[Congressional Record Volume 142, Number 140 (Wednesday, October 2, 1996)]
[Senate]
[Pages S12150-S12152]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                          UNFINISHED BUSINESS

  Mrs. KASSEBAUM. Mr. President, as the 104th Congress draws to a 
close, I want to spend a few moments discussing what I believe are some 
important initiatives which are not going to make it into the statute 
books this year. Although I am deeply disappointed that the many 
months--and years--which have gone into these efforts have not borne 
fruit, I am confident that they have taken enough root that they will 
rise once again in the 105th Congress.
  Unfortunately, the list of proposals falling into this category is 
much longer than I might wish. I will not go through the entire litany, 
but I do want to set out what I was attempting to accomplish with 
respect to the Food and Drug Administration [FDA], the National 
Institutes of Health [NIH], and our Nation's job training programs.
  Legislation to reform the Food and Drug Administration, S. 1477, was 
reported by the Committee on Labor and Human Resources with strong 
bipartisan support. Members on both sides of the aisle spent long hours 
in negotiations, and I want particularly to commend the Senator from 
Maryland [Ms. Mikulski] for her unflagging efforts on behalf of reform. 
Unfortunately, these negotiations failed to produce an agreement which 
would not be filibustered, and it was therefore not possible to bring 
S. 1477 before the full Senate.
  This legislation was designed to enhance the professionalism, 
stature, and effectiveness of the FDA. In developing the measure, I was 
motivated by a desire to assure that our Nation does not lose its 
leadership in new product development and by a desire to respond to the 
plight of countless individuals who have suffered needless delays in 
obtaining new therapies.
  Through hearings, meetings, and other reviews of the issue, I 
concluded that the performance of the FDA could be substantially 
improved without sacrificing consumer confidence in the safety and 
efficacy of the products they purchase.
  I would like to outline briefly the major principles underlying this 
legislation, because I believe they are important and should serve as 
the foundation for any FDA reform measure considered in the future:
  First, as I stated, the major purpose of S. 1477 was to enhance the 
professionalism of the agency, and it attempted to do so by providing a 
clear statement of the agency's mission and by emphasizing performance 
standards and accountability.
  Second, it attempted to improve the speed and efficiency of the 
product testing, review, and approval process by encouraging 
cooperation between the agency and the manufacturer from the very 
beginning. Too often, all the focus is placed on the back end of the 
process--FDA approval--without giving sufficient attention to steps 
which could be taken to improve the process during the many years 
leading up to that point.
  Mr. President, as you know, it can take sometimes as many as 12 years 
or more before final approval is achieved.

[[Page S12151]]

 We felt strongly in the committee that process could be enhanced 
without hurting in any way safety, efficiency, and efficacy in order to 
bring that time span down.
  There have been instances where the agency has implemented this type 
of cooperative approach--for example, with respect to the testing and 
review of AIDS drugs--and this measure attempted to encompass those 
practices which have been successful.
  Finally, the measure put forward some new options, such as the 
contracting of review of certain medical devices. The point was not to 
take FDA out of the picture. The bill maintained the role of the FDA as 
the final arbiter of safety and efficacy. At the same time, it took 
steps to assure that, at the appropriate point, the agency does come to 
a decision.
  Scientific methods and technology have changed dramatically over the 
past two decades, while our regulatory structures have barely budged. 
An incentive is growing for U.S. companies to move research, 
development, and production abroad, threatening our Nation's continued 
world leadership in new product development--costing American jobs and 
further delaying the public's access to important new products. We can 
address these issues through sound reform legislation, and we should.
  Another important health care matter which deserves priority in the 
105th Congress is the reauthorization of the National Institutes of 
Health. Last week, the Senate approved a reauthorization bill (S. 
1897), and I had hoped the House of Representatives would take it up as 
well. Unfortunately, that will not happen.
  As a consequence, we have lost--for the moment--an opportunity to 
reaffirm the importance of the biomedical research mission of the NIH 
and to enhance the effectiveness of the agency in performing that 
mission.
  All Americans can take great pride in the exceptional contributions 
that the NIH has made. It has compiled an astonishing record of 
biomedical research advances which have transformed all of our lives. 
Vaccines against conditions which once crippled and killed are now 
routine, and drugs hailed as miracles at their inception are as well 
known as aspirin. These past successes against seemingly insurmountable 
odds have inspired confidence and offered hope to those who have 
nowhere else to turn.
  In addition to reauthorizing the important work of the two largest 
institutes--the National Cancer Institute and the National Heart, Lung, 
and Blood Institute--the reauthorization bill approved by the Senate 
attempted to strengthen the ability of the NIH to respond to emerging 
issues in the biomedical research arena and in the larger health care 
environment in which it operates.

  Among other things, this legislation authorized the creation of the 
National Human Genome Research Institute, in recognition that one of 
the biggest future frontiers is that of the human genetic code. The 
elevation of the National Center for Genome Research to institute 
status would serve to better focus NIH resources for this important 
work.
  It recognized the need to invest in the education and training of the 
next generation of clinical researchers by providing for greater 
support for expert training of young biomedical scientists who have 
elected the difficult, and frequently less well-compensated, careers in 
scientific inquiry.
  The bill streamlined the excess and often duplicative infrastructure 
that has grown up over time in the NIH. Every dollar saved from 
unnecessary administrative burdens is another dollar freed up for 
support of biomedical research.
  It established a framework under which additional sources of funding 
could be tapped by creating a biomedical research trust fund within the 
Treasury.
  This legislation included a significant initiative in the area of 
Parkinson's disease research. Based on separate legislation with broad 
bipartisan support in both the Senate and House, this initiative would 
establish up to 10 Morris K. Udall Centers for Research on Parkinson's 
Disease and provide for awards to neuroscientists and clinicians to 
support innovative research.
  Turning to other issues before the labor committee this year, I think 
perhaps my greatest disappointment is the demise of the Work Force and 
Career Development Act. I say it is the greatest disappointment not 
only because its failure is a lost opportunity to bring about 
significant reform in an area where reform is sorely needed, but also 
because we came so close to achieving it.
  This is not a bill which died in committee. It was not killed on the 
Senate floor; in fact, just about a year ago it was adopted by a vote 
of 95 to 2. It did not die in the House, where its companion measure 
was adopted with overwhelming bipartisan support.
  This initiative, which has its roots in legislation I introduced with 
the Senator from Nebraska [Mr. Kerrey], in the 103d Congress, moved 
step by step through the legislative process. Yet, the conference 
report, which was filed on July 25, has been sitting gathering dust due 
to the threats of dilatory action should it be called up.
  I have addressed the Senate on many occasions regarding the need for 
fundamental reform of our Nation's job training programs. I think 
reform is absolutely essential if we are to provide the skilled job 
training which can best address the needs of the people in each of our 
States, because what might be necessary in Kansas might be very 
different in Alabama or in South Carolina. As I have mentioned before, 
the roughly $5 billion which the Federal Government invests in job 
training and related programs is small potatoes in our annual trillion-
dollar-plus budget. Most probably feel, I think, that this is a boring 
subject and ask why should we focus our attention on this. It doesn't 
grab headlines. But if we wish to make welfare reform work, if we wish 
to provide a work force for the next century that is going to meet the 
challenging demands of developing new technology, we have to be more 
flexible in letting States design good job-training programs. I just 
worry, Mr. President, that by maintaining the status quo, we are saying 
that we are willing to live with inadequate programs and that we are 
not willing to step forward with the innovative ideas that I think are 
important, and that I believe the American people think are important. 
These are ideas that will help assure that Government spends money more 
effectively and wisely.

  I contend that it is a travesty to continue to allow these billions 
of dollars to be thrown away on programs where good intentions are not 
sufficient to produce good results. We don't even have the data to know 
what works and what doesn't work.
  That is what the Work Force and Career Development Act is all about. 
It would consolidate narrowly focused Federal categorical programs into 
a comprehensive statewide system--offering States the flexibility they 
need to focus resources where the need is greatest. It would encourage 
the development of true partnerships among educators, trainers, and the 
business community. And it would focus on getting results.
  Many forces in our society are raising the stakes for the effective 
performance of job training programs. Technology has transformed the 
marketplace and the skills which employers seek from their employees. 
The recently enacted welfare reform legislation places a premium on job 
placement and retention.
  My biggest regret at the failure to bring about job training reform 
is the fact that those Americans most in need of quality programs which 
have to continue to muddle their way through the current morass, will 
have to continue to be shuttled from one program to the next, our not 
knowing for sure what will work and where they will be able to find the 
answers they seek. I think it is a disappointment and a shame, our not 
being able to address the conference report before this Congress 
closes.
  There are other reform efforts as well which I believe could have 
made Government programs work better. The Senator from New Hampshire 
[Mr. Gregg] and I developed legislation to reform the Occupational 
Safety and Health Administration [OSHA] in an effort to place greater 
emphasis on improving safety education and less on imposing fines for 
trivial violations. I worked with Representative J.C. Watts on the 
Youth Development Community

[[Page S12152]]

Block Grant Act, an effort to consolidate scattered youth development 
programs into a locally controlled system of positive prevention 
activities.
  A recent edition of Roll Call mentioned the interest of the majority 
leader in spending more time overseeing existing programs, rather than 
creating new ones. I wholeheartedly agree. We do a disservice to the 
American taxpayer to add to Federal obligations while ignoring the 
performance of those we have already made.
  The process of oversight and reform is a long one. It does not happen 
overnight or even over the 2-year course of a Congress. I would like to 
think that the work which has gone into the initiatives I have 
mentioned today will make a contribution to efforts to be undertaken 
next year and the year after that. Although I will not be here to 
shepherd these initiatives through their next phases, I have confidence 
that they will flourish under the care of those who follow.
  Mr. President, this is the last speech I will give on the Senate 
floor. I would just like to say it has been a great honor to represent 
the State of Kansas. I want to say a special thanks to my colleague 
from the State of Alabama, Mr. Heflin, who will be retiring in this 
Congress. It has been an honor to serve with him. I thank my colleagues 
and my staff and the support personnel. It has been a pleasure to serve 
with them for 18 years.
  I yield the floor.
  Mr. HEFLIN addressed the Chair.
  The PRESIDING OFFICER. The Senator from Alabama.

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