[Congressional Record (Bound Edition), Volume 148 (2002), Part 11]
[Senate]
[Page 15661]
[From the U.S. Government Publishing Office, www.gpo.gov]




                PRESERVE THE PEDIATRIC RULE ACT OF 2002

  Mrs. CLINTON. I am very pleased that today the Senate HELP Committee 
voted unanimously to report S. 2394, the Preserve the Pediatric Rule 
Act of 2002, out of Committee, as amended by consensus language to 
assure that, for already-marketed drug, companies have an opportunity 
to conduct studies voluntarily before the rule is invoked, which is 
consistent with current Food and Drug Administration practices.
  Mr. DODD. Does the Senator agree that with the exception of the 
agreed-to amendment to allow a manufacturer to voluntarily study an 
already-marketed drug before the rule is invoked, the legislation we 
passed tracks the existing language and policy of the rule, and ensures 
that FDA and HHS will not weaken or undermine current protections for 
children on drug safety and labeling?
  Mrs. CLINTON. I agree.
  Mr. DODD. Also, as the Senator will remember, last year's Best 
Pharmaceuticals for Children Act BPCA, established a mechanism by which 
drugs that companies did not voluntarily study would automatically be 
referred to the National Institute of Health, HIH, to be contracted out 
for study. Is it not Congress's intention that this tool along with the 
rule should be used to secure safety and efficacy information for kids 
as quickly as possible?
  Mrs. CLINTON. That is correct.
  Mr. DeWINE. We are committed to fighting for dollars for these 
studies, because the contracting process at NIH only works if there are 
funds available. If there are no funds available, we must have the rule 
to ensure that we get needed studies done so that the necessary 
information can be added to the labels of the medicines children use. 
Would the Senator agree that the language of the amendment allows other 
tools to be used, but also makes clear that the rule will be available, 
enforceable, and unencumbered when needed?
  Mrs. CLINTON. I would agree.
  Mr. DODD. We will continue to examine the contracting process at the 
NIH to ensure that it works effectively, in conjunction with the rule, 
so that there is no delay or bottleneck in conducting the studies and 
securing this information for children.
  Mr. DeWINE. That is correct. Congress made several tools, including 
the contracting process under the BPCA, available, but Congress never 
contemplated the exhaustion of all the tools under BPCA before the rule 
could be invoked. This amendment makes clear that as long as the FDA 
has first asked a company to voluntarily conduct the study, the FDA 
will be able to invoke the rule.

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