[Congressional Record Volume 158, Number 74 (Tuesday, May 22, 2012)]
[Senate]
[Pages S3389-S3400]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT--MOTION TO
PROCEED--Resumed
Mr. REID. I move to proceed to Calendar No. 400, S. 3187.
The ACTING PRESIDENT pro tempore. The clerk will report the motion.
The legislative clerk read as follows:
Motion to proceed to Calendar No. 400, S. 3187, a bill to
amend the Federal Food, Drug, and Cosmetic Act to revise and
extend the user-fee programs for prescription drugs and
medical devices, to establish user-fee programs for generic
drugs and biosimilars, and for other purposes.
Schedule
Mr. REID. Madam President, we are now on the motion to proceed to the
FDA user fees bill. The majority will control the first half hour
today, Republicans the final half hour. We will recess from 12:30 to
2:15 today, to allow for our weekly caucus meetings. At 2:15 the motion
to proceed to the FDA legislation will be adopted and the Harkin-Enzi
substitute will be agreed to.
Madam President, there are 12 million people in the United States who
face a cancer diagnosis today. Many have fought back against this
terrible disease and won. Others are still fighting. Each one of them
knows how difficult a cancer diagnosis can be. But imagine coming to
terms with your diagnosis only to find out the lifesaving drug you need
to survive is in short supply or is simply not available. I wish this
were make-believe but it is not; it is real America. That is the
situation faced by many Americans battling cancer and other life-
threatening illnesses.
Through 20 weeks of chemotherapy, my wife Landra and I lived with the
fear that the medicine she needed every Monday morning wouldn't be
there because there were shortages. But fortunately for us the drug was
always accessible. Many Americans have not been so fortunate. One
Nevadan fighting bladder cancer was near the end of treatment when the
medicine he was taking suddenly ran short. Only time will tell whether
the alternative treatment he received was enough to save his life.
Another Nevada woman with bowel cancer was forced to choose a less
effective chemotherapy treatment because the best drug on the market,
one that cures bowel cancer in 75 percent of the cases, was not
available. Only time will tell whether that second-choice medicine was
effective.
Yet another Nevada man was relying on two cancer drugs to keep him
alive longer and give him a greater quality of life, but one drug was
in short supply. Since the drugs only work when taken together, doctors
have only been able to treat him intermittently. That is not good. So
only time will tell how many days or weeks or months or years he lost
because he couldn't get the drug he needed.
Every day these stories play out in hospitals across our country.
Every day, Americans experience shortages of lifesaving FDA-approved
drugs and treatments. These shortages literally put Americans at risk.
As the number of shortages increases each year, more patients are
forced to wait for treatment, and worry. In the last 6 years, drug
shortages have quadrupled. Last year the FDA reported shortages of 231
drugs, including many chemotherapy medicines. That is 231 drugs. How
many tens of thousands of people did that affect? Public pressure has
prompted some drugmakers to voluntarily notify the FDA of impending
[[Page S3390]]
shortages. But Congress must step in to improve communication among
drugmakers, the FDA, and doctors--doctors who have to break the
terrible news that lifesaving medicines are not available.
Voluntary cooperation between the drugmakers and the FDA prevented
almost 200 drug shortages last year, but establishing effective lines
of communication could further reduce the number of shortages and save
patients' lives.
I am pleased that the spirit of bipartisanship begun by my colleagues
Senator Harkin and Senator Enzi continued yesterday. I look forward to
an orderly amendment process and I am optimistic the Senate will move
this legislation without unnecessary delays. I hope I am not
disappointed.
Each year more than 1.5 million Americans are diagnosed with some
form of cancer. It is up to us to ensure that not one of them waits or
wonders if the medicine he or she needs to stay alive will be there
when the need arises.
Recognition of the Minority Leader
The ACTING PRESIDENT pro tempore. The Republican leader is
recognized.
Economic Challenges
Mr. McCONNELL. Madam President, I want to call attention to a couple
of stories from the last 2 days. I think they say a lot about the
difficulties of addressing the economic challenges we face.
The first is a story from Politico. It says the Budget Committee
chairman can't remember the last time he talked to the President. The
Budget Committee chairman can't remember the last time he talked to the
President. Another chairman, dealing with student loans, says he has
not talked to the President in months--in months. The Democratic point
man on energy doesn't seem to talk to the President much at all.
If you want to know why we can't solve these economic problems, this
is it. We have a President who is more interested in running around to
college campuses, spreading some poll-tested message, than he is in
actually accomplishing anything. That is the problem.
The second story, also interesting, is about HHS signing a $20
million contract to promote ObamaCare; $20 million of taxpayer money to
promote a bill most Americans want to see repealed. That is $20 million
of our tax money spent on commercials to promote ObamaCare. Let me
suggest the President spend a little more time trying to do something
about spending, debt, and gas prices, and a little less time trying to
spin the unpopular things he has already done. It might require a
little more work but it is what we need. It is time to lead.
I ask unanimous consent those two articles to which I referred be
printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
[From Politico, May 22, 2012]
Dems Wait by Phone for Obama
(By Manu Raju)
He doesn't call. He doesn't write. He doesn't drop by for a
visit.
That's what some of the most senior Democrats in Congress
are experiencing from President Barack Obama these days.
Senate Budget Committee Chairman Kent Conrad (D N.D.) is
trying to cut a deal on the nation's fiscal crisis, but he
can't recall the last time he talked to the president. Sen.
Tom Harkin (D Iowa) is in charge of one of Obama's top
priorities--preventing a rate increase on student loans--but
he hasn't talked to the president in months. And Sen. Jeff
Bingaman (D N.M.) is the go-to guy on high gas prices, but
the chairman of the Energy and Natural Resources Committee
hasn't spoken to the president much since the previous
Congress.
``I think the reality is the current Congress is not
constituted in a way that makes it likely that we can do very
much,'' Bingaman said, ``and that's reflected in what we wind
up doing on the floor and understandably the president is not
as engaged--at least with me.''
Obama is certainly in regular touch with the top Democratic
leaders on the Hill--Nancy Pelosi and Harry Reid--but when it
comes to some key policymakers and chairmen in Democratic
congressional politics, he's far less engaged than earlier in
his presidency. The lack of communication not only reflects a
gridlocked Congress in an election year, but it speaks to the
president's personal style--he's never been much of a
schmoozing, back-slapping type in the spirit of Bill Clinton
or Lyndon B. Johnson. And even though he came from the
Senate, Obama wasn't there long enough to develop deep,
bonding friendships with some of the old bulls in Congress.
Obama's disengagement is also a sharp reflection of
political reality: Congress is punting on virtually every
major issue until after the election. So even some of those
GOP deal makers whom Obama may need to court--whether that's
Sens. Olympia Snowe of Maine or Lindsey Graham of South
Carolina--aren't getting as much presidential attention as
they have in the past.
``I don't think governing is a high priority right now,''
said Graham, who said he hasn't spoken to the president ``in
forever'' after speaking with him frequently in the first
couple years of his administration on issues like immigration
and energy policy.
White House officials scoff at those criticisms, saying
they work ``tirelessly'' on the economy.
Jamie Smith, a White House spokeswoman, said the president
and his administration ``have regular and repeated
interactions with members of Congress from both parties in
the House and Senate, and we welcome Republican willingness
to pass the congressional `to-do' list,'' referring to the
president's economic agenda.
But both policy meetings and social gatherings with
committee chairmen, ranking members, back bench freshmen and
GOP swing voters--all hallmarks of the early part of Obama's
term--have been few and far between with the president these
days, lawmakers say.
``There was a while for various reasons where groups of us
were coming to the White House for meetings for one kind or
another, but . . . he's busy,'' said Sen. Joe Lieberman (I
Conn.), chairman of the Homeland Security and Governmental
Affairs Committee, saying the two last spoke in February when
the president offered support for his cybersecurity bill.
``I'm afraid that may be related to the feeling that not
much is actually going to get done here.''
Cutting out committee chairmen is also another sign of the
ongoing decline in influence of the gavel-holders on Capitol
Hill, who in a previous era ran their panels like fiefdoms,
but now have taken a back seat to congressional leaders who
spearhead the legislative deal making. And it's also sign of
the non-stop campaign that dominates politics and has made it
harder to legislate.
Obama has often been criticized for being aloof from
Capitol Hill, but White House officials argue that there's
been regular outreach to lawmakers throughout his entire
term, including by senior aides, legislative liaisons,
Cabinet secretaries and Vice President Joe Biden. Just last
week, congressional leaders from both parties met with Obama,
the first such meeting in months, and there's been an uptick
in coordination between the White House and Senate Democratic
leaders over legislative strategy and political messaging.
Moreover, Democrats argue that when Obama has taken a more
hands-on role in the legislative process, Republicans have
been quick to criticize his involvement and less willing to
embrace his ideas. In this Congress, Obama inserted himself
in the messy deals to avert a government shutdown last spring
and a debt default last summer. But those were reached
between a handful of leaders and the president--meaning most
lawmakers have been cut out of the process.
When Obama has gotten involved at times this year, he's
done so quietly. He made a series of calls to Democratic
senators in March to kill a measure calling for the
construction of the controversial Keystone XL oil pipeline.
And when Harkin threatened in February to filibuster an
extension of the Social Security payroll tax break, the
president made assurances to the Iowa Democrat that persuaded
him to back down, Harkin told Politico.
``If you put two and two together, you can see what
happened,'' Harkin said last week. ``As you know, we're not
taking any money out of the [health care] prevention fund.''
With Congress's approval ratings at all-time lows, there's
far more incentive for the president to divorce himself from
the sausage-making on Capitol Hill--particularly with little
chance of replicating the legislative successes from his
first two years, like on health care and financial services,
which came at a heavy political price.
Rep. Barney Frank (D Mass.), whose name is affixed to the
Dodd-Frank financial services law, spoke with Obama at least
twice a month when negotiations over that bill were taking
shape in 2010.
``The last time I talked to him was a couple months ago,''
he says of his interactions with the president now.
It's not as though Congress doesn't have major issues to
resolve. Unless Congress acts, come Jan. 1, $1.2 trillion in
automatic spending cuts will take effect, with half coming
from defense and national security programs; the Bush-era tax
rates for all income groups will expire; and the payroll tax
break affecting 160 million Americans will end. And it's only
a matter of time before Congress has to deal with a host of
expired business tax breaks, as well as whether to renew
jobless benefits and how to craft a budget deal to again
raise the national debt ceiling.
Some say the president--along with congressional leaders--
needs to begin laying the groundwork now to avoid a
catastrophic logjam that could ensue after the November
elections.
``We could get some more done if he was meeting with a
broad group of people to address key issues certainly,
including the leadership, on a continuous basis,'' said
Snowe, who was a periodic Oval Office guest in the first
year-and-a-half of the administration but said she hasn't met
with the
[[Page S3391]]
president since spring 2010 over energy policy.
Arizona Sen. John McCain, Obama's old rival, said he was
last in for a White House visit soon after the January 2011
Tucson shootings, at which the two discussed acting on
immigration reform and the line-item veto.
``He said they'd be getting back to me very shortly, and I
haven't heard from him since,'' McCain said last week.
But Democrats are quick to argue that Republicans--
particularly in the House--have shown little willingness to
work with the president. And several senior Democrats who
haven't spoken with Obama in a while don't hold it against
him, with the president facing a full slate of competing
interests and a challenging reelection.
Conrad said he still speaks with Biden, senior White House
budget officials and chief of staff Jack Lew.
``We can communicate without the two of us speaking
directly,'' Conrad said of the president.
____
[From The Hill, May 21, 2012]
HHS Signs $20M PR Contract To Promote Healthcare Law
(By Sam Baker)
The Health and Human Services Department has signed a $20
million contract with a public-relations firm to highlight
part of the Affordable Care Act.
The new, multimedia ad campaign is designed to educate the
public about how to stay healthy and prevent illnesses, an
HHS official said.
The campaign was mandated by the Affordable Care Act and
must describe the importance of prevention while also
explaining preventive benefits provided by the healthcare
law. The law makes many preventive services available without
a co-pay or deductible, and provides new preventive benefits
to Medicare patients.
The PR firm Porter Novelli won the contract after a
competitive bidding process. The $20 million contract was
first reported by PR Week. Porter Novelli did not immediately
respond to a request for comment.
Jaczko Resignation
Mr. McCONNELL. Madam President, yesterday, we learned about the
resignation of the chairman of the Nuclear Regulatory Commission, Dr.
Gregory Jaczko. As I said yesterday, I am not surprised by Jaczko's
resignation. Even Democrats on the Commission testified before Congress
that his inappropriate conduct as chairman resulted in a hostile work
environment for women and threatened to undermine the mission of the
NRC itself. But what should surprise us all, is how this administration
could remain silent for more than a year after the allegations of
Jaczko's offensive behavior first surfaced.
Jaczko's alleged behavior is unacceptable in any workplace. The fact
that it was allowed to persist at a critical agency that oversees the
safety of our Nation's nuclear power plants is astonishing. The White
House must now move swiftly with a replacement for Jaczko and I urge
the Senate to move quickly to reconfirm the nomination of Kristine
Svinicki as NRC commissioner before her term expires on June 30th. The
only reason her nomination was held up by the White House and the
Democrat-led Senate in the first place was because she had the courage
to stand up to a hostile work environment, and to the bully who was
responsible for it. Now that Jaczko has submitted his resignation, it's
time for the Senate to move forward on Kristine Svinicki.
Commissioner Svinicki's credentials are unmatched. She is one of the
world's leading experts on nuclear safety. She was confirmed by the
Senate to her current term without a single dissenting vote.
It's time we act. Svinicki has served as commissioner with
distinction, is enormously qualified, has bipartisan support and
deserves a speedy reconfirmation. The American people are best-served
by a commission that is fully functional.
I yield the floor.
Reservation of Leader Time
The ACTING PRESIDENT pro tempore. Under the previous order, the
leadership time is reserved.
The ACTING PRESIDENT pro tempore. Under the previous order, the
following hour will be equally divided and controlled between the two
leaders or their designees, with the majority controlling the first
half and Republicans controlling the final half.
Mr. McCONNELL. Madam President, I suggest the absence of a quorum.
The ACTING PRESIDENT pro tempore. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
The ACTING PRESIDENT pro tempore. The Senator from Maryland.
Mr. CARDIN. Madam President, I ask unanimous consent that the order
for the quorum call be rescinded.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
Mr. CARDIN. Madam President, I ask unanimous consent to speak as in
morning business.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
National Small Business Week
Mr. CARDIN. Madam President, I take this time to bring to the
attention of my colleagues that we are celebrating National Small
Business Week, which is a very important occasion because, as the
Senator from New Hampshire understands, the growth engine for America
is our small businesses. When we are looking at job growth, which we
all know we need in order to get our economy moving again, we know
there will be more jobs created from small companies than from large
companies. About two out of every three jobs created in America will
come from small companies.
We also know when we are looking at innovation, it is the small
businesses that file the patents and come up with the creative new
ideas for America to become as competitive as we need to be. There are
an incredibly larger number of patents per employee from small
companies than from large companies. So the growth engine for America's
economy rests with our small businesses.
I am proud to serve on the Small Business Committee under the
leadership of Chairman Landrieu. We have brought forward many
initiatives that help small businesses, and I think it has made a huge
difference as our economy is starting to recover. We are now looking at
25 consecutive months of continuous private sector job growth where we
have turned around the economy and we are now growing. In large measure
I think it is because of the attention we have paid to the small
business community. We are proud of what it has meant for our entire
country.
Let me speak a little bit about my State of Maryland. We have over
500,000 small businesses in Maryland that employ over 1 million people.
So it is by far a huge part of the Maryland economy. Our strategy over
the last several years during the Obama administration has been to
concentrate on small businesses and, in particular, to help them
recover from this economic recession.
The first effort was to increase the capacity of the Small Business
Administration. I was proud of the Obama budget that put more money
back into the Small Business Administration. I was proud of the
initiative we had in the Senate to add funds to the Small Business
Administration so that the SBA could indeed be the advocate for the
small business community; so that small businesses have an agency in
the government that is fighting for their issues. It has made a huge
difference. When I speak with the small businesses in Maryland, they
tell me they now have a much greater capacity for help through
counselors and advocates at the Small Business Administration.
We then dealt with the No. 1 issue that was brought to our
attention--and I am sure the Presiding Officer has heard the same
stories in New Hampshire I have heard in Maryland--that small
businesses have had a hard time getting access to capital; that we need
to do a better job of providing capital, particularly during a tough
economic period where small businesses don't have the same deep pockets
as the larger companies.
So we increased the SBA loan limits, increased the amount of the
Federal loan guarantee in order to make it more attractive for banks to
lend money to small businesses, knowing full well the government was
standing behind those loans. That made some monies available. We looked
for creative new programs to help our small businesses, including one
in the Treasury Department. We also looked at helping our States by
initiating partnerships with our States.
The additional funds we made available in Washington to help build
the State programs has made many more loans available to small
companies in Maryland. All of that has helped in providing
opportunities for our small businesses.
The reauthorization of the SBIR Program and the STTR Program has made
[[Page S3392]]
a huge difference. Since 1983, in my State of Maryland, $1.5 billion of
funding has come from the SBIR Program. For those who are listening who
may not know what this program is about, it is about innovation. It is
small companies that are involved in biotech and cybertech areas where
they use innovation to create jobs. In my State and in the Presiding
Officer's State, they are using these funds to create opportunities for
America to be competitive internationally.
We can state chapter and verse for our national defense research or
for clean energy technology where small businesses are taking advantage
of these innovative research grants and have been able to build jobs in
our communities and make America more competitive for the future. The
reauthorization and thus predictability of funding under the SBIR
Program and the increased amounts that are available will create, and
has already created, more job opportunities. We got that done, and that
was certainly a major step forward.
We passed bills providing tax breaks to small businesses, including
the expensing of their equipment, so they can go out and buy equipment
and keep things moving.
The ACTING PRESIDENT pro tempore. The Senator's time has expired.
Mr. CARDIN. I ask unanimous consent for an additional 5 minutes.
The ACTING PRESIDENT pro tempore. Is there objection?
Without objection, it is so ordered.
Mr. CARDIN. Madam President, I thank my friend from Arizona for his
courtesy. I will try not to use the entire 5 minutes.
There are other areas where we have also moved forward to help our
small businesses, including credits for their health insurance so they
can cover their employees. In my own State of Maryland, we have set up
an African Trade Office which has provided opportunities in
international trade--an area where we think we can still make progress.
I could talk about many of the success stories of Maryland small
businesses that have used the SBIR Program, including one to develop
new treatment for smallpox vaccines to make them more efficient. We
have had examples of where we are now developing a vaccine to deal with
the common cold.
I was at an SBA event where we honored the leading entrepreneurs in
our State, and I can cite an example of a small businessperson, Janet
Amirault, who was the small businessperson of the year--the CEO of a
software development company. She has had some personal issues with her
health, but despite that, for the last 3 years she has had 90 percent
growth in her revenues. This is the innovation we have in Maryland that
comes out of the small business community.
Taylor Made Transportation Services, which first qualified under the
8(a) program, has now graduated from that. They started with a small
transportation company that provided transportation for people with
special needs and is now providing for diverse transportation needs in
our communities. All of that has developed through small business
programs that we helped develop.
So I come to the floor today to announce a new initiative that I will
be filing today, the Small Business Goaling Act, to deal with another
problem we have with small businesses that I hope we will be able to
take up on the floor of the Senate in the very near future. It would
increase the prime goals for small businesses in government procurement
from 23 percent to 25 percent and increase the subcontracting goals to
40 percent, adding transparency to how government provides procurement
opportunities for government contracts to small businesses.
We have also taken some action in dealing with bundling and trying to
prevent the bundling of small contracts into large contracts that makes
it more difficult for small businesses to get prime contracts. I
believe this legislation will improve transparency and visibility so we
can, in fact, provide more opportunities; so the government leads by
example, by using small companies more to help them grow. It will help
a variety of small businesses, including disabled veteran companies,
women-owned companies, and minority-owned companies so that all will
benefit from these opportunities.
I wish to thank the chairperson of the Small Business Committee,
Senator Landrieu, for her extraordinary help in getting this bill
together. It will help small businesses by allowing them to grow and
create jobs, thereby helping our country in recovery.
Once again, I thank my friend from Arizona for giving me these extra
few minutes. The best way to help celebrate National Small Business
Week is for us to pay more attention to helping small businesses grow.
With that, I yield the floor.
The ACTING PRESIDENT pro tempore. The Senator from Arizona.
The Economy
Mr. KYL. Madam President, today I would like to add a little context
to the discussion of the fiscal cliff our Nation approaches, a
reference to the combination of the largest tax increase in history,
new taxes under ObamaCare, sequestration, and the expiration of the
payroll tax holiday, all of which take effect in January of 2013 unless
the President and the Congress act.
This is a key discussion to have because how we view this so-called
fiscal cliff defines our perspective on how an economy grows and
prospers. Edward Lazear, who is a former Chairman of the President's
Council of Economic Advisers, recently wrote an op-ep that outlines the
various perspectives. I will focus on the two most prominent: the
Keynesian view and the view of supply-side economics.
The Keynesian theory holds that spending is the key to growth--
government spending. Keynesians believe that in recessionary times,
increased government spending can take the place of private sector
activity. That is why they present a false choice between government
spending cuts--in other words, austerity--and growth. Their perspective
holds that growth is contingent on government spending.
This was the thinking behind the President's 2009 stimulus spending
package, the so-called Cash for Clunkers, and a litany of other recent
government spending programs, transfer payments, and temporary tax
credits. I believe the administration's insistence on enacting these
temporary Keynesian spending policies to stimulate consumption is
misguided and the evidence reveals has failed. Remember, the stimulus
was sold as a measure to keep unemployment from topping 8 percent. But,
in fact, unemployment has not dipped below 8 percent for 39 months, and
growth is very anemic. We are experiencing a recovery in name only. So
there is not much evidence that spending can revitalize a sagging
economy; that is to say, government spending, and even if government
spending could be a boost, as Lazear points out, the costs would be
massive. Here is what he writes:
Even if a fiscal stimulus has some benefit, the cost of
fiscal policy is likely to be very large. In order to
stimulate the economy, growth in--not high levels of--
government spending is required. To provide a stimulus
comparable to the 2009 legislation, we would need to increase
government spending by $250 billion.
He goes on:
The Keynesian view implies that keeping spending constant
at the higher level in 2014 would generate no simulative
growth for 2014 . . . because there is no increase in
spending over the 2013 level. . . . If we want to delay our
day of reckoning, we must keep spending at a higher level for
each year that we want to postpone the negative consequences
for growth.
Supply-side economics, on the other hand, holds a different
perspective on growth: that government spending does not increase
prosperity, that tax hikes hurt the economy and stifle growth.
We believe that economic growth stems from combining three inputs:
labor, capital, and technology. These three factors of production
result in output that we can then consume. Without labor, capital, and
technology, there can be no consumption. Focusing on policies that
stimulate consumption targets the wrong side of the equation. In order
to get the economy going, we need to focus on the inputs--labor,
capital, and technology. We also believe government spending cuts are
beneficial because they free up private capital and help align revenues
with government spending.
Lazear argues that supply-siders stand on the firmest ground when it
comes to fiscal policy's effect on economic growth. Here is what he
writes:
On the tax side, there is strong evidence that supports the
supply-siders.
[[Page S3393]]
And he cites, for example, research from Christina Romer. By the way,
Christina Romer was President Obama's first Chair of his Council of
Economic Advisers. Her research shows that raising taxes by 1 percent
of GDP--raising taxes, which is what the administration proposes--
lowers our gross domestic product by nearly 3 percent. So increase
taxes by 1 percent, you lose 3 percent of gross domestic product.
I recently joined 40 of my Republican colleagues in sending a letter
to Leader Reid to make this point, that tax increases will have a
deleterious effect on economic growth. The letter asks that he join us
in working to take the tax threat off the table before the election in
order to create more economic certainty. We know that so-called
``taxmageddon'' is coming. There is no good reason not to act. The
election is not an acceptable excuse. In fact, I would posit that
politicians could be rewarded for acting to avert the catastrophic
effect of this huge tax increase.
In addition to acting to prevent tax hikes, Congress should also
pursue spending cuts to help unleash private capital, boost growth, and
reduce our nearly $16 trillion national debt in the process. To be
clear, cutting government spending does not mean the government should
take a sledge hammer approach and cut indiscriminately. We should be
careful where we cut. We should prioritize. For example, I oppose the
defense cuts on national security grounds, not Keynesian grounds. In
other words, while it is true that cuts in defense spending will result
in job losses, big job losses under sequestration, our national
security is even more important. The automatic spending cuts under
sequestration mean that across-the-board spending to the Department of
Defense will, in the words of the Secretary of Defense, devastate our
national security.
Allowing the sequester to begin as planned would cut 10 percent from
defense in fiscal year 2013 alone and dramatically shrink the size and
capabilities of our military. To avoid this, the Senate should follow
the lead of the House of Representatives, which recently passed
legislation to replace the sequester with other spending reductions.
The legislation will cut $315 billion in spending and will reduce the
deficit by over $242 billion. It is not a perfect bill, but I do
believe it is a good place to start.
My overarching point is this: We should not shy away from prudent
spending cuts for fear that they will hurt growth. It should not be
difficult to find cuts in our $3.7 trillion budget. These cuts
certainly will not derail economic growth if they are done the right
way.
The choice, in other words, between spending cuts and growth is a
false choice. If the President is not truly concerned about boosting
growth and reversing the trends of the last 3\1/2\ years, he should
stop presenting this false choice, as he did, for example, at the G8
summit last weekend, where he actually encouraged German Chancellor
Angela Merkel and other leaders to embrace what he called a ``growth
package'' modeled in part after his own budget-busting stimulus
spending. I hope Chancellor Merkel and other leaders around the world
take a very close look at whether the Obama growth package is something
they wish to bring home after observing the American economy for the
last 4 years.
Preventing tax increases and reducing out-of-control spending is a
better approach to long-term prosperity.
I ask unanimous consent that at the conclusion of my remarks, the op-
ed I referred to by Edward Lazear in the Wall Street Journal of May 21
be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
[From the Wall Street Journal, May 21, 2012]
Three Views of the `Fiscal Cliff'
(By Edward P. Lazear)
Discussion of the so-called fiscal cliff--the combination
of tax increases and spending cuts that will come in 2013 if
Congress and the president don't act--confuses a number of
different issues. The evidence suggests that we should fear
the tax hikes, but not necessarily the spending cuts.
Anyone who uses the term ``fiscal cliff'' accepts a
Keynesian view of the economy, knowingly or not. Both tax
increases and constrained spending are assumed to be bad for
the economy.
But there are two other views: that of the budget balancer
and that of the supply-sider. Rather than term the impending
changes that will occur in 2013 a ``fiscal cliff,'' the
budget balancer thinks of this as ``fiscal consolidation.''
Tax increases reduce the deficit, as do cuts in government
spending. Both are austerity measures that make the
government more responsible and, therefore, both are
conducive to long-run economic growth.
Those who support the Simpson-Bowles plan subscribe, at
least in part, to this view. Various proponents of the plan
may place different weights on the tax-increase side or the
spending-decrease side because they believe the economic
consequence of one or the other is more adverse. But
fundamentally, the target is to decrease the deficit. The
budget balancer regards both tax increases and spending cuts
as moves in the right direction.
The supply-sider has a different view from both the
Keynesian and the budget balancer. Fundamentally, supply-side
advocates focus on the harmful effects of tax increases.
Raising tax rates hurts the economy directly because tax
hikes reduce incentives to invest and because they punish
hard work. As such, tax increases slow growth. But budget
cuts work in the right direction by making lower tax revenues
sustainable. If spending exceeds revenues, then the
government must borrow and this commits future governments to
raising taxes in order to service the debt.
Consequently, the supply-sider thinks of 2013 primarily as
a tax increase and fears what that will do to the economy.
The spending cuts are a positive. Unlike the Keynesians who
view the fiscal cliff as being bad on two counts, or the
budget balancer who views it as being good on two counts, the
supply-sider scores it one-and-one. The tax increases have
negative effects on the economy; the controls on spending are
a positive side effect of the 2013 sunsets.
Which of the three views is correct? Until recently, most
economists believed that fiscal policy was inappropriate for
business-cycle management, and that if stimulus was needed at
all, monetary policy was the best way. Spending ``stimulus''
does not have a strong track record in recent decades. There
is more ambiguity now about the choice between monetary and
fiscal policy, in large part because with interest rates near
zero, the effectiveness of monetary policy is thought to be
more limited.
But even if a fiscal stimulus has some benefit, the cost of
fiscal policy is likely to be very large. In order to
stimulate the economy, growth in--not high levels of--
government spending is required. To provide a stimulus in
2013 comparable to the 2009 legislated stimulus, we would
need to increase government spending by about $250 billion.
But the Keynesian view implies that keeping spending
constant at the higher level in 2014 would generate no
stimulative growth effect for 2014. Despite the higher level
of spending in 2014, we would get no additional growth
because there is no increase in spending over the 2013 level.
Were we to retreat to current levels of spending, there would
be a contractionary effect on the economy as government
spending decreases. If we want to delay our day of reckoning,
we must keep spending at a higher level for each year that we
want to postpone the negative consequences for growth. Given
the state of the labor market, this could mean a few years.
If we waited four years, we would spend $1 trillion to get
$250 billion in stimulus.
On the tax side, there is strong evidence that supports the
supply-siders. Christina Romer, President Obama's first
chairwoman of the President's Council of Economic Advisers,
and David Romer document the strong unfavorable effect of
increasing tax rates on economic growth (American Economic
Review, 2010). They report that an increase in taxes of 1% of
gross domestic product lowers GDP by almost 3%. The evidence
on government spending also suggests that high spending means
lower growth.
For example, Swedish economists Andreas Bergh and Magnus
Henrekson (Journal of Economic Surveys 2011) survey a large
literature and conclude that an increase in government size
by 10 percentage points of GDP is associated with a half to
one percentage point lower annual growth rate.
The evidence suggests that we should move away from worry
over the impending ``fiscal cliff'' and focus more heavily on
concern about raising taxes. And although some Keynesians may
view this as not the best time to control spending growth,
promising to change our ways in the future is as credible as
Wimpy's promise to pay on Tuesday for the hamburger that he
eats today.
The ACTING PRESIDENT pro tempore. The Senator from Iowa.
LightSquared Danger
Mr. GRASSLEY. Madam President, I am pleased to see that Jessica
Rosenworcel and Ajit Pai have been confirmed to the Federal
Communications Commission. They are both highly qualified, and it is
unfortunate that the FCC's stubborn refusal to respond to my very
simple request for information forced me to place a hold on their
nominations for the past 4 months in order to get the FCC to move on
giving me the information to which any Member of Congress ought to be
entitled.
The FCC needs to learn a simple lesson from this episode: The
public's business ought to be public, and transparency brings
accountability. Eventually, the truth will be known, so you
[[Page S3394]]
might as well get it out there when the questions first come up.
I initially placed my hold on the FCC Commissioner nominees because
the FCC had stonewalled a document request that I submitted on April 27
last year regarding their actions related to a company called
LightSquared and the hedge fund, Harbinger Capital, that owns
LightSquared.
Before I wrote my letter on LightSquared, many concerns had already
been raised regarding the company's plans for a terrestrial network and
its potential to interfere with the global positioning system, or
sometimes that is referred to as GPS. In my first letter, I raised
those concerns as well. Unfortunately, the FCC does not appear to have
taken those concerns seriously, but months later, independent testing
verified the danger LightSquared posed to industries, from commercial
aviation to even our own Armed Forces.
It seems strange that a project that was so obviously flawed was
allowed to go so far. But LightSquared had help. In total, LightSquared
has paid 53 different lobbyists, some registered, some unregistered.
They paid one former Governor, three former Senators, nine former
Members of Congress, including a former Speaker and former minority
leader, and a former White House Counsel to advocate for them. These
lobbyists provided entry into the FCC and the White House. But they
could not change the fact that LightSquared's network simply could not
coexist with GPS.
LightSquared has now declared bankruptcy, and it appears its plan to
build a terrestrial network is over, but many questions still remain.
Some of those questions: Why did the FCC give LightSquared this unusual
waiver in the first place? Why did LightSquared's lawyers mention
campaign contributions when they sought meetings at the White House?
Why did a four-star general claim he had been pressured by the Obama
administration not to criticize LightSquared?
When I first asked the FCC for documents, I was told they would take
about 2 years to respond to my request through the Freedom of
Information Act. Then they told me they do not voluntarily turn over
documents to the 99.6 percent of the Members of Congress who do not
chair a committee with direct jurisdiction over FCC. After a lot of
back and forth with the FCC, they told me the reason they do not
respond to 99.6 percent of Congress is because of just a one-line
statement in the Congressional Research Service report. The line reads,
``Oversight is most effective if it is conducted by Congressional
committees of jurisdiction.'' Now, the FCC somehow took this quote and
conveniently came up with the idea that they do not have to give this
Senator any documents. Of course, to anybody in the Congress, this
makes no sense whatsoever, but that is what the FCC hid behind. And, of
course--you know me--I did not give up. The FCC's response to me is
just another variation on what the Justice Department told me when I
started asking questions about Operation Fast and Furious.
Fortunately, we have Members of the House of Representatives who are
not afraid to ask this administration some tough questions. In Fast and
Furious, it was Chairman Issa who held the Justice Department's feet to
the fire to make sure they responded fully and responded completely.
With LightSquared, it was another committee in the House of
Representatives, the House Energy and Commerce Committee. Chairmen
Walden, Upton, and Stearns and their staff have done an excellent job
in making sure the FCC is open, transparent, and provides documents to
Congress, even when they do not want to give those documents to a
Senator who asked for them, meaning this Senator.
I would also like to thank Commerce Committee Chairman Rockefeller
here in the Senate for pressing the FCC personally to release
documents. With all of this help, we are making sure the FCC is open
with the American people about the way they operate because
transparency brings accountability.
In over 30 years of conducting oversight, I can say that when it
comes to providing documents to the Congress, the FCC is one of the
worst Federal agencies I have ever had to deal with. Even after
receiving a document request from the Energy and Commerce Committee in
the House of Representatives, the FCC still tried to play the tired old
games agencies play when they are not acting in good faith.
When they finally turned over their first batch of documents--would
you believe it?--those documents were already publicly available on the
Internet through the Freedom of Information Act. So they weren't giving
us anything we didn't already have access to.
When they didn't convince us they were acting in good faith--because,
quite frankly, they weren't--they gave us a second production. But in
that production, of the first 1,968 pages they produced, all but 3--in
other words, 1,965 pages--were newspaper clippings. Again, the FCC was
playing games. And, of course, that is not acceptable.
Fortunately, we have continued to press the FCC, and we now, with the
help of the House of Representatives, have approximately 8,000
nonpublic internal documents. Still, we have not received all
responsive documents from the FCC yet. We just received another 4,000
pages of documents, and I have been told that approximately 7,000 more
documents are on their way to Congress. We now at least have a path
forward. That is why I lifted my holds a couple weeks ago, so these
nominations could move forward.
I trust the House committee will ensure that the FCC provides those
7,000 or so additional documents. I have always said if you are hiding
something, it is best to get it out in the open, because the longer you
stonewall--in this case the FCC--the worse you are going to look when
those facts finally come out.
The FCC has attempted to stonewall my request for documents for
almost a year, and they have failed. But they failed only thanks to the
help provided by the House Energy and Commerce Committee, and because
of that help we are finally able to review internal documents from the
FCC--the very same documents we should have gotten when we first asked
in our request on April 27 of last year.
As I said when I initially filed my intent to object, I strongly
believe it is critical for Congress to have access to documents in
order to conduct vigorous and independent oversight. Whether it takes 1
day, 1 week, 1 month, or even 1 year--as it did in this case--I will
continue to pursue transparency across the Federal Government because
transparency brings accountability. That is essential so that Congress
can practice its constitutional role of oversight over the Federal
Government.
The role of oversight is this simple: Congress passes laws and
appropriates money. That is not the end of it. Our government is a
government of checks and balances. We have a responsibility, after
passing laws and appropriating money, to make sure the laws are
faithfully executed and the money spent according to the intent of
Congress. That is oversight.
Even now as we review these documents we have already gotten and
begin conducting interviews with key FCC staff, the investigation,
obviously, continues. Step one was getting access to the FCC e-mails.
We took this step so we could make sure we had the facts before we
jumped to conclusions.
Now it is time for step two--asking hard questions of the key FCC
personnel who approved the LightSquared waiver. This process may
continue to take more time, but however long the process takes, I will
continue to press for transparency at the FCC because, again, with
transparency comes accountability.
This agency must operate in an open and transparent manner, and we
must have answers regarding the LightSquared waiver. The people at the
FCC work for the American people, they don't work for themselves.
I yield the floor and suggest the absence of a quorum.
The PRESIDING OFFICER (Mr. Manchin). The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. HARKIN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. HARKIN. Mr. President, we are now on the motion to proceed, as
you know, to the Food and Drug Administration Safety and Innovation Act
of
[[Page S3395]]
2012, which is basically the reauthorization of FDA for the
prescription drug user fees and the medical device user fees. There are
a couple of new provisions in this bill dealing with the generic drug
user fees and the biosimilar drug user fees as well. So this bill is
extremely important.
We have been working in our committee for over a year on it, working
with colleagues on both sides of the aisle. As both Senator Enzi, my
ranking member, and I pointed out yesterday, this has been a true
bipartisan effort. We did not divide up in terms of party--Democrat or
Republican--we divided up in terms of interest areas, and we had
working groups within our committee so that Senators who had a
particular interest in one area or another were on that working group.
We also had Senators who were not on the committee but who had interest
areas in it involved in our working groups. So they and their staffs
had full working knowledge of what was going on all the time and it was
a true collegial effort. Those working groups completed their work
earlier this year.
We also called in all the stakeholders--the prescription drug
manufacturers, the pharmacists, the drugstores, consumer groups, and
practitioners. So we had all the stakeholders involved in this too. And
now we have come up with a bill that has very broad support. I put in
the Record yesterday a list of over 100 different organizations,
everything from the drug manufacturers to consumer protection groups
and consumer groups that are supporting this bill. It has very broad-
based support. And, again, I believe that is due to the fact we
proceeded on the reauthorization of this bill in the time-honored
tradition of the Senate, which is for the committee to take the
reauthorization prospect, to do its due diligence--and we did that for
over a year, as I mentioned--and to make sure people were involved at
every step of the process on both sides of the aisle. We brought in the
stakeholders and continued this effort, as I said, for over a year to
the point where we now have a bill that is broadly supported.
As I said, everyone has a common interest in ensuring our products
don't hurt patients. I have said in our hearings, and I continue to
believe, safety is the paramount consideration. We cannot sacrifice
patient safety on the altar of other considerations. Patient safety is
still the highest standard, the highest mark at which we aim our
sights. But getting the products to patients quickly is also important.
I have heard heartwrenching stories of patients desperately waiting
for treatments, and of inspiring accounts of small startup companies
seeking to fill the needs of these patients with innovative medical
products. Patient groups and industry alike have stressed the need for
efficient FDA processes to get products to patients quickly.
Again--and I will be pointing out later also--FDA does a very good
job of getting products, both drugs and devices, to market quickly. In
fact, of the 154 drugs approved in both the United States and Canada,
in a study done by the New England Journal of Medicine, 132 were
approved here first. So we have not been dragging our heels and FDA
hasn't been dragging its heels in terms of getting the job done.
Some say, well, sometimes products get approved more rapidly in
Europe than they do here. That is true, but it is important to note
that foreign approval standards are different. So it is kind of an
apples-and-oranges kind of comparison. The FDA here approves drugs and
devices based on their safety and effectiveness--safety and
effectiveness. Are they safe and do they actually do what they say they
are supposed to do?
Other countries--basically in Europe--only consider safety and not
whether the device is effective. So as long as it is safe, they approve
it. So, yes, they have a shorter approval time, but they don't take
into consideration effectiveness.
I strongly believe the United States should keep this high standard
of both safety and effectiveness. It is important to know if a device
is effective because that affects a patient's decision whether to
accept the device's risks and whether to forego maybe alternative
treatments.
FDA officials testified before our committee this year. They
submitted documentation showing that 95 percent of medical device
applications were reviewed within the deadlines set in the past user
fee agreement. Now, despite all this good work FDA is doing, patients
were sick or dying. Promising therapies can't be approved quickly
enough. So the bill we have before us will continue to support the
agency and its good work, but it will allow for some very big
improvements.
The medical device industry has agreed to double its user fees, to
pay twice as much, and in return the FDA has agreed to speed review
times, increase transparency, enhance communications--all of which will
get devices to patients more quickly but still keep safety in mind. So
anything we can do to both streamline the process, get drugs and
devices to patients sooner, and make sure we keep our high standard of
safety and effectiveness is not only good for business but critical for
the patients who need them.
I expect the FDA Safety and Innovation Act will have significant
impact on FDA's ability to approve medical products in an efficient and
transparent way. As I said, that benefits everyone. Investors will feel
better about putting their money into medical technologies, companies
will translate their research and development work into sales more
quickly, support for innovation will allow the United States to
maintain its leadership position in the biotech industry, and this will
preserve and create jobs all over America.
In this sector, as long as we preserve safety standards--which is,
what is good for business is good for patients--then, again, if
companies and their investors believe the climate is right to commit
resources to new medical therapies, this means patients who did not
previously have options will have treatments to turn to. So I say this
bill is a win-win for everyone.
Inspiring innovation and improving patient access to medical
therapies are two of the many ways this bill modernizes our regulatory
and oversight system to benefit both patients and the biomedical
industry. The FDA Safety and Innovation Act is a truly bipartisan
consensus bill that reflects the input and shared goals of a wide range
of stakeholders. I hope we will be on the bill shortly after our noon
caucuses and conferences for the two parties this afternoon. I trust
that we will have only relevant amendments to the bill. I hope that has
been accepted on both sides, and that we can discuss the bill and have
the relevant amendments and have them disposed of sometime this week.
So I am hopeful we can get this bill done before we go home for the
Memorial Day recess. But we will be back on the bill this afternoon. I
urge all my colleagues to give this bill their support. We will have
some amendments, I am sure, that will be relevant to the bill. They
will be debated and voted upon. But, nonetheless, I hope we can
expeditiously move this bill and get it done.
The clock is ticking. The FDA authorization runs out at the end of
this summer. You might say, well, we have until then to get it done. We
are out of here the month of August. We are out of here for the Fourth
of July break. We have a Memorial Day break. We have appropriations
bills to do. We have all kinds of things we have to do this summer.
Plus, it is not waiting until the last minute.
FDA needs to know very soon whether they are going to have these
resources. The drug companies need to know whether FDA will have the
resources to continue to do its work. So sometime midsummer FDA will
probably have to start sending out pink slips to people they will not
be able to keep past the end of the summer because they will not have
the funds. It has been estimated that up to 2,000 people could lose
their jobs at the end of this summer if we don't do our work and get
this bill reauthorized.
So time is of the essence. We need to get it done so we can go to
conference with the House, work out whatever little disagreements we
may have, and get the final bill to the President, hopefully sometime
in June so the FDA then will not have to go through any processes of
seeing who they are going to lay off and how they are going to close
things down at the end of the summer.
So, again, time is of the essence. I urge all my colleagues to
support this well-thought-out bill that has taken over a year to put
together. All of the
[[Page S3396]]
stakeholders support it with broad support across America. So I hope we
can get on the bill this afternoon and bring it to a close as soon as
possible.
Mr. President, I yield the floor, and I suggest the absence of a
quorum.
The PRESIDING OFFICER (Mr. Tester). The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. BLUMENTHAL. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. BLUMENTHAL. Mr. President, I am pleased and proud to follow
Senator Harkin, one of the chief authors of the FDA bill, and to thank
him and Senator Enzi for this truly bipartisan, monumental work on a
measure that is essential to the future of the health of our Nation as
well as our economic security.
This bill is a big one. It is a big bill with complex provisions and
an essential purpose: to safeguard the public, to protect patients, and
encourage innovation and invention, which are so important to treating
and curing diseases in this country as well as other problems. This
measure is revolutionary in many ways. It contains complex new
provisions with bipartisan support. Truly, the bipartisanship in
support of this bill makes it noteworthy as well.
I am pleased to say it includes the GAIN Act, which I helped to
author and champion with my colleague, Senator Corker, and 15 other
Senators who have joined in this effort to incentivize the development
of new antibiotics, to treat, stop, and conquer the superbugs, as they
are known, germs that are resistant to antibiotics that now exist. To
provide more drug security, the supply chain needs greater safeguards.
I have worked with Senators Burr, Bennet, Harkin, Grassley, and
Whitehouse on this measure. I am proud to say it is in here. The bill
includes provisions on treatment and research on pediatric diseases and
conditions that is the work of Senators Reed, Alexander, and Murray. I
have been very proud to add to their efforts. Of course, it includes
the work on medical device innovation and safety, which I have done
with Senator Grassley and Senator Kohl.
This measure, in a way, epitomizes the approach we should take to FDA
regulation, which is to enable devices to reach the market more
quickly, to make sure they are safe but available more promptly, to
guarantee surveillance and oversight after they reach the market, and
reporting by industry so we enlist industry as a partner and make the
FDA an ally, not an adversary, with industry in innovation and patient
care.
Nowhere is this approach more necessary than in addressing the drug
shortage problem in this country. It is a problem, it is a crisis, it
is an outrage. The United States should be embarrassed and outraged
that the greatest country in the history of the world, the strongest on
the planet, having developed lifesaving medicines and devoted
extraordinary research and development to make those medicines
available to the people of this country, still has shortages, crisis
shortages in those very pharmaceutical drugs.
That crisis is inexcusable and unacceptable. The bill takes a step in
the direction of addressing and solving this crisis. It is a first
step. I leave no doubt, as I stand here, that I will continue to work
on this problem, to advocate other steps--some that I will suggest
today and others that will be forthcoming in measures I will propose
later.
I first became aware of the drug shortage problem through contacts
with people from Connecticut, patients who suffer as a result of these
drug shortages and doctors who are hugely concerned about the choices
they have to make and the dilemmas they face every day in their
practices, and hospitals that engage in what they call triage, trying
to find drugs to substitute for the ones that are in shortage so they
can care for patients who are literally dealing with life-and-death
situations.
We are not talking about just one or a couple of drugs. Methotrexate
was recently the subject of a New York Times front-page article. It
provides cancer treatment, but there are other cancer-treating drugs
that are also in short supply, essential for both prolonging life and
giving life to patients who otherwise would lose it more quickly. We
are talking about Mitomycin, about Doxil, about Cytaraline. In other
areas of treatment we are talking about epinephrine, which is important
for allergy treatment, zinc injections, which are necessary for
nutrition deficiencies, Propoful, a workhorse medicine commonly used in
emergency rooms across the country when people arrive in need of
anesthesia. For these drugs and hundreds of others, literally hundreds
of others, to be in shortage is unacceptable and inexcusable.
What illustrates this problem perhaps most dramatically are the faces
and voices of the people in Connecticut and in every State around the
country who suffer because of these drug shortages. They are your
neighbors, your friends--my colleagues' constituents. They are coping
with pain, anxiety, sadness, grief, anger--and there are drugs
available to them that would provide relief and remedies. Their docs
cannot get them because they are in shortage.
We are talking about people of great courage and fortitude, such as
Susan Block. She is just illustrative. I have her picture here. My
office helped her to get a drug called Doxil to treat her cancer
because halfway through her chemotherapy treatments for ovarian cancer
she arrived at the hospital one day to learn from her doctor that Doxil
would no longer be available. She called my office in a panic upon
learning that information. Ovarian cancer causes more deaths than any
other cancer of the female reproductive system and Susan was unwilling
to settle for half a treatment. She was right, and her doctor supported
her and my office supported her in securing an emergency delivery of
Doxil for Susan, allowing her to complete treatment.
She has allowed me, graciously, to share this photo with you today.
I am pleased we have been able to help constituents in Connecticut
again and again to secure these medicines when they have been in
shortage, working with manufacturers as well as hospitals in that
effort. But it should not have happened at all.
Not everyone has been this lucky. Stephen Hine of Bethel wrote to my
office after he lost his wife Ann. She died of terminal ovarian cancer.
Ann was also on Doxil. While the drug was not going to save her life--
these drugs do not always save lives--it could have prolonged her life
expectancy. But she could not get Doxil in time and she lost her battle
with cancer. Stephen, her husband, understood that the drug would not
have cured her but it would have helped her live longer to spend more
time with her family, her daughter, who was going to graduate that
spring. It would have meant so much for Ann to see her daughter
graduate. We have a right to ask what kind of nation allows patients to
go without these drugs and forces doctors to make decisions about who
needs them the most.
I thank Senators Klobuchar and Casey particularly for championing
this effort even before I arrived in the Senate and later, personally,
the Chair of the Health, Education, Labor, and Pensions Committee and
the Ranking Member, Senator Harkin and Senator Enzi, for their support.
There are proven measures that will help solve these issues. More
needs to be done, but the drug shortage provisions contained in the
bill before this chamber, which provides for a requirement of
notification in the event of a discontinuance or interruption of the
production of life-supporting, life-sustaining drugs or drugs intended
for use in the prevention of a debilitating disease or condition or a
sterile injectable or a drug used in an emergency are critical. The
reasons these drugs are in short supply was illustrated and documented
by a GAO study. It showed that drugs are in short supply--not just
once, but they are chronically in short supply, some of them many
times--it showed definitively that these drugs are old, sterile, often
injectable, and generic. The market simply is not working for these
drugs. The profit margins are not sufficient to sustain the supply. The
market for these drugs is broken.
If these drugs--to draw the analogy to a utility--were electricity,
the lights would go out. We would not accept that situation. The lights
are going out for patients in Connecticut
[[Page S3397]]
and across the country because the markets are not working and the
government, the FDA, is failing in its responsibilities--under great
pressure, perhaps with good intentions, but still not working
effectively enough. The President of the United States recognized it
when he issued an Executive order that required the FDA to use its
current powers of notification more effectively and to refer price-
gouging cases to the Department of Justice when there is evidence of
them. The markets are not working so there is now a gray market that
involves markups of 200, 300, 500, 800 percent, sometimes even higher,
in the prices of these drugs as they are resold in secondary markets.
Beyond this requirement of notification that is contained in the
bill, there are other measures that are important or necessary so that
we do more to address these problems. I have refiled my amendment from
the HELP Committee markup, along with Senators Franken, Schumer,
Cardin, and Klobuchar, to impose penalties, tough penalties for
manufacturers who fail to notify. Notification is fine but it will be
less effective if there are no penalties for failure to notify. We may
try to walk a balance between enforcement and incentives, but
enforcement in this area is critical, and this measure imposing
penalties for failure to notify is critical as well.
The amendment is a fair one. It provides for penalties of up to
$10,000 per day--up to $1.8 million per violation--for failure to
notify the FDA within a reasonable time frame of known discontinuance
of a lifesaving drug.
I am proposing as well an amendment that would require critical
manufacturing reinvestment. I have worked with the manufacturing
industry to create a public/private partnership to incentivize the
development of additional manufacturing capacity. The root of the drug
shortage problem is that these products are old and generic and
difficult to make so that we need more capacity, we need more plants
making more of these drugs. Over the long term, this kind of
partnership will strengthen the markets and strengthen our capacity. It
says the Secretary of Health and Human Services has authority to
implement an analysis of the root causes of the drug shortage and to
proactively seek these kinds of partnerships with manufacturers to
produce more of the drugs that may be in shortage right now, but to
predict, to forecast, what will be in short supply in the future.
Market manipulation must be addressed more effectively and I have
proposed an amendment that will stop the gray market so far as it is
possible to do, to prohibit market manipulation of drugs that are in
shortage and prohibit the distribution of false information. It gives
the FTC authority to assess penalties for these actions. I thank my
colleagues on the Commerce Committee, Chairman Rockefeller, and also
thank Senator Schumer for his leadership, because he has shown a
similar commitment to addressing these issues.
Our doctors and our health care providers deserve some recourse from
market manipulation. The gray market must be stopped and the FTC must
immediately establish a reporting mechanism for price gougers and gray-
market profiteers.
These measures are a beginning. The notification provision now in the
bill is a start. I thank, again, Chairman Harkin and Ranking Member
Enzi for their leadership and the FDA for its cooperation. The work
cannot stop with this bill. Drug shortages are unacceptable and
inexcusable, and the people of America, if they are aware of it, will
demand that we heighten the fight toward a comprehensive solution.
Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Louisiana.
Child Tax Credit
Mr. VITTER. Mr. President, Senator Sessions and I come to the Senate
floor today to discuss the Child Tax Credit Integrity Preservation Act,
the bill I introduced last year, to address a real problem with IRS
enforcement allowing illegal aliens to access the additional child tax
credit.
The reality is, because of this enforcement problem and this loophole
in terms of how the child tax credit is enforced, illegal aliens who
pay no taxes and are not entitled to this check from the government
received $4.2 billion in 2010 alone. These are checks from the
government through the Child Tax Credit Act.
There have been several studies under the President Obama
administration that say this is ridiculous, this is unintended, we need
to stop this. I am proposing we do and that we move forward in a
simple, bipartisan, commonsense way to stop it. Let me briefly note
some of those studies.
In March of 2009, the Treasury Department said:
As it now stands, the payment of Federal funds through this
tax benefit appears to provide an additional incentive for
aliens to enter, reside, and work in the United States
without authorization, which contradicts Federal law and
policy to remove such incentives.
In July 2011, the Treasury Department, through its inspector general,
issued a report that was actually entitled ``Individuals Who Are Not
Authorized to Work in the United States Were Paid $4.2 Billion in
Refundable Credits.''
So, again, under this administration the Treasury Department and the
IRS underscore that this is a huge problem to the tune of $4.2 billion
every year.
I urge all of us to come together in a straightforward, commonsense,
bipartisan way to fix this problem. The IRS and the Treasury Department
have told us that the fix is simple, and it is clear. We simply need to
mandate that folks applying for the credit use valid Social Security
numbers. That will cut off the fraud, and that will cut off $4.2
billion going improperly to illegal alien families. It will not cut off
the benefit going to anyone who deserves it under the law.
Unanimous Consent Request--S. 577
Mr. VITTER. Mr. President, I ask unanimous consent that the Committee
on Finance be discharged from further consideration of S. 577, the
Child Tax Credit Integrity Preservation Act, and the Senate proceed to
its immediate consideration; that the bill be read a third time and
passed, the motion to reconsider be laid upon the table, and any
statements relating to the bill be printed in the Record.
The PRESIDING OFFICER. Is there objection?
The majority leader is recognized.
Mr. REID. Mr. President, reserving the right to object, first of all,
I want to express my appreciation to the Senator from Louisiana and the
Senator from Alabama for their courtesy. They are going to talk a lot
longer on this matter. They recognized there was a good chance I would
object to their request. They have agreed to allow me to say a few
words before they finish what they have to say on the Senate floor. I
appreciate their courtesy very much because I do have some other things
I need to work on.
Mr. President, the Vitter-Sessions legislation literally takes a
sledgehammer to a problem that deserves some very fine tuning and a
scalpel. There are news reports that have suggested that some have
claimed the child tax credit for children who actually live outside the
United States.
The Tax Code is very clear that the child tax credit is not available
for children living outside the United States. It is very clear. If, in
fact, someone is doing that, then those filers and tax preparers are
committing a fraud on the people of this country. If they are doing
that and there is a loophole that is existing, we need to close that
loophole.
Chairman Baucus has already had his staff work with the IRS to
determine if its procedures are strong enough to stop such fraud. We
believe they are, but if they are not then it is up to Congress to plug
any loopholes that may exist. However, the Vitter-Sessions legislation
eliminates the child tax credit for filers who are fully complying with
the law. That is not a good result. In fact, the legislation that is
proposed fails to address the issue of the child tax credit being
claimed for children not living in the United States, so the problem is
not solved by this legislation. The legislation goes well beyond what
is necessary to stop fraud in the Child Tax Credit Program, and
therefore I object to the consent request.
The PRESIDING OFFICER. Objection is heard.
The Senator from Louisiana.
Mr. VITTER. Mr. President, before the distinguished majority leader
has to leave, I would just ask, through the
[[Page S3398]]
Chair, if we can get some clarification and hopefully come to some
consensus, is he suggesting that illegal aliens in the country should
continue to receive the credit? Is he suggesting that citizens who
qualify for the credit but happen to live outside the country should
not get it?
It seems to me the problem is illegal aliens receiving the credit,
wherever they are physically, not the people outside the country who
are receiving the credit, some of whom qualify for the credit.
If I could bring that point up through the Chair.
Mr. REID. Mr. President, without fully debating the subject--and
others know more about it than I do, but what I do know is that we want
to make sure any children who are here and who are American citizens
and entitled to this get the benefits.
The PRESIDING OFFICER. The Senator from Louisiana.
Mr. VITTER. I would say, through the Chair, thank you for that
clarification. We have exactly the same goal in mind, and I believe
this approach of the Vitter bill--the House has already passed this
approach recently, and its budget outline actually accomplishes that.
By requiring a valid Social Security number, we allow everyone who
truly qualifies for the credit to get it, and we stop it from going to
illegal alien families who do not deserve the credit under the law.
I invite my distinguished colleague from Alabama to add to the
discussion.
The PRESIDING OFFICER. The Senator from Alabama.
Mr. SESSIONS. Mr. President, I thank the Chair, and I appreciate the
insight the majority leader provided. We will look at that and see
where we stand on it, but I would urge that we do not need to wait a
great deal of time for this to be fixed.
The inspector general for Tax Administration of the U.S. Treasury
Department started raising this formally in 2009. The issue actually
came up in 2007 when individuals in the Treasury Department thought
there was something wrong occurring. So the inspector general did a
report, and he has called on us to fix it.
In fact, he said in his report:
We continue to believe the legislation is needed to ensure
compliance with both laws.
I would say that is what we need to do. The House has acted and we
should act. Four billion dollars a year is a great deal of money. It is
about $10 million a day that is going out of the country to individuals
who should not be receiving it.
According to the inspector general's report, the amount of the child
tax credit--and as Senator Vitter said, this is not a tax deduction.
This is a $1,000-per-child tax credit that we have for people in the
United States who work, who have worked lawfully, and who have children
and they get a check. If they owe no income tax at all, and a
substantial percentage of the people who work in America end up not
paying income tax, but they still get a check from Uncle Sam for $1,000
per child.
It was a policy I supported because over the years families had not
gained the kind of deductible advantage that had been done 30 years ago
when people had children, and it leveled the playing field and helped
working families raise children in a decent environment. It is a policy
I like, but it is not for somebody here illegally and has children in
some foreign country. That is not what it is about. It is for $4
billion. It has surged.
In 2005 the inspector general noted that the IRS paid out to these
ITIN filers $924 million in 2005. In 2006, it was $1.3 billion. In 2007
it was $1.7 billion. In 2008 it was $2.1 billion. In 2009 it was $2.9
billion. From 2009 to 2010 it went from $2.9 billion to $4.2 billion.
It has been surging every year.
As a matter of protecting the Treasury of the United States from
abuse, the IG says we need legislation. The Senator from Louisiana has
drafted legislation that will do the job precisely as it should. Would
the Senator agree that Congress should not wait around another year? It
is something that the House already passed, and if we passed it, it
would become law in perhaps a matter of days.
The PRESIDING OFFICER. The Senator from Louisiana.
Mr. VITTER. Mr. President, if I could respond through the Chair.
I absolutely agree with the Senator from Alabama. Too often folks in
Washington want to make things overly complicated. Some issues debated
in the Congress are complicated. Other issues are not complicated, but
they are made a whole lot more complicated than they need to be made,
and this is one of those.
All we are saying is folks who qualify for this benefit under the law
should get it, but folks who don't qualify, including illegal alien
families, should absolutely not get it. The law is clear on that. What
we have is an enforcement problem. We also have the Obama
administration, through the Treasury Department, absolutely agreeing
that this is an enforcement problem and that this bill is the
legitimate and proper solution.
Again, in March 2009 the Treasury said:
As it now stands, the payment of Federal funds through this
tax benefit appears to provide an additional incentive for
aliens to enter, reside, and work in the United States
without authorization. . . .
That means it is a magnet to draw more illegal crossings into the
country.
Again, in July 2007, the Treasury inspector general had a whole
report, and the title was ``Individuals Who Are Not Authorized to Work
in the United States Were Paid $4.2 Billion in Refundable Credits.''
That inspector general said what we need is fixed legislation just like
this.
In fact, this is what we do with regard to the earned-income tax
credit. We require a valid Social Security number for that separate tax
credit. We are simply applying that valid fix to this different tax
credit.
Again, let's not make a pretty straightforward situation difficult.
Let's fix a glaring problem. As the Senator from Alabama said, it is a
$4.2 billion-a-year problem. We come to the floor every day to talk
about soaring deficits and debt, to talk about impending cuts in
defense and other areas, and yet we have this glaring $4.2 billion
savings that we are not taking advantage of.
The House has acted. The House recently acted and passed exactly this
provision. Let's act in a bipartisan, commonsense way in the Senate and
tell the American people we are going to stop wasting $4.2 billion a
year for this completely unauthorized purpose.
The PRESIDING OFFICER. The Senator from Alabama.
Mr. SESSIONS. Mr. President, I would point out to my colleagues how
much $4 billion is. It is a matter that we deal with on a regular basis
around here. It is a number that has come up several times recently.
For example, we had a shortfall in our plans to fund the Federal
highway program--a deeply disappointing event that we couldn't get that
bill passed. It started out as a $4 billion shortfall. They worked that
number down, but it is still not fully paid for. We would like just a
few billion dollars to pay for the bill, and it hasn't been passed.
The student loan fixed rate where the interest rates would be
dropped--if I am not mistaken, that was $4 billion. We need it to
reduce interest rates on student loans. That is $4 billion, according
to the IG, going out of our country wrongfully every year that we could
save.
The President spent a lot of time traveling around the country saying
we should raise taxes on the rich and we should pass the Buffett tax.
He had a proposal for the Buffett tax. How much would the Buffett tax
raise? It would raise $4 billion. That is how much closing this
loophole would raise. Frankly, I am a little disappointed that the
Treasury Department officials and the administration itself haven't
immediately seized upon this loophole that is costing the taxpayers
large amounts of money and responded themselves by sending legislation
over and asking us to pass it. Why aren't they asking us to pass it to
begin with? Well, the inspector general, who is an independent--who
gets a little independence within the Department of Treasury but, in
fact, is an employee of the Secretary of the Treasury--he says we need
this legislation. Quoting his report:
Clarification to the law is needed to address whether or
not refundable tax credits such as ACTC may be paid to those
who are not authorized to work in the United States.
Well, of course they ought not to be getting a check from the U.S.
taxpayers if they are not authorized to be working here.
[[Page S3399]]
So as the ranking member on the Budget Committee, knowing how tight
our budget is, I salute Senator Vitter for doing it this year as well
as last year when he saw this problem and attempted to get it passed. I
am pleased the House has passed it. I think if we keep working at it, I
say to Senator Vitter, maybe we can get it done in the Senate,
remembering that $10 million a day is going out of the country for
every day we fail to act.
The PRESIDING OFFICER. The Senator from Louisiana.
Mr. VITTER. Mr. President, I wish to thank very much my colleague
from Alabama for his leadership on the Budget Committee and his
leadership on issues such as this. I want to encourage the
distinguished majority leader to look at the actual details of the
problem and this legislation. When he does, he will see that this
legislation is very finely tuned to the actual problem, and it is an
outrageous problem.
There has been quite a bit of media attention on this abuse over the
last several months. A lot of it came out of Indiana. A tax preparer
there brought cases in Indiana and said he got no response from the IRS
when he tried to report completely fraudulent returns using fake income
and documents. He pointed to a number of actual tax forms in which
illegal aliens were exploiting this. He said: ``I can bring out stacks
and stacks. It is just so easy, it is ridiculous.''
An illegal alien who was actually interviewed admitted in another
case that his address was used by four other illegal aliens who didn't
even live there. All told, they claimed 20 children were living in one
trailer, and they received checks from the government through this
program totaling over $29,000. Only one child was ever observed at that
mobile home. Twenty other children who live in Mexico have never even
visited the United States.
Again, let's not make a simple fix overly complicated because it is
not. This is an outrageous abuse. The Obama administration Treasury
Department has said so. They have endorsed this fix. The House has
passed this fix. Let us in the Senate pass this fix on a bipartisan
basis and save the American taxpayer $4.2 billion each and every year.
With that, Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Alabama.
Mr. SESSIONS. Mr. President, to conclude, I think the American people
are unhappy with their leaders. They feel as though the money they have
sent here is not being well spent, is not being watched closely enough.
We have a big judicial conference for the second year--since 2010, the
second time--to go spend $1 million on a resort conference in Maui. We
have the Solyndra loans going out to cronies that are not being paid
back in any way. We have the General Services Administration having a
big party out in Las Vegas with hot tubs and magicians and so forth. We
have no budget for three consecutive years in the U.S. Senate. And what
are we hearing from many of our leaders here in Washington? Well, we
have a problem, American people. We have too big a debt. Send us more
money. Send more money. We don't have enough. We are borrowing 40 cents
of every dollar we spend. Send more money.
I think the American people are tired of hearing that. I think they
have a right to be tired of hearing that. Until this country is willing
to face up to saving $10 million a day on this kind of manipulation
that has been going on since 2007, at least, and has been raised by the
inspector general since 2009, until those kinds of things are stopped,
I don't think they should send any more money to Washington. We need to
honor the money they are sending.
I thank the Chair and yield the floor.
The PRESIDING OFFICER. The Senator from Massachusetts.
tribute to thomas hudner
Mr. BROWN of Massachusetts. Mr. President, I rise to speak about a
historic ceremony that took place in Boston Harbor--the birthplace of
the American Revolution--this very morning.
This morning, the United States Navy named an Arleigh Burke class
guided-missile destroyer for retired United States Navy Captain Thomas
Jerome Hudner, Jr., of Concord, MA. The ceremony took place aboard the
oldest commissioned warship in our United States Navy, the USS
Constitution.
As the Presiding Officer knows, it is a distinct honor for any
service member to have a Navy vessel commissioned in his or her name.
What made the event today extremely rare is that Captain Hudner is the
Navy's last living Medal of Honor recipient from the Korean War.
As the story my colleagues are about to hear shows, no one could be
more worthy of this distinction than Tom Hudner.
Tom is a native of Fall River, MA. He was a student at Phillips
Exeter Academy when the Japanese attacked Pearl Harbor. As a leader on
his school's athletic fields and in its student government, naturally
he responded to the call to arms. And although World War II ended
before his commissioning at the Naval Academy in Annapolis, Hudner
began a storied Navy career that would earn him our Nation's highest
military honor.
During his first few years in the Navy, Hudner served as a
communications officer aboard various warships before being accepted to
the Navy's flight school in Corpus Christi, TX. After earning his wings
of gold, Hudner became one of the ``Fighting Swordsmen'' of Strike
Fighter Squadron 32 aboard the aircraft carrier USS Leyte.
Just a few years after the racial integration of the U.S. military,
Hudner began flying alongside a young ensign named Jesse LeRoy Brown,
the Navy's first black pilot. Brown was born and raised in the
segregated, deep south town of Hattiesburg, MS, a world away from
Hudner's home in Fall River, MA.
In the summer of 1950, less than a year after Hudner finished flight
school, North Korean Communist forces invaded the Republic of Korea.
Within months, President Truman ordered the Leyte into action off the
coast of Korea where Hudner and his wingman, Jesse Brown, immediately
began flying reconnaissance and attack sorties against Communist
positions. Not long after their squadron joined the fight, Chinese
forces invaded the Korean peninsula and threatened to overrun U.S.
positions.
There are no routine missions in wartime, especially when flying
close air support over enemy positions. On the afternoon of December 4,
1950, Hudner and Brown were on a mission to destroy enemy targets near
the Chosin Reservoir. About an hour into the mission, Brown's Corsair
was hit by enemy fire, began to lose fuel and he was forced to crash
land his aircraft into a snowy mountainside.
The events that transpired over the next few hours became enshrined
in the history of American Naval aviation.
Despite exposure to hostile ground fire, Hudner continued to make low
passes over Brown, who was trapped in the wreckage of his destroyed
aircraft. When Hudner saw that his wingman's plane was burning, he
deliberately crash-landed his own aircraft, risking his life. And
though injured in the violent landing, Hudner ran to try to rescue
Brown.
For Tom Hudner, never leaving your wingman was more than just a
phrase he learned in flight training, it was a covenant. A short time
later a rescue helicopter pilot arrived, and both he and Hudner tried
in vain to free Brown from the wreckage. With night falling and Ensign
Brown lapsing in and out of consciousness, Hudner was finally forced to
evacuate the bitter cold crash site. Brown's final words to Hudner were
to tell his wife Daisy that he loved her. He would do that in person.
On April 13, 1951, Daisy Pearl Brown was in the audience when
President Harry S. Truman presented Thomas Hudner with the Medal of
Honor for his heroic attempt to save Ensign Brown.
Over the next two decades, Hudner continued to serve with distinction
in the United States Navy. In addition to flying many of the Navy's
newest jet fighters, Hudner's career would take him from various ships
and air bases where he served in positions of increasing
responsibility, including as executive officer of the USS Kitty Hawk
during the Vietnam War.
Hudner and Brown's wife Daisy remained friends, their lives
intertwined by the events decades earlier on a snowy mountainside on
the other side of the globe. In fact, the two friends would stand
together at another ceremony some 22 years later when the
[[Page S3400]]
U.S. Navy commissioned the first American warship in honor of an
African American, the USS Jesse L. Brown.
Hudner retired from the U.S. Navy at the rank of captain in 1973, and
while his day-to-day service in the military would end, he continued to
serve his fellow veterans through the USO and a variety of veterans'
organizations. In fact, for most of the 1990s, Hudner served as
commissioner of the Massachusetts Department of Veterans Affairs.
Today, the newly commissioned USS Thomas Hudner will serve as a
living legacy to heroism and service. Think about it for a moment. When
a sailor or Marine is assigned to this ship, they will proudly tell
their family and friends about Hudner and Brown. When the Hudner makes
a port call, those in the communities it visits will see the ship in
port and meet scores of crew members with ``USS Thomas Hudner''
stitched on their shoulder.
And when citizens around the world learn about Captain Hudner's
specific act that the Navy has described as ``conspicuous gallantry and
intrepidity at the risk of his life above and beyond the call of
duty,'' they will begin to understand what uncommon valor truly is. Tom
Hudner's story will serve as an inspiration to a future generation of
Americans.
Please allow me to thank Captain Hudner for his lifetime of
exceptional service to our Nation and his dedication to his fellow
veterans. I ask my colleagues and our Nation to join me in wishing him
and his wife Georgia all the very best in the years ahead.
Mr. President, I yield the floor.
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