little action on FDA's part will preempt State action. Yet we have no 
assurance the FDA is actually up to the task of filling the void left 
by the States. Again, we have had no hearings, no public record, no 
expert testimony. In fact, the industry cannot cite one example of a 
burdensome State regulation that this law preempts. I hope that if that 
is not the case, that this record will be clarified. The industry 
cannot cite--you have not heard in this debate here this afternoon the 
industry citing one example of a burdensome State regulation. Instead, 
they suggest that the benefit of this law is prospective. They claim 
they are concerned about what the States might do in the future. This 
is legislation for a problem that does not exist. But they see that 
this was the chance to get on this particular train, and they are 
riding it.
  The stark reality is that, according to the cosmetic industry itself, 
the industry spends 70 percent of its lobbying dollars influencing 
State legislatures. I suppose we should really call this the FDA 
Lobbying Relief Act. I find scarce comfort in the fact that this bill 
will relieve cosmetic lobbyists from having to lobby 50 States, who can 
now focus on Congress. Even worse, if this provision is enacted, the 
cosmetic lobbyists will spend their time getting FDA to act in some 
small way on a safety issue simply to create a broad scope of Federal 
preemption of the State in that area.
  This is irresponsible deregulation, putting the proverbial cart 
before the horse. Let me emphasize that if we want to truly reform the 
FDA's regulation of cosmetics, we should start with ensuring they are 
protecting the American public from unsafe cosmetic products. Once the 
American people can be confident that FDA has the authority and the 
resources to protect them, that FDA is up to the task, then we can talk 
about State preemption. That is the way we have always approached State 
preemption in the past, and that is the only way to approach it now.
  The proponents of this provision claim that by permitting States to 
petition for exemptions, there is adequate protection for States 
rights. In reality, the high procedural hurdles in this provision, 
especially the extreme, burdensome requirements of formal rulemaking, 
ensures a lengthy process where industry will entangle States in years 
of hearings. Given the lack of Federal presence in the area of cosmetic 
regulation, it is unconscionable to make the States jump through hoops 
in order to continue to protect and warn their citizens.
  They finally say, ``Well, OK, you can make some progress and deal 
with this, but you're going to have to jump through all these hoops.'' 
How many times have we been hearing on the floor about rules and 
regulations and the bureaucracy of Federal regulatory agencies, and 
here we have those that support this proposal on cosmetics setting up 
hoops for any of the States to jump through--hoops and landmines--hoops 
for the States to jump through in order to continue to protect and warn 
their citizens?
  I assure my colleagues that this is only the first instance of where 
you will witness efforts at sweeping preemption in the absence of 
significant Federal activity. We will be faced with a barrage of bills 
seeking to preempt State authority in the area of public health 
regulation. It is certainly ironic that this Congress is so determined 
to undermine States rights.
  Mr. President, let me emphasize again how this provision hinders 
States from protecting their citizens at the end of the day. The 
labeling and packaging of a cosmetic is preempted completely under this 
language. States will be unable to communicate safety concerns in the 
most effective and sensible manner--through labeling and packaging. 
Even if the States retain some vestige of authority over cosmetic 
safety, this bill ties their hands and prevents them from giving the 
public the information it needs to make informed choices. ``Right to 
know'' under this provision means ``right to no information.''
  What about the FDA? Today, the FDA has fewer than two people working 
on labeling and packaging. In fact, most of the 30 people working in 
the FDA Office of Cosmetics work on the regulation of color additives 
and not actually on cosmetics. The reason for this underwhelming 
presence is simple: FDA has put limited resources in the cosmetic 
program because they simply do not have adequate legal authority to 
address cosmetic safety. If you can't enforce the law because there is 
no enforcement authority and because the standards are basically 
nonexistent, you are not going to squander valuable personnel where 
there are drugs and medical devices to approve, and foods to keep safe.

  For example, if the FDA suspects a cosmetic safety problem exists, as 
they do with the use of alpha-hydroxy, acid face creams, the agency 
faces high hurdles in bringing any kind of regulatory action. The FDA 
bears the burden of demonstrating by its own testing that the product 
is injurious to health. The FDA cannot make the company demonstrate 
they are selling a safe product. That is important, Mr. President. The 
FDA cannot come in and say to the company, ``Show us the information 
for the product you are testing to

[[Page S8867]]

demonstrate this is a safe product.'' No, they do not have that power 
or authority. The FDA cannot require the companies to come in, and the 
FDA, by its own testing has to demonstrate that the product is 
injurious to health.
  Today, the FDA knows how many milligrams of aspirin are in a tablet 
and they know how much sodium is in human or animal food and can 
require disclosure of this information to consumers, but the FDA does 
not have to know how much alpha-hydroxy acid is in face cream. The 
agency cannot even require the cosmetic companies to disclose the 
presence of a known carcinogen like alpha-hydroxy acid to consumers. We 
need to understand, Mr. President, that the agency cannot even require 
the cosmetic companies to disclose the presence of a known carcinogen--
they cannot do it--like alpha-hydroxy, to consumers.
  It is, frankly, no wonder that 70 percent of the cosmetic industry 
lobbying takes place in the States because that is where the action is. 
That is where the standards are being set. That is where the standards 
are being set and enforced.
  My colleagues do not have to take my word. We have a letter from the 
National Governors' Association, Association of Food and Drug 
officials, and the Association of State Legislatures, voicing strong 
opposition to this whole provision. We have a letter from the 
conservative Republican Attorney General of California, Dan Lundgren, 
strongly opposing this provision, and speaking eloquently about the 
importance of State laws on cosmetic safety.
  In my own State we have a bill that would extend the same public 
health protections enjoyed by California under their right-to-know law, 
Proposition 65. Proposition 65 is so successful and so popular with 
California voters that the committee has excluded it from preemption. 
No one has refuted the positive impact Proposition 65 has had on the 
public health. No one has. But instead of taking a law that is working 
so effectively to protect the public and encourage other States to 
emulate California today, we are debating whether to preempt every 
State but California.
  Some of my colleagues have expressed satisfaction with grandfathering 
Proposition 65. They should delay their celebration. This bill 
grandfathers Proposition 65 in its current form, which applies to 
reproductive toxins and carcinogens. But California cannot react to 
future scientific developments by warning its citizens against other 
hazardous substances.
  I will include the whole letter and I ask unanimous consent the 
complete letter be printed in the Record.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                                              State of California,


                                        Department of Justice,

                                   Los Angeles, CA, July 14, 1997.
     Re S. 830, FDA Modernization and Accountability Act of 1997--
         Potential Preemption of California Health and Safety 
         Laws.

     Hon. James M. Jeffords,
     Chairman, Senate Labor and Human Resources Committee, Hart 
         Office Building, Washington, DC.
       Dear Senator Jeffords: It has come to our attention that S. 
     830, the FDA Modernization and Accountability Act of 1997, is 
     moving rapidly through Congress. We understand that this 
     omnibus bill, which covers the entire gamut of FDA authority, 
     also contains language in section 761 on National Uniformity 
     for Non-prescription Drugs to the effect that no state may 
     establish or continue in effect any requirement ``that 
     relates to the regulation of a drug intended for human use 
     that is not subject to the requirements of section 503(b)(I) 
     or a cosmetic'' unless is it identical to the Act. While this 
     is only a small portion of a major piece of legislation, we 
     are concerned that this provision may be construed to preempt 
     states from imposing any requirements on cosmetics or over-
     the-counter drugs, and could therefore prevent the State of 
     California from enforcing significant laws dealing with the 
     health and safety of its citizens in the absence of a 
     specific FDA exemption. California laws which could 
     potentially be affected by the FDA Modernization Act in its 
     current form include the Sherman Food, Drug and Cosmetic Law, 
     and the Safe Drinking Water and Toxic Enforcement Act of 1986 
     (``Proposition 65'') as they apply to manufacturers of 
     cosmetics and over-the-counter drugs.
       Regulation of health and safety matters has historically 
     been a matter of local concern and the federal government has 
     been reluctant to infringe on state sovereignty in these 
     traditional areas of police power. As noted by the Supreme 
     Court in United States v. Lopez, 154 U.S. 151, 131 L.Ed.2d 
     626, 633 (1995), ``a healthy balance of power between the 
     States and the Federal Government will reduce the risk of 
     tyranny and abuse from either front.''
       Thus, many federal statutes that preempt state regulation 
     in the traditional health and safety area do so narrowly, if 
     at all. For example, the Federal Insecticide Fungicide, and 
     Rodenticide Act and the Federal Hazardous Substances Act 
     preempt only labeling requirements and the Medical Device 
     Amendments to the federal Food, Drug and Cosmetics Act 
     preempts state requirements only if there is an existing, 
     very specific federal requirement in effect. In contrast, 
     the ``National Uniformity'' provision of S. 830 as 
     currently proposed, appears to generally preempt all state 
     requirements, not just labeling requirements, even when 
     there is no existing federal requirement in effect.
       As noted above, S. 830 would, in the absence of specific 
     FDA exemption, appear to prevent the State of California from 
     enforcing both the Sherman Food, Drug and Cosmetic Law as 
     well as Proposition 65, a state ``Right to Know'' statute, 
     passed by the voters of California in 1986. Proposition 65 
     requires that persons who expose others to certain levels of 
     carcinogens or reproductive toxins give a clear and 
     reasonable warning.
       Proposition 65 has been used successfully to reduce toxic 
     contaminants in consumer products and has repeatedly been 
     instrumental in creating positive changes in products 
     regulated by the Food and Drug Administration. The federal 
     government has at least twice in the past ten years followed 
     the lead of the State of California after the state entered 
     into various settlement agreements under Proposition 65 that 
     required lower levels of contaminants in various products. 
     For example, in 1990, after California filed suit under 
     Proposition 65 concerning lead leaching from ceramic dishes, 
     the Food and Drug Administration (``FDA'') adopted stricter 
     lead standards for dishware. In 1991, the state brought an 
     action concerning lead-foil wine bottle caps, resulting in 
     industry-wide agreement to convert to tin or plastic caps. A 
     year later, the FDA adopted a standard barring lead-foil 
     caps.
       Most recently, this office entered into settlements, just 
     approved by the court, with the major manufacturers of 
     calcium supplements and antacids (a non-prescription drug), 
     both of which are taken in large quantities by pregnant women 
     and many of which contained lead at levels that caused 
     concern for the health of the fetus. The settlements require 
     the manufacturers to lower the lead levels in their products 
     substantially below previously mandated food and 
     pharmaceutical levels. The manufacturers intend to make these 
     changes on a nationwide basis. As has been the pattern in the 
     past, the calcium settlements have served as a model for 
     federal action, and the FDA is now considering changes to the 
     federal standards for lead in calcium supplements and 
     antacids.
       While we appreciate the need for national uniformity of 
     regulation in certain areas, the provisions of Proposition 65 
     have been in existence for over ten years and have repeatedly 
     been found not to be preempted by federal law.\1\ In June of 
     this year, the Federal Occupational Safety and Health 
     Administration approved Proposition 65 in the California 
     workplace, ruling that it did not impose an undue burden on 
     interstate commerce. (U.S. Department of Labor, Occupational 
     Safety & Health Administration 62:31159-31181--Supplement to 
     California State Plan, Approval (June 9, 1997)).
---------------------------------------------------------------------------
     \1\ See, e.g., Committee of Dental Amalgam Manufacturers v. 
     Stratton, 92 F.3d 807 (9th Cir. 1996) (no preemption by 
     Medical Device Amendments to Federal Food, Drug and Cosmetics 
     Act); Chemical Specialities Manufacturers, 958 F.2d 941 (9th 
     Cir. 1992) (no preemption by Federal Insecticide, Fungicide 
     and Rodenticide Act and Federal Hazardous Substances Act 
     (``FHSA''); People v. Cotter, 53 Cal.App.4th 1373 (1997) (no 
     preemption by FHSA).
---------------------------------------------------------------------------
       Propostion 65 as well as the Sherman Food, Drug and 
     Cosmetic Law are examples of the type of state regulation 
     that protects the health and safety of its citizens and that 
     coexists comfortably with federal regulation. The states 
     should be permitted to continue in their historical role as 
     guardians of the welfare of their citizens. We therefore 
     respectfully urge you to seek modification of your bill to 
     address this issue.
           Sincerely,
     Daniel E. Lundgren,
                                                 Attorney General.
     Theodora Berger,
                                       Assistant Attorney General.

  Mr. KENNEDY. Reading from the last paragraph:

       Proposition 65, as well as the Sherman Food and Drug Law 
     are examples of the type of State regulation that protects 
     the health and safety of its citizens and that coexist 
     comfortably with Federal regulation. The States should be 
     permitted to continue in their historic role as guardians of 
     the welfare of their citizens. We therefore respectfully urge 
     you to seek modification of your bill to address this issue.

  There it is, Mr. President, from the attorney general of California, 
a conservative Republican, who understands as a person that has been 
working and implementing this legislation why this proposal is rotten 
and why it ought to be adjusted.
  Mr. President, a few years ago, the agency proposed establishing a 
cosmetics hotline to receive consumer complaints. The FDA hoped to fill 
in gaps

[[Page S8868]]

because their voluntary cosmetics adverse event reporting systems had 
dismal compliance rates of well below 40 percent. The majority of all 
cosmetics health problems were going unreported, and here was an 
ingenious solution. The reason the reporting systems were all voluntary 
is because the FDA does not have the authority to require companies to 
tell consumers what kind of problems consumers are having. Put Congress 
and some heavy lobbying together and you get a congressional 
prohibition forbidding FDA from establishing the hotline. So we were 
denying the FDA from having a hotline.
  When will it stop, Mr. President? We are preempting all of the 
States, except California, from taking any steps to give the FDA any 
kind of additional authority. Then when there was the effort to just 
establish a hotline so people could call in and register their 
complaints, the funding for that hotline was dropped. I wonder why? I 
can tell you why. I gave you some examples of why, just a few moments 
ago, with the consumer complaints to various agencies, including the 
FDA, with people writing in. No, we are not going to hear from the 
public.
  Finally, Mr. President, there was some reference earlier about 
medical device legislation in Europe. We often hear about FDA's 
regulation of drugs as the international gold standard. I refer to our 
country's regulation of cosmetics as the fool's gold standard. Cosmetic 
regulation in other countries is far superior to our own. The European 
Union requires full ingredient listing on packaging, documentary proof 
of good manufacturing practice, and similar proof that extensive 
testing has been carried out on all products. Mexico recently adopted 
regulation mandating expiration dates on all cosmetics. Although New 
York recently adopted just such a rule, it may live a short life--the 
bill before the Senate would preempt that regulation even if FDA does 
not have its own regulation in place.
  Let's continue on our world tour. Canada requires that manufacturers 
submit data showing that a product is safe under normal use conditions. 
Sweden is initiating product registration for cosmetics and Denmark is 
considering a similar law. Malaysia requires mandatory registration of 
cosmetics. The list goes on, but the point is clear. We are not content 
to lag behind other countries in protecting our citizens. We prefer to 
buck the trend and expose them to greater hazards. As experience has 
shown in other countries and in California with Proposition 65, the 
industry can readily comply with meaningful safety standards when they 
are imposed.
  Unlike food or drugs, cosmetics are not essential to our health. We 
use them because their benefits are so clear. We need only mention this 
summer's unprecedented beef recall to illustrate that our food supply 
is not perfectly safe. But cosmetics are a different matter. We are not 
compelled to use them. For that reason, we should be far less willing 
to accept injury and death from such products.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER (Mr. Helms). The clerk will call the roll.
  The bill clerk called the roll.
  Mr. KENNEDY. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Mr. President, earlier I reviewed for the Senate the 
actions that have been taken by the States which have resulted in 
additional kinds of protections for safety for the American consumer in 
those States, primarily in California. I reviewed some of the items 
that posed the principal health hazards for citizens--the lead, the 
mercury, and other items and what has happened by the States when 
removing those items.
  Then I also mentioned, Mr. President, the limitations we have in 
terms of the Food and Drug Administration in taking any actions to 
protect people and the power of the cosmetic industry in refusing to 
even have a hotline. We have hotlines in so many different and 
important areas for American people. We have them with regard to 
battered women, as one of the principal sponsors for that. We are not 
comparing that need with this one but there is enormous importance and 
enormous justification and that has been a powerful, powerful 
instrument for battered women in our society.
  We wanted to try and have at least a hotline for people that might be 
able to have been impacted adversely by these cosmetics. We mentioned 
already that there are 46,000, at the last count, people going to 
emergency rooms--46,000. And we know the dangers which are out there in 
terms of impacting the American consumer and they have increased 
dramatically with the increase in products. It has been recognized by 
the companies and the industry itself by the number of products and the 
complexity and the toxins that have been included.
  So the only real opportunity that we have other than going to the 
States and reviewing the kind of complaints that they have has been 
from the various agencies of government. I mentioned just a few moments 
ago about these various items and I will go into greater detail with 
the companies and what the allegations are and what the results are on 
Monday. I have them here but I will not take the additional time.
  The fact is, these are the kind of results we are having, Mr. 
President. When California runs into those circumstances they can do 
something about it. When California found out about a particular 
product, the State was able to do something about it. Now, under this 
legislation, on this preemption, 49 States will not be able to do 
something about it. California has been grandfathered in, but all of 
the rest of us that come from other States will not be able to get that 
kind of a protection.
  Now, I just mention the kind of injury complaints that have been 
included. They include, going through this code which we are gradually 
going through, injury code 14 includes rash, redness, swelling, 
blisters, sores, weeping, lumps, inflammation, sunburn, chemical burn 
and irritation; code 19, pain, to include itching, stinging, burning, 
soreness, and tingling; injury code 20, tissue damage--other than 
thermal burn, peeling, splitting, cracking, hair, or nail breakage; 
code 21, discoloration; code 22, infection; code 23, nervous system 
reactions, to include dizziness, headache, irritability, nervousness, 
numbness; injury code 24, respiratory reaction, to include choking, 
coughing, sneezing, shortness of breath, wheezing; code 25, digestive 
system reaction, upset stomach, nausea, loss of appetite, vomiting, 
diarrhea; code 26, bleeding, code 27, urinary tract infections; code 
28, flammability resulting in thermal burns; code 29, blurred vision; 
code 30, death as a result of inhalation or sniffing deaths, and code 
31.

  These are serious, Mr. President. These are serious health hazards. 
Before we in this body and the House of Representatives see a piece of 
legislation tagged on to the important Food and Drug Administration, 
the medical device and the pharmaceuticals which are so important, on 
which we have made so much progress, on which all of us are hopeful 
will finally result in a bipartisan agreement, we see the greed of the 
cosmetic industry go right out there and tag on this amendment as one 
of the last amendments to preclude the States--they have gotten the 
Government effectively precluded, unlike the European countries. The 
European Union, and most of the other industrial countries of the 
world, have some protections. They have been able to preclude the 
Federal Government, and now they are precluding the States from 
protecting the consumers and putting them at risk for all those kinds 
of illnesses and sicknesses that I have talked about here that are 
resulting from all of those products.
  That is what we are being asked to embrace. That is what we are being 
asked to embrace. For those that understand the importance--the 
Attorney General of the State of California, who has been working on 
this, makes it so clear: Don't do it, Senator. Don't do it, Senate of 
the United States. Don't do it in the Congress and Senate. Mr. 
President, don't sign that legislation. He wants to be able to protect 
the people in California, as other public health officials want to be 
able to protect their people in the other 49 States. That is the issue. 
That is the issue.
  We are going to come back to it again and again and again, Mr. 
President, because it is of such enormous importance to the health and 
safety. The other side of the balance is the

[[Page S8869]]

question of greed by the cosmetics industry. Usually, when we are 
making tough decisions around here--and we have made them--we have 
limited funding; for example, for the food programs for our elderly 
people. We have to make a judgment, are we going to treat more people 
in congregate sites where you can feed more elderly people with limited 
resources, or are we going to carve out some and feed them at home, 
which means you will get to less people, you will get those people that 
are homebound. What do you do under those circumstances? You are 
placing needy people of one side against needy people on the other.
  No easy answers on this. Painful judgments and decisions on that. We 
don't always get it right. We understand that. People of good will can 
differ on that and feel strongly about it, and we respect them here in 
this body. But under this circumstance, we are talking about the 
profits of the cosmetics industry and the risk to the American 
consumer. That is what the balance is. That is what is unacceptable. 
That is what is outrageous and that is why that cloture vote was 
necessary, so we begin to wake up America as to what is happening to 
these States. That is what we are going to have an opportunity to 
debate as we go to this bill, plus the other measures.
  Mr. President, the last unacceptable element of this bill is an 
assault on the basic environmental protections contained in the 
National Environmental Protection Act, which is a key Federal 
environmental statute that regulates the Government's own actions 
through environmental impact statements. Under NEPA, Federal agencies 
must undertake a comprehensive environmental planning process for every 
major action they take. This law is a crucial statutory assurance that 
the work of the Government, the actions of regulated industries are 
consistent with the guiding principles of environmental protection.
  Section 602 of the bill broadly exempts FDA's activities from 
environmental impact assessment under NEPA. This is the first 
preemption of NEPA in a regulatory agency and is the beginning now of 
cutting back very, very important environmental issues. For what 
reason? Why are we, in our committee that is responsible in terms of 
the education and the health and basic research, and the basic 
oversight of laws dealing with labor and management, pensions, and some 
of the older Americans activities --why in the world are we going 
around here in terms of preempting NEPA from the FDA? Who do you think 
was interested in that? Perhaps some of the industries who want to get 
out from under filing the environmental impact statement. If we are 
starting off with this agency, we know exactly what is going to happen 
in each of the other agencies.
  This week, I spoke with the Vice President who expressed his serious 
personal concerns about this provision. Just a few sentences: This bill 
opens the door to weakening environmental protection, and lays a 
welcome mat down for future exemptions and attacks on the effective and 
essential environmental statute. This is an act of environmental 
extremism, which should have no place in this or any other bill.
  The reauthorization of the prescription drug and user fee is 
tremendously important to assure that the FDA will have the resources 
to review the new drugs. That is what we ought to be addressing.
  Mr. President, what is the parliamentary situation?
  The PRESIDING OFFICER. The Senator from Massachusetts has 55 minutes 
28 seconds remaining.
  Mr. KENNEDY. Fine. I thank the Chair. I want to prepare to yield back 
the balance of my time this afternoon. As I understand, from a previous 
agreement, we will have time to continue this debate, I believe, on 
Monday next for a period of 4 hours, with the time evenly divided, 
starting at 11 o'clock, is that correct?
  The PRESIDING OFFICER. Yes.
  Mr. KENNEDY. I yield back the remaining time this afternoon.

                          ____________________