[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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