[Congressional Record Volume 154, Number 101 (Wednesday, June 18, 2008)]
[Senate]
[Page S5760]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BROWN (for himself and Mr. Brownback):
  S. 3151. A bill to amend the Federal Food, Drug, and Cosmetic Act 
with respect to priority review vouchers; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. BROWNBACK. Mr. President, I rise to engage my distinguished 
colleague from Ohio in a colloquy.
  Mr. BROWN. I yield to the Senator.
  Mr. BROWNBACK: I want to express my support for our provision 
included in the Food and Drug Administration Amendments Act of 2007, 
FDAAA, signed into law this Congress, to award an FDA priority review 
voucher to encourage the development of treatments for tropical 
diseases. According to the World Health Organization, roughly one 
billion people, or nearly one of every six people worldwide, are 
affected by at least one tropical disease. However, less than 1% of the 
roughly 1,400 drugs registered between 1975 and 1999 treated such 
diseases. These diseases are often referred to as the ``neglected 
diseases'' because of the lack of modern treatments available to 
address them and their disproportionate impact on very low income 
populations.
  Since the purpose of the priority review voucher is to encourage 
research and development for diseases for which there is currently 
little or no market, our intent is that the priority review voucher 
creates a strong incentive for investment in the often financially 
risky business of drug and biologic procurement for neglected diseases. 
Basic economics dictate that the voucher will create the strongest 
incentive by being freely transferable among private businesses, with 
each voucher having the capacity for transfer multiple times, without 
restriction. This interpretation is the intent of Congress. Any 
imposition of restriction by the Food and Drug Administration on the 
number of times and manner of transfer of the voucher will have the 
effect of negating its value, which is contrary to Congressional 
intent. I yield to my distinguished colleague to elaborate on this 
point.
  Mr. BROWN. I concur with my colleague on the importance of creating a 
strong incentive for development of treatments for neglected, tropical 
diseases through a freely transferable priority review voucher. 
Accordingly, I rise today to introduce, along with my colleague from 
the State of Kansas, a bill that would codify the authors' intent of 
two parts of the priority review voucher law. First, any priority 
review voucher awarded under the provision is freely transferable 
without restriction on the number of times it can be transferred. 
Second, the priority review voucher can be redeemed only for a human 
drug application that is not already pending with the Food and Drug 
Administration. I encourage my colleagues in Congress to join us in 
ensuring that this legislation moves quickly through the legislative 
process.
  Mr. BROWNBACK. I thank my friend, the Senator from Ohio, for 
introducing this important measure and for his remarks.
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