[Congressional Record (Bound Edition), Volume 147 (2001), Part 16]
[Extensions of Remarks]
[Page 22791]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 BEST PHARMACEUTICALS FOR CHILDREN ACT

                                 ______
                                 

                               speech of

                           HON. DOUG BEREUTER

                              of nebraska

                    in the house of representatives

                       Tuesday, November 13, 2001

  Mr. BEREUTER. Mr. Speaker, this Member wishes to comment on H.R. 
2887, the Best Pharmaceuticals for Children Act, and would like to 
command the distinguished gentleman from Pennsylvania, Mr. Greenwood, 
the sponsor of this bill, and the distinguished gentleman from 
Louisiana, Mr. Tauzin, the Chairman of the Committee on Energy and 
Commerce, for bringing this legislation to the House Floor today.
  Mr. Speaker, this Member is unaware of any Member of Congress who 
opposes the appropriate testing, evaluation and proper labeling of 
prescription drugs for use in children. We need to ensure that 
medicines are safe and effective for both children and adults. The only 
question for debate is how to accomplish this critical public health 
objective.
  As you are aware, the Best Pharmaceuticals for Children Act would 
continue a program that grants prescription drug companies an 
additional six-month patent exclusivity, as an incentive for them to 
test their drugs on children. While pediatric exclusivity has resulted 
in an increase in the number of pediatric drug studies and has provided 
valuable information to pediatricians about how to use drugs in 
children, this Member is concerned about the current law for several 
reasons.
  Most importantly, the law has imposed higher prices on consumers 
because it delays the introduction of lower-priced generic drugs for an 
additional six months. This Member is also concerned that the pediatric 
exclusivity provision provides substantial incentives to drug companies 
to test drugs that have high sales, particularly among adults, rather 
than those drugs which pediatricians need more information. It appears 
that brand name drug companies are receiving six months of exclusivity 
for testing a drug on children, even when that testing is of minimal 
value because it is for an indication that rarely occurs in children, 
such as ulcers, hypertension, or Type II (adult-onset) diabetes. 
However, there seems to be adequate provisions which would cause 
companies to initiate such testing to gain an additional six-month 
patent exclusivity only upon FDA request.
  Furthermore, pediatric exclusivity provides little incentive to test 
drugs that are still under patent, but do not result in high profits. 
It appears that pediatric exclusivity leaves many drugs unstudied in 
children, because the drug companies believe they will not make enough 
from six months of additional patent protection.




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