[Congressional Record Volume 147, Number 169 (Friday, December 7, 2001)]
[Senate]
[Pages S12752-S12753]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  MEASURE READ THE FIRST TIME--S. 1789

  Mr. REID. I understand S. 1789, introduced earlier today by Senator 
Dodd, is at the desk, and I ask for its first reading.
  The PRESIDING OFFICER. The clerk will read the bill by title.
  The legislative clerk read as follows:

       A bill (S. 1789) to amend the Federal Food, Drug, and 
     Cosmetic Act to improve the safety and efficacy of 
     pharmaceuticals for children.
  Mr. KENNEDY. Mr. President, I strongly support the Best 
Pharmaceuticals for Children Act, which reauthorizes the pediatric drug 
exclusivity provision enacted as part of the FDA Modernization Act in 
1997. I commend Senator Dodd and Senator DeWine for their effective 
leadership on this provision as well as Senator Clinton for her 
important contributions to this legislation, and I also commend their 
staffs for their long and skilled work on this bill.
  Combined with FDA's Rule that requires pediatric testing for drugs 
and biological products, this legislation is intended to do more to see 
that medicines are adequately tested for safety and effectiveness in 
children.
  The 1997 provision has been a major success in encouraging essential 
studies of pharmaceutical products in children. Dozens of such drugs 
have been studied in children, and many of the products have now been 
relabeled or even reformulated for use in children. But the 1997 
provision has not been an unqualified success. Although many products 
have been studied, others have not. For every label changed, others 
remain incomplete.
  This reauthorization provides that every pharmaceutical product that 
is needed to treat children will, in fact, be studied in children. In a 
few years, there will be far fewer of these products that lack adequate 
information about pediatric use. The Food and Drug Administration will 
be able to act more quickly and successfully to see that drug companies 
label their products for such use. The bill also gives needed new 
priority to the appropriate use of cancer drugs for children.
  In addition to extending and improving this program which has been so 
important in improving therapies for children, the bill closes 
technical loopholes which might have improperly barred generic drugs 
from the market or limited the incentives for generic drug development.
  This is a bill that will make a major contribution to the health of 
American children and I urge its prompt passage by the Senate and the 
House.
  Mr. REID. I ask for its second reading, and I object to my own 
request on behalf of the minority.

[[Page S12753]]

  The PRESIDING OFFICER. The objection is heard.
  The bill will be read the second time on the next legislative day.

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