[Congressional Record Volume 143, Number 157 (Sunday, November 9, 1997)]
[Senate]
[Pages S12241-S12252]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997--CONFERENCE 
                                 REPORT

  Mr. JEFFORDS. Mr. President, I submit a report of the committee of 
conference on the 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, and ask for its immediate consideration.
  The PRESIDING OFFICER. The report will be stated.
  The legislative clerk read as follows:

       The committee on conference on the disagreeing votes of the 
     two Houses on the amendments of the House to the bill (S. 
     830), have agreed to recommend and do recommend to their 
     respective Houses this report, signed by all of the 
     conferees.

  The Senate proceeded to consider the conference report.
  (The conference report is printed in the House proceedings of the 
Record of November 9, 1997.)
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, before us is the conference report on S. 
830, the Food and Drug Administration Modernization Act. This is really 
an excellent moment to bring this up and consider what has been 
accomplished.
  This bill represents the first major reform of the Food and Drug 
Administration in some 30 years. For our committee, it is the second 
major reform

[[Page S12242]]

that we have accomplished this session, the first one being special 
education, which was the first major reform for that program in some 20 
years.
  I am very pleased to be able to say to my colleagues that the FDA 
measure embodies the objectives we originally sought to accomplish.
  This legislation achieves two important goals.
  First, it helps the FDA to get medicine and medical devices to 
patients and doctors sooner and safer.
  And, second, it will extend and improve the Prescription Drug User 
Fee Act, commonly known as PDUFA.
  I am pleased to report that the conference report has the unanimous 
support of the conferees. It deserves the unanimous support of this 
body as well.
  The conference report is the culmination of 3 years of hard work by 
dozens of Senators. It offers the most substantial reform of the Food, 
Drug and Cosmetic Act in decades and will have a positive impact on the 
lives of millions of Americans for decades to come.
  Think how the world of medicine has changed over the past two or 
three decades. The law that governs much of that world, and nearly $1 
of every $3 spent by consumers, must change and adapt as well.
  The measure makes scores of changes in the law that ensures the 
safety of the food we eat, of the drugs we use to fight disease, and 
the medical devices we use to improve the health of Americans. It will 
help patients gain access to new therapies sooner without weakening 
either safety requirements or the authority of the FDA. It gives the 
agency needed tools and resources to manage an increasing workload more 
efficiently. In addition, it contributes to our maintaining America's 
technological leadership in producing pharmaceuticals and medical 
devices.
  Achieving these reforms is a win-win-win situation for consumers, for 
the FDA, and for manufacturers. It is a win for patients and consumers, 
who will gain access to previously unavailable information and obtain 
better therapy sooner. It is a win for the FDA, which will receive new, 
sorely needed resources and streamlining and modernization of 
bureaucratic processes that have not changed in decades. And it is a 
win for the manufacturers, who will have a certainty that the review 
and approval processes applied to their innovative products will be 
applied in a collaborative and consistent manner.
  About 10 months ago, Mr. President, we embarked anew on an effort 
that some characterized as foolish--an effort to modernize the 
regulatory processes of the FDA. Many thought it could not be done. 
Some urged we merely extend PDUFA or we tackle only a few issues 
related to drug regulation and leave the comprehensive modernization to 
another day.
  I am glad we did not choose either of these paths. Instead, we chose 
to forge a bill with broad, bipartisan support, one that took a broad 
view of the changes needed at the FDA.
  In that regard, I particularly want to acknowledge the Democratic 
members of the Labor Committee, and especially Senators Dodd, Mikulski, 
Wellstone, and Murray. They have made countless contributions to this 
legislation, large and small. Their tireless support has been critical 
in our success.
  This measure is the result of the process to consult with individuals 
of all points of view and to benefit from the expertise needed to craft 
legislation on this complex issue. Patients, physicians, consumer 
groups, the FDA, and the manufacturers of medical devices and 
pharmaceuticals all contributed to this effort through their 
participation in hearings and in discussions with the staffs.

  This effort was parallel to that of our colleagues in the House of 
Representatives, which, under the outstanding leadership of Chairman 
Bliley, also produced a strong bipartisan bill with overwhelming 
support. The collaboration and consensus building has continued right 
up to the present, and the quality of this conference report we are 
considering today reflects that process.
  Mr. President, we would not be here today if it were not for the 
effort of my predecessor as the chair of the Labor and Human Resources 
Committee, Senator Kassebaum. Her efforts to advance reform in the last 
Congress paved the way for our work here today. We owe her an enormous 
debt.
  This year, there have been many Members in both Chambers who have 
contributed to this effort. Foremost among them has been Senator Coats. 
The list of provisions of this bill that bear his imprint is far too 
long to recite. But, as an example, the third-party review provision 
has been developed under his leadership, and he has played an important 
role in advancing FDA modernization throughout this process.
  Senator Gregg is to be commended for his proposals to streamline the 
FDA process for consideration of health claims based on Federal 
research and his amendments to establish uniformity for the over-the-
counter, OTC, drugs and cosmetics. Senator McConnell also suggested 
improvements in the regulation of food.
  I am especially grateful to Dr. Frist. He and Senator Mack led the 
way to compromise on the issue of the dissemination of medical 
information to health professionals, an important advance forward.
  Senator DeWine, joined by Senator Dodd, offered an important 
amendment to establish incentives for the conduct of research into 
pediatric uses for existing and new drugs, a needed change. The bill 
was improved by Senator Hutchinson's amendment to establish a rational 
framework for pharmacy compounding, which respects the State regulation 
of pharmacy while allowing an appropriate role for the FDA. And Senator 
Harkin has made many contributions to this legislation.
  Finally, the ranking minority member, Senator Kennedy, has played an 
important role in bringing this conference report to the floor in a 
manner that draws support from all quarters.
  In the House, Chairman Bliley and Congressmen Dingell, Burr, Burton, 
Greenwood and Whitfield have contributed immense energy and leadership 
in reaching this agreement.
  Mr. President, it has been a remarkable year, crowned by a 
remarkable, bipartisan achievement. And I thank my colleagues for their 
support.
  Mr. President, I yield the floor and reserve my time.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, we have waited a very considerable time 
for this moment this afternoon in the U.S. Senate as well as action in 
the House of Representatives and, hopefully, the President's signature 
in the next few days on a matter of very significant importance to the 
issues of quality health for the American people.
  It has been a very considerable process that we have followed over a 
number of years to get to this point.
  I congratulate the chairman of our committee, Senator Jeffords, for 
his leadership all along this long and difficult passage, because I 
think without his perseverance, without his knowledge and awareness and 
his strong commitment on this issue, we would not have this important 
legislation available for the Senate and for the American people.
  Mr. President, one could wonder why it has taken so much time. But we 
have a natural tension between bringing new innovation and creativity 
and breakthroughs in the areas of pharmaceutical drugs and medical 
devices to the market and, on the other hand, protecting the public by 
approving only safe and efficacious products. We have well-intentioned, 
brilliant medical researchers in our country who are absolutely 
convinced that their particular product can provide life-saving 
opportunities for our fellow citizens, members of our families, who are 
suffering extraordinary illness. And we have brilliant researchers at 
FDA that examine scientific information and clinical studies and 
believe that a very significant potential danger is out there for those 
who might use a particular pharmaceutical or medical device. Achieving 
a balance between these two concerns is a difficult task.
  The one who has really balanced these conflicting views has been our 
chairman, Senator Jeffords, working diligently with other members of 
the committee, Democrats as well as Republicans, over a long period of 
time.
  I am convinced that as a result of this legislation the health of the 
American people will be enhanced through faster availability to 
pharmaceutical drugs and medical devices while maintaining important 
protections for the

[[Page S12243]]

American people. I join in supporting this landmark FDA conference 
report.
  This is a very important piece of legislation. I think in many 
respects this will be one of the most important pieces of legislation 
of this year, and possibly of this Congress.
  Mr. President, I want to commend Chairman Bliley, John Dingell, as 
well as Chairman Bilirakis, Sherrod Brown and other members of the 
House committee for their bipartisan work. We had a good conference 
where Members were knowledgeable and very committed in terms of finding 
common ground. I believe as a result of this conference we have an even 
stronger bill than was passed earlier.
  In addition, I commend the Patients' Coalition and Public Citizen, 
who worked to assure that the needs of patients were fully and fairly 
considered in the legislation. I appreciate the assistance of the 
Massachusetts biotechnology and medical device industries, who provided 
me with valuable insight into these complex issues and their concerns.
  I also commend Secretary Shalala, the dedicated men and women at the 
FDA, and the Clinton administration for their skillful and impressive 
role in developing so many aspects of these needed reforms.
  The most important part of the bill is the extension of the 
Prescription Drug User Fee Act [PDUFA] which was originally enacted in 
1992. PDUFA is one of the most important FDA reform measures ever 
enacted. It provides funds for FDA to hire hundreds of new reviewers 
who, in turn, are able to expedite the review and approval of 
pharmaceutical products. A critical element of PDUFA's success was the 
establishment of measurable performance targets, which was negotiated 
between the industry and the FDA.
  Under the PDUFA provisions in this bill, in addition to moving 
products through the regulatory process more quickly, the FDA and 
industry will also establish a cooperative working relationship and 
shorten drug and device development times, which now represent the most 
significant delay in bringing new products to market.
  In addition, the bill includes a number of other constructive 
provisions to enhance cooperation between industry and the FDA to 
improve regulatory procedures.
  I am particularly gratified that the bill includes broader use of 
fast-track drug approval. The streamlined accessibility procedure now 
available primarily to cancer or AIDS will be available for drug 
treatments for patients with all life-threatening diseases.
  The bill provides for expanded access to drugs still under 
investigation for patients who have no other alternatives. The 
compromise combines protections for patients with expanded access to 
new investigational therapies, without exposing patients to 
unreasonable risks.
  The bill includes a new program to provide access for patients to 
information about clinical trials for serious or life-threatening 
diseases.
  It provides incentives for research on pediatric applications of 
approved drugs and for development of new antibiotics to deal with 
emerging, drug-resistant strains of disease.
  It requires companies to give patients advance notification of 
discontinuance of important products. And in that connection, I am 
disappointed that we were not able to address the issue of assuring 
that asthma patients and others will not be put at risk by any abrupt 
discontinuance of inhalers containing CFCs. I have been informed by FDA 
that no notice of proposed rulemaking will be issued before this 
summer, which will give Congress plenty of time to return to this 
question, if necessary.
  Mr. President, the current legislation is an improvement over the 
bill approved by the Labor Committee earlier this year--that bill 
included a number of provisions that as originally proposed could have 
jeopardized public health.

  The original bill provided a pilot program for third-party review 
under which private third parties, certified by the Food and Drug 
Administration but selected and paid by the manufacturer, would have 
reviewed the safety and effectiveness of medical devices to determine 
whether or not they could be sold.
  The original proposal would have included many of the most complex 
and risky devices, such as digital mammography machines, and a host of 
other devices to detect and treat cancer and other dread diseases.
  Under the final bill, these devices may not be included in the pilot 
program.
  The original bill required the Food and Drug Administration to 
approve devices for marketing even if the Food and Drug Administration 
knew defects in the manufacturing process would make the devices unsafe 
or ineffective. The final legislation eliminates this requirement.
  The original bill would have prevented the Food and Drug 
Administration from looking behind the label proposed by a device 
manufacturer seeking approval of a product, even if the product was 
false or misleading. The final legislation assures that the Food and 
Drug Administration will be able to require full and complete 
information for physicians and consumers on any potential use of the 
device, not just the one claimed on the label submitted with the 
application for approval.
  And the final legislation preserves the State authority to regulate 
cosmetics, an area of significant potential hazard to consumers.
  The legislation includes an important compromise on information on 
off-label use of drugs. This compromise will allow companies to 
circulate reputable journal articles about off-label use of drugs but 
will ultimately enhance the public health and safety because the FDA 
will be given the opportunity to review, comment on, and approve 
articles which the companies will circulate. The compromise also 
requires companies to undertake studies on the safety of their drugs 
for the specific off-label use and submit applications to the FDA for 
approval of their drugs for these uses within 3 years. Currently, too 
many off-label uses of drugs have never been reviewed for safety and 
effectiveness.
  The bill assures the Food and Drug Administration will continue to 
conduct appropriate environmental impact statements, rather than be 
exempted from the standards that apply to every other governmental 
agency.
  The compromise included in the bill assures the Nutrition Labeling 
Act is not undercut or weakened, and any health claims by food 
manufacturers have to be substantiated.
  The legislation maintains existing standards for approval of 
supplemental use of drugs while streamlining the process by which they 
can be approved.
  In summary, the current legislation is a vast improvement over the 
bill approved by our committee earlier this year. As a result of 
extensive discussion since then, including the 3 weeks of debate in the 
full Senate and our subsequent negotiations with the House, I believe 
every one of these problem issues has been resolved satisfactorily.
  The bill we enact will get safe and effective products to market 
while assuring the Food and Drug Administration will have the tools it 
needs for public health. It is a landmark achievement. I urge all of my 
colleagues to support it.
  Mr. JEFFORDS. Mr. President, I yield 4 minutes to the Senator from 
Tennessee.
  Mr. KERRY. Mr. President, my understanding is when this business is 
completed that Senator Harkin has unanimous consent for 20 minutes, and 
I ask unanimous consent, following Senator Harkin, I be permitted to 
speak in morning business for 20 minutes.
  The PRESIDING OFFICER (Mr. Hagel). Without objection, it is so 
ordered.
  Mr. COATS. Reserving the right to object, I don't intend to object, 
but I know there is an effort underway to try and bring the omnibus 
appropriations bill forward and I know a lot of Members are waiting 
around so they can take that vote. In fact, I was discussing that.
  This isn't my call, but I ask the Senator if he could withhold until 
we can get some understanding of when that vote might be. It might be 
that it won't come before the Senator's 20 minutes, but if we add time 
here, 20 minutes there, and an additional 20 minutes, it could delay 
past the time when they now have commitments. I want to make sure we 
check that out.
  Mr. KERRY. If I could allow my order to stand, I would be sensitive 
to

[[Page S12244]]

the need for a vote, and if need be, I will respond.
  Mr. COATS. I accept that, and withdraw my objection.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The Senator from Tennessee is recognized.
  Mr. FRIST. Mr. President, 3 years of hard work, which was begun by 
Senator Nancy Kassebaum, have resulted in the passage of the conference 
report to the Food and Drug Administration Modernization Act of 1997 in 
the Senate today. This legislation represents the first major, 
comprehensive reform effort since the initial amendments outlining 
regulation for drugs in 1962 and for medical devices in 1976. This 
major reform will help improve the FDA by strengthening its efficiency, 
accountability, and its ability to safeguard the public health.
  There are several provisions contained in this bill that constitute 
significant reform and improvements to increase the efficiency of 
product review. For example, this legislation gives FDA authority to 
increase its access to scientific and technical expertise outside the 
Agency by allowing interagency collaboration with Federal agencies such 
as the NIH and CDC, and with the National Academy of Sciences. Also, 
the bill gives FDA the explicit authority to contract with outside 
reviewers and expand its current third party medical device review 
pilot program.
  To help alleviate the confusion and frustration that many applicants 
feel when working with the FDA, the bill will require the FDA to codify 
evidence requirements for new drug and medical device application 
submissions and encourages improved communication between the agency 
and industry. And after 60 years, the FDA will be made more accountable 
by giving it a mission statement and requiring the FDA to develop a 
plan of action to meet its requirements under law. The bill will also 
reauthorize for 5 years the Prescription Drug User Fee Act, known as 
PDUFA, which has been tremendously successful in improving and speeding 
the review of much needed pharmaceutical products.
  Most importantly, the bill Congress sends to the President will help 
patients. Individuals with a serious life-threatening disease or 
condition will have access to a new clinical trial database providing 
information on investigational therapies. Patients will benefit from 
the expansion of the fast-track drug approval process for new drugs 
intended for the treatment of serious or life-threatening conditions 
built on the existing program for AIDS and cancer drugs. And, patients 
that have no other alternative but to try an unapproved investigational 
product will have access to investigational therapies and medical 
devices.
  The bill also includes a provision that will allow reprints of 
scientifically, peer-reviewed medical journal articles and medical 
textbooks about off-label uses of FDA-approved drugs and devices to be 
shared with physicians and other health care practitioners. This 
provision will help get life-saving information to doctors, so they can 
be better informed when making decisions about how to treat their 
patients.
  As a physician, I have used off-label uses to treat my patients in 
the past and understand its tremendous importance to the patient. Over 
90 percent of treatments for cancer patients are off-label and the 
American Medical Association has estimated that between 40 percent and 
60 percent of all prescriptions are for off-label uses of prescription 
drugs. I would like to acknowledge the tremendous work on this 
provision during the last few years by my friend, Senator Connie Mack 
and Mark Smith of his staff.
  There are a number of people who worked hard to insure passage of 
this reform effort. I would like to thank Senator Jeffords, the 
chairman of the Labor and Human Resources Committee, for leading the 
bipartisan effort on FDA Reform in the Senate. I also acknowledge the 
leadership of Senator Coats, who has done significant work on 
provisions affecting medical devices in the bill. I also thank Senators 
Gregg, DeWine, Dodd, Milkulski, Kennedy and Harkin and their staffs for 
their hard work in conference. I would like to thank our House 
colleagues and their staffs who worked with us in conference and I 
especially recognize the able leadership of the chairman of the House 
Commerce Committee Representative Tom Bliley and the ranking member 
John Dingell. I would also like to acknowledge and thank Secretary 
Donna Shalala and the FDA for working with us to help modernize and 
improve the FDA.
  In particular, I would like to thank Jay Hawkins, Mark Powden, and 
Sean Donahue of Senator Jeffords' staff, Vince Ventimiglia of Senator 
Coats' staff, and Kimberly Spaulding of Senator Gregg's staff who were 
critical to the development of the bill. I thank them for their 
dedication and tireless effort on this important bill.
  I especially want to thank the tireless work and outstanding 
leadership of Sue Ramthun, my staff director for health affairs, who 
has been so instrumental in passage of this bill.
  I believe we have made a step in the right direction that will 
improve patient care and that this bill begins the debate on the long-
term investment necessary to move the agency forward in areas such as 
regulatory research, professional development, and collaborative 
efforts between Government and academia, and I hope to continue working 
with my colleagues in a bipartisan manner to further improve the FDA in 
the following years.
  Mr. KENNEDY. I yield 2 minutes to the Senator from Maryland.
  Ms. MIKULSKI. Mr. President, I am so happy this day has finally come, 
in which the U.S. Senate, and I believe the House, will pass a 
conference report to modernize the Food and Drug Administration and to 
bring it into a 21st century framework.
  I want to thank Senator Jeffords for the patient leadership he has 
provided in moving this bill, and a special thanks for the collegiality 
of his staff in working with mine. I also would like to acknowledge the 
special role that Senator Coats has played. I have enjoyed working with 
him these last 3 years. We will miss him here as he undertakes next 
year a new life in encouraging faith-based community groups to become 
more involved. I think in this bipartisan collegial exchange we have 
come up with an outstanding bill that is going to save lives, save jobs 
in the United States of America, give us a product to export around the 
world that is translingual, transcultural, but certainly helps our 
people and at the same time puts patients first.
  I want to particularly thank my own staff, Lynne Lawrence, for the 
active work she has done, and Roberta Haeberle and Kerry O'Toole in the 
excellent backup they have provided.
  Why do I like this bill? First of all, we reauthorize the 
Prescription Drug User Fee Act. What this will mean is we will be able 
to have 600 reviewers who will be able to work at the Food and Drug 
Administration making sure that we cut the review time, streamline the 
process, be able to move drugs, biologics and devices for clinical 
practice in a more expedited fashion, and at the same time be able to 
protect safety and efficacy. We do protect safety and efficacy while we 
move along at a quicker step with more people.
  A reauthorization of PDUFA gives us the right people and now we have 
the right legislative framework to do it. One of the important aspects 
of this legislation is the streamlining process, and yet at the same 
time maintaining safety and efficacy upon the approval process so more 
and more clinical things will be able to go into clinical practice.
  I am delighted that this day has finally arrived. It is a great day 
for patients and physicians. They will get new medical products in a 
more timely and efficient manner. It is a great day for American 
business. They won't have to go through unnecessary regulatory hoops to 
get these new products on the market.
  This legislation, carefully crafted between the House and Senate, 
represents a solid, bipartisan effort. We could not have reached this 
point without the incredible dedication and persistence of the chairman 
of the Labor Committee, Mr. Jeffords. I thank him for his heartfelt 
devotion to this bill, and for never giving up. I also thank his staff, 
Jay Hawkins, Sean Donohue, and Mark Powden for all their hard work.
  Let me also acknowledge the tremendous contributions of our ranking

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member, Mr. Kennedy. There is no doubt this is a better bill because of 
his efforts. I also want to acknowledge the hard work of our 
counterparts in the House, the chairman of the Commerce Committee, Mr. 
Bliley and the ranking member, Mr. Dingell. Many thanks also go to the 
fine staff of the Commerce Committee for their excellent work.
  Mr. President, I have worked on FDA reform for a number of years. 
When I was a Member of the House of Representatives, we embarked, on a 
bipartisan basis, to ensure consumer protection and to prevent dumping 
drugs that did not meet our standards on Third World countries.
  Coming to the Senate, I joined with my colleague from Massachusetts, 
Mr. Kennedy, and the Senator from Utah, Mr. Hatch, in fashioning the 
Prescription Drug User Fee Act [PDUFA]. PDUFA has enabled FDA to hire 
more people to examine products that were being presented for 
evaluation and get them to patients more quickly.
  The leadership of Kennedy-Hatch on PDUFA has not only stood the test 
of time, it has shown that we can expedite the drug approval process 
while maintaining safety and efficacy. I am so pleased that this 
successful legislation will be reauthorized for 5 years.
  But while PDUFA has made a huge difference, it became clear PDUFA was 
not enough. More staff operating in an outdated regulatory framework, 
without a clear legislative framework, was deficient.
  That is when we began to consult with experts in public health, 
particularly those involved in drugs and biologics. While we were 
considering all this, the world of science was changing. We experienced 
a revolution in biology. We went from a smokestack economy to a 
cyberspace economy. We went from basic discoveries in science from the 
field of chemistry and physics to a whole new explosion in biology, in 
genetics and biologic materials.
  It became clear we needed an FDA with a new legislative framework and 
a new culture. This is when we began to put together what we called the 
sensible center on FDA reform. We worked with Republicans and Democrats 
alike, because we certainly never want to play politics with the lives 
of the American people.
  Senator Kassebaum chaired the committee during this initiative. We 
took important steps forward. I say to Senator Jeffords, you assumed 
that mantle, and you brought us to the point today where we will 
achieve final passage of FDA reform. I thank you for that.
  What will this legislation do? Why is it so important? It streamlines 
and updates the regulatory process for new products. It reauthorizes 
the highly successful Prescription Drug User Fee Act. And it creates an 
FDA that rewards significant science while protecting public health.
  It will mean that new lifesaving drugs and devices will get into 
clinical practice more quickly. It will enable us to produce products 
that we can sell around the world, and through this, save lives and 
generate jobs.
  FDA is known the world over as the gold standard for product 
approval. We want to maintain that high standard. At the same time, we 
want to make sure that FDA can enter the 21st century.
  This legislation gets us there. It sets up a new legislative and 
regulatory framework that reflects the latest scientific advancements. 
The framework continues FDA's strong mission to protect public health 
and safety. At the same time, it sets a new goal for FDA, enhancing 
public health by not impeding innovation or product availability 
through unnecessary redtape that only delays approval.
  There has been an urgency about reauthorizing PDUFA. Its authority 
expires at the end of September. PDUFA has enabled FDA to hire 600 new 
reviewers and cut review times from 29 to 17 months over the last 5 
years. Acting now means that people who have been working on behalf of 
the American people can continue to do their jobs. We won't risk losing 
talented employees and slowing down the drug approval process.
  Delay would have hurt dedicated employees, but more importantly, it 
would have hurt patients. Patients benefit most from this legislation. 
Safe and effective new medicines will be getting to patients quicker.
  We're not only extending PDUFA; we're improving it. Currently, PDUFA 
only addresses the review phase of the approval process. Our 
legislation expands PDUFA to streamline the early drug development 
phase as well.
  Instead of a carload of paper--stacks and stacks of material--being 
deposited at the FDA's front door, companies will be able to make 
electronic submissions. This not only reduces paperwork, but actually 
provides a more agile way for scientific reviewers to get through the 
data.
  Updating the approval process for biotech is another critical 
component of this bill. Biotech is one of the fastest growing 
industries in our country. There are 143 biotech companies like that in 
my own State of Maryland. They are working on AIDS, Alzheimer's, breast 
and ovarian cancer, and other life-threatening infections such as 
whooping cough.
  The job of FDA is to make sure that safe and effective products get 
to patients. Our job as Members of Congress is to fund scientific 
research and to provide FDA the regulatory and legislative frameworks 
to evaluate new products and make them available to doctors and 
patients.
  This is why I fought so hard for this. This is exactly why I fought 
for this. My dear father died of Alzheimer's, and it did not matter 
that I was a U.S. Senator. I watched my father die one brain cell at a 
time, and it did not matter what my job was.
  My father was a modest man. He did not want a fancy tombstone or a 
lot of other things, but I vowed I would do all I can for research in 
this and to help other people along these lines.
  Every one of us has faced some type of tragedy in our lives where we 
looked to the American medical and pharmaceutical, biological, and 
device community to help us.
  When my mother had one of her last terrible heart attacks that was 
leading rapidly to a stroke--there was a new drug that is so 
sophisticated that it must be administered very quickly. You need 
informed consent because even though it is approved, it is so dramatic 
that it thins the blood almost to the hemophilia level. I gave that 
approval because my mother was not conscious enough to do it.
  Guess what? That new drug approved by FDA, developed in San 
Francisco, got my mother through her medical crisis with the hands-on 
care of the Sisters of Mercy in Baltimore at Mercy Hospital. Mother did 
not have a stroke because we could avoid the clotting that would have 
precipitated it.
  Thanks to the grace of God and the ingenuity of American medicine, we 
had my mother with us 100 more days in a way that she could function at 
home, have conversations with us and her grandchildren.
  Do you think I am not for FDA? You think I am not for safety? You 
think I am not for efficacy? You bet I am. And this is what this is all 
about. It is not a battle of wills. It is not a battle over this line 
item or that line item. It is really a battle to make sure that the 
American people have from their physicians and clinical practitioners 
the best devices and products to be able to save lives. That's why I'm 
so pleased that we were able to achieve a bipartisan bill.
  So, Mr. President, I thank you for the time. If I seem a little 
emotional about it, you bet I am. I love FDA. I am really proud they 
are in my State. I thank God for the ingenuity of the American medical 
community. And that is why I am so pleased we will be voting on the 
conference report today.
  All of us are happy that this bill will finally pass.
  Mr. JEFFORDS. Mr. President, I yield Senator Coats 4 minutes. He is a 
man whose tenaciousness and ability have made this a better bill.
  The PRESIDING OFFICER. The Senator from Indiana is recognized for 4 
minutes.
  Mr. COATS. Mr. President, as the Senator from Vermont has said, this 
is the first reform in 30 years at FDA. Obviously, a lot has changed in 
the industry. New drugs and new devices, new methods of bringing life-
saving and health-improving benefits to the American people, and the 
people of the world. I think it is remarkable, particularly given the 
fact that it has been nearly 2\1/2\, 3 years now that we have been 
specifically working on this legislation in the committee, through a

[[Page S12246]]

number of hearings, through a considerable, lengthy, and complex 
committee consideration, extensive floor debate. There were very 
difficult procedural hurdles to overcome and a difficult conference. We 
now arrive at this point with a bill that, very shortly, will be 
passed. This has only been done with a bipartisan effort.
  I want to return the compliment to the Senator from Maryland. I thank 
her for that. I am not sure that everyone is going to miss me around 
this place, given my role in this bill, in trying to bring it forward. 
But I thank her for her kind words. Senators Dodd, Mikulski, Harkin, 
and Wellstone joined Republicans in the committee to produce a 
bipartisan piece of legislation, and they supported us on the floor. I 
thank Senator Jeffords and his leadership, and Senator Gregg, Senator 
Frist, Senator DeWine, and others on the Republican side, who 
contributed to the effort in moving the bill forward.
  I would be remiss not to acknowledge the extraordinary work of so 
many staff people that helped to move this forward.
  I thank my chief of staff, Sharon Soderstrom, and particularly Vince 
Ventimiglia, someone whose tireless efforts and thorough knowledge of 
the issues at hand, and at whose persistence we continued through all 
of the obstacles placed in the way of this legislation, and it was all 
accomplished in a manner of courtesy and respect, which is, 
unfortunately, all too rare around this place. He is an exceptional 
person. I don't believe we would be here without his efforts--even 
though he is not here right now; he is probably digging through the 
bill to make sure all the t's are crossed and the i's are dotted. He 
was exceptional in this whole effort.
  This bill provides help to the Food and Drug Administration, who did 
not have the capacity nor, I believe, in the past, the managerial 
leadership that allowed FDA to keep pace with the marvelous 
breakthroughs we have had in the pharmaceutical and medical device 
area, which brings life-saving benefits and health-improving benefits 
to people. Six-hundred additional people, paid for by the industry in a 
tax against them to reauthorize PDUFA, will help speed up the drug 
approval process.
  Now, for the first time, we give assistance to FDA on medical devices 
because we have a procedure where outside parties can, with FDA 
certification, approval and oversight, review medical device 
applications. This is going to provide for the medical device section 
what PDUFA provided for the drug section. This was a very critical part 
of the legislation, and I am pleased that it was retained in our 
efforts.
  We are here and it is a victory for the American people. It took a 
lot of effort by a lot of people. It is a testament to the persistence 
of many, some of whom are speaking here on the floor today. I am proud 
to play a role in this effort because I believe we are addressing some 
fundamental concerns, going to the very health and safety and very 
lives of the American people and people throughout the world. Mr. 
President, it is with that, I yield whatever remaining time I have.
  Mr. KENNEDY. Mr. President, I will yield 5 minutes to the Senator 
from Rhode Island, but first I yield myself 15 seconds.
  I want to give the assurance to my friend and colleague from Indiana, 
as one that didn't always see eye to eye with the good Senator on some 
of these issues, I pay tribute to him for the strength of his 
commitment and the power of his logic and argument, and the passion 
which he has demonstrated out here.
  I have enjoyed his friendship and have always valued the opportunity 
to exchange ideas with him.
  Mr. COATS. I thank the Senator. We have had some interesting 
exchanges of ideas.
  Mr. REED. Mr. President, I believe I have 5 minutes.
  The PRESIDING OFFICER. The Senator is correct.
  Mr. REED. Mr. President, I rise today in support of the conference 
report on S. 830, the Food and Drug Administration Modernization and 
Accountability Act of 1997. This is an important bill with serious 
implications for the protection of the health of the American people. 
Although I did not support this bill when it was first considered on 
the floor of the Senate, I am pleased that significant changes have 
been made and that this final version of the legislation is worthy of 
support.
  This FDA reform bill is the result of ongoing negotiations both prior 
to and subsequent to the Labor Committee's markup of the bill. Through 
this process, a number of provisions that seriously threatened public 
health and safety were dropped or otherwise resolved. I am particularly 
pleased that improvements made include important protections to the 
third party review process. Significant changes and additions also 
include provisions regarding health claims for food products, health 
care economic claims, a notice of discontinuance when a sole 
manufacturer stops producing a drug, and a range of other items.
  The original Senate-passed bill contained a provision regarding the 
FDA device approval process that posed a serious threat to public 
health. In effect, the Senate-passed bill would have limited the FDS's 
current authority to ask device manufacturers for safety data. It would 
have prohibited the FDA from considering how a new device could be used 
if the manufacturer has not included that use in the proposed labeling. 
As a general matter, the FDA does not consider uses that the 
manufacturer has not included in its proposed labeling. However, there 
are instances when the label does not tell the whole story. It is these 
instances--when the label is false or misleading--that my and Senator 
Kennedy's amendment addressed.
  I was not alone in my concern about this issue. Indeed, this 
provision was also identified as worthy of a veto threat by the 
administration. The Secretary of the Department of Health and Human 
Services said on numerous occasions that if this provision were not 
changed, that she and other top Presidential advisers would recommend 
that President Clinton veto this bill.
  By accepting the House language on this device labeling issue, the 
conferees have struck a reasonable compromise that will give the FDA 
the authority it needs to ensure that medical devices are safe and 
effective. In this case, the legislative process has worked, and worked 
well. I commend the conference committee for the sensible compromise 
they reached on this important issue.
  The FDA is responsible for assuring that the Nation's food supply is 
pure and healthy and to provide a guarantee that drugs and devices are 
safe and effective. The FDA has an immense impact on the lives of all 
Americans. Indeed, the FDA's mandate requires it to regulate over one-
third of our Nation's products. Few Government agencies provide this 
kind of important protection for the American people. On a daily basis, 
the FDA faces the delicate balance between ensuring that patients have 
swift access to new drugs and devices while guaranteeing that those new 
products are safe and effective.
  The bill we are considering today contains many positive elements. It 
reauthorizes the important Prescription Drug User Fee Act, one of the 
most effective regulatory reforms ever enacted. The legislation also 
includes a number of provisions that will improve and streamline the 
regulation of prescription drugs, biologic products, and medical 
devices. I believe that these important reforms to the operation of the 
Food and Drug Administration will increase its efficiency and speed the 
delivery of important new medical treatments to patients.

  One of the most important elements of this legislation is the 
aforementioned reauthorization of the Prescription Drug User Fee Act, 
often referred to as PDUFA. PDUFA established an important partnership 
between the agency and the industry, and has successfully streamlined 
the drug approval process.
  I am pleased that this bill will provide expedited access to 
investigational therapies. This provision builds on current FDA 
programs related to AIDS and cancer drugs. Another important element 
will allow the designation of some drugs as ``fast-track'' medications, 
thus facilitating development and expediting approval of new treatments 
of serious or life-threatening conditions. The bill will also require 
the Secretary of the Department of

[[Page S12247]]

Health and Human Services to establish a data base on the status of 
clinical trials relating to the treatment, detection, and prevention of 
serious or life-threatening diseases and conditions. Patients have long 
needed access to such information, and I am pleased that this bill 
provides a mechanism to grant it.
  I am also pleased that this bill contains my amendment requiring that 
within 18 months of the date of enactment, the FDA must issue 
regulations for sunburn prevention and treatment products. In August 
1978, the FDA published an advance notice of proposed rulemaking to 
establish a monograph for over-the-counter sunscreen drug products. To 
date--almost 20 years later--while progress has been made, this rule 
has not been made final.
  Sunburn prevention and treatment products can go far to help prevent 
sun exposure related to skin cancer. The facts on skin cancer are 
compelling: one person an hour dies of malignant melanoma; half of all 
new cancers are skin cancers; one million Americans will develop skin 
cancer this year, making it nearly as common as all other types of 
cancer combined.
  The Food and Drug Administration has a key role in our response to 
this skin cancer epidemic through the regulation of safe and effective 
sunburn prevention products that are vital to avoiding skin damage from 
the sun's rays.
  Mr. President, I am pleased that this compromise is a bill that I can 
support. I look forward to working with my colleagues to oversee the 
implementation of this important legislation and to ensure that its 
provisions streamline FDA processes while also protecting the public 
health of the American people.
  I compliment Chairman Jeffords, Senator Kennedy, and many other 
colleagues in both the Senate and the House of Representatives who have 
worked hard on this bill together to eliminate many other troublesome 
provisions in the bill as originally introduced.
  Mr. President, again, I support the conference report on S. 830, the 
FDA reform bill. The challenge throughout this process has been to 
balance a more efficient, streamlined, and productive FDA with their 
obligation to protect the public health. It has been a difficult task, 
but we made remarkable progress over the last several months. At the 
committee level, there was a serious discussion and debate. I could not 
support that version because at that time there were still outstanding 
issues which I thought could jeopardize the public health and safety.
  When we reached the floor, there was another serious and productive 
debate about this legislation. Once again, I felt there were issues 
that had to be further addressed before I could support the measure. 
Today, happily, through the work of the conferees and colleagues on the 
floor today, we have reached a point where we have legislation that 
both provides for a streamlined, productive, and efficient FDA, and 
continues to give FDA the authority to protect the public health.
  With specific regard to the debate on the floor, there was one major 
issue that I felt was very important, and that was to allow the FDA to 
have the authority to carefully review medical devices that may be used 
by the public. The legislation at that time circumscribed significantly 
the ability of the FDA to look beyond the label, look beyond the listed 
use by the manufacturer, to contemplate possible other uses that may 
take place when the product is in the stream of commerce. Fortunately, 
through the work of the conferees, this situation has been resolved.
  Indeed, on the floor I offered an amendment with Senator Kennedy. It 
did not pass, but I think that effort helped spur a concentrated effort 
during the conference to develop a legislative formula to give the FDA 
the power to regulate these devices appropriately.
  We have many, many things to be thankful for in this bill. One issue 
I would like to address, also, which does not rise up, in some 
respects, to the major reforms, PDUFA or these issues, but it is 
critically important; that is, the issue of protecting the public with 
respect to sunscreen products and sunburn products. I am pleased to 
note that the FDA has been directed to promulgate regulations within 18 
months with respect to these products which are sold to the public to 
protect them from the Sun. This might seem like an innocent product, 
but, in fact, we are seeing a remarkable growth in incidence of skin 
cancer throughout the United States. One person an hour dies of 
malignant melanoma, skin cancer. Half of all the new cancers developing 
are skin cancer. One million Americans will develop skin cancer this 
year alone. So we have to begin to focus our attention on those 
products which are advertised to protect the American public.
  Once again, I think this is totally consistent with the role of the 
FDA. I am pleased that this provision has been included in the 
legislation.
  Let me conclude by saying, again, I believe we have struck the vital 
balance between an efficient, productive FDA and their obligation, 
historically and statutorily, to protect the public health. We have 
done that through the work of Senators Jeffords, Kennedy, and many 
others. I personally thank them and applaud them for their efforts 
today.
  I would be remiss if I didn't also thank my staff member, Bonnie 
Hogue, for her help through this entire process. I yield the balance of 
my time.
  Mr. JEFFORDS. Mr. President, I will now yield to the Senator from 
Utah, who has been a tremendous help over the years on FDA. In fact, I 
am going to give him all the rest of my time --all 3 minutes.
  Mr. HATCH. Mr. President, I wanted to take this brief opportunity to 
commend Chairman Jeffords for a job well done--for producing a bill 
which will dramatically improve the way the Food and Drug 
Administration does business as we move into the 21st century.
  That has been one of my top priorities during my service in the 
Senate. I am proud that we are having the opportunity today to vote on 
this historic legislation which will have so many benefits for my State 
of Utah.
  Utah is the home to over 100 medical device manufacturers, and 
several pharmaceutical manufacturers as well. We also are the Nation's 
leading producer of dietary supplements.
  The Utah Life Sciences Industries Association, the leading trade 
association for Utah device and drug manufacturers, has worked closely 
with the Congress in formulating this legislation, which will have many 
positive effects for Utah.
  On behalf of our Utah drug and device manufacturers, let me thank you 
Chairman Jeffords, and our colleague in the House, Chairman Tom Bliley, 
for producing a bill which has encouraged the FDA to work in a more 
collaborative manner and to get the job done, to get it done 
professionally and expeditiously, without all the bureaucratic hassles 
we have experienced in the past.
  And on behalf of the dietary supplement manufacturers, and most 
importantly the 100 million or so consumers--most of whom seem to have 
called our offices in the last few weeks--let me thank you for making 
sure that the bill does not undo the Dietary Supplement Health and 
Education Act in any way and that dietary supplements will remain what 
they are, food products, not drugs.
  Finally, I wish to thank all of the staff who worked literally 
through the night to make today's passage of the conference report for 
S. 830 possible. You can be proud of your work.


                retirement of kathleen ``kay'' holcombe

  Mr. HATCH. Mr. President, I could not let this opportunity pass 
without recognizing the extraordinary contribution that Kay Holcombe 
has made during almost 25 years of Government service.
  Kay, who currently serves as the top health staffer on my good friend 
Representative John Dingell's Commerce Committee staff, has worked in a 
variety of positions in Government, including 6 years on Capitol Hill. 
Unfortunately for us, she plans to retire at the end of this session--
while a fantastic opportunity for her, a regrettable loss the Congress 
and the Nation.
  I grew to know and appreciate Kay in 1984, when I was chairman of the 
Labor Committee and Kay joined our staff as an American Political 
Science Association congressional fellow. What Kay

[[Page S12248]]

brought to that job was considerable. She is bright, witty, an expert 
on any issue she studies, and, above all, a true professional who puts 
good policy above politics.
  What I recall most vividly about Kay's period on the Labor Committee 
was her incredible ability to juggle lots of balls without dropping any 
of them. I could always count on her to get the job done, and, in fact, 
to do her job and the job of three others.
  I believe that Kay stands out among Government employees for the 
common sense she brings to any position and for an ability to bring 
consensus to the most difficult of issues.
  We are witnessing that ability today with passage of the conference 
report on the FDA reform bill, a bill which--quite simply--would not 
have been possible without Kay Holcombe.
  Her work on the Dietary Supplement Health and Education Act also 
stands out in my mind, where Kay's knowledge and skills as a tactician 
helped us overcome many an impasse. And, I might add, she was, and I 
suspect is, the only staffer in the Capitol who understands many of the 
words we wrote into that act, the most memorable of which was 
``lyophilize''.
  Her background as a bench scientist at NIH, with subsequent 
experience in almost every one of the Public Health Service agencies, 
is a record of accomplishment and experience that cannot be matched on 
Capitol Hill.
  I, for one, will miss Kay's expertise sorely. And while I am thrilled 
for her as she enters this challenging new period in her life, and I am 
saddened at our loss here in the Congress.
  To Kay, her husband Frank, her daughter and son-in-law Anne and Tony, 
and her mother Ginny, I wish the best as the family enters a new period 
of life after Capitol Hill. I hope it will be happy indeed.
  Mr. KENNEDY. Mr. President, how much time do I have?
  The PRESIDING OFFICER. The Senator has 8 minutes 33 seconds.
  Mr. KENNEDY. I yield 4 minutes 33 seconds to the Senator from 
Connecticut.
  Mr. DODD. Mr. President, I want to begin by thanking my colleagues 
who have spent innumerable hours creating a bill that will bring 
lifesaving drugs and medical devices to the American people more 
quickly and efficiently, without compromising safety or effectiveness.
  First, Senator Jeffords is to be commended for his leadership. His 
staff, most notably Jay Hawkins and Sean Donahue, also deserve our 
appreciation for their hard work and dedication to seeing this 
legislation enacted.
  Although the process was at times a difficult one, I'm pleased to say 
that a spirit of bipartisanship and compromise ultimately prevailed, as 
evidenced by the overwhelming Senate vote of 98 to 2 in September on 
this bill.
  I'd also like to thank my fellow Senate conferees--Senators Kennedy, 
Coats, Harkin, Gregg, Mikulski, Frist, and DeWine for their successful 
efforts to negotiate a workable compromise with our colleagues in the 
House.
  We should take pride in the legislation that has been created--the 
first substantial update of FDA's rules for regulating drugs and 
devices since the 1970's.
  We should take pride in the fact that this bill will speed critical 
products to patients without compromising the high safety standards 
that Americans have come to rely on.
  Mr. President, I'd like to speak for a moment about some of the 
positive reforms contained in this bill.
  At the heart of the bill is the 5-year reauthorization of PDUFA, the 
Prescription Drug User Fee Act--a piece of legislation remarkable for 
the fact that there is unanimous agreement that it really works.
  In the 5 years since this initiative was created, the fees collected 
under PDUFA have cut drug approval times in half. With its renewal as 
part of this bill, we can expect drug approval times to drop an 
additional 10 to 16 months.
  In addition, by improving the certainty of product review process, 
this bill encourages U.S. companies to continue to develop and 
manufacture in the United States. This bill asks the FDA and industry 
to begin collaborating early in the approval process to prevent 
misunderstandings about agency expectations that ultimately could delay 
a needed product from reaching consumers.
  This bill also establishes or expands upon several mechanisms to 
provide patients and other consumers with greater access to information 
and to lifesaving products.
  For example, this bill will give individuals with lifethreatening 
illnesses greater access to information about ongoing clinical trials 
of drugs--information that may offer the only hope for those patients 
who have not benefited from treatments already on the market.
  Based on a bill originally championed by Senators Snowe and 
Feinstein, I offered an amendment in committee, which I was pleased to 
see adopted, to expand an existing AIDS database to include clinical 
trials for all serious or lifethreatening diseases.
  Individuals struggling with chronic and debilitating diseases should 
not be burdened with the daunting task of searching, without 
assistance, to locate studies of promising treatments. This database 
will provide one-stop-shopping to help those patients quickly and 
easily access vital information.
  Mr. President, I am particularly pleased that this bill incorporates 
the Better Pharmaceuticals for Children Act, legislation originally 
introduced by our former colleague from Kansas, Senator Kassebaum, and 
now cosponsored by myself and Senator DeWine.
  This provision addresses the problem of the lack of information about 
how drugs work on children, a problem that President Clinton recognized 
recently as a national crisis.
  According to the American Academy of Pediatrics, only one-fifth of 
all drugs on the market have been tested for their safety and 
effectiveness in children. This legislation provides a fair and 
reasonable market incentive for drug companies to make the extra effort 
needed to test their products for use by children.
  I was pleased to join Senator Jeffords as the first Democratic 
cosponsor of this bill. I would thank him again for the hard work and 
long hours that he and his staff have contributed.
  I look forward to joining my colleagues in voting in favor of this 
legislation.
  Let me join here, Mr. President, the chorus of praise for those who 
have been involved in putting this bill together. It has been a long 
journey and not always an easy one, but I think the final product is a 
good one. I commend the chairman of the committee, Senator Jeffords, 
and his staff, Jay Hawkins, Sean Donohue, Jeanne Ireland of my staff, 
for their hard work and dedication in seeing this process to its 
conclusion. We swept the Senate with an overwhelming vote of 98 to 2 on 
what I thought was a good bill. Our conferees worked very hard. I thank 
Senators Kennedy, Coats, Harkin, Craig, Mikulski, Frist, and DeWine for 
their successful efforts in this area as well.
  This is a critically important piece of legislation that will 
expedite the process of getting needed medicines and devices to 
patients, without compromising safety or effectiveness. That was a 
desired goal of everybody here.
  Let me, if I can, mention two or three provisions in the bill that I 
think are worthy of special note. One, of course, is a 5-year 
reauthorization of PDUFA, which is very, very important. I think it 
demonstrates the success of the PDUFA and how well it worked over 5 
years.
  Secondly, I also would like to commend our colleagues for accepting 
the several mechanisms to provide patients and consumers with greater 
access to information and to life-saving products. For example, this 
bill gives individuals with life-threatening illnesses greater access 
to information about ongoing clinical trials and drugs that could be 
very, very important to them and their families. By the way, Senator 
Snowe and Senator Feinstein deserve particular credit. It was 
originally their idea that we incorporated in the bill, the Better 
Pharmaceuticals for Children Act. Former Senator Kassebaum of Kansas 
originally authored that idea, Mr. President. Senator DeWine and I 
included it in this bill. I think it has been improved upon in the 
conference. It is a very important provision that could make a huge 
difference for young children and their families who want to have 
reliable products that will become available to them.

[[Page S12249]]

  So, Mr. President, let me conclude by again thanking all those who 
have been involved in this process. Passing this legislation can truly 
be considered one of the very fine achievements of this first session 
of this Congress. I look forward to its effectiveness with the American 
consumer.


                         APPROPRIATIONS TRIGGER

  Mr. BUMPERS. Mr. President, on September 23 of this year, my 
colleague, Senator Cochran, chairman of the Appropriations Subcommittee 
on Agriculture, Rural Development, and Related Agencies, rose on the 
floor of the Senate to express objection to a provision of the FDA 
reform bill that would direct the appropriations subcommittee to 
provide established levels for salaries and expenses of the Food and 
Drug Administration through fiscal year 2002. If the appropriations 
bills did not meet those levels, referred to as trigger, the FDA would 
not be able to collect or use receipts authorized by the Prescription 
Drug User Fee Act [PDUFA]. The effect of the provision Senator Cochran 
found so troublesome would have been to place a budgetary gun to the 
head of the appropriations subcommittee under threat of PDUFA fees not 
being collected and the Nation's drug approval process placed at risk. 
As ranking member of the appropriations subcommittee, I shared Senator 
Cochran's concerns, but honestly hoped that the problem he highlighted 
would be corrected before we were faced with final passage of the 
conference report on FDA reform. While the conference report before us 
today does provide some relief in fiscal years 2001 and 2002 from the 
earlier Senate language, I am still disappointed that more progress was 
not achieved to inject a greater dose of realism into the expectations 
of the FDA authorization committees of the House and Senate.
  I do not mean to detract from the very important work of the FDA nor 
to minimize the need to push ahead aggressively with drug approvals. I 
equally appreciate the concerns of the prescription drug industry, 
which will be responsible for paying the PDUFA fees, that their 
considerable contributions will be used to supplement, not supplant, 
the drug approval process. However, an unfortunate charade has been 
employed to suggest the language now contained in FDA reform is going 
to protect, in fact guarantee, increases in the level of Federal funds 
appropriated for FDA drug approvals. I must point out to my colleagues 
that the language before us does nothing to assure that very goal and I 
feel compelled to highlight the provision's failing.
  FDA reform would require the appropriations bills for fiscal years 
1999 through 2002 to provide levels for the FDA salaries and expenses 
account at levels no lower than the fiscal year 1997 level adjusted by 
the lesser of inflation based on the consumer price index or changes in 
growth of national domestic discretionary spending. The FDA salaries 
and expenses account contains funding for all activities of FDA, 
including drug approvals, subject to an appropriation other than 
amounts for buildings and facilities. The FDA reform legislation 
contains no requirement that FDA allocate any portion of the salaries 
and expenses account for drug approvals. Therefore, while our 
appropriations subcommittee may comply with the full letter of FDA 
reform requirement, that act alone would provide no assurance to the 
drug industry that the FDA appropriation would be used as they expect. 
FDA certainly has other pressing budgetary demands such as the need to 
account for the rental space arrearage for which the General Services 
Administration is threatening action against FDA, and continued work on 
tobacco issues. FDA will also need increased attention in the area of 
food safety which continuing headlines, such as that appearing in the 
Washington Post this weekend about the more than 700 people made ill by 
contaminated food in southern Maryland, will no doubt place greater 
workload on the agency. An arbitrary appropriation trigger will produce 
no magic bullet aimed solely at the problem of drug approval backlogs.
  Mr. President, I might have a little more understanding for the 
concerns of the drug industry if there was any merit to their claim 
that the appropriations subcommittee would not hold faith with their 
requests. Over the past 10 years, our subcommittee has increased new 
budget authority for FDA salaries and expenses from $456,004,000 to 
$857,501,000. In fact, I would like the Record  to reflect the amounts 
provided in that account on a year-to-year basis since fiscal year 1988 
to the present, and I ask unanimous consent the year and amounts be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

       Fiscal year 1988--$456,004,000.
       Fiscal year 1989--$487,344,000.
       Fiscal year 1990--$574,171,000.
       Fiscal year 1991--$656,519,000.
       Fiscal year 1992--$725,962,000.
       Fiscal year 1993--$746,035,000.
       Fiscal year 1994--$813,339,000.
       Fiscal year 1995--$819,971,000.
       Fiscal year 1996--$819,971,000.
       Fiscal year 1997--$819,971,000.
       Fiscal year 1998--$857,501,000.

  Mr. BUMPERS. I have included this history of funding to show how the 
amount of appropriations for FDA salaries and expenses has increased 
every single year since fiscal year 1988 except for the period between 
fiscal year 1995 and fiscal year 1997 when the level was held at a 
freeze. I also want to note that the 3-year period connecting fiscal 
year 1995 and fiscal year 1997 was a period in which the 602(b) 
allocation to our subcommittee fell by 11 percent. I hope my colleagues 
see in this history a commitment by our subcommittee to recognize the 
importance of FDA's activities. Further, I hope my colleagues see that 
even during a time when nearly all other programs under our 
jurisdiction had to take significant reductions, FDA was held harmless. 
I believe this history reflects well on the commitment and good faith 
of our subcommittee.
  An obvious result of the provision contained in FDA reform will be 
continuing further reductions in other programs under the jurisdiction 
of our subcommittee. Those programs will again have to suffer unless, 
in the unlikely event, we receive substantial increases in our future 
602(b) allocations. There are many, many other programs for which our 
subcommittee is responsible that are important to people and 
communities all across the Nation. Our bill provides funding for all 
activities at the U.S. Department of Agriculture--except the Forest 
Service--and the Commodity Futures Trading Commission. At USDA alone, 
there are hundreds of programs essential to rural and urban America 
that will be harmed, again, if our subcommittee is expected to provide 
FDA, and FDA only, with inflation increases through fiscal year 2002. 
USDA programs have already been radically cut by our subcommittee over 
the past several years while, as noted above, FDA was provided 
substantial increases or, at least, held constant.
  I understand a few other proposals were suggested, and rejected, 
during consideration of the FDA reform legislation. One proposal was to 
hold FDA to a freeze, something which we have shown we have done 
historically. Another proposal would have specifically protected the 
FDA activities for drug approvals. That approach would have better 
addressed the concerns I outlined above. I understand this proposal to 
protect FDA drug approvals was rejected due to objections from nondrug 
related industries concerned that FDA resources might be transferred 
from their own specific priority areas to drug approvals. Ironically, 
that is the same concern I have heard from groups fearful about what 
the provision in FDA reform will do to USDA and CFTC programs.
  Mr. President, at times I feel there is an outright assault on the 
appropriations process. Too many times in recent years we have seen 
requirements imposed on the Appropriations Committee by other 
legislative and procedural vehicles that continuously impairs our 
ability to respond to agency needs and responsibilities to our states 
and the American people. Based on administration projections, the 
trigger mechanism contained in FDA reform would force the 
appropriations subcommittee to increase the FDA salaries and expense 
account from the current $857 to $876 million in fiscal year 2002. 
According to the President's 1998 budget, the projected request for FDA 
salaries and expenses for fiscal year 2002 is only $691 million. This 
is a difference of nearly $200 million, an

[[Page S12250]]

amount worthy of deliberate consideration by the appropriations 
subcommittee. Additionally, the FDA reform provision does not account 
for the possibility of a tobacco settlement that might replace current 
appropriations expenditures, consolidation of food safety functions in 
some agency other than FDA, or other potential changes that would 
affect, and possibly reduce, the budgetary requirements of FDA. Even 
though the provision does attach the trigger to the lesser of the 
consumer price index or changes in the growth of national domestic 
discretionary spending, there is no guarantee that any increase in 
overall domestic discretionary totals will be reflected in the 602(b) 
allocation for our subcommittee.
  For the coming year, I can assure my colleagues that I will work with 
Senator Cochran and others to assess the requests of all agencies and 
departments that will come before our subcommittee. I strongly believe 
that we have been fair in our setting of priorities and that we will 
continue to consider the merits of all requests in order to balance the 
fiscal demands and resources in a manner consistent with our abilities, 
good judgment, and the recommendations of all Senators.
  Ms. MOSELEY-BRAUN. Mr. President, I support S. 830, the conference 
report for the Food and Drug Administration Modernization and 
Accountability Act of 1997, and commend the conferees for quickly 
reaching agreement on compromises that will ultimately improve the FDA 
and improve the public's access to cutting edge medical technology.
  I am also pleased that we are going to pass this important 
legislation before adjourning for the year. The American people will be 
much better off as a result of our actions here today. S. 830 is a 
perfect example of Congress enacting public policy that Americans both 
want and need.
  There is no disagreement as to the caliber of the Food and Drug 
Administration. FDA is one of the finest regulatory agencies in the 
Nation and the world. However, the length of time and amount of 
paperwork required for FDA approval of new products may still be 
excessive. For many companies, particularly small and startup 
businesses, the FDA application process is a formidable time consuming 
obstacle. These barriers exist despite the recent agency improvements 
to their review process. In some cases, the length and complexity of 
the process can force companies to launch their products abroad rather 
than here in America. This is a troubling prospect, particularly given 
the increasingly competitiveness of global markets.
  The FDA, like all other entities, must evolve and adapt to the 
changing global landscape. Traditional methods of product review are no 
longer efficient. Industrialized and emerging nations now participate 
in multilateral trade agreements aimed to reduce trade barriers. While 
the U.S. continues as the world's premiere economy, our market 
dominance is dwindling. A recent Washington Post article indicated that 
our Nation was far more dominant economically following World War II, 
when the U.S. economy accounted for more than 25 percent of the world's 
output, than it is today. Evolving global markets hold untapped 
potential for product manufacturers. The ability to lucratively launch 
products abroad will bring pressure on the FDA to harmonize its 
regulatory policies with other international safety and performance 
standards. The traditional policies that have made the U.S. the ``gold 
standard'' in public health protection threaten to undermine our 
competitiveness. In order to maintain its status as the gold standard, 
the FDA must implement polices that encourage the launching of new 
products in this country, as opposed to Europe, and ensures that the 
United States maintains its technical and scientific leadership in 
health disciplines.
  Mr. President, S. 830 strikes a delicate balance between protecting 
the public health, fostering global trade under multilateral 
agreements, ensuring swift access to new health technology for 
Americans, and strengthening the U.S. technical and scientific 
leadership.
  The conference agreement reauthorizes the Prescription Drug User Fee 
Act (PDUFA) for an additional 5 years. PDUFA has been one of the most 
successful pieces of governmental reform legislation. During the 5 
years since we first passed PDUFA, the average approval time for 
pharmaceutical products has dropped over 40 percent. The pharmaceutical 
and biologics industries overwhelming support reauthorization of PDUFA 
because they have seen tangible results from their fee payments. The 
American public also supports reauthorization of PDUFA because they 
have received access to innovative treatments in a more timely manner.
  S. 830 also makes considerable progress in expediting patients' 
access to important new therapies and potentially life saving 
experimental treatments. I have long held that access to alternative 
medical treatments is an essential part or health care freedom of 
choice. Under the conference agreement, patients with fatal illnesses 
will no longer be denied access to potentially life-saving treatments. 
I am sure that each of my colleagues can recount tales of constituents 
who have encountered considerable bureaucratic red-tape in their 
efforts to access a non-FDA approved but potentially life-saving 
treatment. Although I have great respect for the role that the agency 
and its employees play in protecting consumers from unsafe and 
ineffective products, there is a problem when informed Americans cannot 
get access to desired therapies. S. 830 makes some much needed reforms 
to enhance that access.
  Mr. President, the conference agreement includes reasonable 
compromises on provisions concerning medical device labeling, 
dissemination of information concerning drug off-label use, and 
regulation of device manufacturing. Ensuring that unapproved medical 
devices not get onto the market that clearly have a different use than 
the labeling indicates is a vitally important task. This issue alone 
was responsible for delaying approval of the Senate version of the FDA 
Modernization Act. I am pleased that the conferees reached an agreement 
to give FDA the necessary regulatory authority but not subject 
manufacturers to the whims of various application reviewers. FDA will 
be given the necessary authority to prevent fraudulent labeling as a 
means of achieving product approval.

  Similarly, S. 830 strikes an appropriate balance between protecting 
the public interests and allowing manufacturers to share important off-
label use information with providers. It would have been a grave 
mistake to either prevent the distribution of off-label use information 
or not allow the FDA to play a vital role in ensuring the adequacy of 
information being distributed by manufacturers. I know that a lot of 
work went into the compromise reached regarding off-label usage 
information and the agreement greatly benefits the American public.
  Mr. President, I would also like to congratulate patients groups for 
their steadfast pursuit of this reform. During this year, I have met 
with countless numbers of my constituents who will immediately have 
better access to medical treatment as a result of this conference 
agreement. Each time we met, their message was loud and clear--pass FDA 
reform now. This is a resounding message that I cannot ignore.
  S. 830 builds on the reforms that the FDA has already put into place 
over the past 5 years. The agency has taken a number of steps to 
streamline administrative functions and work better with industry and 
consumers to facilitate the availability of cutting edge medical 
technology. The success that FDA has achieved in reducing the time to 
review new drugs and get potentially life-saving therapies on the 
market is laudable. However, more improvements are needed and S. 830 
moves another step in the right direction.
  My support for S. 830 is not a complete endorsement of the bill. 
There are a number of important provisions absent from this 
legislation. I am particularly concerned that the bill does not 
adequately address food safety, which will certainly emerge as a major 
public health issue. Most of the recent criticism of the FDA has 
focused on the biologics and medical technology areas. Regulation of 
imported food products will probably be the pressing issue of the next 
millennium. As more imported agricultural products find there way to 
American tables, there

[[Page S12251]]

will be more pressure upon FDA to act to prevent tainted products from 
getting to the market. The recent problems with tainted meat and 
poultry highlight this need for greater focus on food safety. 
Hopefully, Congress can revisit the shortcomings in food safety 
standards next year.
  Nonetheless, S. 830 is a good start down the road of FDA reform. This 
conference agreement is better than the bill passed by either the House 
or Senate and considerable better than the bill developed last year. I 
am happy to have a conference agreement that I can support and that I 
truly believe moves the country in the right direction. S. 830 is good 
for patients, good for the industry, and good for the Nation's global 
competitiveness. I hope that my colleagues will join me in supporting 
this important legislation.
  Mr. KENNEDY. Mr. President, how much time do I have?
  The PRESIDING OFFICER. The Senator has 5 minutes 48 seconds.
  Mr. KENNEDY. I yield myself 5 minutes.
  Mr. President, I just want to review once again, very briefly, the 
principal provisions in the legislation which I think are enormously 
constructive and positive.
  First of all, building on the PDUFA record, this provision that we 
have enacted expands the existing program by setting additional 
performance targets. It puts special emphasis on expanding early 
cooperation and FDA and the industry, which will reduce the development 
time, so that the drug development process, not just the regulatory 
review process, can be expedited. That is very important.
  There are many other positive achievements in the legislation. I am 
particularly gratified, as I mentioned earlier, with the broader use of 
the fast-track approval. The streamlined accessibility procedure now 
available primarily to patients with cancer or AIDS will also be 
available for drug treatments for patients with any other life-
threatening diseases. This bill also provides for expanded access to 
drugs still under investigation for patience who have no other 
alternatives. The compromise combines protections for patients with 
expanded access to new investigational therapies, without exposing 
patients to unreasonable risks.
  The bill includes a new program to provide access for patients to 
information about clinical trials for serious or life-threatening 
diseases.
  It provides incentives for research on pediatric applications of 
approved drugs and for development of new antibiotic to deal with 
emerging, drug-resistant strains of diseases.
  It requires companies to give patients advance notification of 
discontinuance of important products. And in that connection, I am 
disappointed that we were not able to address the issue of assuring 
that asthma patients and others will not be put at risk by any abrupt 
discontinuance of inhalers containing CFC's. I have been informed by 
FDA that no notice of proposed rulemaking will be issued before this 
summer, which will give Congress plenty of time to return to this 
question, if necessary.
  The bill includes many measures that will reduce unnecessary 
regulatory burdens and appropriately clarify its authority.
  These provisions, as well as others, are extremely constructive and 
will be enormously helpful to the American consumer.
  Mr. President, I would like to mention some of the staff who have 
been a crucial part of this whole process. Those members of our staff 
on the Labor Committee: Nick Littlefield, David Nexon, Diane Robertson, 
Debbie Kochevar, Pearl O'Rourke, Jim Manley, Leslie Kux, and Carrie 
Coberly.
  Bonnie Hogue with Senator Reed, Sabrina Corlette and Peter Reinecke 
with Senator Harkin, Jeanne Ireland with Senator Dodd, Deborah Walker 
with Senator Bingaman, Anne Grady with Senator Murray, Linda DeGoutis 
with Senator Wellstone, Lynne Lawrence with Senator Mikulski, and Anne 
Marie Murphy with Senator Durbin.
  With the Republicans are the following staff:
  Jay Hawkins, Sean Donohue, and Mark Powden, with Senator Jeffords; 
Vince Ventimiglia with Senator Coats; Kimberly Spaulding with Senator 
Gregg; Sue Ramthun with Senator Frist; and Saira Sultan with Senator 
DeWine.
  Also, the House staff were instrumental in the success of this 
conference:
  Kay Holcombe, as Senator Hatch has indicated, worked with us when she 
worked with Senator Hatch on the committee years ago and was very 
constructive during this process. Howard Cohen, Rodger Currie and Eric 
Berger also with the Commerce Committee, and Paul Kim on Congressman 
Waxman's staff.
  And I thank the FDA staff: Bill Schultz, Peggy Dotzel, and Diane 
Thompson.
  I thank them all very much for all of their help and their 
involvement.


                         privilege of the floor

  Finally, I ask unanimous consent that Tom Perez, a Justice Department 
detainee on the Judiciary Committee, be given floor privileges for the 
remainder of the session.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Mr. President, how much time remains?
  The PRESIDING OFFICER. One minute forty-five seconds.
  Mr. KENNEDY. Mr. President, we again thank our colleagues and friends 
and look forward to the passage of this legislation.
  If there are no other comments, I would be prepared to yield the 
remainder of our time.
  Mr. JEFFORDS. Mr. President, I yield the remainder of my time.
  The PRESIDING OFFICER. The question is on agreeing to the conference 
report.
  The conference report was agreed to.
  Mr. KENNEDY. Mr. President, I move to reconsider the vote by which 
the conference report was agreed to.
  Mr. JEFFORDS. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  Mr. JEFFORDS. Mr. President, I would like to take a moment to thank 
the staff who have worked to make this bill possible. In the office of 
Senate Legislative Counsel, Robin Bates, Elizabeth Aldridge, and Bill 
Baird worked tirelessly to produce countless bill drafts and 
amendments. I would also like to commend House Legislative Counsels 
David Meade and Pete Goodloe for their work on the conference report.

  The staff at CRS, especially Donna Vogt, and at GAO, including 
Bernice Steinhardt deserve thanks for their willingness to provide 
essential information and documents on extremely short notice.
  The staff to the members of the committee contributed greatly to the 
success of this bill. Vince Ventimiglia with Senator Coats' staff 
worked closely with mine in a true partnership on all aspects of S. 
830.
  In addition, Kimberly Spaulding with Senator Gregg, Sue Ramthun with 
Senator Frist, Saira Sultan with Senator DeWine, and Kate Lambrew-Hull 
with Senator Hutchinson all played important roles in fashioning 
compromises on key provisions of this conference report, as did Dave 
Larson and Barry Daylin.
  Similarly, three staffers for members of the minority on the 
committee played pivotal roles throughout the process--from the 
premarkup stage through the development of this conference report. 
Their assistance was critical to making this bill a bipartisan success.
  Lynne Lawrence with Senator Mikulski deserves special mention in 
recognition of her hard work both in the last Congress and in this one 
on FDA reform. Following passage of this conference report, Lynne will 
be leaving Capitol Hill. I am extremely pleased that she will be 
leaving on a high note, and we all wish her the best with future 
pursuits. Jeanne Ireland with Senator Dodd and Linda Degutis, a fellow 
with Senator Wellstone also provided invaluable assistance throughout 
the process.
  Finally, I thank, of course, the Labor and Human Resources Committee 
majority and minority staffs. On the minority staff, I would like to 
thank Nick Littlefield and David Nexon and two minority fellows Diane 
Robertson and Debbie Kochever.
  On my own staff, I would like to thank the majority staff director 
Mark Powden, Jay Hawkins, and majority fellow Sean Donohue. All have 
devoted substantial portions of their time over the past 10 months to 
this effort.

[[Page S12252]]

  Jay Hawkins, in particular, has been key to making this conference 
report a reality. His tireless efforts, his unfailing good humor, and 
his patience have allowed this process to maintain steady forward 
progress to a highly successful outcome.
  The round-the-clock work, particularly over the past few days, of all 
the staff involved in the conference is greatly appreciated.
  Mr. President, I could not be happier with this moment and at this 
time will happily leave the floor.
  Mr. HARKIN addressed the Chair.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. TORRICELLI. Mr. President, will the Senator from Iowa yield?
  Mr. HARKIN. I yield without losing my right to the floor for a 
unanimous-consent request.
  Mr. TORRICELLI. Mr. President, I ask unanimous-consent that at the 
conclusion of the remarks of the Senator from Iowa, I be able to 
address the Senate for 20 minutes.
  The PRESIDING OFFICER. The Senator should be aware that under a 
previous order the Senator from Massachusetts is to be recognized after 
the Senator from Iowa.
  Mr. TORRICELLI. Then I will amend my unanimous-consent request that 
after those Senators are recognized under the unanimous-consent request 
that I be a able to address the Senate for 20 minutes.
  Mr. JEFFORDS. Reserving the right to object, I make a point of order 
that a quorum is not present.
  Mr. HARKIN. Mr. President, I have the floor, I believe, and I yielded 
only to the Senator for the purpose of a question.
  The PRESIDING OFFICER. The Senator from Iowa is recognized, and he 
has the floor.
  The unanimous-consent request from the Senator from New Jersey is on 
the floor. Without objection, it is so ordered.
  Mr. JEFFORDS. I object. I make a point of order that a quorum is not 
present.
  Mr. HARKIN. Mr. President, I believe I have the floor. I only yielded 
for the purpose of a unanimous-consent request.
  The PRESIDING OFFICER. The Senator from Iowa has the floor.
  Mr. HARKIN. Mr. President, I will reclaim the floor in my own right 
and let these Senators work it out if they want to come back.
  The PRESIDING OFFICER. The Senator from Iowa has the floor and is 
recognized for 20 minutes. He may proceed.
  Mr. HARKIN. Thank you, Mr. President.

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