madam chairman , first of all , let me express my appreciation to the leader on our side on this subcommittee , the gentlewoman from connecticut ( ms. delauro ) xz4001030 . 
this is her first year as the minority rank on this subcommittee , and she is doing an outstandingly good job , and we all very much appreciate the work that she is doing . 
i also want to express my appreciation to my chairman . 
he also is doing a very good job , particularly under a very difficult set of circumstances ; and those difficult set of circumstances are , particularly , the allocation that this subcommittee has been afforded . 
but that , of course , is universally true . 
all of these subcommittees have been afforded very small , ineffective allocations , ineffective to do all the things that need to be done . 
but , nevertheless , in spite of that , i think the chairman has done a good job . 
there is one aspect of this bill , however , to which i would like to draw attention , because it is an aspect of the bill that is entirely deficient and not only deficient but , because of these deficiencies , the result is a potential for serious harm to a large number of american citizens . 
that is the way in which the food and drug administration is treated in this legislation , and the fact that the congress has not provided to the fda the kinds of authority that it needs in order to protect the general public against the marketing of prescription drugs in ways that are causing serious harm to large numbers of the american people . 
now , recently we have had two experiences , that is , the nation has had two experiences , with drugs that have been very difficult and dangerous . 
the first is antidepressants and the way that they have been marketed . 
they have been marketed largely to people who were targeted for marketing off-label . 
a lot of the people who they were marketed to and who used them were young folks , young people , teenagers . 
the effect of these antidepressants on young folks , youngsters , teenagers , people in their early 20s particularly , has been to engender in them a deep sense of depression which , in many cases , has led to suicide ; and it has taken us a long time to get attention focused on that problem . 
another example is the so-called cox-2 inhibitors , or prescriptions such as vioxx . 
vioxx has presented a major , major problem to consumers across the country . 
it is likely that several hundred thousand people , as a result of the use of vioxx , have fallen into conditions where their health has been seriously injured ; and it may be , and probably is , that more than 100 , 000 people suffered death as a result of the use of this prescription drug vioxx . 
now , that comes about as a result of the failure of this congress to give the fda the kind of authority it needs to deal with the drug companies ; and i later in the debate on this legislation will offer two amendments to deal with this problem . 
but , right now , i want to draw the attention of the members of this house to this issue . 
this is a serious issue which affects the health and safety of the american people in material and very dramatic ways . 
it is an issue that is causing the unnecessary death of large numbers of americans , and it is an issue that we have not dealt with and should deal with , and if we do address it properly , it will alleviate this condition and stop placing so many of american citizens in the kind of dangerous , desperate circumstances that they have fallen into which have caused serious injury to their health and death in large numbers of people . 
so what we need to do is to give the food and drug administration the authority to deal with the pharmaceutical companies in the way that any regulatory agency would deal with the entity that it is regulating . 
for example , in the case of vioxx , once that drug got on the market and it became clear that people were being injured as a result of exposure to it , and the off-label marketing of that drug particularly , once that became clear , the food and drug administration was not in a position to tell the drug company that they had to engage in an educational program which would ensure that people to whom the drug would be dangerous would not be using it . 
they could not order the pharmaceutical company to do anything with regard to the labeling on that drug . 
they had to negotiate with the company . 
so these are some of the major issues that we are facing , one of the major deficiencies in this legislation that needs to be addressed , and i will be offering two amendments later on in the debate , and i hope that the members of this congress will embrace those amendments . 
