[Congressional Record Volume 143, Number 39 (Monday, April 7, 1997)]
[Senate]
[Pages S2762-S2764]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  FDA REFORM AND PDUFA REAUTHORIZATION

  Mr. JEFFORDS. Mr. President, we are here today to talk about the need 
for us to reauthorize the Prescription Drug User Fee Act and pass 
legislation to modernize the Food and Drug Administration.
  I will just remind everyone as to what happened last year. The Senate 
Labor Committee passed an FDA reform bill out of committee with a 
strong, bipartisan vote of 12-4.
  So we are here today to alert the body that we intend to move forward 
expeditiously this year in order to ensure that we improve the FDA 
review process for new products as well as reauthorize the Prescription 
Drug User Fee Act. And we are going to do so in a bipartisan manner.
  Let me state that I intend that these issues will move together. It 
is my goal, as chairman of the authorizing committee, to have a bill 
ready for the full Senate's consideration before midyear. During the 
last Congress, my predecessor, Senator Kassebaum, led our committee in 
reporting out legislation which emphasizes the FDA has a role in 
bringing needed products to the public in a timely fashion as well as a 
role of protecting the public from harm.
  This year, I look forward to continuing that work. The objective of 
modernizing the FDA is to make more information and better products 
available to the public in an expeditious way, to foster and improve a 
new product review process, and require that the agency be as efficient 
and effective as possible in carrying out its statutorily defined 
duties.
  As chairman of the Labor and Human Resources Committee, my approach 
will be to identify problem areas in the FDA regulatory system for 
drugs, devices, and other products which can be improved with 
legislation and gives the FDA the tools it needs to address other 
problems administratively.
  Specifically, we will target areas that have the effect of needlessly 
delaying patient access to safe new therapies and products. In 
addition, we must not squander scarce FDA resources on bureaucratic 
procedures which confer no demonstrated public health benefit.

[[Page S2763]]

 We must also reauthorize the successful Prescription Drug User Fee 
Act, also known as PDUFA.
  In 1992, the pharmaceutical and biotechnological industries were so 
concerned about the length of time taken by FDA to approve new drugs 
that they were willing to adopt FDA's proposal that they pay user fees 
in exchange for faster reviews. FDA has been able to reduce mean 
approval times for new drugs to which user fees were paid from almost 
30 months in 1992 to 15.5 months in 1996. We need to continue this 
effort.
  Notwithstanding the success in reducing the review time for new drug 
applications, the period of time it takes pharmaceutical and 
biotechnological groups to work with FDA on the drug development phase 
before an application is even submitted has lengthened. It is my hope 
that we can introduce new performance measures for the FDA in 
addressing the drug development phase and further enhancing the drug 
review and approval phases as part of the reauthorization of PDUFA.
  It is essential to note that these user fees are contingent on the 
Appropriations Committee's making available to the FDA the pre-1992 
level of appropriated funds to the Agency updated for inflation. This 
provides the assurance that user fees do not become a substitute for 
funds appropriated from general revenues.
  The administration's budget puts this important principle at risk 
with an 8-percent cut in the funding for the FDA. I know of Chairman 
Stevens' interest in the FDA and its approval process. I look forward 
to working with him, the other Appropriations Committee, and the 
majority leader to make sure that the FDA has the full level of funding 
it needs to perform its vital functions across each of the centers.

  Mr. President, the Labor and Human Resources Committee will move 
expeditiously to have the reauthorization of PDUFA and legislation to 
modernize the FDA ready for the consideration of the Senate.
  Mr. President, I know the Senator from Maryland is here and also 
wants to join myself and the majority leader in making sure that the 
Senate does what it must do in order to make the improvements necessary 
to bring the FDA up to what it can be and should be.
  Mr. President, I yield the floor.
  Ms. MIKULSKI addressed the Chair.
  The PRESIDING OFFICER. The Chair recognizes the Senator from 
Maryland.
  Ms. MIKULSKI. Mr. President, I want to state very clearly that I 
agree with the distinguished majority leader, the Republican leader, 
and the respected chairman of the Labor and Education Committee, Mr. 
Jeffords, in reauthorizing the Prescription Drug User Fee Act this 
year. And I also support strong bipartisan agreement on FDA reform. The 
time has come. The time is now. It is a window of opportunity to just 
do it.
  I am so pleased that we are proceeding on this, and not only in a 
bipartisan fashion, but a nonpartisan fashion. I had the pleasure of 
working with the former chairman, Senator Nancy Kassebaum of Kansas, 
who retired, on fashioning a bipartisan framework on FDA reform.
  I am so pleased that her successor, Senator Jeffords, has picked up 
the same framework as a working document for us to be able to proceed 
because this is what the American people want us to do--to work 
together to be able to have a Federal agency that oversees the approval 
of our pharmaceuticals, biotechnology, and biomedical devices to ensure 
their safety and efficacy, but also to make sure they move out into 
clinical practice in a timely way. This is what we need to do because 
it will save lives and generate jobs in the United States of America.
  So I look forward to working with the distinguished chairman in 
fashioning the bill in committee and with the Republican leader in 
moving it to the Senate floor, because it is time to bring a smokestack 
regulatory framework into the computer age. FDA needs to adopt a new 
culture and move into the 21st century. That is why FDA reform is so 
important. We need a new regulatory framework that will make sure that 
we bring exciting new biomedical technology devices to not only 
millions of Americans in a timely fashion but this is a global field 
that will enable us to export around the world.
  Our country has been often known for exporting smart weapons of war 
but this will enable us to export smart new technology in the war 
against disease. This will be absolutely crucial.
  Reform is of great interest in my State of Maryland. Maryland is home 
to many biotechnology companies and medical device manufacturers and 
they are creating new scientific products which will save lives.
  In the 104th Congress, under the able leadership of now retired 
Senator Kassebaum, we reached that bipartisan consensus on effective 
and responsible FDA reform. Then I was pleased to join several of my 
Democratic colleagues in supporting the Kassebaum bill. And I am 
committed to achieving meaningful bipartisan reform this year.
  Coupled with FDA reform though, this is the year that we must 
reauthorize something called PDUFA. As has been outlined very ably by 
the chairman of the committee, this Prescription Drug User Fee Act has 
shown that it will significantly reduce drug approval time because it 
generated fees that have been used to hire more staff. It enabled the 
FDA to move more expeditiously in moving new drugs to patients more 
quickly. For example, new AIDS drugs are being approved now in a matter 
of months rather than a matter of years.
  FDA itself is located in my own State. They work under very difficult 
situations. They work out of modular buildings, many of which are 
spread over 27 different sites. They often are short-staffed. And they 
need to make sure we pass PDUFA so that they have the adequate 
resources they need to do the job while we help them fashion an 
adequate legislative and regulatory framework.

  We can build on this great track record. With the extension of PDUFA 
for another 5 years, we can have the opportunity to make further 
improvements. What can be done with some new drugs should be done for 
the benefit of many other patients.
  Mr. President, we are talking about the need to provide all the help 
we can to a Government agency that has an enormous impact on the day-
to-day lives of Americans. The FDA is involved with everything from the 
drugs we take to the food we eat. Let us move on PDUFA and FDA reform 
in a sensible, responsible bipartisan manner. And as this is done, we 
must focus on the values of safety and efficacy while we will also 
streamline our process.
  I know also in the Chamber is the distinguished Senator from Oregon 
[Mr. Wyden], who when we worked on the original PDUFA was in the House. 
He brings a great deal of knowledge to that. And we know he will be 
part of our bipartisan effort. So we thank you, I say to the Senator, 
and look forward to working with you.
  In conclusion, I would like to also thank the chairman of the 
committee, Mr. Jeffords. He established a committee now called Public 
Health and Safety. It is the first time I believe in the committee's 
history that we have had a committee devoted strictly to focusing on 
the public health needs of the American people. The Centers for Disease 
Control and NIOSH and others will be so absolutely crucial. And being 
the gentleman that he is, he yielded that plum to another member of the 
committee, and enabled Dr. Bill Frist to chair that committee, who 
brings to the committee the experience as a physician of a hands-on 
clinical practice as well as the know-how and what it really takes to 
be able to save lives.
  This is what we need to be doing--the right committee structure, the 
right attitude within the committee so that we can all work together so 
that at the end of the term, we might not have solved every budget 
problem, we might not have balanced every line item, but at the end of 
this term people will be safer, their food, their pharmaceuticals, and 
so on, will be able to move quicker, faster, cheaper, maintaining 
safety and efficacy because of what this committee has done. I look 
forward to cooperating with that.
  Mr. President, I yield the floor.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Chair recognizes the Senator from Vermont.
  Mr. JEFFORDS. We are awaiting the arrival of the majority leader. I 
know the Senator from Oregon has somewhat

[[Page S2764]]

of a lengthy statement. I wonder if he would be willing to be 
interrupted by the majority leader should he arrive and that we also 
would place his statement preceding mine such that it would appear in 
the order originally intended.
  Mr. WYDEN. I thank the gentleman for his courtesy. Perhaps we might 
wait a few more minutes for the leader.
  Mr. JEFFORDS. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. LOTT. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Sessions). Without objection, it is so 
ordered.
  Mr. LOTT. Mr. President, this Congress has an opportunity to build on 
the progress made in the 104th Congress to assist the Food and Drug 
Administration in meeting the needs of millions of Americans who are 
awaiting the advancement of new medicines.
  Over the years, I have known individuals who have needed medicines 
and medical procedures that they could not get because the FDA had not 
done whatever was necessary, in their opinion, to approve these 
procedures. I have known of examples of people going to Mexico for 
medicine or to England for a medical procedure because they could not 
get that procedure in America. Yet 20 years later, one of the 
procedures that Americans had to go to England to get now is so common 
it is almost done as an outpatient procedure. That is ridiculous, and 
it is time we make some progress in advancing these new medicines in a 
more expeditious manner.
  We also have an urgent need to act to extend the highly successful 
law that will expire later this year unless it is renewed in a timely 
fashion.
  Let me review last year's legislation that would enable the FDA to 
meet the demands of the rapidly approaching 21st century.
  This past year, we had wide bipartisan agreement on essential 
elements of FDA reform in both Houses of Congress. In the Senate, the 
Labor and Human Resources Committee approved S. 1477, the Food and Drug 
Administration Performance and Accountability Act, by a 12-to-4 
bipartisan margin. In the House, H.R. 3199, the Drug and Biological 
Products Reform Act was cosponsored by more than 200 Members of both 
parties.
  It was unfortunate, Mr. President, that despite the best efforts of 
then Labor and Human Resources Chair Nancy Kassebaum, as well as my 
colleagues Senator Dan Coats and Senator Chris Dodd, we ran out of time 
last year before S. 1477 could be brought to the Senate floor. I wanted 
to do it. They wanted to do it. A bipartisan group wanted to do it. In 
the face of a threatened filibuster by some Senators, we were not able 
to bring it to the floor with that threat hanging over the legislation.
  However, as the urgency of this legislation becomes more and more 
apparent, I am confident that the Labor and Human Resources Committee 
under the able leadership of the distinguished Senator from Vermont 
[Mr. Jeffords], will undertake this worthy effort without delay.
  Congress must also consider another important law this year, the 1992 
Prescription Drug User Fee Act which is scheduled to expire on 
September 30, 1997.
  The user fee law was the result of a historic agreement between 
Congress, the Food and Drug Administration, and the pharmaceutical and 
biotechnology industries. Industry agreed to pay $347 million in user 
fees during the 1993-97 period, which enabled the FDA to speed up the 
approval process by employing an additional 600 reviewers. Unless this 
vital law is renewed, the advances made by the FDA will be interrupted 
and the progress will be damaged.
  As majority leader, I plan to do everything I can to ensure that 
PDUFA, the legislation I just referred to, is reauthorized for another 
5 years, thus ensuring that our sickest patients will have fast access 
to life-saving products.
  Mr. President, Congress must meet these two challenges. We must act 
now for the patients all across America. I certainly commend Senator 
Jeffords for his efforts in this area, his leadership, and my good 
friend, the Senator from Maryland, Senator Mikulski. She has been a 
leader in getting this colloquy and getting these statements printed in 
the Record today. I commend her and urge my colleagues on the 
appropriate committee and on both sides of the aisle to support these 
two very important pieces of legislation.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Oregon is recognized.
  Mr. WYDEN. Mr. President, I ask unanimous consent to speak for 30 
minutes as in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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