[Congressional Record Volume 141, Number 198 (Wednesday, December 13, 1995)]
[Senate]
[Page S18564]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. KASSEBAUM:
  S. 1477. A bill 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; to the 
Committee on Labor and Human Resources.


the food and drug administration performance and accountability act of 
                                  1995

 Mrs. KASSEBAUM. Mr. President, I introduce the Food and Drug 
Administration Performance and Accountability Act of 1995. This 
comprehensive reform bill is designed to ensure that Americans continue 
to enjoy and our Nation continues to lead the world in the development 
of new, life-saving and life-enhancing pharmaceuticals and medical 
devices and wholesome, abundant, and affordable foods by reforming the 
role of the Food and Drug Administration in the testing and review of 
new products.
  Over the years, the FDA's requirements for clinical testing and its 
premarket reviews of new products have grown increasingly complex, 
time-consuming, and expensive. From the 1960's to the 1990's, for 
example, the time required to complete clinical trials for new drugs 
has grown from 2\1/2\ years to nearly 6 years. From the beginning of 
the process to the end, it takes an average of 12 years and costs $359 
million to bring a new drug to market. By law, the FDA is required to 
review and act on applications to market new drugs and devices within 
180 days. Today, however, it takes the agency on average 649 days to 
complete its review of new devices and 570 days to complete its review 
of most new drugs.
  These increasing FDA demands on new product development and delays in 
new product reviews are reducing incentives for research and 
development, encouraging American companies to locate abroad, delaying 
Americans' access to new pharmaceuticals and medical devices, and 
costing American jobs.
  The legislation I am introducing today is designed to correct these 
problems. First, the bill makes clear that a prime mission of the FDA 
is facilitating the rapid and efficient development and availability of 
safe and effective products that will benefit the public. It puts the 
agency on notice that Congress and the American people expect it to 
allocate its time, energy, and resources accordingly.
  Second, the bill puts teeth into statutory deadlines for agency 
action. The FDA commissioner is required, in consultation with patient 
advocacy groups and the regulated industries, to establish and meet 
yearly performance standards that will bring the agency into compliance 
and keep it in compliance with statutory deadlines for action on 
premarket approval applications. The commissioner will be required to 
report yearly on the agency's performance and, if the agency is out of 
compliance, to contract with outside experts for product reviews.
  Third, to ensure that desperately ill and suffering patients have 
access to promising new therapies, the bill will expand access to 
investigational new pharmaceuticals and medical devices. To ensure that 
physicians are as fully informed as possible about these new therapies 
and about new uses for already approved therapies, the bill will ease 
the agency's current severe restrictions on the dissemination of 
information about them.
  Fourth, the bill establishes a collaborative clinical testing and 
review process. It requires the agency to meet with companies in the 
early stage of the clinical testing to establish the parameters for 
testing and avoid last-minute changes in protocol designs once testing 
is underway. Once testing has been completed and the agency receives an 
application for product approval, the agency would again be required to 
meet with companies to better ensure the smooth and timely review of 
the application.
  Fifth, the bill provides the agency with the statutory flexibility it 
needs to make changes in its clinical testing policies and product 
review procedures. For example, it modifies current law, which appears 
now to require two or more clinical studies, to permit the agency to 
base its approval on one well-designed clinical study when appropriate. 
As further examples, the bill updates outmoded statutory requirements 
for the regulation of biological products, reduces the number of 
medical devices that the agency is required to review, and makes it 
easier for the agency to use national and internationally recognized 
performance standards in evaluating the safety and effectiveness of 
devices.
  In these and in a number of other ways, the FDA Performance and 
Accountability Act of 1995 will transform the FDA from a growing 
barrier to innovation into an active partner in innovation.

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