[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.
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