[Congressional Record Volume 153, Number 126 (Thursday, August 2, 2007)]
[Senate]
[Pages S10685-S10687]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  UNANIMOUS-CONSENT REQUEST--H.R. 2900

  Mr. REID. Madam President, I ask unanimous consent that the Senate 
proceed to the consideration of Calendar No. 270, H.R. 2900, the FDA 
reauthorization bill; that all after the enacting clause be stricken 
and Senator Kennedy's substitute amendment be inserted in lieu thereof; 
that the bill be read the third time and passed, the motion to 
reconsider be laid on the table, and the Senate insist on its 
amendment, request a conference with the House, and that the Chair be 
authorized to appoint conferees, with the conferees being the members 
of the HELP Committee.
  Further, there were tax measures in this matter that we dealt with on 
the floor. They have been stricken from the bill. That is what Senator 
Kennedy's amendment is all about. I hope we could go to conference on 
this matter.
  The PRESIDING OFFICER (Mr. Akaka). Is there objection?
  Mr. ENZI. Mr. President, reserving the right to object, and before I 
object, I need to understand the rationale of the majority leader to 
propound the request at this time. I sent a letter last week. I ask 
unanimous consent that the letter be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         U.S. Senate, Committee on Health, Education, Labor, and 
           Pensions,
                                    Washington, DC, July 27, 2007.
     Hon. Harry Reid,
     Majority Leader, Hart Senate Office Building, Washington, DC.
     Hon. Mitch McConnell,
     Minority Leader, Russell Senate Office Building, Washington, 
         DC.
       Dear Senator Reid and Senator McConnell: I urge you to 
     appoint conferees as soon as possible to S. 1082, a bill that 
     renews expiring authorities at the Food and Drug 
     Administration (FDA) as well as reforms our drug safety 
     system.

[[Page S10686]]

       Every day, we hear about a new problem the FDA faces in 
     protecting our health. From contaminated seafood to tainted 
     toothpaste, this agency is in dire need of Congressional 
     support to carry out its mission. Reauthorizing these 
     programs is critical to ensure that new drugs and medical 
     devices reach the patients who need them.
       As you know, this work period is nearly over. If the drug 
     and device user fee programs are not renewed prior to the 
     recess, FDA will have no choice but to send what is known as 
     a ``Reduction In Force'' or layoff notice to hundreds of FDA 
     employees involved in these programs. These highly skilled 
     and dedicated public servants are not likely to wait until 
     Congress musters enough interest to act to maintain the user 
     fee programs. They will find other jobs. A staff exodus would 
     be a disaster for this agency, and for the public health it 
     safeguards so zealously.
       This comprehensive bill will provide new authorities for 
     FDA to be able to react in a timely way to any safety 
     problems that arise after a drug has been brought to market. 
     FDA needs these tools both to get drugs to the market quickly 
     and efficiently and to respond to potential problems the same 
     way, especial1y when lives are on the line and people need 
     new drugs and therapies.
       We must think carefully about our priorities for the 
     limited time we have before the recess begins, and take 
     strong action to give the FDA the resources and tools it 
     needs to protect us. Appointing conferees now would send a 
     powerful message that Congress is working as hard as FDA is 
     to make these programs work.
           Sincerely,

                                              Michael B. Enzi,

                              Ranking Member, Committee on Health,
                                   Education, Labor, and Pensions.

  Mr. ENZI. Mr. President, this letter is asking for a conference to be 
appointed. But it is my understanding the House never intended to 
appoint one this week. Had I known that, I would not have delivered the 
letter. We were working in a very bicameral, bipartisan manner on 
getting this done.
  At that time, the key players for this legislation--Representatives, 
Senators, Republicans, and Democrats--were engaged in a very productive 
bicameral, and bipartisan preconference negotiation. We had all rolled 
up our sleeves and decided that we were going to complete the 
legislation before the August recess.
  We had a good core agreement, focused on good policy. That is not to 
say that there weren't a few sticking points. There always are a few of 
those, but we were making significant progress and coming to a better 
understanding of each other's legislation. Thus, the appointment of 
conferees would have been a simple step in the process.
  However, a week later, we are not in the same place. As the majority 
leader knows, this body can seemingly operate in Senate dog years. One 
week can be a lifetime. In that short week, there were a series of 
unfortunate events. These events made it impossible for us to meet the 
goal of completing this key legislation before August recess. I don't 
want these unfortunate events to derail this process.
  The first unfortunate event was a discussion on the House floor last 
Friday afternoon between Representative Cantor and Representative 
Wasserman-Schultz. In that discussion, the House leadership indicated 
that they did not intend to have the FDA bill on the House suspension 
calendar this week. Given that I am not one to watch the House floor, I 
did not realize that this decision had been made by House leadership 
last Friday. On Monday, that information was conveyed to my staff by 
the staff of key Democrats engaged in discussion. The House Democrats 
did not see how this FDA bill was to get done before recess.
  Had I known that this was what the House Democrats wanted a few days 
before, I would not have hand-delivered that letter to the majority 
leader and the minority leader.
  Partially, I believe the decision by House Democrats was related to 
other items, other priorities facing the House. Like us, the House has 
been discussing the SCHIP legislation this week. Unlike the Senate, the 
House committees overlap such that the same committee that works on FDA 
issues also works on SCHIP issues. While we pride our staff in being 
able to do the impossible, forcing both FDA and SCHIP at the same time 
would be well past impossible. Thus, the House Democrats made a 
choice--SCHIP over FDA.
  Partially, I also believe that the House leadership felt as if they 
could get a ``better deal'' if they were to wait until September and 
build up additional pressure related to reduction in force directly 
related to the reauthorization of the core of the FDA drug safety bill. 
I hope to disabuse them of that reality.
  If we are to answer to the American people, to give FDA the necessary 
new authorities, we must do this in a bipartisan manner. We should not 
politicize this. We should not hold out for ``better deals'' but work 
together to forge a strong agreement that every American can support.
  Therefore, I urge my colleagues not to politicize this issue. Too 
much is at stake for us to begin the blame game. Instead of blaming 
each other for potential failure, we should be working to ensure our 
success. We should be developing a process agreement for how we are to 
complete this key legislation. We should begin defining the scope of 
the conference to ensure that extraneous proposals do not weigh down 
our ability to quickly respond when we return in September.
  As part of that first step, I would like everyone to know what I 
believe is the appropriate scope of the conference. First, we must 
include the reauthorizations of user fee programs at the FDA to ensure 
that nearly 2,000 employees at that agency are not laid off. These 
staff not only ensure that drugs and devices are appropriately and 
efficiently reviewed before they are allowed to go to market, but they 
also are in charge of key postmarket safety monitoring of those 
products. We must reauthorize the Prescription Drug User Fee Act and 
the Medical Devices User Fee Modernization Act.
  Beyond these items, during our Senate debate on FDA, we discussed key 
provisions that provided FDA with new authorities to assist the agency 
in quickly and effectively responding to potential safety issues. These 
new authorities include requiring labeling changes, requiring 
postmarket studies to more fully examine potential risks, and to have 
access to clinical trials information for patients and providers. In 
addition, we discussed how to address potential conflicts of interest 
of advisory committee members to ensure greater transparency and 
preserve scientific integrity. I commend Senator Mikulski and Senator 
Grassley for their work in this area.

  In addition, we must include three key provisions that focus on 
children. The first two--the Best Pharmaceuticals for Children Act and 
the Pediatric Research Equity Act--ensure that drugs used in children 
are tested on children. The third proposal would increase our ability 
to have devices geared toward children.
  Beyond those, there were a series of other provisions which were key 
to our bipartisan agreement. There is the Reagan-Udall Foundation 
provisions to ensure that FDA has additional tools to advance the 
science behind its regulations. The Senate also debated and then 
accepted a variety of important provisions related to citizens 
petitions, direct-to-consumer advertising, counterfeit drugs, and 
antibiotics and enantiomers.
  Senator Stabenow, Senator Brown, Senator Lott, Senator Thune, Senator 
Hatch and Senator Coburn developed a proposal on citizens petitions 
that will end the abuse of the system while preserving FDA's ability to 
review those petitions that have public health merit. Senator Roberts 
and Senator Harkin worked together successfully to solve the difficult 
issue of how to see that direct to consumer advertisements provide 
effective safety information to patients while meeting the stringent 
test of constitutionality. Senator Dorgan and Senator Snowe contributed 
a proposal on counterfeit drugs that will be included here as well. 
Senator Hatch, Senator Brown, and Senator Burr developed key public 
health provisions to ensure access to new antibiotics and drug 
enantiomers.
  Senator Brown and Senator Brownback offered an important incentive to 
encourage the development of drugs for tropical diseases. All of these 
items are important components to this legislation and speak to the 
larger bipartisan nature of our agreement. Let me say that again. We 
worked deliberately to ensure that our bill was bipartisan.
  Finally, there were a variety of provisions included within the 
Senate bill to address key food safety provisions. Senator Sessions, 
Senator Stevens, and Senator Durbin and I worked on

[[Page S10687]]

amendments that addressed issues with food and pet food safety.
  While I have discussed several key provisions that have been within 
the scope of our discussions, we must also discuss what should not be 
within the scope of this legislation. While a sense of the Senate 
indicated our desire to make generic biologics--or what I like to call 
biosimilars--available to American consumers to reduce the costs of 
some medications while preserving quality, the House has so far made it 
clear that such legislation would not be welcome on this legislation. 
They prefer to move through regular order. I understand that desire. I 
prefer regular order, too.
  During our discussion on the Senate floor, there was one provision 
that I believe put the bill in jeopardy--an importation amendment. The 
House opted not to include this provision so that they could deal with 
it at a later date. This bill is not the time for this debate, given 
that we are focusing on key bipartisan proposals.
  So, I turn to the majority leader, and I ask him to refrain from 
politicizing this issue. I ask him to work with me to define the scope 
of the conference, to develop a plan for getting this legislation done.
  Until the House leadership is in agreement with our plan, we should 
not force the issue today by appointing conferees too early. If we do 
this too early, we set ourselves up for the blame game, not for getting 
this key legislation done. This place should not be about ``gotcha'' 
politics when lives are at stake.
  Mr. President, I don't know what the logjam is at the moment. I 
understand there is some concern on the biologics. There isn't any 
reason this cannot be completed, but I am afraid the motion, if we are 
doing this, would appear to put the blame on the House, or on the 
Republicans--I am not sure which--and I don't think we can do that at 
this point in time. Maybe later in the day.
  Mr. REID. Mr. President, if this is the way the Senator feels, I am 
happy to have him and Senator Kennedy see if this can be worked out.
  I withdraw my unanimous consent request.

                          ____________________