[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11360-11361]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              DRUG SAFETY

  Mr. KENNEDY. Mr. President, hopefully during this afternoon we will 
have a chance to move irrevocably toward bringing the FDA into the 21st 
century, in terms of safety and security for American families. We do 
that with our primary focus making sure that in this time of the life 
sciences, the extraordinary breakthroughs we are seeing every single 
day, that the Food and Drug Administration is going to bring those new 
opportunities to American families but do it safely and do it 
efficaciously and do it in a way which is going to ensure that every 
family in America is going to have safe prescription drugs and safe 
products over which the FDA has jurisdiction.
  I thank my friend from Wyoming for all his good work. We are going to 
have a series of three votes, and then we may very well set a pathway, 
hopefully, toward a successful conclusion of this legislation. He and I 
are both eager to see this legislation in the conference to work out, 
with the House of Representatives, the points of difference with the 
House. We are also eager to work out the extremely important area of 
the follow-on biologics. It is an enormously important area of public 
health, and it is going to demand a great deal of time and careful 
attention to make sure we get that issue correct.
  It is important to not fail the American people but to see progress 
made in addressing this issue. The only way we can do it is make sure 
we get legislation that is going to pass the Senate, pass the House of 
Representatives, and move into conference. We are strongly committed to 
doing that.
  I commend our colleagues for all their good work and assistance. We 
had a rigorous markup in our committee for several hours. There were a 
number of different amendments. We have addressed the issue of food 
safety with the Durbin amendment. This issue has been on the front 
pages all over this country and all over the world, particularly with 
regard to pet food as well as food safety generally. This legislation 
will go a long way toward giving assurances to American families that 
all of our food products are going to be safe and secure.
  There are other provisions such as developing a nonprofit foundation 
so we can draw from the private sector and the public sector to make 
sure that agency is going to have the best of new techniques and new 
modalities, and to try to make sure the products that are before the 
Agency are going to be safe and secure and available as fast as 
possible. There will be a new emphasis in terms of science and also, as 
my friend from Wyoming points out, a toolbox that will be available to 
the FDA in order to ensure that we can get drugs more rapidly to the 
consumer but make sure they will be safer for American families, using 
the best of new technology, information technology, to make sure they 
are going to be more safe.
  I am enormously appreciative of the work of my friend from North 
Dakota, Senator Dorgan, on the issue of cost and price. Part of this is 
making sure we are going to have drugs that will be safe, but we also 
want to make them accessible and available. I commend him and all those 
who have been a part of this process. This is certainly an aspect of 
the prescription drug issue that we should constantly address.
  I thank Senator Roberts and Senator Harkin for working with Senator 
Enzi and me on the important issue of DTC, direct-to-consumer 
advertising. We have accomplished our common goal of a constitutionally 
sound, effective, workable way to make sure that DTC ads provide 
accurate information to patients about the drugs they are taking. This 
amendment strikes the moratorium on DTC ads that had given rise to 
Constitutional concerns, and I think we have a very solid resolution. I 
wish to thank Senators Stabenow, Brown, Lott, Thune, Coburn and Hatch 
for reaching agreement on the difficult issue of citizens petitions. 
Their amendment prohibits the abuse of the citizens petition process, a 
process that led to unwarranted delays in the approval process of FDA 
drugs, while making certain the FDA can review issues that have merit. 
The list also includes a novel proposal from Senator Brownback and 
Senator Brown to encourage the development of new therapies for 
neglected diseases. Under this innovative and thoughtful proposal, 
companies that have developed new treatments or vaccines for tropical 
diseases will receive a credit entitling them to a priority review at 
FDA for a product of their choosing. The proposal will not raise costs 
to consumers nor will it change safety standards. It is a very solid, 
imaginative, and creative approach. I commend Senator Hatch for his 
amendment on antibiotics, as well Senators Brown, Burr, Stabenow and 
others for contributing important proposals to this amendment.
  The amendment strikes the right balance between innovation and 
access, and closes a loophole that eliminated the incentives to bring 
old but never approved antibiotics to market.
  If there were more time, I would describe other amendments on the 
list, but I simply wish to thank all our colleagues. This issue is a 
matter of enormous importance and incredible consequence to the safety 
and security of the American consumer. This legislation brings the FDA 
into the 21st century. I commend my friend and colleague Senator Enzi 
for all his work. Most of all, I want to thank our staffs. They have 
been tireless, over this past week, on a variety of different 
amendments and prior to that time as we worked our way to the floor of 
the Senate.
  This is a very comprehensive bill. It is enormously important. We 
believe it will help in providing greater safety for American families, 
greater innovativeness in terms of breakthrough drugs and in terms of 
food safety, and greater opportunities for the FDA to have the best 
science there is.
  Mr. President, whatever remaining time that I have, I yield it to the 
Senator from Vermont.
  I yield the floor.
  Mr. DORGAN. Mr. President, I will allow the Senator from Kansas, if 
he would prefer, to proceed for his 5 minutes, asking that I be 
recognized for 10 minutes following his presentation.
  Mr. ROBERTS. Mr. President, I thank the distinguished Senator. I 
thank the distinguished Senator from Vermont for allowing me to speak.

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