mr. chairman , i know that this issue is controversial . 
i know that there are members of the house who really do not want to address it this afternoon . 
but we should put that aside . 
we should put it aside because the safety and security of the american people are at stake here . 
the food and drug administration was established by this congress in order to ensure that pharmaceuticals and subsequently various forms of medical devices and other materials which are used by people who are ill , that those devices and materials can be used by people in a way that is safe and secure and sound . 
but the fact of the matter is that that is not happening , and we have the ocular proof in front of us every single day . 
i mentioned a few moments ago the situation of antidepressants . 
these antidepressants came on the market without proper , careful review ; and in addition to that , they began to be marketed for off-label uses . 
as a result , large numbers of teenagers , young people , people in their twenties , began to use them when they should not have been using them , and the usage of those antidepressants induced suicidal potential in those people , and many of them carried it out . 
many , many people took their lives in direct relationship to the use of those antidepressant drugs . 
when that became apparent , the food and drug administration was not able to deal effectively with the drug manufacturers because they did not have the authority . 
they do not have the authority to tell the drug manufacturers that when a problem becomes evident after the drug is on the market that the drug company should , at the very least , change the label , put information on the label that tells people this kind of experience has been shown to happen by this group of people so that people can be warned about it and therefore not be likely to take it and so that doctors can understand that and not be likely to prescribe it . 
that simple act would save the lives of tens of thousands of people . 
failing to do it almost inevitably is going to cost the lives of tens of thousands of americans , because it will not be much longer before we see another antidepressant situation or cox-2 inhibitor situation , vioxx situation , come on the market if we do not change the rules , if we do not give the fda the power to deal effectively with these drug manufacturers . 
the vioxx case is a very clear , strong case in point . 
after a certain period of time when that drug was on the market , it became obvious that people who were taking it were suffering strokes and/or heart attacks . 
the fda , when it became aware of that , was not able to do anything effectively about it . 
they did not even ask the drug company to take the drug off the market . 
finally , merck came to the table and properly removed vioxx from the market , but only after hundreds of thousands of people in this country were seriously affected , and we estimate at least 60 , 000 people lost their lives , and the number may be higher than that ; and all of that began to get the attention of the press and people across the country began to understand it . 
now , for god 's sake , what are we doing here ? 
are we just going to stand by idly while these circumstances continue to happen , while more and more drugs come on the market , week after week , month after month , while more and more people take them without understanding the implications and more and more people suffer , even die , as a result of that ? 
this congress has the responsibility to act . 
we need to make that food and drug administration live up to its responsibilities . 
and by simply saying in a technical way that , no , we can not do it today , that does not meet the need , not by any stretch of the imagination . 
this amendment needs to come to the floor , and this amendment needs to get the kind of attention that it properly deserves on behalf of the safety and security and the lives of the american people and to be adopted . 
so i move the amendment , and i ask my colleagues to embrace it today . 
vote for it ; support it . 
let us pass it this afternoon . 
