[Congressional Record Volume 143, Number 158 (Monday, November 10, 1997)]
[Senate]
[Pages S12482-S12483]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                FDA MODERNIZATION AND ACCOUNTABILITY ACT

 Mrs. MURRAY. Mr. President, there are very few pieces of 
legislation that we will act on that has the kind of impact that S. 830 
will have on improving the quality of lives for millions of Americans. 
Ultimately, this legislation will impact every Member of this body. S. 
830 represents a historic piece of legislation that will reform and 
modernize the Food and Drug Administration.
  This legislation will result in the more rapid approval of new, 
lifesaving drugs and medical devices without jeopardizing a strong 
public health protection role for the FDA. Millions of people will have 
access to break through medical technology faster. More children will 
also benefit from the rapid improvement in drugs and devices to treat 
serious and life-threatening illness. And, finally the FDA will be 
given the resources it needs to meet the challenges and demands of 
protecting the public health and approving safe and effective drugs in 
a more timely manner.
  When I made the decision to seek a seat on the Senate Labor and Human 
Resources Committee I did so because I wanted to be directly involved 
in the development of education and public health reform. I am proud to 
have worked with Chairman Jeffords in his effort to shepherd through 
the FDA reform legislation. I know that at times this was a difficult 
task and his leadership and patience were truly tested. I want to thank 
him for his willingness to forge a bipartisan bill that addressed many 
of the concerns that I had early in the process. I also want to thank 
Senator Kennedy for his efforts on behalf of patients and consumers. 
Senator Kennedy's hard work and commitment to a strong public health 
role for FDA resulted in some real improvements in this legislation.
  The fact that we have before us today a bipartisan reform agreement 
is in itself a historic accomplishment. Prior to the 105th Congress I 
thought that I had a pretty good understanding of how the agency worked 
and where improvements needed to be made. What I discovered is that the 
drug and device approval process from lab to patient is a complex 
process involving numerous steps. The pressure on the FDA to improve 
safe and effective drugs and devices with minimal delay is 
overwhelming. In addition, the FDA must regulate billion dollar 
industries that have almost unlimited resources. What I have learned 
from this process is that the FDA is by far one of the most important 
public health agencies, but it is also one that we all seem to take for 
granted.

[[Page S12483]]

  S. 830 is not just about the reform or modernization of a Federal 
agency. The activities of the FDA effect every single one of us, every 
single day. Whether it is taking an aspirin or brushing our teeth the 
FDA was involved. It ensured that the aspirin and the toothpaste was 
safe and effective. The FDA manufacturing standards protect these 
products so that we can feel confident that they were not contaminated 
or tampered with prior to our purchase.
  The agency is also involved in making sure that new technology to 
diagnosis or screen for life-threatening illnesses is reliable and that 
the claims made by the manufacturer are consistent with the available 
technology. The FDA must also ensure the safety and effectiveness of 
all drugs as well. When we pick up a prescription like an antibiotic at 
the pharmacy, we never think twice about the safety or effectiveness of 
the drug. We simply assume that if taken properly it is safe and 
effective at treating an ear infection. It is because of the success of 
the FDA that we do take so much of this for granted.
  This is not to say that there have not been problems in the past. 
But, I believe the changes and improvements made by S. 830 addresses 
some of these problems and that the commitment made by the chairman to 
maintain aggressive and effective oversight of the agency will prevent 
significant problems in the future. I know that there are some who are 
skeptical of the reforms and modernization called for in this 
legislation and they point to past problems at the agency as their 
proof. I am not dismissing past mistakes by the FDA, but I also do not 
believe we can allow the past errors to paralyze the agency. We have to 
move toward the future, and learn from the mistakes of the past.
  The agency has been given a daunting task with limited resources. 
However, it has become obvious over the years that a major 
modernization was necessary in order to keep pace with the rapid 
changes in drugs and devices and the globalization of the biotech 
industry. In 1992 the Prescription Drug User Fee Act [PDUFA], the 
partnership between the agency and the prescription drug industry, was 
enacted. This major effort has proven to be a major success for the 
FDA, industry, and patients. I am pleased that we were able to include 
reauthorization of PDUFA in S. 830 that builds on the success of the 
1992 legislation.
  I am pleased that we have completed this process and are sending a 
solid, bipartisan bill to the President for signature. I am confident 
that enactment of S. 830, FDA Modernization and Accountability Act will 
prove to be one of the major accomplishments of the 105th Congress. I 
know that I am proud to have been directly involved in the development 
of this legislation.
  I look forward to working with Chairman Jeffords and Senator Kennedy 
in the same bipartisan manner as we tackle other public health reform 
initiatives.

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