[Congressional Record Volume 143, Number 157 (Sunday, November 9, 1997)]
[House]
[Pages H10531-H10539]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
CONFERENCE REPORT ON S. 830, FOOD AND DRUG ADMINISTRATION MODERNIZATION
ACT OF 1997
Mr. BLILEY. Mr. Speaker, I move to suspend the rules and agree to the
conference report on the Senate bill (S. 830) to amend the Federal
Food, Drug and Cosmetic Act and the Public Health Service Act to
improve the regulation of food, drugs, devices, and biological
products, and for other purposes.
(For conference report and statement, see prior proceedings of the
House of today.)
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Virginia [Mr. Bliley] and the gentleman from Michigan [Mr. Dingell]
each will control 20 minutes.
The Chair recognizes the gentleman from Virginia [Mr. Bliley].
General Leave
Mr. BLILEY. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days within which to revise and extend their remarks
and include extraneous remarks on the conference report on S. 830.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Virginia?
There was no objection.
Mr. BLILEY. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, today we stand on the verge of medical advances that
will revolutionize the quality of health care in America, and today we
make the promise of better medicines and treatments a reality for
millions of Americans. The bipartisan conference agreement reached
earlier this afternoon to modernize the FDA is a victory for American
patients.
After almost 3 years of work by the Committee on Commerce, we have
delivered a piece of legislation that will do more to help patients
than any legislation passed in decades. When we first discussed the
need to modernize the FDA in 1995, we knew that outdated rules were
slowing down the vital work of the agency and that patients were the
ones who were suffering. Vital new medicines and medical devices were
not getting to the patients who needed them quickly enough.
As I said back then, it is not right that American patients are
having to go overseas to get the care they need to stay alive. Congress
had to act. Our FDA reform team conducted the most extensive
legislative outreach in recent memory. Literally thousands of hours
were devoted to reaching out to all corners of the country. Our goal
then was to achieve a balanced legislation, legislation that the
President would be eager to sign.
Today we have fulfilled our objectives. This agreement will result in
a better and more efficient FDA. It will enhance the safety of the
medicines we take and the medical devices we use and the foods we feed
our children. Medicines will be approved faster, medical devices will
get to people sooner, and those with life-threatening diseases will
have access to the best experimental new drugs that science can
provide. That is important, because when you are sick, when you are
suffering, every minute counts.
Some of my colleagues deserve special praise and thanks. Their work
on this issue has been tireless, and the credit for this legislation
belongs to them. The members of our FDA reform team, the chairman of
our Subcommittee on Health and Environment, the gentleman from Florida
[Mr. Bilirakis], along with the gentleman from Pennsylvania [Mr.
Greenwood], the gentleman from North Carolina [Mr. Burr], the gentleman
from Texas [Mr. Barton], and the gentleman from Kentucky [Mr.
Whitfield].
I also want to reach across the aisle to thank our friends, the
gentlewoman from California [Ms. Eshoo], the gentleman from New York
[Mr. Towns], and the gentleman from Texas [Mr. Hall], and all our
ranking members, the gentleman from Michigan [Mr. Dingell] and the
gentleman from Ohio [Mr. Brown], for their invaluable contributions to
this effort. And to our colleagues over in the Senate, Senators
Jeffords and Kennedy.
I also want to thank my committee staff, Howard Cohen, Eric Berger,
and Roger Currie, as well as the personal staffs of the FDA reform
team, Patti DeLoache with the gentleman from Florida [Mr. Bilirakis],
Mora Guarducci with the gentleman from Pennsylvania [Mr. Greenwood],
Alyson Neuman with the gentleman from North Carolina [Mr. Burr], Beth
Hall with the gentleman from Texas [Mr. Barton], Pete Bizzozero with
the gentleman from Wisconsin [Mr. Klug], and Tim Taylor with the
gentleman from Kentucky [Mr. Whitfield].
I would also like to extend my gratitude to the able and hard-working
legislative counsels who helped craft this measure: David Meade, Pete
Goodloe, and Liz Aldridge.
[[Page H10532]]
Finally, I would like to express my sincere gratitude for the hard
work and dedication of minority counsel Kay Holcombe. She is leaving us
at the end of this session, and, believe me, she will be greatly
missed, not just by the gentleman from Michigan [Mr. Dingell] but by
this chairman as well.
They should all be proud of a job very well done. The American people
thank them, and so do I.
Mr. Speaker, I reserve the balance of my time.
Mr. DINGELL. Mr. Speaker, I yield myself 4 minutes.
(Mr. DINGELL asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. Mr. Speaker, from the beginning, our goal in reforming
Food and Drug has been to benefit patients and people. We can talk
about a lot of things, but when we get right down to it, the question
is keeping people safe, seeing to it that foods, drugs, cosmetics,
devices and other things which are regulated by Food and Drug which are
absolutely essential to the life of people are safe and that they come
quickly to market.
The bill does a number of things. First, it reauthorizes the
Prescription Drug User Fee Act. This is a program that has given FDA
the resources needed to approve drugs in a way that none of us would
have anticipated 10 years ago. Today, new drugs are reviewed by FDA in
a year or less. Drugs essential for people with serious and life-
threatening illnesses are reviewed in 6 months or less. This is
enormous progress.
The bill authorizes a clinical trials data bank that would be
established through the National Library of Medicine at NIH. Patients
with serious illnesses will be able to get critical information about
experimental therapies being tested in clinical trials.
The bill codifies a number of procedures that FDA developed over the
years to expand access to experimental drugs and medical devices to
people with serious illnesses and emergency situations through so-
called expanded access protocols.
Market incentives are included in this bill to encourage companies to
produce pediatric studies of drugs, so that the labeling of these
products will be useful to pediatricians. Today, most of these drugs
prescribed for children have no proper pediatric label. The bill
remedies this situation. I expect the FDA will use this new authority
carefully to avoid detrimental impact on the availability of generic
drugs.
The medical device provisions of the legislation have been the most
controversial and difficult. I am pleased that the conference report
includes provisions based on a careful consideration of two goals:
Expediting the availability of new, sophisticated products; and
protecting patients from medical devices that are either unsafe or not
effective.
The bill gives the FDA the ability to streamline its evaluation of
medical devices, but without compromising its ability to make
absolutely sure that the products are safe, that they work the way they
are supposed to be, and are labeled properly.
I am also pleased the conference report retains two significant
provisions from the House bill. One makes certain FDA will not be
forced to approve a product the agency knows the manufacturer cannot
make according to good manufacturing practices. The second ensures that
FDA can evaluate all aspects of a new medical device, not just the ones
that the manufacturer chooses to include in the label.
I am concerned, Mr. Speaker, that while we are busy reforming the
Food and Drug Administration, we put a number of burdens on the agency
and that the potential to interfere with the review and approval of new
products is real. I am also concerned that the speed which is required
may have an element of risk for the consuming public for patients and
for people involved in health care.
Mr. Speaker, I want to commend and thank my good friend and
colleague, the gentleman from Virginia [Mr. Bliley], for his excellent
work on this important legislation and for his leadership in what has
been a truly bipartisan effort.
In addition, the work of the subcommittee chairman, the gentleman
from Florida [Mr. Bilirakis], was essential to the success of the
effort, as were the labors of the gentlewoman from California [Ms.
Eshoo], the gentleman from Texas [Mr. Barton], the gentleman from
California [Mr. Waxman], the gentleman from Ohio [Mr. Brown], the
gentleman from Pennsylvania [Mr. Klink], the gentleman from North
Carolina [Mr. Burr], the gentleman from Pennsylvania [Mr. Greenwood],
and the gentleman from Kentucky [Mr. Whitfield].
Our Senate colleagues, Senators Jeffords, Kennedy, and Coats worked
very hard.
The staff of the committee, Howard Cohen, Eric Berger, Roger Currie,
and the staff of the conferees, Kevin Brennan, Paul Kim, Emmett
O'Keefe, Pattie DeLoache, Alyson Neuman, Beth Hall, Mora Guarducci, and
Tim Taylor were valuable and important in the accomplishments of this
legislation, as were the tireless efforts of David Meade and Peter
Goodloe of House Legislative Counsel and Elizabeth Aldrich of Senate
Legislative Counsel.
I want to refer to the work done by my dear friend and our valuable
staff member, Kay Holcombe, who will be leaving us at the end of this
year. Simply put, without her labors, we would not have achieved the
consensus FDA bill that we have before us today. It took a great deal
of effort on her part, her unquestioned integrity, her considerable
intelligence, her extensive expertise, and her legislative tenacity to
help us get to the point where we are.
The legislation is a fitting capstone to the labors of all who have
participated, but especially to Kay's distinguished career in public
service and her 4 years with the staff of the Democratic part of the
committee. Her retirement is a loss to all.
This is a fine piece of legislation. I urge my colleagues to support
it.
Mr. BLILEY. Mr. Speaker, I yield 5 minutes to the gentleman from
Florida [Mr. Bilirakis], the very able chairman of the Subcommittee on
Health and Environment of the Committee on Commerce,
Mr. BILIRAKIS. Mr. Speaker, I thank the gentleman for yielding me
time.
Mr. Speaker, I rise, of course, in support of the conference report.
As chairman of the subcommittee of jurisdiction, I believe the
conference report represents our best effort in many years to improve
the health and safety of all Americans.
In short, this comprehensive law will chart a new course in public
protection, allowing the Government to fulfill its obligation to
protect the public health without undue delay, while ensuring that we
preserve the economic incentives inherent in our free market system.
Although it has taken many months, indeed, many years of hard work,
this legislation represents a bipartisan effort to work through our
political differences and resolve contentious issues.
Over the last 3 years, Mr. Speaker, the Committee on Commerce and my
Subcommittee on Health and Environment in particular have produced a
number of landmark bills which have enjoyed support from both sides of
the aisle.
Last year, for example, the Subcommittee on Health and Environment
produced the innovative Food Quality Protection Act and legislation to
substantially improve the operation of the Safe Drinking Water Act. In
addition, my subcommittee crafted a health insurance portability act to
make basic reforms to the health insurance system and worked on the
Balanced Budget Act of 1997 to include the new children's health care
program and important reforms to the Medicare and Medicaid programs.
{time} 2000
We also reauthorized the Ryan White Act, thus authorizing Federal
dollars to States for HIV education, prevention and health service
programs. I am very proud of these important accomplishments,
particularly because they were done in a bipartisan way.
The foundation of the present FDA bill was developed during the last
Congress, and from the beginning, our effort has been an open process,
open to anyone interested in FDA reform. Our committee conducted 17
separate formal hearings on FDA reform and FDA-related issues. This
represents 72 hours, 44 minutes, and 2,094 pages of testimony.
There are many who deserve credit for bringing this legislation to
the
[[Page H10533]]
floor today, several Committee on Commerce members in particular: The
gentleman from Pennsylvania [Mr. Greenwood]; the gentleman from North
Carolina [Mr. Burr]; the gentleman from Texas [Mr. Barton]; the
gentleman from Wisconsin [Mr. Klug]; the gentleman from Kentucky [Mr.
Whitfield]; the gentleman from Ohio [Mr. Brown]; the gentlewoman from
California [Ms. Eshoo]; the gentleman from California [Mr. Waxman]; the
gentleman from Pennsylvania [Mr. Klink]; the gentleman from Texas [Mr.
Hall]; the gentleman from New York [Mr. Towns], along with our personal
staffs who have dedicated many long hours to this bill. However, it was
the leadership and direction, of course, of the gentleman from Virginia
[Mr. Bliley], our full committee chairman, and the gentleman from
Michigan [Mr. Dingell], our ranking minority member, which enabled us
to bring the consensus bill before the House today. At the beginning of
this Congress the chairman of the full committee made it clear that he
wanted action to FDA legislation and his determination to see this
through has been a guiding force in our deliberations.
In addition, the cooperation of both HHS Secretary Donna Shalala and
Acting FDA Commissioner Dr. Michael Friedman during this process
enabled us to achieve our ultimate goal of creating thoughtful and
practical FDA reform legislation which will be signed into law, I
trust, by the President this year.
Finally, I want to acknowledge and thank the most important people,
the committee staff on both sides of the aisle, for their dedication
and hard work in crafting this important legislation, especially Howard
Cohen, Kay Holcombe, who is leaving us, and, boy, are we going to miss
her; Rodger Currie, Eric Berger, David Meade, Pete Goodloe and Pattie
DeLoache of my personal staff.
I am proud of this legislation, Mr. Speaker. It will reduce the
overregulation of research-based businesses while greatly improving the
lives of millions of Americans. I believe we have done our work and
done it well. I urge my colleagues to support this conference.
Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the distinguished
gentleman from Ohio [Mr. Brown].
Mr. BROWN of Ohio. Mr. Speaker, today the House considers the
conference report on the reform of the Food and Drug Administration.
The debate on FDA reform progressed from irrational and unfounded
accusations about FDA's regulation of medical products to much more
rational discussions about how to modify this agency's regulatory
policies and procedures in a way that will ease unnecessary regulation
without reducing essential protections of public health.
I want to commend the gentleman from Virginia [Mr. Bliley] and the
gentleman from Michigan [Mr. Dingell], the ranking member, and the
gentleman from Florida [Mr. Bilirakis], chairman of the subcommittee,
for their diligence in holding the House conferees together on issues
that this body believed in. I want to commend the tireless work of our
staffs, particularly Kay Holcombe and Howard Cohen.
This was not an easy task, particularly in light of the tremendous
differences of opinion about what constitutes ``unnecessary
regulation.'' To make the system more accessible to consumers, it was
necessary to draw a line between creating reasonable public processes
and overburdening the FDA with administrative duties that take time
away from the most important functions of getting safe and effective
new products to market as quickly as possible.
Many argue that FDA reform is essential, because new and improved
products were not reaching American consumers quickly enough. The facts
simply did not bear this out. The FDA's Center for Devices literally
overhauled its operations and dramatically improved its review time for
new products. We reached a compromise where critics of this process and
the medical device industry can be comfortable.
Perhaps the most important provision included in this legislation is
the reauthorization of the Prescription Drug User Fee program. This
program has provided the resources that FDA needed to make it the world
leader in the review and approval of new drugs. If there were one
single reason for Congress to pass this bill today, drug user fees is
that reason.
Some of us may not be completely satisfied with the reforms of FDA
regulation of generic drugs. I believe, however, that the debate led to
some very much needed improvements. While these products are not the
so-called miracle drugs we read about in headlines, generic drugs are
critically important, because they provide options for physicians and
for patients that often are less expensive than brand name products.
Generic drugs literally save billions of dollars in health care costs,
much of those savings occurring to the Federal Government through
Medicaid, Veterans and Department of Defense facilities. In addition,
savings in drug costs are important especially for senior citizens who
obviously purchase the largest percentage of prescription drugs.
Mr. Speaker, I was especially pleased that a number of issues raised
by Democratic members of the subcommittee, chaired by the gentleman
from Florida [Mr. Bilirakis], were addressed in this legislation. I
appreciate the willingness of the bill's sponsors, the gentleman from
Virginia [Mr. Bliley] and the gentleman from Florida [Mr. Bilirakis],
to engage in these negotiations, and they were able to hold the House
position during this conference.
Mr. Speaker, FDA is a remarkably effective agency. I have never been
persuaded that massive changes in law were needed to correct some
dreadful problem lurking under the surface.
I ask my colleagues to pass the conference report.
Mr. BLILEY. Mr. Speaker, I yield 2 minutes to the gentleman from
North Carolina [Mr. Burr].
Mr. BURR of North Carolina. Mr. Speaker, I thank the gentleman for
yielding me this time.
Mr. Speaker, today we take a historic step towards the future of
health care in America. Today we will vote on the conference report for
the Food and Drug Administration modernization legislation, originally
H.R. 1411 in the House, and now S. 830.
FDA modernization is not radical, it is responsible. It is not
senseless, it is safe. For thousands of patients and their families,
the FDA has become a cold, inhuman and indifferent bureaucracy with a
lagging drug and medical approval process and a culture of
unresponsiveness and disconnect. The FDA has become an obstacle in some
American families in the hope for new treatments. The FDA, regulating
25 cents of every dollar in the U.S. economy, affects every American
family.
This legislation will prepare the agency for technology and medical
breakthroughs for the 21st century. This legislation provides hope from
the corner store pharmacist who wants to provide the best medication
possible to his customers, to the hospital passionately fighting
against an outbreak of an antibiotic-resistant bacteria strain, to the
rural doctor who desperately seeks medication to treat patients, to the
terminally ill cancer patient who has no medical option left in the
struggle against a devastating disease.
This legislation in fact puts a human face on the Food and Drug
Administration. By infusing common business sense into the daily
operation of FDA, we will enable the agency to approve safe drugs more
efficiently and to reduce skyrocketing costs of research and
development that is bogged down in bureaucratic red tape.
I want to thank the gentleman from Virginia [Mr. Bliley], the
chairman of the committee, Chairman Jeffords in the Senate, the
gentleman from Florida [Mr. Bilirakis], the gentleman from Michigan
[Mr. Dingell], the FDA Reform Task Force, the committee staff, my staff
and the Senate staff who literally spent hundreds of hours working on
this very important legislation that I believe deserves the support of
our entire House membership.
Today we celebrate hope and life. This legislation would not be
possible without hundreds of patients who brought their personal
stories to Washington. Unfortunately, many of those patients did not
live to see this day.
Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the distinguished
gentlewoman from California [Ms. Eshoo].
Ms. ESHOO. Mr. Speaker, I thank the gentleman from Michigan [Mr.
Dingell] for yielding me this time.
[[Page H10534]]
This evening I rise in strong support of the conference report, and I
urge my colleagues to support it as well. Let me start out by
acknowledging the leadership, and without the leadership of the
gentleman from Virginia [Mr. Bliley], our committee chairman, the
gentleman from Florida [Mr. Bilirakis], our subcommittee chairman, and
certainly the gentleman from Michigan [Mr. Dingell], our ranking
member, and the gentleman from Ohio [Mr. Brown] of the subcommittee,
and all of the Members from my side of the aisle as well as the
majority, we would not come to this moment.
Like all conference reports, it represents a compromise. Nonetheless,
the agreement is entirely consistent with the bill which passed the
House by a voice vote last month. That is highly unusual for a bill of
such substance and such importance to come to the floor and be passed
by a voice vote. I am proud of the role that I was able to play in
this.
The FDA, I believe, will be a better agency because of this
legislation. Drugs and medical devices will get to patients sooner
without any reduction in the safety and the effectiveness of these
products.
I am particularly pleased that a compromise was reached among the
conferees on a provision allowing for accredited third parties to
review medical devices, and that the House held its position with
regard to the labeling of devices. Had the House not insisted on this
language, this conference report would have been vetoed, and all of our
hard work would have been lost.
I hope, Mr. Speaker, that my colleagues appreciate the tremendous
bipartisan, bicameral support that went into bringing this conference
report to the House today. The list of people to thank is far too long
to mention here, but there is one, because I think if there were a
subset title to this bill, it would be the Kay Holcombe Act of 1997.
The tributes that have been paid to her are well-deserved and she
should receive the gratitude and the applause of the American people,
because they are the ones that we really went to the table for, and
were it not for her professionalism, her patience, her hard work, we
would not have arrived at this moment.
I salute everyone that was a part of this, and if there is anyone on
either side of the aisle that thinks that there are not unending
opportunities to seize in the Congress, they are wrong. I found one
with my colleagues, and one of them seated on the other side of the
aisle, Joe Barton, my partner on the medical device bill, many thought
that with the two of us being partners that it could not be done. It
was done, we come to this moment, and I urge my colleagues to support
the conference report. It is good for the American people, and we are
proud of the effort.
Mr. BLILEY. Mr. Speaker, I yield 2 minutes to the gentleman from
Texas [Mr. Barton].
(Mr. BARTON of Texas asked and was given permission to revise and
extend his remarks.)
Mr. BARTON of Texas. Mr. Speaker, I thank the gentleman from Virginia
for yielding me this time.
Mr. Speaker, most of us go through life being blessed with good
health for ourselves and our loved ones, but as Members of Congress, we
have all been literally begged by parents of sick children and our very
ill adult patients themselves to try to help them work through the
regulatory nightmare that is the current FDA review process.
When the bill before us becomes law, that nightmare will be no more.
Instead of confrontation, we will have consultation and cooperation
between the FDA, patient groups, researchers, and manufacturers.
Instead of needless bureaucracy, we will have streamlined procedures
for bringing the most comprehensive new medical devices and drugs to
market as soon as is safely possible.
In the medical device section of the bill that the gentlewoman from
California [Ms. Eshoo] and I cosponsored together in the House, we have
a very practical third-party review process, we have a dispute
resolution procedure that will allow researchers and manufacturers to
work out their differences with the FDA reviewers; we have a
reclassification of the existing device section that will let a lot of
devices that are now class 3 be class 1 or class 2. Very importantly,
we have an expanded and reformed use for humanitarian medical devices
that will bring some of these experimental devices as quickly as
possible to the market.
I must thank the gentlewoman from California [Ms. Eshoo], who has
just been a one-man band in trying to force compromise and get me to
back down when I really did not want to. She has done excellent in
that. The staff level, in addition to the other staffers, I would like
to thank Bill Bates of the office of the gentlewoman from California
[Ms. Eshoo], Alan Sloboddin of the committee oversight staff, and Beth
Hall of my staff, who have all done yeoman's work.
This is not a perfect bill, but it is a great start. I am going to
use the oversight chairmanship to oversee implementation, and I hope
that we pass this unanimously this evening. It is good for the American
public.
{time} 2015
Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from
California [Mr. Waxman].
Mr. WAXMAN. Mr. Speaker, my congratulations to the gentleman from
Virginia, Chairman Bliley, and the gentleman from Florida, Mr.
Bilirakis, and our Democratic leaders, the gentleman from Michigan, Mr.
Dingell, and the gentleman from Ohio, Mr. Sherrod Brown, for producing
the Food and Drug Administration Modernization Act, which marks the
successful end of a long 3-year process. I do not agree with some of
the provisions in this bill, and I certainly would have written it
differently, but I do support it today.
I have no difficulty in supporting this legislation in large part
because Chairman Bliley developed a process where all Members could
participate, their views could be heard, and compromises could be
reached. That kind of leadership is harder than some might think,
because there is always pressure to be partisan and to get what one
side and only one side wants. But if we are going to ever pass
legislation into law, we have to recognize that it needs to be done on
a bipartisan basis, and we have to have a process where we try to find
common ground.
I want to express my appreciation to our chairman for his leadership.
I do have some reservations about the scope of many of the provisions
in this legislation, particularly when it comes to the off-label
promotion of drug and devices and third-party review of devices. But I
want to point out that these are experimental provisions with sunsets
which will allow us to critically reexamine their public health
consequences.
I applaud very strongly the reauthorization of the Prescription Drug
User Fee Act, which I was proud to have authored. It has been very
successful and has allowed the FDA to speed the approval of drugs.
There are a number of other provisions that we ought to take note of
because they will directly benefit many patients. The requirement that
drug companies report on their fulfillment of postmarketing studies
fills an important gap in ensuring that critical information is
reaching patients. The clinical data base will create new opportunities
for patients to have greater access to comprehensive information about
experimental therapies for serious and life-threatening diseases. It is
my expectation that companies will work with the FDA in this enterprise
in the same cooperative spirit in which it is enacted.
The pediatric drug provision complements the FDA's recent
regulations, and provides targeted incentives to improve the quality of
health care for infants and children. Although I had reservations
regarding the need to provide additional market exclusivity following
the proposal of the regulations, there may still be limited situations
in which this provision will encourage new clinical research to
establish the safety and effectiveness of drugs for children.
The provision requiring notice of discontinuance of the manufacture
of life-saving drugs will ensure that patients receive time to find
alternatives to medicines which will no longer be available. Instead of
having to make medically sensitive decisions in haste, they will have 6
month's notice of a company's decision which could have tremendous
implications for their health. Only a company with ``good
[[Page H10535]]
cause'' will be permitted to end distribution or manufacture of its
drug with less than 6 months notice, and in that event, the FDA will be
able to determine the accuracy of this claim through records and
documentation.
The preemption of state laws regarding over-the-counter drugs and
cosmetics has been resolved in an important compromise, under which the
FDA is granted new enforcement authority over OTC drugs, the states are
not preempted with respect to cosmetic safety, and preemption of
cosmetic packaging and labeling only occurs where the FDA has taken
action on specific and narrow questions. Most importantly, this
provision does nothing to affect California's Proposition 65, an
innovative state initiative that has helped reduce Californians'
exposure to toxic hazards.
This bill is a far cry from the proposals first floated three years
ago which ran roughshod over consumer protections, supplanted our own
product approvals with those of other countries, and weakened crucial
statutory guarantees of safety, effectiveness and quality. The reason
for this striking difference was the persistent skepticism of American
consumers, who understood that it is the FDA which ensures that our
food is safe and our medicines are safe and effective.
This was made clear by the Patients' Coalition, which represents a
hundred patient and consumer organizations and hundreds of thousands of
patients. For three years, the Coalition has vigorously opposed extreme
and controversial proposals for FDA deregulation. Today, this bill will
receive bipartisan support because of the Coalition's unremitting
vigilance and hard work in defeating efforts to weaken public health
protections through FDA ``reforms.''
Given the extraordinary success of PDUFA, it makes sense for Congress
to apply user fees to other areas of FDA jurisdiction, including
medical devices. Enacting such fees, modeled on authorized, additive
user fees under PDUFA and not upon the unauthorized ``sham'' fees
frequently proposed by OMB, would bring similar efficiencies to the
device approval process.
Regrettably, this legislation does not do so. Instead, it enacts
substantial new burdens on the FDA and, in particular, the Center for
Devices and Radiological Health. I am deeply concerned that unrealistic
deadlines and dozens of new mandates will slow the tremendous progress
that has been made in speeding device approvals. It remains to be seen
whether we will inadvertently divert limited staff, time and resources
from the FDA's most important business--ensuring that our food supply
is the safest in the world and that drugs and devices are safe and
effective.
I want to recognize the important work of the staffs on both sides of
the aisle in developing this legislation. Without them it would have
been impossible for us. I want to compliment as well those in the
Senate who played such an active role, and all of my colleagues who
have played an important role, in developing this legislation.
I especially want to recognize the dedication and hard work of Kay
Holcombe, our Commerce Committee staff, and the work of Howard Cohen,
Eric Berger and Rodger Currie, the Majority committee staff, on this
legislation. I would also emphasize the tireless work by the
professionals at the FDA, including Bill Schultz, Peggy Dotzell and
Diane Thompson, and the representatives of the Patients Coalition,
Scott Sanders, Michael Langen, Maura Kealey and Tim Westmoreland.
I complement Chairman Bliley and Congressman Dingell of the Commerce
Committee, and Chairman Jeffords and Senator Kennedy of the Senate
Labor and Human Resources Committee, for their hard work and join my
colleagues in supporting this important legislation.
Mr. BLILEY. Mr. Speaker, I yield myself 15 seconds.
Mr. Speaker, I just want to thank the very kind and generous remarks
of the gentleman from California [Mr. Waxman]. I hope that not too many
of my people down in Richmond were watching. It might have an adverse
affect on me in the next election. But again, I thank him very much,
and I have enjoyed working with him.
Mr. Speaker, I yield 3 minutes to the gentleman from Pennsylvania
[Mr. Greenwood], whose work played a great part in bringing this
legislation to us this evening.
Mr. GREENWOOD. I thank the chairman for yielding, Mr. Speaker, and I
thank him also for the opportunity to chair this task force.
When Chairman Bliley asked me to chair the task force on the FDA
reform, I did not know a whole lot about the FDA, not more than most
people did, but I learned an awful lot. One of the things that I
learned is that we are approaching what I think will be a golden age of
medicine. We are making such incredible breakthroughs right now in
biotechnology and genetic engineering, in pharmacology, in the
development of high-tech medical devices, that I believe that we are
going to give the next generation in the next century, as well as many
of us, opportunities to defeat diseases that have plagued mankind for a
very long time, and be able to relieve people from their suffering from
these diseases.
But central to this promise is the role of the Food and Drug
Administration. The Food and Drug Administration exists for the very
critical job of making certain that all of these miracle cures, all of
these devices and drugs, are both safe and effective.
The problem we discovered is that the agency had become bureaucratic,
and the law that governs it had become antiquated and was not keeping
up with this modern age of miracle cures. We set about the role of
seeing if we could make the FDA work more efficiently, bring these
cures to those who are suffering more rapidly, while still maintaining
the golden standard of safety and efficacy.
I also learned of some very human situations. I learned that I had a
constituent whose name is Shelbie Oppenheimer. She is a hero to me. She
is a 30-year-old woman who at the age of 28 was running a day care
center and discovered that she had ALS, Lou Gehrig's disease. It is a
progressive, fatal neuromuscular disorder that attacks nerve cells and
pathways in the brain and spinal cord.
There is no cure for it, but there is a new medication that can delay
the onset of the disease and slow its progress. My constituent, Shelbie
Oppenheimer, and her husband, Jeff Oppenheimer, desperately want her to
have access to this medication. Mr. Speaker, it is my hope that this
legislation gives Shelbie Oppenheimer the extra time and the extra hope
that this new medication will provide her.
I would like, Mr. Speaker, to dedicate this bill to Shelbie
Oppenheimer and to all of the other Shelbie Oppenheimers around the
country who are waiting for the Congress to reengineer the FDA so that
it can approve these new miracle cures for them more rapidly.
I am also pleased that the legislation that I had introduced
separately, the better pharmaceuticals for children bill, has been
incorporated into this reform package, so we can bring the miracles of
modern medicine not only to adults, but to the children who up until
this time were not the subject of trials.
I would like to thank all of my colleagues and the chairman, the
gentleman from North Carolina [Mr. Burr], the gentleman from Texas [Mr.
Barton], the gentleman from Wisconsin [Mr. Klug], and the gentleman
from Kentucky [Mr. Whitfield], for their assistance, and certainly echo
the comments of those who have praised our very, very able staff.
Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the distinguished
gentleman from New Jersey [Mr. Pallone].
Mr. PALLONE. Mr. Speaker, the conference report before us has been
the product of hard work, tough negotiations, and true bipartisanship.
The result is a well-crafted bill that will reauthorize the
Prescription Drug User Fee Act, and enact common-sense Food and Drug
Administration reform.
I want to congratulate the chairman and the ranking member and the
professional staff of the committee on both sides of the aisle,
particularly Kay Holcombe, for their work on this very successful piece
of legislation.
Pursuant to the bill, patients will have access to safe new drugs,
treatment, and equipment faster than before; businesses will be able to
save their customers money without sacrificing safety; and the FDA will
be able to focus more time and money on regulating medical treatments
instead
[[Page H10536]]
of pushing paper. I think it is a win for everyone.
Mr. Speaker, I just wanted to mention a few provisions of the bill
that I am particularly concerned with, concerning the drug provisions.
I am particularly pleased with the inclusion of a bipartisan amendment
that would provide for notification when a company terminates a product
which could cause severe harm to a patient because of its
discontinuance.
To allay industry concerns, I ask that there would be included in the
bill a good cause waiver that allows the FDA to waive the time
requirement. I understand that the provision has been slightly modified
in conference in that companies have to certify to the FDA that these
good cause waiver requirements are met. This provision still represents
good citizenship by the sole-manufacturers of medical products, and I
believe that the conference report compromise is a good one.
In addition, two amendments concerning mercury were incorporated into
this bill. One of them requires the FDA to restudy the impact of a form
of organic mercury in nasal sprays on the brain, and the second
provision provides for a study that would examine the sale of mercury
as a drug or for other home use. These are both good government
provisions. I appreciate the work of the committee for including them
in the conference report.
On the device side, I wanted to congratulate the gentlewoman from
California [Ms. Eshoo] and the gentleman from Texas [Mr. Barton] for
their ability to find common ground with the FDA and the industry on
many issues. While third-party review may not be the panacea, freeing
up the FDA's limited resources to review and approve high-risk devices
is the next best thing, especially without greater resources being
devoted to the FDA directly.
Finally, I am very pleased that language was included, the House
language, to ensure that this legislation does not hinder the FDA's
authority to reduce teen smoking. We are going to be dealing with the
issue of teen smoking and tobacco in general in the committee. I know
we are going to start having hearings on it next week. I think it was
important and sound policy that this provision be included.
I just want to urge adoption of this conference report. I know that
the committee and the staff and all have worked very hard on this. I
think it is a very successful bill that will be passed into law and
signed by the President.
Mr. BLILEY. Mr. Speaker, I yield 1 minute to the gentleman from
Florida [Mr. Stearns], a member of the committee.
(Mr. STEARNS asked and was given permission to revise and extend his
remarks.)
Mr. STEARNS. Mr. Speaker, I am here to support the FDA reform bill,
and to compliment the chairman and ranking member, and, of course, the
subcommittee chairman, the gentleman from Florida [Mr. Bilirakis], who
is a colleague. But I am disappointed that this legislation lacks a
provision preventing the FDA from going forward with its proposed plan
to ban certain metered-dose inhalers.
I have introduced legislation, and myself and other colleagues have
worked hard to try and lobby the conference. We were not successful.
The FDA is proposing to ban metered-dose inhalers containing
chlorofluoro- carbons sooner than America agreed to in the Montreal
Protocol. I am going to reach out to both sides to see if we can pass a
standing piece of legislation, because CFC damage is there, it hurts
the ozone layer, but, frankly, we need to phase it out and not move
abruptly.
The Federal Government allows the use of CFCs for bear repellant and
wasp and hornet sprays, yet the FDA wants to take away medicines for
metered-dose inhalers because they have CFCs. Are killing bugs and
chasing away bears really more important than the health of our
children? I do not think so. Next session, Mr. Speaker, let us keep the
FDA from banning these inhalers until safe and effective alternatives
are developed.
Mr. DINGELL. Mr. Speaker, I yield 2 minutes to the distinguished
gentleman from Rhode Island [Mr. Kennedy].
(Mr. KENNEDY of Rhode Island asked and was given permission to revise
and extend his remarks.)
Mr. KENNEDY of Rhode Island. Mr. Speaker, I thank my colleagues who
have been speaking out on this issue, most notably the gentleman from
Florida, Mr. Cliff Stearns, who just spoke. Asthma kills roughly 5,000
people every year. There are over 30 million Americans who depend on
those metered-dose inhalers, such as the one I have in my pocket, in
order to relieve themselves of the terror of being gripped with asthma.
What the FDA has proposed is they have proposed phasing out these
metered-dose inhalers because of their CFC content. CFC content in
metered-dose inhalers contributes less than 1 percent of the
chlorofluorocarbons in the atmosphere, yet the FDA would like us to
believe that by banning these inhalers, we will get about complying
with the Montreal Protocol and achieving a reduction in
chlorofluorocarbons.
As my colleague, the gentleman from Florida, Mr. Cliff Stearns, said,
this is all while the EPA has yet to ban refrigeration and air
conditioning, which contributes 58,000 tons of CFC's, things such as
solvent applications, red pepper bear repellant, lubricant coatings,
and foam blown with CFC's used in coaxial cables.
The point I am going to make is we are going after less than 1
percent of the CFC's in the atmosphere by banning these metered-dose
inhalers when we have not taken into full account the public health
impact on asthmatics all across the country who depend on these
metered-dose inhalers in order to relieve them from their asthma.
I can tell the Members, I have four different inhalers. I think there
is only one of them that has a non-CFC component. We should not be
rushing to ban these inhalers without fully testing and evaluating the
impact of those non-CFC inhalers, so we do not adversely impact the
public health of our people.
I want to thank the gentleman from Michigan [Mr. Dingell] and the
gentleman from Virginia, Chairman Bliley, for agreeing to a bill that
will address this issue in the upcoming year.
Mr. BLILEY. Mr. Speaker, I yield 1 minute to the gentleman from
Kentucky [Mr. Whitfield].
(Mr. WHITFIELD asked and was given permission to revise and extend
his remarks.)
Mr. WHITFIELD. Mr. Speaker, I thank the gentleman for yielding time
to me. I want to give special thanks to the gentleman from Virginia
[Mr. Bliley] and the gentleman from Michigan [Mr. Dingell] for the
leadership they have provided. I rise in strong support of this
conference report of FDA reform legislation as it relates to medical
devices, prescription drugs, and food.
{time} 2030
The food provisions of the final version of this bill reflect closely
the hard work of the House in addressing the need for fine-tuning the
Nutrition Labeling and Education Act of 1990. Clearly, much more needs
to be done before we can assert that our Nation's food laws have been
completely reformed. However, this is a responsible down payment of
food reform that we can expect to benefit public health.
I want to commend those Members and staff on both sides of the aisle
who worked so diligently as we were successful in passing this
legislation overwhelmingly. I would urge all Members of the House to
support this conference report.
Mr. BLILEY. Mr. Speaker, I yield 1 minute to the gentleman from
Pennsylvania [Mr. Fox].
Mr. FOX of Pennsylvania. Mr. Speaker, the gentleman from Virginia
[Mr. Bliley], the chairman, and the gentleman from Michigan [Mr.
Dingell], the ranking member, should be very proud of this legislation.
FDA reform is certainly one of the most important pieces of
legislation to pass in this session. I know from testimony in my own
home county, Montgomery, Pennsylvania, we had hearings regarding the
fact that many people waiting for a cure, a vaccine, whether they have
ALS, or cancer, or AIDS or epilepsy, up until now, it took $5 million
and 15 years for many of our drug companies to get approval from FDA.
This legislation will hasten the available market for miracle cures
going from lab to the patient without bureaucratic delay. It will speed
up that
[[Page H10537]]
approval time. Independent agencies will be able to do the testing.
This will be a lifesaving procedure because of this legislation's
adoption.
I also want to thank the gentleman from Florida [Mr. Bilirakis], the
gentleman from North Carolina [Mr. Burr], the gentleman from
Pennsylvania [Mr. Greenwood], and the gentleman from Texas [Mr. Barton]
for all of their leadership on this issue, because Americans, in a
bipartisan fashion, want to have the drugs that are available for them
to live longer and to live better. And the same applies, of course, to
medical devices and biologics. I appreciate the support of every Member
of this entire House to support this FDA reform.
Mr. BLILEY. Mr. Speaker, I yield 1 minute to the gentleman from
California [Mr. Bilbray], a member of the committee.
Mr. BILBRAY. Mr. Speaker, I have the privilege of representing the
49th District of the State of California, San Diego, which has one of
the largest concentrations of pharmaceutical companies in the world,
but also has more biotech industries in the area than anywhere else in
the world, including a combination of Britain and Japan combined.
Mr. Speaker, I like this bill, and I think my constituents will
appreciate this bill, not because of those industries, but because of
what it does for consumers.
The fact is, Mr. Speaker, there are two ways of hurting a patient.
One is to give them inappropriate treatment. But the other, and sadly
all too common way of hurting a patient, is not to provide appropriate
treatment and to deny that appropriate treatment to people who are ill.
One of the problems we have had in the past is that there have been
medication and treatment that have been denied the American consumer
that have been available all over the world. This bill is a
progressive, well balanced bill that will finally now improve the
situation to allow the American consumer to have what they need
desperately: safe, effective drugs, as soon as possible. I appreciate
the support for the bill.
Mr. DINGELL. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, I think we are witnessing an extraordinary event in this
Congress and, indeed, almost in any Congress. In the closing days of
the session, with the usual tensions and mischief that exist, we are
finding great enthusiasm on a very fine piece of legislation which
started out rather under a dark star and which, through some remarkable
cooperation, has come to the point where we have not only agreement but
firm agreement on a good bill, something which is going to help
manufacturers, help the economy, to help the consumers and patients. It
is going to help the medical profession, it is going to make Americans
safer, and it is going it see to it that good drugs, safe and
efficacious, come more quickly to the marketplace.
It is also going to see to it that the other responsibilities of the
Food and Drug Administration are conducted in a more efficient and
speedy fashion. It shows what real bipartisanship can do when Members
of Congress on both sides of the aisle get together and when there can
be the kind of cooperation and goodwill there was in the conduct of
this particular negotiation.
The result is a fine piece of legislation, one which will benefit the
country, one which will benefit the industry, one which will make for
better government, and one which will do something else, and that is to
protect the consumer and see to it that we get to the American people
the best drugs in the fastest and safest and the most assured fashion.
I urge my colleagues to support the bill.
I want to commend my colleague, the gentleman from Virginia [Mr.
Bliley], for his fine leadership in this matter. And I want to express
my personal thanks and that of the Members on this side of the aisle to
Kay Holcombe for the superb job that she has done in preparing this
piece of legislation for consideration today. I also am grateful to
Secretary Shalala, Dr. Friedman, and the excellent FDA staff for their
assistance.
Mr. Speaker, I yield back the balance of my time.
Mr. BLILEY. Mr. Speaker, I thank the gentleman from Michigan [Mr.
Dingell] for his kind words. Without his help, we would not be here.
Mr. Speaker, I yield the balance of our time to the gentleman from
Iowa [Mr. Ganske].
Mr. GANSKE. Mr. Speaker, my congratulations to all who have been
involved with this bill.
As a physician, I am very proud to be in favor of this bill. This
bill will help bring new and better drugs and medical devices to the
market. It will also help older drugs be better used. There are many
off-label uses of older drugs that are beneficial to our constituents,
like aspirin to prevent heart attacks; 80 to 90 percent of cancer
treatment is off-label. In fact, for some diseases, off-label treatment
is a standard of care.
Section 7 of H.R. 1411 improves to help public health by increasing
the amount of accurate, balanced, scientific information that is
available to physicians and other health care professionals. This has
been an important compromise between the administration, the FDA, and a
bipartisan Congress.
Secretary Shalala said the language that we have agreed to will give
the FDA the opportunity to review new information in advance of its
dissemination to ensure that it is accurate and balanced. This
provision is supported by the AMA, the American Cancer Society, the
National Multiple Sclerosis Society, and many other groups who know
that greater dissemination of scientific information means better care
for patients.
Please vote for this bill.
Mr. WHITFIELD. Mr. Speaker, thanks are owed to several Members for
their leading role in the development of the food provisions of this
bill. Special thanks must be given to Chairman Bliley, ranking minority
member Dingell, as well as Messrs. Towns, Hall, Gankse, and of course,
the author of the food reform legislation in the last Congress, Mr.
Klug. Praise is also due to the exceptional work of committee counsel,
Eric Berger, as well as James Derderian and to staff of members of the
committee including Tim Taylor of my staff, Brenda Pillors, Grace
Warren, and Jon Traub. Special note should be made of the work of Kay
Holcombe, who has served the Commerce Committee and Public Health as a
whole with extraordinary professionalism of many years.
The food provision of the final version of this bill reflects closely
the hard work of the House in addressing the need for fine tuning of
The Nutrition Labeling and Education Act of 1990 [NLEA]. Clearly, much
more needs to be done before we can assert that our Nation's food law
has been reformed. However, this is a responsible down payment of food
reform that we may reasonably expect to benefit public health.
A compelling problem that is addressed by this legislation is the
Food and Drug Administration blocking truthful, nonmisleading
information from American consumers. As a matter of public health, this
has prevented, either by prohibition or excessive delay, consumers from
receiving important information about the nutritional content or health
benefits of various foods. This problem also takes the form of an
abridgement of the first amendment rights of persons who seek to make
truthful, nonmisleading statements about a food. FDA has an absolute
duty to act within statutory time frames for action on petitions for
claims. The failure to do so would constitute a violation of first
amendment rights of petitioners. Particularly given the vulnerability
of petitioners to retaliation from the FDA, the courts are urged to be
expansive in issues of standing in suits regarding failure by the
agency to take timely action.
Specifically, the conferees have brought forth a bill that addresses
these issues by providing a maximum review time for final action on
petitions for claims, including a requirement that the Secretary report
on any instances where final action is not taken within the 540 day
review period so that the committees of jurisdiction may be promptly
informed of a breakdown in the regulatory scheme. Also, special
streamlined review mechanisms are provided for health or content claims
that are based on the conclusions of authoritative scientific bodies,
such as the National Academy of Sciences. The Secretary is granted
authority to make proposed rules effective immediately as an
exceptional tool to assure that the FDA's duty to pre-approve claims
can be met without delay that undermines the regulatory scheme or
threatens the first amendment right of petitioners. Unnecessary
requirements regarding referral statements that accompany certain
nutrient content claims have been eliminated under the bill. And, in a
matter where both food safety and first amendment rights have been
jeopardized by heavy handed regulatory requirements, an important
provision of the bill addresses the labeling of foods treated by
irradiation.
[[Page H10538]]
To implement the irradiation amendment, FDA is to expeditiously
conduct a rulemaking to revise its current irradiation disclosure
requirement. The current requirements of the rule, a ``Treated with
Radiation'' or ``Treated by Irradiation'' statement, accompanied by the
international radura symbol, make clear that the process has been used.
However, it is equally clear that this requirement has had the perverse
effect of discouraging many consumers from purchasing food that has
been made safer by this process. The conferees are concerned that the
current disclosure requirement may be perceived as a warning and that
it may raise common but inappropriate anxieties about radiation
technologies. FDA should use the new rulemaking to assure that
disclosures are only required as necessary to inform consumers of a
material fact regarding the food. FDA's 1986 preamble to its final rule
regarding irradiation disclosure well explained the general rule
regarding disclosure of material facts and how that rule relates to
food that has been irradiated:
In this case, the standard for misbranding under sections
403(a) and 201(n) of the act is whether the changes brought
about by the safe use of irradiation are material facts in
light of the representations made, including the failure to
reveal material facts, about such foods. Irradiation may not
change the food visually so that in the absence of a
statement that a food has been irradiated, the implied
representation to consumers is that the food has not been
processed.
The Agency recognizes, however, that the irradiation of one
ingredient in a multiple ingredient food is a different
situation, because such a food has obviously been processed.
Consumers would not expect it to look, smell, or taste the
same as fresh or unprocessed food, or have the same holding
qualities. Therefore, FDA advises that the retail labeling
requirement applies only to food that has been irradiated
when that food has been sold as such (first generation food),
not to food that contains an irradiated ingredient (second
generation food) but that has not itself been irradiated.
Thus, FDA determined that disclosure is required to convey to
consumers the material fact that the food is not fresh or unprocessed.
Given the fresh appearance of food treated by irradiation, FDA
determined that the omission of such a disclosure would cause a false
or misleading presentation of the food. FDA has authority in this
regard only to prevent false or misleading presentation of the food.
FDA would exceed its authority if it were to prohibit a truthful,
nonmisleading presentation of the food. In any situations where FDA
determines that an irradiation disclosure remains necessary, it is
obliged to achieve that objective in a minimally burdensome manner.
Disclosure statements may only be required where presentation of the
food would be false or misleading absent a disclosure statement.
Statements different from the current disclosure requirement would
suffice if they inform consumers of the material fact that is basis for
the disclosure requirement. FDA is obliged to permit disclosure of the
material fact through any statements that are not false or misleading.
Moreover, the conferees expect FDA to take pains to assure that where
disclosure is appropriately required, such required statements not give
rise to consumer confusion that could inhibit use of this pathogen
reducing technology. It would be unacceptable for FDA to justify a
disclosure requirement that may cause consumer confusion with the
excuse that the confusion may be corrected by a proper consumer
education program. On its face, such an approach creates burdens that
inhibit the use of this technology and, as a consequence, food safety.
The conferees strongly support the consumer right to know. The act
contemplates that right being addressed through a vast array of
truthful, nonmisleading voluntary label statements, as well as required
disclosure of material facts that are not obvious in the presentation
of a food. With respect to food that has been irradiated, this
legislation does not limit FDA's existing authority to require
disclosure nor does it forbid use of the international radura symbol as
one of the means of making such a disclosure. The conferees expect FDA
to continue to require necessary disclosures to prevent consumers from
being misled about any material fact about a food.
Also in the area of labeling, I am disappointed to note that the
Senate conferees would not accept the elimination of antiquated and
bizarre provisions of the Food, Drug and Cosmetic Act that apply only
to margarine. It is a sad measure of our food regulatory system when
industries seek competitive advantage over one another through the
imposition and maintenance of absurdly burdensome requirements such as
these.
I am pleased to report that the conferees have agreed to direction
for FDA to take final action within 60 days on the petition to permit
the irradiation of beef. This petition has been pending in FDA for over
3 years, despite the requirement that FDA act on such petitions within
6 months. Also, the bill includes reforms in the review of food
labeling packaging materials that should assist FDA in expediting
appropriate approval of both these materials and, through greater
efficiency of operation, all food additive petitions.
I urge my colleagues to vote for the conference report so that we may
make this down payment on food law reform.
Mr. TOWNS. Mr. Chairman, I join my colleagues in applauding the
scheduling of the conference report on S. 830, legislation to reform
the Food and Drug Administration, prior to our adjournment of the 1st
session of the 105th Congress. This bill is the culmination of 2 years
of hard bipartisan work by the Commerce Committee to modernize
procedures that the Food and Drug Administration uses to approve drugs,
devices and food products. Once again, Mr. Chairman, the Commerce
Committee under the able leadership of our chairman, Mr. Bliley, and
our ranking member, Mr. Dingell, have demonstrated that we have the
ability to develop comprehensive legislative responses to critical
public policy questions. I also want to especially acknowledge the
efforts of our subcommittee chairman, Mr. Bilirakis and our ranking
subcommittee member, Mr. Brown, for the willingness to guide the
deliberations on this bill in a bipartisan fashion.
Without the modernizing steps that have been incorporated in this
legislation today, the FDA would continue to be seen as a barrier to
new innovative therapies and products. The bill before us today
represents a careful balance between a new, streamlined process and
consumer protections against harmful products. These innovations in the
way the FDA will do business from now on makes the approval of drugs
and devices a more predictable process.
Finally, Mr. Chairman, I am most pleased about the provisions in this
bill which relate to food products. I had the wonderful experience of
working closely on these issues in a bipartisan fashion with the
gentleman from Kentucky [Mr. Whitfield], the gentleman from Wisconsin
[Mr. Klug], the gentleman from Pennsylvania [Mr. Greenwood], and the
gentleman from Texas [Mr. Hall]. While some argued that food reforms
were too controversial to include in this bill, my colleagues and I
never stopped believing that we could craft reasonable and meaningful
food reforms that would be acceptable to the industry, FDA, and
consumers alike. With the able assistance of our committee counsels on
both sides of the aisle, Eric Berger and Kay Holcombe, the measure
incorporated in S. 830 accomplish this goal. The food issues in this
bill build on the success of the Nutrition Labeling and Education Act
and they represent a modest downpayment on more significant food law
reforms, including the question of national uniformity.
Mr. Chairman, I join my colleagues from the Commerce Committee in
urging the immediate passage of this legislation.
Mr. RAMSTAD. Mr. Speaker, I rise in strong support of the Conference
Report on comprehensive legislation to reform the Food and Drug
Administration [FDA]. And I thank Chairman Bliley and the others who
worked so hard to bring this important Conference Report to the floor
for passage before Congress adjourns for the year.
Reforming the FDA's approval process has been a major goal of mine
since I first came to Congress in 1991. In fact, in an effort to
educate House members about the need for reform for medical devices,
Representative Tim Valentine and I founded the bipartisan House Medical
Technology Caucus, which I now chair with Representative Anna Eshoo.
As we all know, it now takes 15 years and $350 million to get the
average new drug from the laboratory to the patient. The average time
for the FDA to approve a medical device has increased from 415 days in
1990 to 773 in 1995--even though the FDA is currently required by law
to take no longer than 180 days to approve new devices.
This is precisely why I became an original cosponsor of the medical
device section of this reform package. The medical device provisions
will save lives, improve health and create jobs in the United States by
getting medical devices to market faster.
I also strongly support the sections in the bill to reauthorize the
Prescription Drug User Fee Act [PDUFA] and reform the approval process
for pharmaceuticals and animal drugs.
Mr. Speaker, these reforms passed today will force the FDA to get its
act together so life-saving devices and drugs will get to people who
need them as expeditiously and safely as possible.
The health care consumers, medical device and pharmaceutical
companies of America deserve nothing less!
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Virginia [Mr. Bliley] that the House suspend the rules
and agree to the conference report on S. 830.
The question was taken; and (two-thirds having voted in favor
thereof)
[[Page H10539]]
the rules were suspended and the conference report was agreed to.
A motion to reconsider was laid on the table.
____________________