[Congressional Record Volume 143, Number 116 (Friday, September 5, 1997)]
[Senate]
[Pages S8837-S8850]
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 PRESIDING OFFICER (Mr. Coats). Under the previous order, there 
will be debate until 9:50 a.m., equally divided, on S. 830. It will be 
a little bit less than 12 minutes.
  Mr. JEFFORDS. Mr. President, I yield myself 2 minutes.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.
  Mr. JEFFORDS. Mr. President, I salute the majority leader for moving 
the debate on the FDA modernization forward. We should no longer 
needlessly delay consideration of S. 830, the Food and Drug 
Administration Modernization and Accountability Act of 1997.
  S. 830 represents months of bipartisan effort to address serious 
shortcomings in the FDA's regulatory procedures. Two hearings were 
held. The measure passed the committee with a strong bipartisan 14-to-4 
vote, and months of negotiations have ensued with dozens of 
accommodations made for Senator Kennedy and the administration.
  For almost 20 years, Congress, the General Accounting Office, and 
numerous advisory commissions have examined, reviewed, and made 
recommendations to modernize the FDA.
  During 1978 and 1979, Senator Kennedy championed legislation that 
would have required FDA to do some of the very same things we are 
requiring of it in S. 830.
  In 1982, the Commission on the Federal Drug Approval Process, 
convened at the request of Representatives Albert Gore and James 
Scheuer, recommended simpler investigational new drug requirements. The 
Commission recognized that drug effectiveness could be demonstrated by 
one study in appropriate cases, and it urged greater use of outside 
expert advice and improved interactions with industry.
  In 1989, the advisory committee on the FDA, on which Dr. David 
Kessler served, made a key recommendation. It said:

       . . . the agency should be guided by the principle that 
     expeditious approval of useful and safe new products enhances 
     the health of the American people. Approving such products 
     can be as important as preventing the marketing of harmful or 
     ineffective products.

  In 1991, Vice President Quayle's Council on Competitiveness 
recommended that the FDA expand the use of outside reviews and advisory 
committees, interpret efficacy with a more appropriate standard, and 
enhance internal agency management.
  More recently, Vice President Gore has used the President's 
``reinventing Government'' initiative to improve the FDA product 
approval system and to eliminate outmoded FDA regulations for a variety 
of drugs, medical devices, and food products.

[[Page S8838]]

  Last year, the committee on Labor and Human Resources held four 
hearings on reforming the FDA. The witnesses testified about the same 
problems that have been described for 20 years, and they recommended 
many of the same solutions that have been recommended for 20 years.

  This year, the Labor Committee continued its effort to modernize the 
FDA. The committee held two hearings in early 1997. The first hearing 
was dedicated to the FDA, and the second hearing included 
representatives from patient and consumer coalitions and from the food, 
drug, and medical devices sector regulated by the FDA. It is no easy 
task that we ask FDA to perform. Americans want the FDA to hold the 
gate tightly shut against unsafe or ineffective products while opening 
it wide for the next generation of innovation. Clear statutory guidance 
is needed to assist the agency to find this delicate balance and to 
bring our food and drug laws and regulatory systems into the next 
century. S. 830 contributes significantly to reaching that balance. The 
measure embodies the bipartisan conclusions and recommendations reached 
for the past 20 years for accomplishing this difficult task of 
balancing risk and promise.
  Mr. President, a few have charged that this Congress is moving too 
fast. They ask, ``What's the rush?'' But they have asked the wrong 
question. For the past 20 years, every administration has sought to 
make FDA better--to make better, safe and more effective products more 
readily available. After almost 20 years, we must ask ourselves, why 
delay further? Why continue to delay reforms that have been studied, 
reviewed, recommended, restudied, and endorsed again and again for over 
20 years? Clearly, the FDA should be modernized now.
  The PRESIDING OFFICER. The Chair informs the Senator from Vermont, on 
his time, there are 4 minutes 24 seconds remaining.
  Mr. JEFFORDS. Thank you. I yield the floor.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I have how much time?
  The PRESIDING OFFICER. Eight minutes.
  Mr. KENNEDY. I yield myself 6 minutes.
  The PRESIDING OFFICER. The Senator is recognized for 6 minutes.


                         Privilege of the Floor

  Mr. KENNEDY. Mr. President, I ask unanimous consent that Diane 
Robertson be given the privilege of the floor during the consideration 
of this legislation.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Mr. President, first of all, I congratulate my friend 
and colleague, Senator Jeffords, for the attention he has given to 
trying to bring the FDA into the modern world and to trying to consider 
a wide variety of different recommendations and suggestions and for 
working with the members of our committee, both the Republicans and 
Democrats.
  This has been a trying process, but I commend him--and I speak for 
all of those on our side--for the diligence with which he has 
approached this and the knowledge he has demonstrated on this 
particular range of issues.
  We all understand, the American people understand, that the principal 
responsibility of the FDA is to preserve and protect the public health. 
This is different from other agencies. Therefore, any alteration or 
change in the authority of the FDA and in consideration that various 
aspects of the law have to be balanced against what is in the short-
term, medium-term and long-term interest of the public health of the 
American people. The FDA is the singular agency throughout the world 
that has demonstrated that it understands that particular commitment 
and has done an extraordinary job.
  Many of us have frustrations about the FDA on particular products in 
our State and about general kinds of process and procedure. But no one 
can review the history of the FDA and not understand that today the FDA 
is the principal instrument for approving new drugs and new medical 
devices. This legislation today is to try to extend what we call the 
PDUFA, which is a proposal that was enacted under the leadership of 
Senator Hatch and myself a number of years ago, which provides user 
fees by the major drug companies to make sure that we will have the 
expertise to consider various drug products more rapidly. There is an 
important need for the extension of that particular proposal, and all 
of us want to see it extended. I am a strong supporter of extending it. 
There are many, many features of this legislation which I support.
  But having said that, Mr. President, we have to look at the remaining 
items that need attention and, in particular, one which is completely 
unacceptable and enough to warrant and justify the attention of the 
Members of the Senate about whether we are prepared to move ahead and 
consider this legislation, with that particular provision in in, that 
is now before the U.S. Senate. It is a provision that was not a part of 
either the initial proposal that was advanced last year by Senator 
Kassebaum or advanced this year by Senator Jeffords. It concerns the 
whole question of the preemption of the States with regard to cosmetics 
and over-the-counter medicines, but primarily on the issue of 
cosmetics.
  There are other important protection items dealing with unsafe or 
ineffective medical devices, including provisions that could undercut 
FDA's ability to regulate cigarettes, and there is a back-door assault 
on one of the most important environmental protections. We will have a 
chance to get into those later in the course of the morning.
  I want to point out what this legislation is going to do with regard 
to cosmetics, to all of the Members as we are coming over here to 
consider a cloture vote. We have to recognize and we will have a chance 
later on in the morning to point out the limitation of the Food and 
Drug Administration in regulating cosmetics. It has virtually no 
regulatory authority in this area.
  The American people should take no satisfaction in extent of the 
protections regarding the cosmetics they use every single day because 
the Food and Drug Administration does not have the jurisdiction to 
determine what is in those cosmetics, whether they are safe and whether 
they are effective. Absolutely none. There are only two members of the 
FDA who are out there supervising this issue--only two members of the 
FDA--in terms of looking out after the packaging and the labeling 
provisions--two members.
  The enforcement, in terms of protection of the public health on the 
issues of cosmetics, are left to the States. That is where the real 
regulatory authority is today. And now, because of the greed--and it is 
greed--of the cosmetic industry and because of the success of a 
referendum in California, they want to preempt any kind of protections 
for the health and the safety enacted by the States with Federal 
legislation that will effectively eliminate for all time the 
possibility of the States providing protection on health and safety. 
That was put into this legislation as an amendment. That amendment has 
been objected to, not just by the Senator from Massachusetts, but by 
all of the Governors of the 50 States.
  I will submit the correspondence from the National Governors' 
Association and from a principal Republican Attorney General Dan 
Lundgren of the State of California, a State that has done more in 
terms of protecting the American public as a result of the legislation 
passed in California than anyone else.
  The last GAO study points out that in the cosmetics used primarily by 
women in this country every day, 125 ingredients are suspected of 
causing cancer, 20 ingredients are suspected of damaging the nervous 
system, 20 ingredients are suspected of causing birth defects. And the 
list goes on and on and on.

  And to put that into this legislation without a single day of 
hearings--without a single day of hearings; the last hearings in the 
Senate of the United States were in 1978--will amount to a wholesale 
threat to the health of the American consumer. Primarily the women of 
this country do not deserve the kind of vote for cloture in moving 
ahead and effectively denying us the opportunity for a full debate and 
discussion of the issues that this provision deserves. That is why I 
hope that the vote on cloture is not successful.
  The PRESIDING OFFICER. The time of the Senator has expired.

[[Page S8839]]

  Mr. JEFFORDS. I yield 2 minutes to the Senator from Connecticut, 
Senator Dodd, and the remaining time after that to Senator Coats.
  Mr. DODD addressed the Chair.
  The PRESIDING OFFICER. The Senator from Connecticut.
  Mr. DODD. I thank my colleague from Vermont.
  Mr. President, I urge our colleagues to vote to invoke cloture on 
this. But let me say at the outset here I want to commend our 
colleagues, and particularly my colleague from Massachusetts on this 
matter. He has labored for many, many years on FDA legislation. And he 
brings up an issue here regarding the cosmetics issue which will 
certainly be the subject of debate and has been the subject of debate 
in our committee over the last 2\1/2\ years. In the most recent round 
of markups--we have been through a couple markups--the bill has had 
pretty substantial bipartisan support coming out of the committee. I 
think our vote was something like 14 to 4 in the last markup.
  This is an important piece of legislation. September 30 is coming. We 
have to reauthorize PDUFA. This is the first time we have been able to 
deal with FDA in a way that will not only guarantee that we will have a 
quicker response on these applications, but also a safe and efficient 
and effective response for the consumers, the patient groups of this 
country.
  This is a very important piece of legislation. I commend my colleague 
from Vermont, the chairman of the committee, for his leadership on 
this. The committee has worked very, very hard on this, my colleague 
from Indiana and others. We have had some very difficult issues over 
the last 2\1/2\ years to try to reach compromise on and resolve them. 
And we have, by and large, with the exception of this one issue which 
is a great testament to the efforts of the members of the committee and 
the staffs that have worked on this.
  But I think it is time now that we bring the bill to the floor and 
try to leave it up to the Members themselves to resolve any outstanding 
issues that we have or, hopefully, over the next coming days, to 
achieve a compromise so we can avoid a kind of battle here on the floor 
over one or two remaining issues.
  Mr. President, I urge that we move forward on this. We have done a 
good job I think in the committee. It is not uncommon for there to be 
an outstanding issue. I urge the invoking of cloture.
  The PRESIDING OFFICER (Mr. Jeffords). The Senator's time has expired.
  The Senator from Indiana has 2 minutes 24 seconds.
  Mr. COATS. I would like to yield some of that time to the Senator 
from Maryland, if she is interested in making some comments. I have a 
limited amount of time, but I would be happy to yield a portion of it.
  Ms. MIKULSKI. Thank you very much.
  I wish to say to my colleagues, we have worked very long and hard to 
move FDA reform ahead, to make sure that products, whether they be 
pharmaceuticals, biologics, or cosmetics, are available in a safe way 
to the American people. There are policy differences, but they should 
be decided on the basis of debates and votes. We should not hold up 
reform on the basis of process.
  Let us vote for cloture. Let us move the bill forward. Let us resolve 
our differences in the usual and customary way. I ask my colleagues to 
join with me to vote for cloture, and then move forward in an adequate, 
robust and well-amplified debate on the issues.
  I thank the Senator from Indiana.
  Mr. COATS. Mr. President, I would like to add my support, in a 
bipartisan way, to the remarks as stated by the Senator from 
Connecticut and the Senator from Maryland and the efforts that have 
been undertaken by the chairman, Chairman Jeffords, and all of us on 
the committee over the past 2\1/2\ years to move this bill forward.
  There has been extensive debate on this in committee, 2\1/2\ years' 
worth. There has been extensive hearings on this. There has been 
extensive negotiation, and there has been extensive compromise on the 
part of those of us who are advocating FDA reform.
  We have made concession after concession after concession to Senator 
Kennedy and the administration and to those who have opposed our 
efforts in an attempt just to get the bill to the floor. Every time we 
solved one issue, a new one pops up that we had discussed over and over 
and over and voted on in committee, but it does not mean that we should 
not move forward with the process.
  All we are asking for today is to move this bill forward so that 
Senator Kennedy and others who have concerns with it can raise their 
objections, can debate it once again, can negotiate some more. But to 
stop the bill from going forward, to keep the drugs from being 
approved, to keep funds from going into FDA, to deny people the 
benefits from FDA approval of drugs and devices, simply because a 
Senator has a problem with one portion of the bill, I think certainly 
does not serve this body well.
  So I urge our colleagues to support the effort to invoke cloture so 
that we can move ahead with this.
  Mrs. BOXER. Will the Senator yield?
  Mr. COATS. I would be happy to.
  The PRESIDING OFFICER. Time has expired.
  Senator Kennedy has 1 minute.
  Mr. KENNEDY. Mr. President, it is not just one Senator. Let me read 
from ``The National Governors' Association, The National Conference of 
State Legislatures.''

       When the Senate Labor and Human Resources Committee 
     considered the Food and Drug Administration Reform 
     legislation . . . the committee adopted an amendment proposed 
     by Senator Gregg that preempts state regulations, disclosure 
     requirements, labeling, and warning requirements as they 
     apply to nonprescription drugs and cosmetics. The National 
     Conference of State Legislatures and the National Governors' 
     Association, vigorously oppose this provision and hope that 
     it will not be part of the bill when it is reported by the 
     Senate.

  These are the Governors, the State legislatures. The Secretary of 
Health indicated that ``We and the administration all agree PDUFA is in 
the best interest. However, as maintained in its present form, with the 
outstanding issues not addressed, we will be forced to recommend to 
veto the legislation.''
  We are talking about health and safety. And we will have a chance to 
develop that in the postvote of this. But this bill contains too many 
important provisions with PDUFA and the medical devices and the drug 
provisions to go forward. And I believe that it should go forward, but 
not with this provision.
  The PRESIDING OFFICER (Mr. Coats). Time has expired.


                             Cloture Motion

  The PRESIDING OFFICER. By unanimous consent, pursuant to rule XXII, 
the Chair lays before the Senate the pending cloture motion, which the 
clerk will state.
  The assistant legislative clerk read as follows:

                             Cloture Motion

       We, the undersigned Senators, in accordance with the 
     provisions of rule XXII of the Standing Rules of the Senate, 
     do hereby move to bring to a close debate on the motion to 
     proceed to Calendar No. 105, S. 830, the FDA reform bill:
         Trent Lott, Jim Jeffords, Pat Roberts, Kay Bailey 
           Hutchison, Tim Hutchinson, Conrad Burns, Chuck Hagel, 
           Jon Kyl, Rod Grams, Pete Domenici, Ted Stevens, 
           Christopher S. Bond, Strom Thurmond, Judd Gregg, Don 
           Nickles, Paul Coverdell.

  The PRESIDING OFFICER. The question is, Is it the sense of the Senate 
that debate on the motion to proceed to the consideration of S. 830, 
the FDA Modernization and Accountability Act, shall be brought to a 
close?
  The yeas and nays are required under the rule. The clerk will call 
the roll.
  The assistant legislative clerk called the roll.
  Mr. NICKLES. I announce that the Senator from Arizona [Mr. McCain], 
the Senator from Alaska [Mr. Murkowski], the Senator from Pennsylvania 
[Mr. Santorum], and the Senator from Wyoming [Mr. Thomas] are 
necessarily absent.
  Ms. MIKULSKI. I announce that the Senator from Kentucky [Mr. Ford] 
and the Senator from Ohio [Mr. Glenn] are necessarily absent.
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The yeas and nays resulted--yeas 89, nays 5, as follows:

                      [Rollcall Vote No. 220 Leg.]

                                YEAS--89

     Abraham
     Allard
     Ashcroft
     Baucus
     Bennett
     Biden
     Bingaman
     Bond
     Boxer

[[Page S8840]]


     Breaux
     Brownback
     Bryan
     Bumpers
     Burns
     Byrd
     Campbell
     Chafee
     Coats
     Cochran
     Collins
     Conrad
     Coverdell
     Craig
     D'Amato
     Daschle
     DeWine
     Dodd
     Domenici
     Dorgan
     Enzi
     Faircloth
     Feingold
     Feinstein
     Frist
     Gorton
     Graham
     Gramm
     Grams
     Grassley
     Gregg
     Hagel
     Harkin
     Hatch
     Helms
     Hollings
     Hutchinson
     Hutchison
     Inhofe
     Inouye
     Jeffords
     Johnson
     Kempthorne
     Kerrey
     Kerry
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lott
     Lugar
     Mack
     McConnell
     Mikulski
     Moseley-Braun
     Moynihan
     Murray
     Nickles
     Reid
     Robb
     Roberts
     Rockefeller
     Roth
     Sarbanes
     Sessions
     Shelby
     Smith (NH)
     Smith (OR)
     Snowe
     Specter
     Stevens
     Thompson
     Thurmond
     Torricelli
     Warner
     Wellstone
     Wyden

                                NAYS--5

     Akaka
     Cleland
     Durbin
     Kennedy
     Reed

                             NOT VOTING--6

     Ford
     Glenn
     McCain
     Murkowski
     Santorum
     Thomas
  The PRESIDING OFFICER. On this vote, the yeas are 89, the nays are 5.
  Three-fifths of the Senators duly chosen and sworn having voted in 
the affirmative, the motion is agreed to.
  Mr. JEFFORDS. Mr. President, I want to most sincerely thank my 
colleagues for the tremendous vote to move forward on FDA reform. This 
is most rewarding. All of the proponents and supporters are pleased to 
know that we can go forward at this time.
  This is a tribute to a lot of hard work and compromise from a lot of 
Members on both sides of the aisle and both sides of the issue. The 
vote represents the best of bipartisanship from Senators who support 
it, and even from opponents and the administration. Today is just the 
first step, but it could hardly be a better one. We will need to debate 
this bill, consider amendments to it and, no doubt, improve it. I 
believe that there are still changes that can be made to accommodate 
the concerns that have been expressed here by the opponents. I know we 
can find solutions to those.
  We will need to debate this bill, consider amendments and, as I say, 
no doubt, improve it. But I hope by this time next week, the Senate 
will have given its resounding support to this bill. It is too 
important to the American people to let it languish. It is too 
important for us not to move it out as quickly as possible.
  Mr. President, I yield the floor.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I understand we have a time agreement, am 
I correct? Would the Chair be kind enough to state it?
  The PRESIDING OFFICER. The agreement is: Under a previous order, 
there will be 8 hours of debate, equally divided between the Senator 
from Vermont [Mr. Jeffords] and the Senator from Massachusetts [Mr. 
Kennedy].
  Mr. KENNEDY. I thank the Chair. The legislation we are debating today 
includes many positive elements. It reauthorizes the important 
prescription drug user fee program, one of the most effective 
regulatory reforms ever enacted. It includes a number of other 
provisions that will significantly improve and streamline the 
regulation of prescription drugs, biologic products, and medical 
devices. And I am pleased that through a long process of negotiation, 
both prior to and subsequent to the markup of the legislation, many 
provisions that seriously threaten public health and safety were 
dropped or compromised. But a bill that includes the damaging 
provisions that remain in this bill, should not become law.
  I have received a letter this morning from the Administration 
announcing their opposition to these provisions and their judgment that 
the bill should be vetoed if they are not eliminated. It would be the 
height of folly for the Senate to doom this important legislation to 
failure by taking it up before the provisions that merit a veto are 
removed or changed.
  The provisions that make this bill unworthy of passage by the Senate 
include: The preemption of State regulation of cosmetics and over-the-
counter medicines; the elimination of two important protections against 
unsafe or ineffective medical devices, including a provision that could 
undercut FDA's ability to regulate cigarettes, and a backdoor assault 
on one of the most important environmental protections. The most 
egregious and unjustified provision in this bill would effectively 
preempt the State regulation of over-the-counter drugs and cosmetics. 
These provisions were not included in the chairman's original mark. 
They were not the subject of significant hearings. They have no place 
in a bill whose primary purpose is to reauthorize the Prescription Drug 
User Act.
  If this bill were serious about dealing with issues of over-the-
counter drug and cosmetic regulation, it would undertake a serious 
reform of the whole regulatory structure to assure that consumers are 
adequately protected and not include a single provision designed to 
protect the profits of wealthy companies at the expense of the health 
of consumers. Preemption of cosmetic regulation is fundamentally 
outrageous and shows a callous disregard for the health of American 
women, especially those who are pregnant. It shows a callous disregard 
for the likelihood of birth defects in newborn babies. Cosmetics are 
used far more broadly than most prescription drugs, medical devices, 
and biologic products.
  Whether the issue is hair spray, or shampoo, or lipstick, or baby 
powder, or suntan lotion, or soap, or toothpaste, Americans assume that 
the products they use are safe. But this confidence is too often 
unjustified because Federal oversight of this $20 billion industry 
today is extremely limited. The basic law regulating cosmetics has not 
been updated since 1938. The FDA has less than 30 employees overseeing 
this huge industry. Only two deal with packaging and labeling.
  The legislation, Mr. President, the food and drug and related law, 
has 126 pages dealing with drugs and devices. It has 55 pages for 
foods. It has 1\1/2\ pages of Federal law dealing with cosmetics. It 
basically does not deal with regulating the cosmetics of this Nation.
  The FDA has no authority to require manufacturers of cosmetics to 
register their plans or products. The FDA has no authority to require 
manufacturers to register their plans or products. It cannot require 
manufacturers to file data on the ingredients of their products. So 
there is no information with regard to the ingredients of their 
products. That is completely different, obviously, from the complex and 
vigorous review schedules which are places for pharmaceuticals and for 
medical devices. The FDA cannot require the manufacturers of cosmetics 
to file data on the ingredients in their products. It cannot compel 
manufacturers to file reports on cosmetics-related injuries. It cannot 
require their products be tested for safety, nor can it require that 
the results of safety testing be made available to the agency. It has 
no power, as it does with prescription drugs and medical devices, to 
require that the tests be done or that they gather information as a 
result of tests. It has no oversight authority in terms of making sure 
there are safe manufactured products. None of that currently exists 
with regard to cosmetics. The FDA does not have the right of access to 
manufacturers' records, and it cannot require recall of a product. The 
FDA is virtually outside the loop with regard to giving assurances to 
the American people about the health and safety of their products. This 
is unlike prescription drugs, it is unlike over-the-counter drugs, it 
is unlike medical devices. The FDA is outside the loop.
  A study by the respected, nonpartisan General Accounting Office 
reported that more than 125 ingredients available for use in cosmetics 
are suspected of causing cancer. Twenty cosmetic ingredients may cause 
adverse effects on the nervous system, including headaches, drowsiness, 
and convulsions. Twenty cosmetic ingredients are suspected of causing 
birth defects. The GAO concluded that cosmetics are being marketed in 
the United States that may pose a serious hazard to the public. That is 
the GAO. They concluded that cosmetics are being marketed in the United 
States that may pose a serious hazard to the public.
  The legislation that is before us is saying that the States should 
not be able to do anything about it. This is the primary issue in terms 
of the health the American people--may we have order, Mr. President?
  The PRESIDING OFFICER. The Senate will come to order. Senators will 
cease audible conversation. Would the

[[Page S8841]]

Senators to the Chair's left cease conversation.
  The Senator from Massachusetts.
  Mr. KENNEDY. The cosmetic industry wants the public to believe that 
no effective regulation is necessary at either the State or Federal 
level. They are the masters of the slick ad and expensive public 
relations campaign. But all the glamorous pictures of the world cannot 
obscure the basic facts. This is an industry that is underregulated 
and, too often, hazardous.
  A mother of a beautiful 6-year-old girl in Oakland, CA, found this 
out when she used a hair product on her child that resulted in second-
degree burns on her ears and neck. A 59-year-old California woman 
almost died from an allergic reaction to hair dye. A 47-year-old woman 
had her cornea destroyed by a mascara wand. In another tragic case, a 
woman's hair caught fire as a result of an inflammable hair treatment 
gel. She lost her hair and was severely scarred. Beauty parlor 
employees are particularly vulnerable to asthma and other diseases that 
result from exposure to chemicals in the products that they use.
  In fact, for every 1 million cosmetic products purchased, there are 
more than 200 visits to the doctor to treat cosmetic-caused illnesses. 
In 1987, a study for the Consumer Product Safety Commission found that, 
in 1 year alone, cosmetic products resulted in 47,000 emergency room 
visits. These severe reactions are only the tip of the iceberg. As the 
GAO study 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. The 
injury estimates generally account for only the acute toxic effects--
the effects that are seen right away. It is a fact that many of the 
ingredients, according to the GAO, included in many products are toxic 
in nature, maybe carcinogens, that take time to work their way through 
the body system and only later reflect themselves in incidence of 
cancer, or assaults on the nervous system, or birth defects long after 
they are used.
  In the face of limited Federal authority to protect the public 
against these hazards, and the even more limited resources devoted to 
preventing them, you would think that the Congress would want to 
encourage the States to fill the regulatory vacuum. Since the Federal 
Government is not doing it, you would think we would want the States to 
make sure that they are protecting their consumers.
  That is logical. We are talking about a health and safety issue. We 
are not talking about the economic regulations. We are talking about 
health and safety issues. If we are not going to have a responsibility 
in doing it, you would think we would want the States to move ahead and 
at least ensure the protections. But not in this legislation. 
Effectively we are preempting the States--telling the States they can't 
do it. We are not doing it, and we are not going to permit the States 
to do it either, ever.
  That is the effect of the provisions that have been included and 
added on to the bill in Committee--not in the initial proposal offered 
by Senator Kassebaum, not in the initial proposal offered by Senator 
Jeffords. It was one of the last of the amendments that were 
considered. There have been no hearings on this issue since 1978, 1988 
in the House of Representatives. Still we have moved ahead, basically 
at the whim of the cosmetic industry, a $20 billion industry. This bill 
entirely bars the States from regulating packaging and labeling and 
places severe limits on the States' ability to establish other forms of 
regulation.
  Mr. President, just listen to this language on the scope of the 
preemption provision on the packaging or labeling of a cosmetic: `` * * 
* 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, clear as can be; no more information for the people of 
California, no more information for the people in the Midwest or the 
East. This is what it says. ``This preemption 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.''
  We don't do it at the Federal level, and we are denying the States 
the opportunity. What is the cosmetic industry so afraid of that they 
are precluding any public information or any other form of public 
communication relating to safety? What are they so frightened about? Is 
the almighty dollar worth that much when you are talking about 
carcinogens and toxic substances?
  There it is, Mr. President, as clear as can be. The language, no 
warning labels, no information that a product contains carcinogens or 
can cause severe allergic reactions; no ``keep out of the reach of 
children'' labels; no notification that a product has been recalled 
because it is dangerous or adulterated; no expiration dates. Mexico 
requires expiration dates. The European Union has expiration dates. Sri 
Lanka has expiration dates. But no way--particularly in products such 
as mascara that can deteriorate and adulterate and cause serious 
threats to people's eyes--no expiration dates. The materials have been 
held in terms of the danger of mascara over a period of time without 
endanger rates or warnings to the public that use mascara; no 
preemption, right here in this legislation.
  We are talking about health and safety. That is why we voted on this 
measure--health and safety issues.
  We have already spent more time on this issue now this morning than 
we spent in the committee in its discussion. No ``keep out of the reach 
of children'' labels; no notification that a product has been recalled 
because it is dangerous or adulterated; no notification. The cosmetic 
industry seems to believe that for purchases of their products 
ignorance is bliss. In fact, what you don't know today can severely 
injury you, or even kill you.
  Some States are already taking an active role in protecting 
consumers. Many more may do so in the future. But not if this bill 
becomes law. Minnesota has passed a hazardous product labeling bill 
requiring a warning on all products that are ignitable, corrosive, 
reactive, or toxic. You would think that all consumers should be 
entitled to that kind of information about products which they put on 
their faces or spray on their hair or wash their bodies with. But the 
cosmetic industry disagrees.
  California requires notification if a product contains carcinogens or 
reproductive toxins that cause birth defects. You would think every 
consumer should be entitled to that information. Not after you pass 
this provision. When you take the time later in this debate to go 
through each of these and show the medical information, the study, the 
research which supports that finding, there are products that contain 
carcinogens and reproductive toxins. The studies have been done by some 
of the great research institutions in this country, but the data from 
their studies, warnings to expectant mothers, or to others who are 
going to use that product cannot be communicated to the American public 
by the States.
  That authority will be gone. You can do all the research you want, 
find everything you want, but that authority will be gone. It is out. 
You would think that the consumer should be entitled to that 
information.
  We had support for nutritional labeling around here for consumers to 
have information. It is one of our most important achievements, that 
people have some idea of the nutritional content of their diets, their 
fiber, and the various nutritional elements included in those. People 
want to know. That is enormously important in terms of the general 
health and dietary needs of the American people. But here we are 
talking about carcinogens. We are talking about toxic substances. We 
have the information that is being made available to the public on the 
one hand. But when it comes back to items that are going to endanger 
the health and safety, we are saying, no way--no at the Federal level 
and no at the State level.
  Texas is investigating hormone creams that may affect the 
reproductive health of young women. You would think the States should 
be encouraged to take this kind of action. But this law prohibits it.
  New York requires expiration dates on cosmetics because products can 
break down and be subject to bacterial contamination after a certain 
time period.

[[Page S8842]]

  Most of you would think that this is basic information that every 
consumer should have. But not the cosmetics industry. If you want to 
try to say, OK; we had a preemption of various States' activities with 
regard to food and nutrition, yes. We did. We worked that process out. 
It was worked out with the various interests of the American consumer, 
and it is protected. If you want to go back and see where you want to 
have a national program in terms of preemption in terms of these 
dangers, you are going to talk about a completely different regulation. 
But that isn't recommended. That isn't suggested. That isn't talked 
about. That isn't being considered here. No. All it is saying is you 
are not doing it here at the Federal level. Legislation under the Food 
and Drug Act doesn't permit you to do it, right in that page and a 
half. It shows that they don't have the authority to do it. And we are 
not going to permit you to do it at the State level.
  Mr. President, this provision of the bill is an example of what I 
consider to be the worst kind of sweetheart deal for special interests 
at the expense of the public interest. It is intolerable that it should 
be included in a bill that purports to be the Food and Drug 
Administration Modernization and Accountability Act. We are supposed to 
be out here modernizing the FDA, on the one hand, balancing the very 
important public health interests and also trying to consider the 
legitimate interest of the patient and the consumers using medical 
devices and new pharmacy products. That is a balance. It is a difficult 
and a complex one. You want to bring on line the new kinds of 
innovative products. But you don't want to do it if it poses a threat 
to public safety. That is a balance. And we have differences about the 
time, the process, and the procedure. Those are legitimate public 
health debates and discussions.
  But not with regard to cosmetics.
  So we have worked through the whole area with regard to 
pharmaceuticals and with regard to devices. There are two items which I 
think are of major importance that still need to be addressed. We have 
made very significant and important progress on the matters that are 
enormously important to the health and the safety of the American 
public.
  And because that train is going down the track, here comes an old 
industry, the cosmetic industry, to hook this sweetheart deal right on 
it; hook right on it.
  I hope we are not going to hear from other Members that we now need 
to have hearings now on various other issues after what we have seen on 
the cosmetics. I hope we are not going to have those issues. I heard 
the other day that we need more study in terms of the testing of 
children. We need more hearings on all of this. We have had extensive 
hearings over in the House and some hearings over here. But we need 
many more days of hearings before we jump into this at this direction--
when you are talking about health and safety. And that has effectively 
never been done.
  Another unacceptable part of this bill, Mr. President, contains the 
two provisions dealing with the safety of medical devices, which I will 
come to in just a few moments.
  I see a friend and colleague, the Senator from Rhode Island, here on 
the floor. I would be glad to yield to him whatever time he might take.
  The PRESIDING OFFICER. The Senator from Rhode Island is recognized.
  Mr. REED. Thank you, Mr. President. I thank the Senator from 
Massachusetts for yielding.
  Mr. President, over the past several months, we on the Labor 
Committee have been working diligently and effectively to try to create 
a Food and Drug Administration reform bill--a bill that truly balances 
the need for technological innovations and flexibility but that doesn't 
upset the fundamental obligations of the Food and Drug Administration 
to protect the public's health and safety. And we have made progress.
  We have to recognize that the purpose of this bill fundamentally is 
the reauthorization of the Prescription Drug User Fee Act. That is the 
critical dimension that we are faced with. With the expiration of that 
authority at the end of this month or the beginning of the next fiscal 
year, we would lose a very valuable program, a program that has 
generally provided great success in speeding up approval, of ensuring 
that drugs are brought to the marketplace in a much more efficient and 
effective way. Linking the authorization of the Prescription Drug User 
Fee Act to the controversial FDA reform proposals may threaten many of 
the benefits of PDUFA--the acronym for the Prescription Drug User Fee 
Act. I hope that will not be the case. I hope we can work out some of 
these details and reach a suitable conclusion.
  Much of the credit is due to the leadership of both Senator Jeffords 
and Senator Kennedy. They have been working diligently to arrive at a 
legislative proposal that would balance the need for a rapid and 
effective regulatory response to the approval of medical drugs and 
devices but also fundamentally protect the public health. Frankly, I 
suggest that this is the motivation for our debate today.
  The critical issue has to be, must be, and should be the protection 
of the public health and safety. That is why we have a Food and Drug 
Administration. That is why we maintain a strong, vigilant Food and 
Drug Administration.
  We have agreement, I believe, that PDUFA is working, and that we can 
move forward with PDUFA. The industry is, indeed, thrilled by it. It 
works well. They pay fees dedicated to the examination and review of 
proposed drugs and devices. These resources have enabled the FDA to 
speed up the process.
  In terms of the FDA process, PDUFA has done a great deal. The bill 
that we are considering on the floor today includes a reauthorization 
of PDUFA, and represents many improvements in the original bill that we 
started with, and, indeed, even the bill that emerged from the 
committee. But there are still critical issues that have to be 
addressed in terms of protection of the public health and safety. They 
are complicated issues. They are issues that require careful review and 
deliberation.

  One of the disappointing aspects of this process is that the final 
version of this bill was just released publicly Wednesday, the same 
time the cloture motion was filed. Again, in the spirit of careful, 
thorough, thoughtful review, this does not provide the best opportunity 
to review all the nuances of this legislation.
  So that is why I believe the effort today, led by Senator Kennedy, is 
a very important one. It allows this body to more carefully, more 
intelligently and more thoroughly review provisions that will affect 
the lives of untold Americans. I daresay that the Food and Drug 
Administration reaches the lives of every American, probably more so 
than any regulatory agency in this country.
  All the prescription drugs on the shelves, all of the medical devices 
that are used--all of them, the food additives, all of these things--
are influenced by FDA action. We have to be very careful, very 
thoughtful and, I believe, methodical. So today's debate--and again I 
commend Senator Kennedy for ensuring that we do have a thorough 
debate--is vitally important to that goal.
  I mentioned that we have made progress on this bill, but I should say 
there are also areas that need improvement--desperately need 
improvement. There is one in particular I would like to speak to for a 
moment, and that is the issue of medical device labeling.
  This bill contains a medical device provision which potentially opens 
up a serious public health loophole. Section 404 of this bill would 
prevent the Food and Drug Administration, before clearing a device for 
the market, from examining whether a device will be used for an 
unlabeled use before clearing it for use in the market. This provision 
could allow the gaming of the FDA process where companies could attempt 
to escape a requirement of providing essential safety and effectiveness 
data by adopting a very narrow use for the device.
  For example, under this bill, a company could get approval for a 
biopsy needle from the FDA, even though it may be used in practice--
and, indeed, this would be something that the company might have 
knowledge of--for an entirely different purpose, such as for tumor 
removal. Yet, the company could avoid submitting to the FDA any safety 
or effectiveness data on this device for tumor removal because FDA

[[Page S8843]]

would be prohibited by law from asking for that data. In other words, 
the FDA would be prohibited from looking behind the limited proposed 
use of the device.
  Another example is a company which receives approval of a general 
surgical laser, even though the laser is clearly designed for prostate 
surgery. The public health of the American people is dependent upon a 
thorough and complete review of such devices, and yet, section 404 
would essentially put blindfolds on the agency. They very well might 
know from general literature, the company might very well know from its 
sales force who, when they present this product, hear medical 
professionals saying, ``This is great, but I'll use it for something 
else,'' and yet the FDA would not be able to require data on this 
likely use. This provision would prevent the FDA from providing for the 
safety and effectiveness of medical devices.
  The issue of allowing FDA to look beyond the conditions of use on the 
label and evaluating the use of a device is somewhat of a gray area. 
Certainly, advances in technology, new uses by the medical profession 
of devices should not be inhibited, but we also do not want to 
compromise the ability of the FDA to protect the public health. That is 
the great balance we must strike in this legislation: allowing for 
technological flexibility, regulatory efficiency, but not compromising 
the public health of the American people. It is a balance that we are 
edging close to.
  We have made progress since the adoption of this bill at the 
committee level, but more progress can and should be made. We are 
committed to making such progress. We are committed, I think, to coming 
up with final legislation that will reflect both the need for 
technological efficiency and innovation, but also protecting the public 
health of the American people.
  I hope we can do that. I know that we desperately want, all of us, to 
reauthorize PDUFA so that we can continue that outstanding record of 
regulatory efficiency and approvals that have been generated by PDUFA. 
But, I don't think any of us want to create a situation where months 
from now or years from now we are confronted with public health 
problems because we acted hastily or we acted without the thoughtful, 
careful review that is necessary to develop legislation that protects 
the public health and provides for all of the new innovations that are 
fast becoming part of our medical marketplace.
  Again, I commend Senator Kennedy for his unflinching efforts to 
ensure that these concerns are fully addressed. I also thank and 
commend the chairman of the committee who has worked diligently, 
sincerely and doggedly over these last several months to try to bring 
together opposing views on the committee. I believe we are close but 
not quite there yet. I believe in the days ahead, we can, in fact, 
reach a position of which we will all be very, very proud. At this 
time, I am prepared to yield back to the senior Senator from 
Massachusetts.
  Mr. KENNEDY. I thank the Senator very much for identifying not only 
this issue on cosmetics, but also the issue of the medical devices 
proposal. That is an extremely important measure. Obviously, if there 
is advertisement and an intention for a certain kind of purpose and 
technologically it is suitable for that purpose, it meets the health 
and safety standards to be used for other kinds of purposes, that 
raises some very, very important questions.
  The particular example that the Senator gave with regard to the 
biopsy needle is a current one. We understand it might be a suitable 
device in getting a biopsy in terms of cancer, but there are those 
actually using it to extract certain kinds of tumors. Whether it does 
that or not--and people assume it is going to be effective in doing 
that because it is used for other purposes --this is something that the 
device has not been tested for or intended. I think they there are very 
important health issues that are related and can be addressed. There 
are ways of trying to address those particular issues. We have tried to 
do this, and we still have important health and safety issues which I 
think are unresolved.
  Mr. REED. If the Senator will yield for response, one of my fears is 
that not only would this situation result in perhaps not giving the FDA 
data on uses that the companies are aware of in the marketplace, but it 
might provide a subtle incentive in marketing these devices to 
encourage uses that are not authorized by the FDA and certainly not to 
be attentive to those types of uses and report back to regulatory 
authorities.
  Again, when we think about this legislation, we have to think about 
also that there are a complex set of incentives and disincentives for 
the best possible behavior by pharmaceutical and device companies. I 
don't think any of us would like to unwittingly create a situation in 
which devices approved for one use are cavalierly marketed by companies 
for other uses and are merely winked at when they do not fall within 
the category of the approval. So that is another important issue.
  There is another aspect of this which I would like to raise with 
Senator Kennedy, and that is, I understand that Secretary Shalala has 
communicated concerns about this issue. I understand that she is 
concerned about this and her concern may be of such a level that it 
could suggest that she recommend to the President a veto of this 
legislation. A veto would be, I think, particularly unfortunate since 
we have worked so hard, we have made so much progress, and we have 
reached a point where we are very close to legislation which could 
virtually pass with unanimity in this body. It would be unfortunate 
that this type of provision of the bill would disrupt that process. I 
wonder if that is correct.
  Mr. KENNEDY. The Senator is quite correct. In the Secretary's letter, 
she mentioned several items. 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:

                                           The Secretary of Health


                                           and Human Services,

                                Washington, DC, September 5, 1997.
     Hon. James M. Jeffords,
     Chairman, Committee on Labor and Human Resources, U.S. 
         Senate, Washington, DC.
       Dear Mr. Chairman: I am writing to reiterate the 
     Administration's commitment to continue working with you to 
     accomplish the timely reauthorization of the Prescription 
     Drug User Fee Act (PDUFA) of 1992 and the passage of 
     constructive bipartisan Food and Drug Administration (FDA) 
     reforms. I very much appreciate your leadership and hard work 
     on the important issues that are raised by the FDA 
     legislation and the spirit of cooperation and accommodation 
     that resulted in agreement on so many of the provisions in 
     the Food and Drug Administration Accountability Act of 1997, 
     S. 830. However, we are concerned that a timely 
     reauthorization of PDUFA is in jeopardy.
       Mr. Chairman, since S. 830 was reported out of Committee in 
     June, we have come a long way and have reached agreement on 
     what appeared to be the most difficult issues in the bill, 
     including the dissemination of information by drug and device 
     manufacturers, the effectiveness standard for drugs and 
     biologics, the regulation of health economic claims, and the 
     regulation of drugs made through pharmacy compounding. 
     Unfortunately, we continue to have serious concerns about a 
     number of issues that remain unresolved. We think that most 
     of these issues can be worked out, but there are four issues 
     that have the potential for jeopardizing our mutual goal of 
     timely reauthorization of PDUFA and passage of constructive, 
     bipartisan FDA reform.
       The first of these issues is preemption of the state 
     regulation of over-the-counter drugs and cosmetics. The 
     Administration has serious concerns about far-reaching 
     preemption--particularly in the absence of a strong federal 
     program. The second issue relates to what FDA may consider in 
     making substantial equivalence determinations for newly 
     marketed devices. For example, the bill requires the Agency 
     to review the intended use of a new device based on the 
     manufacturer's proposed labeling--even if the device's 
     technology clearly indicates that the device will be used for 
     a use not included in the labeling. Third, the bill seriously 
     undermines what was sought to be accomplished by the National 
     Environmental Policy Act by virtually eliminating the 
     requirement that FDA disclose the environmental impact of new 
     products that it approves. The Administration recently took 
     significant steps to decrease the burdens that were 
     associated with conducting environmental assessments for FDA-
     approved products. We can think of no reason to jeopardize 
     the environment by eliminating a review that is not costly to 
     industry. Fourth, the PDUFA trigger as currently proposed in 
     the bill would undercut the bipartisan budget agreement by 
     denying FDA access to user fees at expenditure levels 
     consistent with the Balanced Budget Agreement and would 
     interfere with my ability to allocate resources 
     appropriately throughout the Department. Finally, with 
     respect to the pediatric labeling issue, we want to work 
     with the Congress to assure that any provisions in the 
     final bill complement the recent FDA actions and reach our 
     mutual goal of effectively protecting our nation's 
     children

[[Page S8844]]

     and providing needed information to health professionals 
     who treat them.
       Mr. Chairman, we in the Administration all agree that 
     reauthorization of PDUFA is in the best interest of the 
     American public. We believe that we are close to reaching 
     consensus on a bipartisan bill that includes this essential 
     reauthorization. However, if the bill were maintained in its 
     present form, and the outstanding issues were not addressed, 
     I would be forced to recommend to the President that he veto 
     this legislation.
       The Office of Management and Budget advises that there is 
     no objection to the presentation of this report, and that 
     enactment of S. 830 would not be in accord with the 
     President's program.
           Sincerely,
                                                 Donna E. Shalala.

  Mr. KENNEDY. Mr. President, the letter says:

       The second issue relates to what FDA may consider in making 
     substantial equivalence determinations for newly marketed 
     devices. For example, the bill requires the agency to review 
     the intended use of a new device based on the manufacturer's 
     proposed labeling, even if the device's technology clearly 
     indicates the device will be used for a use not included in 
     the labeling.

  So I think the point the Senator makes where they get approval for a 
particular purpose, it might be easier to get it for one purpose but 
with the clear intention of marketing for another purpose in which 
there has not been testing, and that can produce a hazard to the 
individual.
  We have seen, for example, in some of the laser technologies that 
they have been approved for certain kinds of cutting procedures, and 
then they have been in certain instances adopted, for example, for 
prostate cancer, where they have not been tested and have not been 
effectively cleared and pose some very important health hazards.
  So this is something that is very important, as we are moving through 
innovation, because we want to make sure we get those innovations. We 
want to make sure that the products are tested and have full 
information and disclosure.
  I thought we worked out language to try and deal with that. It is an 
important health issue, and I appreciate the Senator's focus and 
attention on it. It is a matter of sufficient importance in terms of 
public health that we would have this identified by the Secretary as 
being one of the two or three items that the Secretary has identified 
would pose sufficient health hazard as to indicate a recommendation for 
a veto.
  Mr. REED. If the Senator will yield again, I concur with his 
analysis, with the danger, and also with the fact this has risen to the 
level of the Secretary of Health and Human Services as a significant an 
obstacle to passage or acceptance by the President. Again, I don't 
think any of us are suggesting that pharmaceutical and device 
manufacturers are going to--some may, but I hope not--deliberately try 
to bait and switch. But the market is evolving so much and there is so 
much innovation that if the FDA can't, by reviewing the literature, 
make an estimate of what a device might be used for and ask for data on 
that likely use, then I think we are really constraining FDA--as I said 
before, putting blinders on the FDA.
  That, I think, would be a mistake in policy. And I also feel, based 
upon my sense of the progress we have made to date, that this is not an 
unsolvable issue. This issue is one that there is compromise language, 
with which we can both provide for innovation, we can provide for 
marketing, we can avoid cumbersome demands by the FDA. But we can still 
give the FDA the authority to say, ``Listen, you are marketing this 
device for a very specific use, but we are aware that it would likely 
be used two or three others ways. How does this device work in those 
contexts?'' This is a very serious issue.
  Once again, without the efforts of the Senator from Massachusetts to 
try to focus on these issues, it well could have been lost in the 
clamor of getting out of here and getting on with other business. It 
would be, in the long run, unfortunate for the public health of the 
American people.
  Let me conclude by saying that it is vitally important in ensuring 
when the bill passes--and I believe we all hope it passes--it passes in 
a way we will all be proud of and will deal with all these issues that, 
leaving no unintended loophole or unintended consequences. I hope that 
we will have thought it through, worked it out and come up with 
legislation that will provide for the kind of technological innovation 
we all want, provide for the kind of efficient regulatory review that 
we all want and certainly protect the safety of the American public 
which not only we want but the American people demand. I yield the 
floor.
  Mr. KENNEDY. Mr. President, I thank the Senator from Rhode Island for 
raising those issues, because that is a rather technical issue, it is a 
rather targeted question, but one that is of very significant 
importance.
  I certainly agree with the Senator that we don't believe that the 
overwhelming majority of the medical device manufacturers don't intend 
to do such things. But what we have to try and do is make sure that 
those who may want to--and that is basically what happens in any 
regulatory procedure--you want to try and catch those particular items 
which are dangerous; that this is one that, with the tremendous 
expansion, in terms of certainly medical device technology, that we 
should address.
  I appreciate the Senator saying that it can be addressed. We had 
language that we had considered, that I thought the device industry had 
been very supportive of and was acceptable. Then in the rush at the 
end, somehow individuals who had been involved in it felt they didn't 
want to have any further kind of adjustment or change in the language.
  I think it is significant--and I am sure the Senator would agree and 
the chairman would agree--that we have had, in the fashioning of this 
bill great support and cooperation from the industry, from the 
pharmaceutical and also the device industry. We have perhaps some 
differences that have been moving along on particular kinds of items, 
but I must say--and I think the Senator would agree; I know he is proud 
of the industry in his own State, as I am in my State--we have had 
enormous cooperation and help. So many of these items are 
technologically difficult, complicated, and involved. We are basically 
generalists as Members of the Senate. We have some information and try 
to develop some expertise in particular areas of responsibility, but 
this gets to an involvement in detail which is enormously complex. When 
we have responsible industry involvement trying to help us. I did find 
that in other parts of the legislation it was very helpful. What we 
hope to do as this whole process moves ahead is come back and visit 
this provision and see if we cannot address it.
  Mr. REED. If I may, if the Senator will yield, I, too, concur with 
the support, the assistance, the advice, and I think the general 
goodwill that the industry has brought to this debate. We are now, 
though, at the detail level, the fine detail, technical detail, and 
that is critically important. These are the types of details which 
later on come back to haunt us sometimes if they are not done well.
  Mr. KENNEDY. Yes.
  Mr. REED. The industry has been responsive and reasonable, and we 
want to incorporate their best advice but also recognize that our 
ultimate responsibility is to the health of the American people.
  Something else, too, that the Senator alluded to was that this 
industry is becoming a very important part of our economy, not just 
nationally but locally. In Rhode Island we have several companies that 
are emerging as leaders in the industry. They offer not only 
extraordinary opportunities to help the American people, indeed, the 
people of the world, through medicine and devices, but also are 
becoming increasingly important economic powers within our 
communities--sources of jobs, employment and the types of activity that 
we certainly want to encourage.
  Part of our motivation today is to ensure that we do this right. We 
need to give them the kind of direction and incentives that will make 
them stronger competitors in the international marketplace, stronger 
sources of strength in the communities of America, but also make them 
responsible and accountable to the American people through appropriate 
regulation. All of these things we can accomplish because I believe 
that the differences that separate us at the moment are not 
fundamental, ideological or in any other sense broad based. They are, 
rather, important details which will ensure or not ensure that this 
legislation can be used effectively to protect the public health.

[[Page S8845]]

  So again I thank the Senator.
  Mr. KENNEDY. I thank the Senator.
  When we are talking about these technicalities, we have to remember 
that some of these items, particularly those medical devices that enter 
the body, have enormous health implications. I remember chairing, in 
1974 or 1975, the Dalkon shield hearings where we found that 2,300 
American women died from a perforated uterus from the Dalkon shield. 
That was before we had a Food and Drug Administration that really 
looked into medical devices.
  We have the Shiley heart valve that passed through the FDA, and then 
eventually the FDA was able to uncover some of the difficulties with 
that and took steps. I think, if my memory serves me correctly, they 
were going to use a perfected Shiley heart valve over in Europe, and 
they altered some opening where the blood went through by just about 10 
degrees, and that resulted in a rather significant increase in the 
failure of that medical device which was actually marketed abroad. The 
FDA was very much involved in seeing the termination of that.
  So even very modest changes or alterations can have important kinds 
of health implications. We are not going to be able to solve all the 
problems and we are not interested in producing a bureaucracy that is 
going to halt innovative and creative ways of dealing with some of 
these issues. But it is important that we are talking about a Food and 
Drug Administration and public health.
  As I mentioned briefly at the outset, this is the one agency that is 
intimately involved with public health. It has broad jurisdiction on a 
wide variety of items, and it has important responsibilities for the 
public health. This is where the buck stops. Some feel it ought to just 
be the agency to fast track various kinds of devices or fast track 
various pharmaceuticals without considering the health and 
efficaciousness of those products. That is why I think it is useful to 
pause here for a little while to give some focus to exactly this 
legislation and what its implications are going to be in terms of 
public health.
  I thank the Senator.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. I would like to speak for a few moments just to try to 
allow those of my colleagues who are viewing us here as to why all this 
controversy. We just saw a vote of 89 to 5 in favor of moving forward 
with a bill that has come out and is ready to be placed before the 
body. Why is that occurring with all of these horrible problems which 
we have just been hearing about?
  Take a look at this bill. This bill is 152 pages long--152 pages 
long. We are talking about four pages on cosmetics and two pages on 
medical devices. So we have to keep things in perspective. This bill 
has tremendous support because in almost every instance the issues that 
are of concern to people are taken care of.
  But why all of this discussion about cosmetics? Because nobody is 
doing anything. That is why the controversy. The question is who should 
do something. Now, the question is whether or not you want some 
uniformity, and that is the Federal Government, the FDA, which we have 
tremendous confidence in, to take on the issue of warning about the 
problems of cosmetics and to have a uniform approach, uniform labels 
and those things so, if you go from one place to another, you don't get 
confused about what you should or should not be using or doing.
  That is the question here. It revolves down to this. Right now, the 
States say, oh, my God, you can't tell us what we can do. Well, they 
haven't been doing anything, with the exception of California. It is 
not something we are moving into and pushing aside all existing 
regulations; there are none. The question is who ought to do it. Well, 
to California we said, OK, you have that so we will carve you out. Go 
forward. You have yours out there. That is fine. The Federal Government 
will not intervene, will not do away with that. So the bill presently 
says, California, what you have done is fine. The question is everyone 
else.
  Now, since nobody has moved into this, it is not like you have a 
whole bunch of States out there panicked because their existing rules 
and regulations are going to be superseded. It is natural for Governors 
and State legislatures to scream and say, oh, my gosh, you can't take 
our power away to do something.
  So where did we get down to before we came here? We got down to this 
close--this close. This is how close we are. We said, OK, if the FDA 
has not done something and has not established that this cosmetic is a 
dangerous one, then the States can move in. And if they feel 
differently, that it is and therefore we should do it, they have the 
power to do that.
  That is the way it is right now. But we say that if the FDA has 
acted, then we want uniformity and so we should try to make sure that 
people across the country will have uniformity.
  Then the issue was raised, well, suppose the FDA says that it is 
dangerous because it may cause problems on your face. Suppose the State 
believes it may have something to do with your blood system. Does that 
mean they cannot warn people that this cosmetic may be dangerous if it 
gets into your bloodstream?
  Well, that is the issue. That is how far apart we are. On the two 
pages that deal with devices, the issue is about as narrow as that. It 
comes down to the question of, if a manufacturer says this device is 
for this purpose, and the FDA says, well, maybe we want to make sure 
that we know all the other purposes it might be used for, so they 
should alert us to those. We are down that far on those two pages, and 
we are down to within a few lines on the other four pages, but the 
other 146 pages there isn't really much disagreement with.
  So I want to make sure we have things in perspective here. That is 
why the support, that is why we had the 89-to-5 vote on moving forward 
on this. But these are important issues. It is important for us to make 
sure that people know that with respect to cosmetics they are going to 
be protected and who is going to do it and what kind of awareness are 
we going to be able to have and what are the States rights versus the 
Federal Government.
  So that is where we are. I will go at length later, but right at this 
point I want to make sure we understand where we are and what the issue 
is. In cosmetics, nobody is doing anything now with the exception of 
the State of California. We think the FDA ought to get in there. They 
ought to make sure that the cosmetics that are advertised are safe, 
that we know what problems could be caused and that we have uniformity 
in the country, so that when you go one place to another, you will have 
the ability to be able to rely upon uniformity as to what the various 
products may or may not do to you.
  On the other hand, if the FDA does not take any action and a State 
thinks that this particular cosmetic or whatever is harmful, then they 
have the power to act.
  So that is where we are. I want to reassure people that this bill 
does not ignore the problem of cosmetics. For the first time it really 
emphasizes that the FDA and the States should do something. What should 
they do? That is not going to be taken care of in the legislation 
because we would not know. But we do know that there is a need out 
there and that the FDA should have the authority to act and that they 
should have the authority to provide uniformity. But, on the other 
hand, the States should not be stripped of their rights to protect 
their people in the event the FDA has not acted.
  Mr. President, I just wanted at this time to pause to try to make 
sure that everybody understands where we are and why we got the 89-to-5 
vote to move forward.
  I yield the floor.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. The fact is that the FDA does not have the authority 
today--just does not have it. It has the authority to deal with 
pharmaceuticals and with medical devices but not with the issues which 
involve health and safety.
  I will spend a moment or two just going through the Food and Drug 
Administration Act, the actual law. It is a page and a half. And there 
cannot be a fair reading of this, of these provisions, section 601 to 
603. To believe that there is any adequate protection for American 
consumers in this page and a

[[Page S8846]]

half is folly. I mentioned earlier the FDA has no authority to require 
manufacturers to register their plants or products. It cannot require 
manufacturers to file the data on the ingredients in their products. It 
cannot compel manufacturers to file reports on the cosmetic-related 
injuries. It cannot require that products be tested for safety or that 
the results of safety testing be made available to the agency. It does 
not have the right to have access to manufacturers' records. It cannot 
recall a product.
  Now, those are powers the FDA has with regard to pharmaceuticals and 
medical devices, but not with regard to cosmetics that may also be 
carcinogenic, and may also include toxins. We are not talking about an 
unimportant matter. We are talking about questions of health and 
safety. I find it difficult, with all respect, to say, ``Well, look, in 
California, we've carved that out. All of our Members will probably 
understand that means. ``We have carved out California.'' California 
considered this and took action. But if Minnesota--and they have been 
interested in taking some action on some products--wants to take action 
down the road in the future to protect its consumers, it cannot do it. 
In my State of Massachusetts, that has very similar legislation to that 
of California pending now, and they hope to be able to pass it in the 
next legislative session--they are out. They are finished.
  We have taken care of one State, California. I am glad we did not 
wipe out California because I am interested in the protection of the 
citizens of California. They are going to get some protection, but not 
full protection, because you are going to preempt other health and 
safety statutes in California. This did not provide all the protections 
in California. Nonetheless, I am glad that the consumers in California 
are going to get some protection. But I cannot understand why we are 
denying other States from making a judgment that they want some 
protection. That is what this legislation does.
  An additional point others will make is, ``Well, we're just dealing 
with packaging and labeling.'' But that is where the States act, with 
packaging and labeling. We do not see the withdrawal of products. They 
are able to do that and have been effective at it, in California. And I 
will get into how effective they have been, because they have been very 
effective in protecting consumers, not only in California, but the rest 
of the country, because when California, as a result of an extensive 
kind of medical research, has discovered that various products may 
contain carcinogens or dangerous and toxic substances, and required 
those products to be labeled, what happened? The manufacturer changed 
the product. And I will get into the examples.
  This is the power that regulations on labeling and packaging can 
have. This is where they have been effective. These are the key 
elements, the possibility of developing warning labels. They have not 
had to develop the warning labels in California because the companies 
and the manufacturers have changed the products. One of the outstanding 
examples is Preparation H. Where there were products that were 
dangerous to consumers, the California regulations were effective in 
improving product safety. The manufacturer reformulated the product 
itself and says now it is better than it even was before. That was as a 
result of research that was done to uncover potentially dangerous 
substances that had been included in the product.
  So, Mr. President, we have an agency that cannot practically deal 
with and has been restricted from packaging and labeling. We have seen 
a carveout, a carveout in the FDA authority in section 601 that talks 
about various products. It says they will not be able to deal with 
either poisonous or adulterated cosmetics, and cannot apply to coal-tar 
hair. Coal-tar hair dye. There is the cosmetic industry able to write 
right into the law ``coal-tar hair dye,'' even though the research has 
shown what that has done in terms of making hair dyes more dangerous 
than they need to be. The cosmetics industry has been effective enough 
to get written into this legislatively that, even though it is 
dangerous, there cannot be any kind of oversight of it. That is the 
power. That is real legislative power.
  Mr. President, just on this question of the FDA and its ability to 
deal with this, let us go back to what the GAO said should be done if 
we were to have an FDA that would be able to provide adequate 
protection for the public health. This is a public health issue and a 
safety issue. That is what we are dealing with with regard to 
cosmetics.
  The other items that we mentioned earlier deal with health and safety 
and are of importance. But on cosmetics, we are effectively talking 
about health and safety issues. When the GAO last looked at the FDA, 
and were charged with making recommendations, these are the 
recommendations that they made. They said:

       We recommend that the Congress amend the Food, Drug and 
     Cosmetic Act to give FDA adequate authority for regulating 
     cosmetic products. Specifically, we recommend that the 
     Congress authorize FDA to require:
       Registration of all cosmetic manufacturers.
       Registration of cosmetic products and filing of ingredient 
     statements [so that they know what ingredients are in the 
     various products].
       Manufacturers to submit to FDA data to support the safety 
     of their products and the ingredients in them [to demonstrate 
     the safety of their products prior to putting them on the 
     market. Before marketing, to be able to give the assurance of 
     safety and also to be able to get the ingredients of these 
     products].
       Premarket approval by FDA of certain classes of cosmetics 
     or ingredients when the agency deems such approval necessary 
     to protect the public health.

  Why? Because they take notice that some of these products contain 
possible carcinogens and some of them have toxic products. They are 
saying we ought to be able to demonstrate the safety of those products 
rather than put them out in the marketplace and endanger the public.
  The GAO report further recommends that:

       Manufacturers to submit to FDA consumer complaints about 
     adverse reactions to cosmetics.
       Manufacturers to perform specific testing FDA deems 
     necessary to support the safety of a cosmetic or an 
     ingredient.

  So if the FDA were to make a judgment that they believe that items 
may cause birth defects, may cause an assault on the nervous system, 
may somehow threaten seriously the health and the well-being of the 
consumer, that they would be able to ensure there is going to be 
adequate testing. Those are very minimal standards. These 
recommendations are from the last review for the power and the 
authority for the FDA.
  Now, do you think we have any of those today? No, we do not have any 
of those. And all we have to protect the consumer is what is happening 
at the State level. That is all we have. With this legislation, we are 
effectively preempting the States from providing those protections to 
the consumers in their States.
  I find it extraordinary how quickly we are to be willing to accept 
that particular provision without hearings. We understand the power of 
the cosmetic industry. We understand why this has come up. This has 
come up, Mr. President, because of the action that has been taken by 
California. Because California has acted in various cases in order to 
ensure that the cosmetics that are being used by Californians are safe 
and effective. They do not want to have to keep dealing with this. 
Nonetheless, manufacturers have changed their products. They have made 
them, in so many different instances, safer. That is the way it should 
be.
  If we are not going to do it at the Federal level, why do we take 
away the power of the various States? It is effectively like preempting 
the States from having State police. All the States have various State 
police in order to look after safety and security in their States. We 
are saying, we are not going to provide any kind of help and 
assistance, but, in addition, we are taking away your safety, a means 
of protecting your people as well. And that, I believe, is wrong.
  Mr. President, I want to just mention some of the various items since 
we have talked in generalities here about some of them. Some of these 
items that we have addressed here have posed a threat to the health and 
safety.
  First of all, we have hair dye, the coal tar in the hair dye. That is 
a potential carcinogen. It is a danger in terms of the American public 
and the consumer. One State, California, has a State law. Ohio has 
tried to deal with this, but they have been basically unable to do so. 
The industry has been so

[[Page S8847]]

powerful it has been able to get written into the law, into the bill 
itself, that we cannot tamper with something we know is directly a 
public health hazard. In public health we know that, and still it is 
written into the law.
  We have the old Grecian Formula. It does not have to go through the 
FDA. It had lead in it--lead. People thought, well, we can use it 
because it is just a hairspray. We know what happens when lead is 
ingested. We know it causes mental retardation, for example, in 
children.
  One of the principal problems in inner cities is old paint chips that 
have the lead content. We know the incidence of mental retardation, and 
if you go into any urban area in this country and go to the great 
county hospitals, they have a lead paint poisoning program. You see the 
incidents of mental retardation that are a direct cause of lead in the 
paint. The children are either eating the chips or they are playing 
outdoors and the chips are ingested. They get on the cats and dogs, and 
children pet them and then scratch themselves or put their hands in 
their mouths.
  It just goes on. We understand that. That has been well understood 
and documented for 30 years now. But we now know there was lead in 
Grecian Formula. This came out as a result of the various analyses in 
California. There was a certain amount of concern about it, but then 
there was action by the company, and they said, look, maybe there is 
lead in it, but it is on your hair, and you are not ingesting it, so, 
therefore, it is not a problem. Then other studies showed that people 
were washing their hair and were also embracing their children and 
touching their children and working with their animals or their pets, 
and this was picking up the flakes and, if the dye was being used over 
a considerable period of time, the lead posed a significant and 
important threat to children.
  So what happened? Grecian Formula changed their ingredients as a 
result of this to make a safer product. They did not miss a beat in 
terms of being able to market it and being able to be successful. But 
it was changed, and that is because of local activity--not the FDA, but 
because of local activity.
  Mr. President, I will give further illustration, but I will just at 
this point remind Senators, as we are going through some of these 
examples, there may be those who say, ``Well, OK, you've got a half 
dozen out there, but is that really enough to try to resist this 
provision to preempt State activities?'' Well, the last serious study 
that was done by a congressional committee was actually done by our 
colleague, Congressman Wyden, who held landmark hearings in 1988.
  The industry gave his subcommittee a list of 2,983 chemicals used in 
cosmetics. The National Institute of Occupational Safety and Health at 
NIH analyzed the 2,983 chemicals and found 884 cosmetic ingredients had 
been reported to the Government as toxic substances. Let me just repeat 
that: The industry, the cosmetic industry, provided to the Congress a 
list of 2,983 chemicals that are being used in cosmetics.
  The National Institute of Occupational Safety and Health, what we 
call NIOSH, which is the center for expertise in being able to analyze 
various toxic substances, and NIH analyzed these chemicals and found 
that 884 cosmetic ingredients have been reported to the Government as 
toxic substances.
  We have known for 10 years that a third of cosmetic chemicals are 
toxic, but we have done nothing to strengthen the consumer protections. 
Instead, we would rather weaken the consumer protections. Instead of 
trying to make some progress to protect the consumer we are taking 
steps to put them at greater risk. Does that make any sense?
  We had debate and discussion about the Delaney amendment with regard 
to carcinogens and processed food and we debated those issues and said 
is it not time to alter, change, and modify that? We passed very good 
legislation dealing with pesticides, insecticides, and fungicides just 
2 or 3 years ago because we were looking at the fact that the best 
estimate is that there are probably 2,600 to 3,000 Americans that were 
dying because of pesticides and insecticides that were being put on 
products and were being ingested. We have run into problems. We had 
extensive hearings about the dangers of insecticides on children, 
because children eat more bananas and certain types of food and 
products have more insecticides, and therefore it has more of an impact 
in terms of their bodily functions.
  We spent hours and hours and days and days on hearings because we 
wanted to provide protection against carcinogens in our food supply. 
Here we have now, according to NIOSH, and according to the NIH, 884 
cosmetic ingredients that have toxic substances. Rather than trying to 
do something about those in terms of examining those in relationship to 
what is being done in the House and in terms of the well-being of the 
consumer, we have not only had no enforcement or regulatory protection 
at the Federal level but we are eliminating what actions could be taken 
at the State level.
  It makes no sense, Mr. President, makes no sense at all. That is what 
the effect of the preemption does. I read the language on the 
preemption and that is effectively what that language does.
  Now, Mr. President, we have a situation, for example, that has come 
up in fairly recent time, a hair spray that might be inflammable, and 
we find out that the State of Minnesota was looking at trying to make 
some effort to try and identify the dangers that result from this.
  Mr. President, there is a Senator here that would like to address the 
Senate and I am happy to accommodate him.
  Mr. JEFFORDS. Mr. President, I yield such time as he may consume to 
the Senator from Indiana.
  The PRESIDING OFFICER. The Senator from Indiana.
  Mr. COATS. Mr. President, I thank the chairman and I thank the 
ranking members who are ahead of me for allowing me this time. I have a 
schedule conflict and I appreciate the opportunity to say a few words.
  I will have more to say as we move forward with this legislation. I 
wanted to make some opening remarks. I am very pleased that we are 
actually here at this time with the legislation on the floor. It has 
been a long and arduous road that we have traveled over this past 2\1/
2\ years to address the need for FDA reform. We have, as the chairman 
and Senator Kennedy said, had numerous hearings. We have listened to 
the Commissioner of the FDA and his representatives and employees and 
colleagues. We have listened to outside experts. We have heard from the 
various industry groups. But the real reason that we are here is not 
just the fact that a few Senators got an idea that perhaps we ought to 
address some issues at FDA. The real reason we are here is that all of 
us have been besieged by consumers, by patients, by, yes, manufacturers 
of drugs and devices and others who have outlined to us the nightmare 
that exists at FDA in terms of approving products for beneficial use by 
patients.
  What I will primarily do this morning is briefly state the ``why'' of 
the need for FDA reform and save my remarks on what we have done--which 
I am sure will be outlined by many others--save my remarks on what we 
have done for debate on Monday, Tuesday, or following that, depending 
on how long this discussion goes on.
  First of all, let me state that the precipitating reason for moving 
forward was the need to reauthorize PDUFA. That is the user fee that is 
paid for by the drug prescription industry to allow FDA to hire 
additional personnel and to employ additional technology to speed up 
the approval of drugs. I am not sure who bears the responsibility for 
lack of personnel or lack of updating technology.
  I have worked with Senator Mikulski on a more comprehensive 
modernization of FDA, consolidating their campus, giving them the new 
technology that they need, and giving them the personnel that they 
need. Because SBA was in such desperate shape in terms of its ability 
to use drugs we enacted sometime ago a user fee whereby the industry 
itself would be taxed with the money designated specifically to hire 
the personnel and improve the process and procedures for approval of 
prescription drugs. That is what finally moved us from debate and delay 
to the NIOSH action.
  I am particularly pleased that Senator Jeffords, the chairman, 
responded to my concerns that if we move only with a limited PDUFA 
reauthorization we will have addressed only

[[Page S8848]]

a small part of the problem that exists at FDA, that what we needed was 
a comprehensive bill, broad in scope, that would allow us to address a 
number of problems that exist at FDA, including substantive reform for 
medical devices and other products regulated by the agency. I commend 
the chairman for agreeing to do that. We held extensive hearings and 
broadened the scope of the bill. The bill we have put forward is one 
that does address a number of issues and that is why it receives such 
widespread support from the Congress.
  Clearly, the vote in committee, a strong bipartisan vote for moving 
this process forward in support of the comprehensive bill and the vote 
that was just taken this morning--overwhelming, almost historic in 
proportion--vote on cloture I think indicates the depth and the breadth 
not only of the bill but of the support for the bill with Democrats, 
Republicans, liberals, conservatives, moderates, everybody in between. 
Only a handful, literally a handful of Senators voted against cloture. 
So I think that shows the need for moving forward on this bill.
  FDA bureaucracy and delay, inconsistent rules, lack of willingness to 
use outside expertise--all of this has jeopardized the health of 
American patients. FDA opponents of reform like to state, ``Oh, we 
cannot jeopardize the health and safety of Americans,'' and yet in 
their insistence on maintaining virtually status quo in total FDA 
control on their assistance on that, they have denied Americans 
lifesaving and health-improving benefits both through prescription 
drugs and devices and other forms of medical assistance. They have 
denied people the opportunity to beneficially affect their health and 
have forced them to go outside the United States, forced manufacturing 
companies to go outside the United States, forced drug device companies 
to go outside the United States in order to market their product 
whereby they would be subject to the rules and regulations of foreign 
countries rather than this country.
  To imply that only the United States FDA has the wisdom to be able to 
determine what is in the best interests of the health and safety of its 
citizens is, I think, a slap in the face to countries like Germany, 
Britain, France, and others who have similar approval processes that 
benefit the citizens of their own country.
  FDA average review time, just taking medical devices, average review 
time for low- to moderate-risk medical devices, the so-called 510(k)'s 
in 1995 increased over the previous 6 years by over 200 percent, from 
82 days to 178 days, for total review days from 66 days to 137 days for 
time actually in the FDA's hands. The law says they need to do this in 
90 days--the law. We passed the law, a statute here that says that the 
FDA on low- and moderate-medical devices you have 90 days. The FDA 
said, OK, 90 days. In that period of time since we passed the law it 
has doubled in terms of the amount of time they take to review those. 
Those are average review times.
  Specific examples show how ridiculous and how scandalous the process 
is or has been at FDA. Fortunately, we are in the process of looking 
for a new Commissioner, and hopefully that Commissioner will bring some 
business sense instead of simply an ideological bent to the agency and 
provide for some expediting of some of the devices that do not pose 
serious health risk to Americans at all.
  We all hear about this whole idea that FDA is standing at the bridge, 
keeping Americans from being subjected to the most egregious of 
violations, drugs and devices perpetrated by a greedy industry that is 
concerned only about the bottom line.
  I have a device manufacturer in my State that makes hospital beds. 
That device manufacturer, which is well respected on a national basis, 
that device manufacturer designed a new bed cover. This is the cover 
you put over a mattress, on a bed. The bed had been approved, the 
mattress has been approved, the old device cover has been approved. It 
is a piece of cloth. But they designed a new one that prevents bodily 
fluids from leaking into the mattress. Obviously, that could be a 
potential health risk to not only that patient but perhaps a subsequent 
patient. So they had come up with a new mattress pad which achieved 
significant improvement in promoting the health of patients who would 
use that mattress.
  Of course they had to submit it to FDA for approval. This is a class 
I device, the lowest risk to the patient. So they submitted it to FDA, 
and the FDA took 476 days to review that mattress pad before it would 
grant approval. So we talk about the average review times and 
protection of the party but when you bring it down to specific examples 
of the ineptness and the bureaucracy that exists at FDA, there are 
examples on both sides.
  The other side likes to use relatively rare anecdotes and of course 
many of these go back 20, 30, and 40 years, and no one--no one in 
support of FDA reform--is stating we ought to compromise on health and 
safety. What we are trying to do is say we think we can expedite and 
utilize new technology that improves health and safety if FDA could get 
its act together. Now, if you takes 476 days to approve a mattress pad 
which clearly is in the benefit of the health and safety of hospital 
patients because it prevents bodily fluids from seeping through the 
currents mattress pad, then if it takes 476 days to do that, something 
is wrong at FDA. Meanwhile, new 510(k) notifications have dropped 
dramatically, from 7,000 annually in 1989 to a projected 4,800 in 1998. 
So high-risk, if you look at that, and novel device review times 
increased from 348 days to 773 days, on average. Many are far longer 
than that. Some have been languishing in the system for 4 and 5 years.

  Now, the statute says that FDA has 90 days on low to moderate risk, 
180 days on high risk, and yet, FDA's average review time in 1995 is 
773 days on high-risk and novel devices. So, clearly, something needs 
to be done.
  What the committee has tried to do is simply say, let's take an 
agency that we need, an agency that is important to the health and the 
safety of Americans and let's see if we can improve it, let's see if we 
can reform it. The best step and the first step was the resignation of 
the Commissioner, who admitted to the committee in what was one of the 
most astounding statements I have ever heard any agency head ever 
deliver, which was basically saying, ``I am incapable of doing this. 
You in Congress are going to have to force me to do it. I need the 
pressure from Congress to do it.'' Can you imagine a CEO of a 
corporation coming before the board of directors and saying, ``I am not 
capable of running this company efficiently like you want me to, but if 
you will put pressure on me and force me to do it, then I can go to my 
vice presidents and say the board is insisting that I do this''? Is 
that an example of the weakest form of management and oversight that 
you can possibly imagine? I could not conceive that the then 
Administrator, Dr. Kessler, of the FDA would make such a statement. ``I 
am incapable of doing it, but you force me to do it and then maybe I 
can convince the people that work for me that we ought to do 
something.''
  Well, let me talk about another example of intolerable delays. This 
isn't a mattress pad. This goes to life and death. The product was a 
stent, a small, mesh, spring-like device used to keep coronary arteries 
from closing. A new stent product that was developed by a manufacturer 
was submitted to the FDA in November 1986. In August 1987, FDA said, 
``We need more paperwork.'' It took them that long to figure out they 
needed more paperwork. In April 1988 and in August 1989 and in June 
1991 were additional requests for more paperwork. An FDA panel meeting 
was held in May 1992, and they gave unanimous approval to the product. 
Four years after it was first submitted, an FDA panel gave unanimous 
approval to the product. It then took the agency an additional year to 
issue a letter allowing the device to go to market.
  Now, have you ever heard of such bureaucratic ineptness? After 4 
years of reviewing paperwork on a life-saving device, on which the 
statute said the FDA had 180 days--after 4 years, the FDA panel met and 
gave unanimous approval. From that time, it took 1 year for the FDA to 
issue the letter saying, ``Congratulations, you have been approved.''
  Now, critics of reform talk about the potential threat to American 
health and safety for approval of devices. But

[[Page S8849]]

they never talk about the demonstrated not only threat but consequence 
to the safety and health and even life of Americans for ineptness and 
delay in the approval of drugs. How many people died or suffered 
serious incapacity because a life-saving stent on which we could not 
get a letter of approval from FDA, which approved it, until 1 year 
later? How many people, over a 5-year period of time, lost their lives 
because a life-saving device didn't receive FDA approval for 5 years? 
Let's say it took 4 years; let's grant them that it took 4 years of 
reviewing paperwork to make sure that this life-saving stent device was 
worthy of FDA approval. There is no excuse. What possible excuse could 
there be for a delay of 1 year in submitting the letter so the company 
could go ahead and market the product?
  Dr. Frist, who is a member of our panel, said, ``I would have loved 
to have had that stent. I known what that stent does. I've used that 
stent. Had I known that stent was available before approval * * *''--to 
think that it was languishing in FDA 1 year after FDA approved it 
unanimously--it took them a year to get the letter out so that they 
could market the device. So there are people lying in their graves.
  This Senator is tired of hearing about FDA being the guardian of the 
health of Americans and we should not move forward with any kind of 
reform at all. When you touch the words ``reform of FDA'' and try to 
move up their approval process or expedite the process at all, why, 
then you are jeopardizing the health and safety of Americans. The 
burden of that lies on the shoulders of those who won't move forward 
with responsible reform.
  Fortunately, today, this Senate, in an overwhelming bipartisan vote--
only five people opposed--said it is time to move forward with reform 
and it is past the time to move forward with reform. We owe apologies 
to the families of the Americans who have been denied life-saving 
treatments and devices because people have blocked reform and efforts 
to move forward.
  A Hoosier who attended one of our FDA hearings recently had a life-
saving vascular graft implanted in his body. Mr. Friar testified before 
our committee. He was one of the fortunate patients to receive the 
graft because he needed the product only after it was approved. Other 
patients who were denied that before FDA got around to approving it, 
were not so fortunate.
  I could go on and on with examples, but I won't. I do get exercised 
over it because it is unfair to characterize those that try to seek 
meaningful reform as those who somehow don't care about the health and 
safety of American people. We care so much we want to get something 
done. We want to get some reform underway.
  The Hudson Institute, in late 1995, surveyed this question and came 
up with an estimate. It is difficult to talk about an estimate when we 
are talking about human life. The Hudson Institute is a respected 
institution. Let me cite an example from their study. Delay in 
approving the coronary stent, they say, reached 27 months. The FDA gave 
access to this product to American patients 27 months after European 
patients had access to the product. Depending on how one attributes 
responsibility to the agency, partial or total, the regulatory delay is 
estimated to have resulted in 1,600 to 2,900 lives lost, patients whose 
lives were lost because of bureaucratic excess.
  So we stand on this floor and talk about it being irresponsible to 
move forward with FDA reform and we delay FDA reform. We won't even 
allow a disputed issue to come to a debate on FDA reform, when we are 
talking about a potential loss of lives of Americans who are denied 
products because of FDA ineptness.
  That is the human side of the question. I am not even going to get 
into the business side of the question because the two don't even begin 
to compare. We have lost manufacturing and jobs to overseas facilities 
in record numbers because manufacturers are throwing up their hands and 
saying they will go broke waiting for FDA to approve their products. It 
means a significant number of jobs. Sixty-one percent of U.S. device 
companies plan to market offshore first. We lead the world in drug and 
device product development. But they are being pushed out of the 
country by the FDA. They are being aggressively lured by foreign 
governments who know that our bureaucratically bloated system provides 
them the competitive advantage they need to draw those American 
companies and employees and the brain power away from the United 
States.
  A Netherlands foreign investment company has a publication out 
highlighting the oppressive climate in the United States. They say, 
``Come over here and we will provide a much more favorable climate.'' 
Now, we will hear in rebuttal about some product that was approved and 
later turned out to be a mistake. Well, there are exceptions and there 
will be exceptions, whether they are in the Netherlands or in the 
United States. We are talking about human beings. We can't guarantee 
100 percent perfection. But that is no excuse for not reforming FDA and 
trying to give it the tools and give it the wherewithal to do a better 
job.
  It has been estimated that the delay in U.S. availability of products 
threatens a loss of 50,000 jobs in the next 5 years. This is one of the 
greatest industries we have ever had in this country, in terms of 
promoting job growth, but beyond that, providing health-improving and 
life-saving benefits for the American people. Why do we make it so 
difficult for them?
  I don't want to go any further with that because, as I said, you 
can't compare economic benefit with health benefit. We ought to be 
focusing on the denial of benefits, the loss of life for failure of the 
FDA to meet its statutory requirements. We are not asking the FDA to 
compromise; we are not asking them to compromise on health and safety. 
We are saying: Do what you said you could do, or at least let's look at 
alternatives. I proposed an alternative to try to help the FDA. You 
would have thought I was proposing an amendment to disband the FDA and 
let the free market sort it out. It was nothing of the sort. That is 
not what we are after here. I thought we would try to give them some 
assistance with a third-party review, the FDA certified agencies or 
organizations outside of the FDA. But FDA looked at it and said: You 
have the testing wherewithal and the scientific wherewithal to help us 
expedite approval of these products, and as long as we certify you and 
as long as we approve the process, and as long as we have a veto power, 
even if you approve it, if we have a veto power and say, no, we have 
changed our mind, or we are not sure about that--not even that was 
acceptable to the opponents of this bill. But it is acceptable, 
fortunately, to the majority of the committee. It is acceptable to a 
majority of the American people. It is acceptable to a majority--not a 
majority but a supermajority--of this Congress. But yet with all of 
that debate, there is delay and withholding of moving forward, and 
procedural delays, all in an effort to oppose an honest effort at 
trying to help the FDA do its job. The irony is the FDA was already 
doing some of this. We are trying to provide a way that they can do 
more of it. So the FDA couldn't come forward and say, ``Well, we think 
everything ought to be done within the FDA.'' They admitted they needed 
help from the outside, and we structured the statute in such a way that 
you even wonder if it is going to work because the FDA has so much 
preapproval, during the process approval, postapproval, veto, and 
everything else on the thing. But at least it is a start. At least it 
is a movement in the right direction.

  FDA has made all kinds of promises about internal approval, approval, 
improvement, reinventing itself, and so forth and so on. The record 
speaks for itself. Prescription drug user fee types have improved, and 
we are grateful for that. And they have improved because we taxed the 
industry. The industry said, ``We are so anxious to try to get some of 
these drugs to market we will pay for it. Not only the development of 
the drugs, which is enormously expensive, not only the approval of the 
drug but we will tax us some more and we will give the money to FDA, 
and you can hire more people so you can look at it. If you turn it 
down, you turn it down. But at least get an answer one way or another 
so we can move on to something else, if you don't approve it.''
  People say, Why don't you do the same thing with devices? Let's tax 
the device industry. We are not talking about American-owned products, 
or

[[Page S8850]]

Merck, or Pfizer, Glaxo, major international companies with the funds 
able to do this. The device companies are often small organizations--
startup venture capital organizations. To tax them at this stage is 
going to just accelerate driving them offshore, and in many cases they 
in no way have the wherewithal to provide a tax for that. It is not 
their responsibility. It is a governmental responsibility.
  The President's budget hasn't helped much either. The President's 
budget proposal for fiscal year 1998 reflects something other than an 
effort to strengthen the agency. In fact, it proposed a cut of funding 
for the agency. They wanted to cut the Device Center budget by 27 
percent. Clearly that calls for congressional action to address the 
issue, to ensure that the bureaucracy, and the old ways of doing 
business give way to some efficiencies and accountability in this era 
of tight budgets.
  So that alone is reason for us to move forward. Here we are now in 
September on PDUFA and a jeopardy of laying off--expiring and laying 
off--a whole bunch of people. And we are way behind the timetable that 
we ought to be on in terms of moving this forward.
  Just on another point about the size of device companies. Of roughly 
8,000 device companies that exist in United States, 88 percent have 
fewer than 100 employees and 72 percent have fewer than 50 employees. 
User fees are clearly not workable in a situation like this. And I am 
pleased that the bill doesn't impose those.
  I have all kinds of statistics here, and all kinds of anecdotes and 
all kinds of stories. The bottom line is we are attempting to bring the 
FDA into this century. This century is almost over. We are attempting 
to try to take a tired, inefficient bureaucratic ideologically driven 
agency and introduce it to the modern era. We are trying to take 
advantage of these marvelous technological breakthroughs in drugs and 
devices and products that are occurring at an ever increasing rate 
around the world, but particularly in the United States, and make them 
available to American consumers to improve their health, to ensure 
their safety, to prolong their lives, to save their lives. That is why 
we have formed an extraordinary coalition between Republicans and 
Democrats. This has nothing to do with party lines, liberals, 
conservatives, and everybody in between. There was an almost 
unprecedented vote in committee of 14 to 4, and we would have had even 
a better vote than that if we went back and did it now because we have 
resolved some of the concerns that those four had. We wouldn't get all 
four. But we would have even a better vote--probably more like 16 to 2 
because we have addressed those concerns that were raised in committee. 
Those Members thought that they had better reserve their vote and 
negotiating ability. And we resolved that.
  We have done an extraordinary amount of negotiating from the time the 
committee passed the bill out until this point. We were that far away 
in July from resolving this. In the negotiations with Senator Kennedy, 
we made 30-some concessions on a bill that passed 13 to 4 in order to 
get the approval of one person because one person could tie this thing 
up procedurally. We made 30-some concessions--concession after 
concession after concession by the chairman, this Senator, and other 
Senators. What is the problem? How can we fix it? Can you work it out? 
Can you go along with the bill, if we did that? Can you do that?
  We finally threw our hands up in total exasperation because every 
time we thought we were at the goal line, no, move the ball back 
another 15 yards to another position. Take that up. Will that do it? 
Yes. Solve that. Then they thought of another one. There was always a 
reason to delay and delay. And then we went through the August recess. 
If we were talking about making a widget, if we were talking about 
something that didn't affect the health and the safety of the American 
people--I suppose that is just part of the process here--but we are 
talking about people waiting for steps that would save their lives; 
waiting for approval from FDA of drugs that can potentially keep them 
from dying, waiting for products that can make their life a little more 
tolerable while we play games in the U.S. Senate because one person 
doesn't think it is a perfect bill in front of him, even though there 
is a widespread majority in support of it. That is wrong.
  So I am glad we are moving forward. I am sorry that we had to invoke 
a procedure to cut off a filibuster to do it.
  I understand people may have some concerns about this bill. It is not 
a perfect bill. It passed through months of arduous negotiation. There 
has been give and take. Every Senator is free to come down here and 
make his point and raise his objection and offer an amendment and take 
a vote. If it passes, the bill will be modified. If it fails, instead 
of taking the ball and going home and saying we are not going to play 
anymore, let's just say apparently I wasn't persuasive enough, or maybe 
I got my facts wrong, or maybe that is not what the majority wants to 
do. But let's not deny health improvements and safety improvements for 
the American people and the American consumer just because we don't get 
our way. Let's move forward. We will now.
  We have invoked cloture. I regret that we had to do that. I regret we 
had to go through the month of August waiting to reconvene, because 
there are people out at FDA that are going to be laid off if we do not 
get this thing moving. All the efforts that we have done to try to hire 
additional people out there will be undermined in terms of drug 
approval because we can't get this bill moving.
  So let's move forward. Let's raise our objections. Let's have a 
debate. Let's have a vote and accept the result, and let's move forward 
with FDA reform.
  Mr. President, I will have more to say about this at a later time. I 
have not gotten into the ``what.'' I was talking about the ``why'' 
here--why do we need reform. I have not gotten into what the bill 
includes. It is a broad bill with a lot of depth. It covers a lot of 
areas. It is significant reform. It is not as much as this Senator 
would like. It is more than some other Senators would like. But it is a 
big step in the right direction.
  I just note for the Record that I don't know what is going on, Mr. 
President, at the White House. We have been without a commissioner now 
at FDA for some time. They nominated someone this week, and then 
withdrew the nomination 24 hours later. I don't know why. But I urge 
the administration to continue its search. I am going to suggest a 
couple of names to them of people, if they need people to look at. I 
don't do it with any hope that they think anybody I would suggest ought 
to head up FDA--not this administration. But we ought to get somebody 
in there who is willing to exercise the oversight and the 
administrative ability to work with the Congress in bringing this 
agency into the modern era and improving the way things are done there. 
There are a lot of dedicated, competent, hard-working scientists and 
researchers and medical personnel at FDA who deserve to have competent 
leadership, competent management, and deserve to have the support of 
this Congress in providing the funds and providing the technology and 
providing the assistance in expediting in an appropriate manner the 
bringing to market of drugs and devices that can make a difference in 
people's lives.
  Mr. President, there is more to come later. I yield the floor.
  Mr. DURBIN addressed the Chair.
  The PRESIDING OFFICER (Mr. Hagel). The Senator from Illinois.

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