[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need to modernize the FDA in 1995, we knew that outdated rules were 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.

                          ____________________