Congressional Record, Volume 158 Issue 75 (Wednesday, May 23, 2012)

[Congressional Record Volume 158, Number 75 (Wednesday, May 23, 2012)]
[Senate]
[Pages S3479-S3509]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT

The PRESIDING OFFICER. Under the previous order, the motion to
proceed to S. 3187 is agreed to and the clerk will report the bill by
title.
The bill clerk read as follows:

A bill (S. 3187) 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.

Amendment No. 2122

(Purpose: In the nature of a substitute)

The PRESIDING OFFICER. Under the previous order, amendment No. 2122
is agreed to.
(The amendment is printed in the Record of Monday, May 21, 2012,
under ``Text of Amendments.'')
The PRESIDING OFFICER. The majority leader.
Mr. REID. Thank you very much, Mr. President. I am sorry I got ahead
of the Chair a little bit.
I ask unanimous consent that the only first-degree amendments in
order to the bill be the following: Bingaman No. 2111; McCain No. 2107;
Sanders No. 2109; Murkowski No. 2108; Cardin No. 2125; Cardin No. 2141;
Grassley No. 2121; Grassley No. 2129; Manchin No. 2151, as modified;
Portman No. 2146, as modified; Portman No. 2145, as modified; Reed No.
2126; Coburn No. 2132; Coburn No. 2131; Durbin No. 2127; Paul No. 2143;
and Burr No. 2130; that there be no second-degree amendments in order
prior to the votes in relation thereto; that there be no motions or
points of order to the amendments or the bill other than budget points
of order and the applicable motions to waive or motions to table; that
there be up to 30 minutes of debate on each of the amendments, with the
exception of the McCain amendment, which will have 2 hours of debate,
and 60 minutes on the bill, with all time equally divided in the usual
form; that at 2 p.m. on Thursday, May 24, all debate time be considered
expired and the Senate proceed to votes in relation to the amendments
in the order listed above; that there be 2 minutes of debate equally
divided in the usual form prior to each vote; that all after the first
vote be 10-minute votes; that the following amendments be subject to a
60 affirmative vote threshold: Bingaman No. 2111, McCain No. 2107,
Sanders No. 2109, and Murkowski No. 2108; that upon disposition of the
amendments, the bill be read a third time and the Senate proceed to
vote on passage of the bill, as amended.
That upon disposition of S. 3187, the Senate proceed to the
consideration of Calendar No. 365, S. 2343; that the only amendment in
order to the bill be an amendment from the Republican leader or his
designee, the text of which is identical to S. 2366; that there be 10
total minutes of debate on the amendment and the bill equally divided
between the two leaders or their designees prior to a vote on the
McConnell or designee amendment; that no amendment be in order to the
McConnell or designee amendment; that no motions or points of order be
in order to the amendment or the bill other than budget points of order
and the applicable motions to waive; that upon disposition of the
amendment, the Senate proceed to vote on passage of the bill, as
amended, if amended; that the amendment and the bill be subject to a 60
affirmative vote threshold; that if the bill does not achieve 60
affirmative votes, S. 2343 be returned to the calendar; and finally,
that the motion to reconsider with respect to the cloture vote on the
motion to proceed to S. 2343 be withdrawn.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
Mr. REID. So, Mr. President, we are going to have votes on these
amendments. It is my understanding that there is time, 30 minutes per
amendment. We need to get as much of that done today as possible. We
have an event for spouses tonight, so we are not going to be working
late into the night. We have tomorrow to finish this. We should be able
to do that. I hope we can. I hope it does not spill and there is no
reason it should spill over until the next day. We are going to also
have votes on the Republican student loan legislation and ours. That is
what we are doing in the next 36 hours.
The PRESIDING OFFICER. The Republican leader.
Mr. McCONNELL. Mr. President, let me just add that I think this is a
good agreement that allows us to go forward on the FDA bill with
appropriate amendments and also allows an opportunity for the Senate to
express itself on the issue of the student loans.
I would join the majority leader in encouraging people to do their
debate today or in the morning because once we get into the votes
tomorrow afternoon, they will be dealt with in rapid succession.
I yield the floor.
The PRESIDING OFFICER. The Senator from Utah.
Mr. HATCH. Mr. President, I rise to discuss my amendment that would
repeal the costly and counterproductive medical device tax in President
Obama's health care law. In the mad scramble to find money to pay for
his $2.6 trillion health spending law, the President and his Democratic
allies created a number of new taxes that serve no purpose other than
to fuel this new spending. Economically, these taxes are a disaster.
They will undercut job creation, and they will increase costs for
patients.
The new 2.3-percent tax on medical device manufacturers, which kicks
in at the beginning of next year, is particularly onerous. For that
reason, last year I introduced legislation to repeal it. That bill, the
Medical Device Access and Innovation Protection Act, S. 17, has been
cosponsored by 25 of my colleagues.
They understand that all of ObamaCare needs to go. The President's
health care law is now over 2 years old. It is not aging well. Even
before ObamaCare became law, the American people made themselves
absolutely clear they wanted nothing to do with this Washington
takeover of the Nation's health care system. The President and his
advisers refused to face reality, telling reluctant Democrats all

[[Page S3480]]

was well in spite of the tea party townhalls.
According to the President and his congressional Democratic
leadership, as soon as the legislation became law, Americans would come
to embrace the wonderful benefits bestowed on them by the Department of
Health and Human Services. It has not quite turned out that way.
Poll after poll shows that substantial majorities of Americans
continue to oppose the law and favor its full repeal. A majority of
Democrats think the law is unconstitutional. In a matter of weeks, the
Supreme Court might issue a coup de grace to President Obama's
misguided adventure in big government.
Whatever the Supreme Court does, I want to be clear about something.
All of ObamaCare needs to go. It needs to be pulled out root and
branch. The entire thing needs to be repealed. That said, some part of
the law stand out for their wrongheadedness. The individual mandate and
Medicaid expansions are flat out unconstitutional.
The IPAB, the CLASS Act, the Medicare cuts, and the employer mandate
all deserve honorable mention for being bad public policy. Among the
most counterproductive parts of the law are its over $500 billion in
new taxes and penalties.
The medical device tax sits at the top of the list of foolish new
ObamaCare taxes, and my colleagues who have supported S. 17 and this
amendment understand the critical importance of eliminating it. I thank
in particular my colleagues, Senator Brown from Massachusetts, and
Senator Toomey from Pennsylvania, who have spoken on this issue and
understand completely the devastation this tax will create for patients
and for employers who provide good jobs for communities in their
States.
Thanks to ObamaCare, medical devices will get hit with a $28 billion
tax. So we are clear about what these medical devices are, they include
surgical tools, bed pans, wheelchairs, stethoscopes, and countless
other products that patients and doctors rely on every day. Surgical
masks, gloves, blood pressure monitors, scissors, needles, cribs,
trays, lights, stents, pacemakers, scales, scalpels, inhalers, and
ankle, knee, and hip braces, and a lot more.
The cost of all of those products is going up thanks to this tax.
Somebody is going to have to pay for it, and that someone is the
already overburdened American taxpayer and middle-class breadwinner.
The President and his supporters seem to think we can simply tax
corporations and individuals with impunity and face no adverse economic
consequences. Yet economists understand when we tax these companies,
employees will pay for it in lower wages, the unemployed will pay for
it with a job that was never created, and patients will pay for it with
higher health care costs.
Whatever our economic circumstances, this tax is bad news. But it is
particularly foolish given the precarious state of our economic
recovery. The President once liked to tout all of the jobs created or
saved by his over $800 billion stimulus bill. Yet by supporting the
medical device tax, the President and his allies have shown a real
disregard for good high-paying American jobs.
Medical device companies employ nearly half a million people. They
pay a salary that is nearly 40 percent higher than the national
average. These manufacturers are small businesses we must be
cultivating if our economy is going to recover and we are going to be
successful in bringing down unemployment.
Roughly 80 percent of medical device companies have fewer than 50
employees; 98 percent have fewer than 500 employees. ObamaCare's $28
billion tax hike on these manufacturers will do nothing to improve
health care, but it will do plenty to undercut the viability of these
companies that provide good wages and good opportunities for American
families.
According to one recent analysis, the medical device industry
provided jobs to 409,000 employees in 2009. Yet this tax could result
in job losses in excess of 43,000. It will hit certain States harder
than others: California, Florida, Illinois, Massachusetts, Minnesota,
New Jersey, New York, Ohio, Pennsylvania, Wisconsin, and my State of
Utah. The presence of medical device manufacturers is significant in
all of these States.
This new tax will roughly double the device industry's total tax bill
and raise the average effective corporate income tax to one of the
highest effective tax rates faced by any industry in the world. The
President and his allies frequently attack industries that choose to
move their operations overseas. But they do not seem to grasp that
their policies are driving these industries to do just that. With the
onset of this new tax, U.S. device manufacturers are increasingly
likely to close plants in the United States and replace them with
plants in foreign countries.
According to another report by the Lewin Group, the medical
technology industry contributes nearly $382 billion in economic output
to the U.S. economy every year. President Obama, in the middle of a
weak economy, facing high rates of joblessness, has decided to attack
that industry. It is bewildering to me. An industry that pays workers
on average $84,156 has become a victim of the President's desire to pay
for his new health spending law or, better put, those workers and the
families they support become the victims of the President's health
spending law.
In my own State of Utah, the device tax is an issue of great
importance. There are over 120 medical device companies in Utah. As the
Utah Technology Council wrote in a letter to me, these companies ``are
a vibrant part of the Utah economy providing high-paying, high-tech
jobs for citizens of our great state.''
They certainly are all of that, and they are under assault as a
result of this tax, targeted for nothing other than their success and
the fact that they were a so-called stakeholder that could pay a so-
called fair share to subsidize the President's health spending bonanza.
I ask unanimous consent that letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

January 25, 2011.
Hon. Orrin G. Hatch,
U.S. Senate,
Hart Office Building,
Washington DC.
Dear Senator Hatch: As you are aware, the Utah Technology
Council represents the life science community in Utah. There
are over 120 medical device companies in Utah that are part
of that community. They are a vibrant part of the Utah
economy providing high-paying, high tech jobs for citizens of
our great state. Many of these companies you would recognize
immediately including Merit Medical, Dynatronics, WorldHeart,
Aribex, Utah Medical, Edwards Life Science, Becton Dickinson,
Watson Laboratories and Fresenius Medical Care.
The Governor of the State of Utah as part of his long-range
economic plan has identified the life sciences, including
medical device companies, as a targeted area of growth for
the state of Utah. The state's economic growth initiatives
recognize the importance of these industries to our future
and the rich resources our state offers to companies
operating in this market. The industry-specific taxes imposed
by the 2010 Patient Protection and Affordable Care Act are of
great concern to us as an industry association because of the
impact these taxes could have in slowing economic growth in
this targeted area.
Therefore, we strongly support the Medical Device Access
and Innovation Protection Act that you are introducing. The
removal of this unfair and onerous tax will assure the
continued growth of jobs and innovation in this important
market sector. We appreciate the fact that you have
recognized the need for this statutory change. The imposition
of an excise tax is particularly burdensome for our small
companies here in Utah that operate on less than average
profit margins. To take 2.3 percent of sales as an excise tax
would render some companies unprofitable and significantly
reduce the profitability of most--not to mention the
catastrophic effect this tax would have on companies that are
already not profitable. If a medical device company is
operating on a 5 percent net profit margin, the excise tax
represents the equivalent of a 50 percent income tax. Such a
tax takes money that would otherwise be deployed in new jobs,
R&D, capital equipment and reinvestment in product lines and
redirects it to an entitlement program. It may seem a small
percentage of sales, but as a percentage of pre-tax profits,
this could range from 25 percent to well over 100 percent.
That is simply unacceptable and unwise tax policy--especially
in the current environment that is already struggling to
produce jobs and economic vitality.
Just as important as the effect on current companies is the
impact on investment capital. This new tax will have a
chilling effect on investors who will likely redirect their
capital to other industries not so burdened with industry-
specific taxes. Few investors

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will appreciate the fact that the government gets paid tax
dollars from sales before investors can be paid from profits.
It is a paradigm that creates significant disincentives for
investment. Without capital investment, job creation and
innovation suffer.
We not only support this legislation to repeal the medical
device tax imposed by the 2010 Patient Protection and
Affordable Care Act, we feel it is essential to protecting an
industry vital to Utah's present and future economic growth.
We lend our full support to your efforts.
Sincerely,

Richard R. Nelson,

Founder & CEO,
Utah Technology Council.

Mr. HATCH. Just yesterday, the Governor of Utah, the Honorable Gary
Herbert, sent a letter to Congress addressing the negative impact this
tax will have on our State. He wrote:

As a Governor of a state with a significant concentration
of medical technology manufacturers, I believe this tax could
harm U.S. global competitiveness, stunt medical innovation
and result in the loss of tens of thousands of good paying
jobs.

Now, there is little doubt the President's medical device tax, one
that unfortunately received the vote of every Democrat in the Senate,
will do just that--kill jobs and undercut our economy.
I ask unanimous consent that Governor Herbert's letter be printed in
the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

State of Utah,

Office of the Governor,

Salt Lake City, UT, May 22, 2012.
Speaker John Boehner,
U.S. Capitol,
Washington, DC.
Minority Leader Nancy Pelosi,
U.S. Capitol,
Washington, DC.
Majority Leader Reid,
Hart Senate Office Building,
Washington, DC.
Minority Leader McConnell,
Russell Senate Office Building,
Washington, DC.
Dear Speaker Boehner, Leader Reid, Leader Pelosi, and
Leader McConnell: On behalf of the State of Utah, I am
writing to express my concern over the impact of the 2.3%
excise tax on medical devices set to begin in 2013. As a
Governor of a state with a significant concentration of
medical technology manufacturers, I believe this tax could
harm U.S. global competitiveness, stunt medical innovation
and result in the loss of tens of thousands of good paying
jobs.
As you know, America is the global leader in medical
technology, one of our only manufacturing sectors in which
the U.S. is a net exporter. The United States annually
exports $5.4 billion more medical technology than we import,
and accounts for 40 percent of the global medical technology
market. However, our lead has shrunk dramatically in the last
decade, and we stand to lose further ground.
One of my priorities as Governor is creating an economic
environment in which business can grow and thrive. As part of
this effort, I supported a comprehensive tax reform strategy
that reduced sales, income, and corporate taxes in the State
of Utah by nearly $400 million. In order for our nation to
remain economically competitive, it is time to also reform
our country's tax system.
The United States has not undertaken major business tax
reform since 1986. While the world's economy has changed, our
tax system has not. The medical device tax is an example of a
policy that runs counter to efforts to make American
manufacturing industries more competitive. In fact, the
medical device tax will make our tax system even less
competitive. Worse still, it is already causing layoffs as
companies prepare to absorb its impact.
At a critical time for both the U.S. economy and state
economies, the new tax will undoubtedly stifle economic
growth and job creation. We must have a national tax strategy
that encourages growth, investment, and export industries, to
help create jobs and expand the economy. Therefore, I
strongly urge you to consider legislation that would repeal
the medical device excise tax before it takes effect.
Sincerely,
Gary R. Herbert,
Governor.

Mr. HATCH. The President's health care law is a travesty. The
American people know it. They think it is fundamentally illegitimate,
unconstitutional to its core, and enacted over the deep and loud
objections of citizens and taxpayers.
All 2,700 pages of that law must be stricken from the U.S. Code one
way or another. Eliminating its medical device tax is absolutely
essential. It is critical for our States, for our economy, and for
America's families and workers. I ask my colleagues join the repeal
effort, and I thank my colleagues who have already joined as
cosponsors.
I would like to briefly touch on one other issue that is of great
importance to me and to the people of Utah and others all over the
country. Over 150 million Americans regularly consume dietary
supplements as a means of improving and maintaining their health.
The passage of the Dietary Supplement Health and Education Act, or
DSHEA, in 1994 brought clarity, predictability, and a better
understanding of what the FDA expected from industry and vice-versa.
DSHEA provides an appropriate structure that balances the risks and
benefits to consumers, with continued access and affordability.
Unfortunately, my colleague from Illinois, Senator Durbin, has filed
an amendment to the current bill that would undo that well-balanced
approach. As the author of DSHEA, along with my dear friend and
colleague, Senator Harkin in the Senate, I strongly oppose his
amendment. It would require facilities engaged in the manufacturing,
processing, packing, or holding of dietary supplements to register with
the FDA, provide a description with a list of all ingredients, as well
as a copy of the labeling for each dietary supplement product.
Additionally, the facilities must also register with respect to new,
reformulated, and discontinued dietary supplement products.
While I appreciate my colleague's commitment, his amendment is based
on the misguided presumption that the current regulatory framework for
dietary supplements is flawed and that the FDA lacks authority to
regulate these products. This is simply not the case. Previously FDA
Commissioners, including Drs. Jane Henney, Mark McClellan, Les
Crawford, and Andy von Eschenbach, as well as the former Deputy
Commissioner, Dr. Josh Sharfstein, have all agreed DSHEA provides an
appropriate and sufficient level of oversight of this industry.
Under DSHEA, Congress set out a legal definition of what could be
marketed as a dietary supplement and safety standards that products
have to meet. It allowed the FDA to develop good manufacturing practice
standards and clarified what types of claims could be made. It provided
the Secretary of Health and Human Services with the authority to impose
an immediate ban on any dietary supplement that poses an imminent risk
to public health.
DSHEA already provides the Secretary with enforcement tools of
seizure, injunction, or criminal prosecution for ingredients that pose
an unreasonable risk of illness or injury, are poisonous or
deleterious, contain unapproved drugs or food additives, or fail to
meet good manufacturing practice standards.
Furthermore, under the Dietary Supplement and Nonprescription Drug
Consumer Protection Act, a manufacturer, packer, or distributor whose
name appears on the label is required to report a serious adverse event
related to the use of a supplement within 15 business days to HHS;
submit any related medical information received within 1 year of the
initial report within 15 business days; maintain records related to
each report for 6 years; and permit inspection of such records.
To me, that sounds like a whole lot of regulation. The FDA already
has a tremendous amount of regulatory oversight and enforcement tools
when it comes to dietary supplements. Yet instead of urging FDA to use
its current enforcement authority to find and punish those companies
that are not following the law, Senator Durbin's amendment serves to
punish all responsible companies with its overreaching mandates.
Finally, I would be remiss if I did not mention another obvious
point. Senator Durbin's amendment would have the devastating effect of
piling on more work for an underfunded agency already struggling to
keep above water with its current core responsibilities.
Now, let me just say this: Before we passed DSHEA, there basically
was no regulation over this industry. We brought together, Senator
Harkin and I, the whole dietary supplement industry to get behind
DSHEA. They are behind it. It took over 10 years to get the good
manufacturing practices completed by FDA--more than 10 years, as a
matter of fact. But we provided for them in that agreement. We provided
all the tools that are necessary to supervise and regulate dietary
supplements. To now add other obligations

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onto this industry is just plain not right, and I hope my colleagues in
the Senate and the House of Representatives will recognize this is an
overreach and not put up with it. We are not going to put up with it. I
will be voting against Senator Durbin's amendment, and I urge all of
our colleagues to do the same.
At this point, I pay tribute to my colleague, Senator Harkin from
Iowa. Senator Harkin worked tirelessly on this bill along with me. We
worked all the way through the Senate on a number of occasions on
various things. We have improved the bill from time to time. We have
gone along with the improvements. We have done everything we can to
protect the American citizens with everything that should be done.
Nothing further needs to be done.
This is an industry that deserves support, not condemnation. Senator
Harkin has been there every step of the way. He is a champion for the
dietary supplement industry, as am I, and a lot of others in this body.
I think it is time to quit trying to overregulate everything to death
and cause costs to go up by leaps and bounds. Dietary supplements are
not inexpensive today, although they are a lot less expensive than they
would be if we keep piling on these regulations.
Frankly, we believe we have all of the necessary language in the law
today to protect the American public regarding dietary supplements. We
have given the Food and Drug Administration all the authority they
need, and every FDA Commissioner has met with me, as I recall, since
DSHEA was passed in 1994, and has said they have enough tools to be
able to supervise this industry properly and they don't need anything
more.
To make a long story short, again, this is an overreach by a
colleague, sincere though he may be, and as important as he believes it
to be. I hope he will withdraw his amendment so we don't have to go
through this again. If he won't, I hope our colleagues on both sides of
the aisle--and this is a bipartisan effort--will rise and say we have
had enough of this and let's vote these kinds of amendments down.
I yield the floor.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Mr. President, I thank the Senator from Utah for his
concluding remarks regarding the amendment that I assume will be
offered by the Senator from Illinois, as it is cleared to be offered.
I thank Senator Hatch for his great leadership on the issue of making
sure the American people can have access to healthy, life-supporting
vitamins, minerals and supplements, without having it go through untold
processes and reviews and approvals by the FDA, and all that kind of
regulation.
Senator Hatch was the leader on the DSHEA bill when we passed it in
1994. I was happy to work in tandem with him on that. It has proven,
through the years, to be a great success for the American people. The
American people all over this country take vitamins and other
supplements, and they are living healthier because of this.
I say to my friend that I heard the Senator from Illinois on the
floor yesterday give an impassioned speech about a very sad case about
a young woman who evidently consumed some energy drinks with a lot of
caffeine in them and had heart arrest and died. It is a very sad story.
But as sad as that is, you can't keep people from abusing things.
People also die every year from aspirin poisoning, where they took too
many aspirin.
Reasonableness has to enter into this. We have worked together to
make sure the labels are good on all of these things, so that people
know what is in them. The FDA has the authority--as the Senator said,
every Commissioner has said they have the authority to keep dangerous
products off the shelf and to remove them from the shelf. They have all
that authority. These cases, as I said, that Senator Durbin brought up
are very sad, and you wish it were not so. I don't think it lends
itself, though, to overturning what has been working now for 17, going
on 18, years and working well for the American people.
I join the Senator from Utah, and I hope the amendment might not come
up. But if it does, it does. I am sure there will be some debate on it.
I join with the Senator from Utah in urging all Members of the Senate
to vote that amendment down. If it comes up, I will move to table that
amendment. Hopefully, we can approach this in a much more judicious,
responsible, thinking manner.
I say to my friend from Utah--and I know he agrees--we are not taking
the position that nothing has ever been changed. We have changed DSHEA
in the past to make it work better. We did it after due deliberation,
committee hearings, and going through the process to see what it means
in terms of access to these products by the American people, to make
sure we keep the intent of DSHEA there.
Again, I am more than willing, as chairman of the committee--and the
Senator used to be chairman of the committee at one time, and then
ranking member--we are always willing to look at these things and have
a hearing on them and get more information. Again, I thank the Senator
from Utah, who has been a great leader on this issue.
Mr. HATCH. I thank the Senator from Iowa. I know Senator Durbin is
sincere, but, my gosh, there is enough regulation and regulatory
authority in this bill, including the amendments we have added
voluntarily, to resolve any problem that exists. Frankly, I hope
everybody will vote against the Durbin amendment.
Mr. HARKIN. Mr. President, how much time does this side have on the
bill?
The PRESIDING OFFICER. For general debate, 24\1/2\ minutes.
Mr. HARKIN. I reserve the remainder of my time on the bill. If the
Senator from Illinois wishes to bring up his amendment, we can bring it
up.
Mr. President, again, I understand I have 24 minutes left.
The PRESIDING OFFICER. That is correct.
Mr. HARKIN. I will make a short general statement about the bill. I
talked about it in the past. I want every Senator to know that we are
now on the FDA reauthorization bill. This is reauthorizing the
prescription drug user fee, the medical device user fees, and then we
are authorizing a new program, the generic drug user fee, biosimilar
user fee, and so we are on the bill now. There is 30 minutes for debate
on each amendment that has been listed. Senators know who they are and
what the amendments are.
I want to make it clear that the unanimous consent we just adopted
says that all debate time will expire at 2 p.m. tomorrow. So I say to
Senators, if you want to take your 30 minutes and debate your
amendment, now is the time to do it. If you wait too long, 2 o'clock
will come tomorrow, you won't have the time, and you will be limited to
1 minute. There will be 2 minutes on each amendment after that. Those
who have amendments and wish to discuss them, you are guaranteed at
least 30 minutes, but all time runs out at 2 p.m. tomorrow. If you want
to talk on your amendment and make your point, now is the time to do it
this afternoon.
I yield the floor.
The PRESIDING OFFICER. The Senator from Illinois.

Amendment No. 2127

Mr. DURBIN. Mr. President, I call up amendment No. 2127.
The PRESIDING OFFICER. The clerk will report.
The legislative clerk read as follows:

The Senator from Illinois [Mr. Durbin], for himself and Mr.
Blumenthal, proposes an amendment numbered 2127.

The amendment is as follows:

(Purpose: To require manufacturers of dietary supplements to register
dietary supplement products with the Food and Drug Administration)

At the end of title XI, add the following:

SEC. 11__. REGISTRATION OF FACILITIES WITH RESPECT TO DIETARY
SUPPLEMENTS.

(a) In General.--Section 415(a) (21 U.S.C. 350d(a)) is
amended by adding at the end the following:
``(6) Requirements with respect to dietary supplements.--
``(A) In general.--A facility engaged in the manufacturing
processing, packing, or holding of dietary supplements that
is required to register under this section shall comply with
the requirements of this paragraph, in addition to the other
requirements of this section.
``(B) Additional information.--A facility described in
subparagraph (A) shall submit a registration under paragraph
(1) that includes, in addition to the information required
under paragraph (2)--

[[Page S3483]]

``(i) a description of each dietary supplement product
manufactured by such facility;
``(ii) a list of all ingredients in each such dietary
supplement product; and
``(iii) a copy of the label and labeling for each such
product.
``(C) Registration with respect to new, reformulated, and
discontinued dietary supplement products.--
``(i) In general.--Not later than the date described in
clause (ii), if a facility described in subparagraph (A)--

``(I) manufactures a dietary supplement product that the
facility previously did not manufacture and for which the
facility did not submit the information required under
clauses (i) through (iii) of subparagraph (B);
``(II) reformulates a dietary supplement product for which
the facility previously submitted the information required
under clauses (i) through (iii) of subparagraph (B); or
``(III) no longer manufactures a dietary supplement for
which the facility previously submitted the information
required under clauses (i) through (iii) of subparagraph (B),

such facility shall submit to the Secretary an updated
registration describing the change described in subclause
(I), (II), or (III) and, in the case of a facility described
in subclause (I) or (II), containing the information required
under clauses (i) through (iii) of subparagraph (B).
``(ii) Date described.--The date described in this clause
is--

``(I) in the case of a facility described in subclause (I)
of clause (i), 30 days after the date on which such facility
first markets the dietary supplement product described in
such subclause;
``(II) in the case of a facility described in subclause
(II) of clause (i), 30 days after the date on which such
facility first markets the reformulated dietary supplement
product described in such subclause; or
``(III) in the case of a facility described in subclause
(III) of clause (i), 30 days after the date on which such
facility removes the dietary supplement product described in
such subclause from the market.''.

(b) Enforcement.--Section 403 (21 U.S.C. 343) is amended by
adding at the end the following:
``(z) If it is a dietary supplement for which a facility is
required to submit the registration information required
under section 415(a)(6) and such facility has not complied
with the requirements of such section 415(a)(6) with respect
to such dietary supplement.''.

Mr. DURBIN. Mr. President, this amendment is very straightforward. I
will not ask for a show of hands among Senators, staff, or those who
are following this debate, about how many of them got up this morning
and took a vitamin pill. I did, and I didn't have a prescription. I
bought it voluntarily. I don't know if it does any good, but it was my
decision, right? I voluntarily made that decision. I think that is a
good thing.
The FDA is an agency that looks at what we buy and consume. It has an
important responsibility. When it comes to certain things, such as
prescription drugs, they test them--maybe the pharmaceutical companies
do the testing, but the FDA monitors it to make sure what is given to
you by your doctor is safe, won't kill you, and is effective. The same
thing is true for over-the-counter drugs. The FDA has that
responsibility.
When it comes to the ingredients and the dosage, those things are
established through the FDA based on disclosures by the companies,
testing, experience--it is all there. But there is another world out
there, a completely different world called dietary supplements, which
includes the vitamin I took this morning. That is a much different
world, a world with less disclosure, less transparency, and far less
regulation. In fact, there is no requirement in the law today--none--
that the people who sell us dietary supplements have to register with
the FDA the name of their product, the ingredients it contains, and a
copy of the label.
That is what my amendment says. We don't require any testing by a
dietary supplement company. We don't require any assertions of safety.
It would require simply that they register with the FDA that they are
selling it in America. That, to me, seems pretty basic. It is not my
original idea. It comes from a report of the General Accountability
Office in 2009. They recommended this after they made a review of the
safety issues with the FDA:

To improve the information available to FDA for identifying
safety concerns and better enable FDA to meet its
responsibility to protect the public health, we [the GAO]
recommend that the Secretary of the Department of Health and
Human Services direct the Commissioner of FDA to request
authority to require dietary supplement companies to identify
themselves as a dietary supplement company as part of the
existing registration requirements and update this
information annually; provide a list of all dietary
supplement products they sell and a copy of the labels and
update this information annually, and report all adverse
events related to dietary supplements.

In other words, did you take the pill and get sick? Does that seem
like an onerous, heavyhanded, big government overregulation of an
industry? Remember, the dietary supplement companies are not all based
in the United States. Products are sitting on the shelf which you may
not know come from other countries, including China. Do we want to know
that? Would you want to know the company that is selling you whatever
it is is at least registered in the United States? Is that too much to
ask if you are going to sell the product in the United States, that
they have to register with the FDA and tell us what the ingredients
are? That seems pretty basic to me. I bet that 99 percent of the
American people thought they already had to do that. No. Let me tell
you that dietary supplements go beyond vitamin pills.
Yesterday I told the story on the floor about a 16-year-old girl in
Hagerstown, MD, who drank two Monster Energy Drinks. When you go to the
store, you see Coke and other things there. There are all kinds of them
out there. She drank two of those Monster Energy Drinks and died of
cardiac arrest. I met with her mom yesterday. She stopped breathing
while watching TV. She was dead on the floor. They took her to the
hospital and barely got her back to life for a little while, and then
she died a few days later.
Is it too much to ask of a dietary supplement company that is making
that to tell us what ingredients are in that drink? Is that the heavy
hand of government? I don't think so.
Here is what we have found. Sometimes ingredients that may appear to
be benign and OK today turn out to be dangerous when you look at them
more closely, and maybe more dangerous for people who are younger,
pregnant, or in a compromised immune situation.
This amendment basically says that American consumers have the right
to know the dietary supplements sitting on the shelf have at least been
registered with the FDA. I heard Senators Hatch and Harkin say this
goes too far, it is too much to ask. I think they are wrong.
Manufacturers, some say, voluntarily provide product labels to the
National Institutes of Health. That is true, and it is a voluntary
system. Good actors share their labels with the FDA, but the bad actors
don't do that. The NIH is in the process of developing a label database
that currently has 7,500 dietary supplement labels. Do you know how
many products are on the market? They have 7,500 labels, with 75,000
products--75,000. So 10 percent are volunteering this information. So
to say the NIH already has the information is 90 percent wrong.

Requiring registration, they say, of these labels is just too much
work for the FDA. No, as a matter of fact, the FDA responded to the GAO
recommendation and said: We agree the agency's ability to ensure the
safety of dietary supplements used by consumers would be improved if
FDA had more information on the identity of firms marketing dietary
supplements as well as the identity and compositions of the products
they market. The FDA responded by saying: We want this information to
keep Americans safe.
So to argue this is a burden we shouldn't put on the FDA, well, they
asked for it. The other thing is about how many supplements are being
sold in the United States. I said 75,000. That was the estimate in
2008. The number, I am afraid, is much larger. In terms of how many
come on the market each year, it is just a wild guess because it is the
Wild West. It is an open market. Any country that wants to export their
dietary supplement to the United States--whether it is from China or
India or Africa or Europe or Mexico--be my guest. They don't even have
to show up and register with the FDA.
This is a simple amendment. It just says any company wishing to do
business in the United States, to sell their dietary supplement, must
tell us who they are and what they are selling and what their label
looks like. That is not too much to ask to protect families from some
harmful consequences.
I reserve the remainder of my time.
Mr. President, I ask unanimous consent that the time Senator Hatch
used

[[Page S3484]]

be counted retroactively against the time in opposition to my
amendment, No. 2127.
The PRESIDING OFFICER. Without objection, it is so ordered.
The Senator from Wyoming.
Mr. ENZI. On this amendment, I appreciate the concern, the interest,
and the effort the Senator from Illinois has gone to on this bill. But
in looking at it, there is still a couple of steps missing if this were
to become law. Yes, it would provide a lot of information to the FDA.
It would, in fact, flood them with information, and I think we would
flood them with more information than they could possibly process.
But that part doesn't even bother me. What bothers me is how we get
that information to the consumer. It is the consumer that needs to know
what they are drinking, eating, and everything else. That is why we
provide labeling on a lot of things. But even the things we already
provide labeling on, the consumer doesn't necessarily pay attention to
it. Probably the people who need to pay the most attention to it don't
pay any attention to it. So just making this information available to
the FDA doesn't get it to the point where the consumer can know. Of
course, anytime we start talking in this area, people get worried about
the amount of regulation we put on things they consider to be very
important to them and can do no harm.
The right way to address this important issue is for the HELP
Committee to have hearings and work together, as we have done on this
bill, to find common ground on the policy. When we find common ground,
as we have on this FDA bill, then we can get something done. But I
think this is a little premature. So I hope people will not support
this amendment at this time.
I yield the floor, and I reserve the remainder of my time.
Mr. HARKIN. Mr. President, how much time remains on this amendment?
The PRESIDING OFFICER. Seven minutes in favor of the amendment.
Mr. HARKIN. Mr. President, I just want to say, first of all, that I
have the greatest respect, as he knows, for the Senator from Illinois.
He is one of the true consumer champions in the entire Congress and has
been for all of his time here. So it is kind of hard to argue against
the Senator when he is such a champion of consumers. But on this issue
I think we part a little company.
I want to make it very clear that under DSHEA, supplement labels must
already disclose their ingredients--must disclose their ingredients.
Even when a product is reformulated, if the supplement contains new
ingredients, then the label must reflect that change. These were all
added to the bill. We added that for consumer protection.
Now, again, it is not as though FDA doesn't know what is out there.
Under current law, supplement manufacturers have to biannually register
their products. There is a biannual registration requirement right now.
So the concern is that FDA just doesn't have the resources to do
anything. I have tried--and the Senator knows because he is on the
Appropriations Committee--to get more funds for the FDA to do this, but
we haven't been able to get the funds necessary for the FDA to even do
what jobs they are supposed to do now.
I repeat for emphasis sake that every FDA Commissioner--those
appointed both by Democratic or Republican Presidents--have said the
DSHEA gives them adequate authority to keep dangerous products off the
shelves. So the authority is already there. What the FDA needs is the
resources. That is money. That means appropriations. Quite frankly, I
don't see that happening this year--that we are going to give them any
more. We are just going to give them more of a burden, and I think it
will give a false sense of security to people because FDA simply won't
be able to do that.
Lastly, as the Senator did say, we do have a voluntary program for
ingredients and things with the dietary supplements with the National
Institutes of Health that is already in place. That is coupled with the
biannual reporting requirements plus the fact every dietary supplement
has to have the ingredients listed on the label. So there is plenty of
consumer protections out there. It is just that we can't protect a
consumer who doesn't want to follow directions, who doesn't want to
follow the guidelines listed on the labels themselves. I don't know how
to protect people from that. Sometimes we just have to continually tell
people to follow the directions. If they follow the directions, they
will be fine.
That is why I think this amendment is ill-timed. I said to the
Senator, and I mean this, that the Senator from Utah and our committee
would be more than happy to have hearings again to flesh it out a
little more and to see just what might be possible. But I come down to
this as the bottom line: The FDA needs more money and they need more
personnel to do this job.
I yield the floor.
Mr. DURBIN. Mr. President, how much time remains on my amendment?
The PRESIDING OFFICER. Seven minutes.
Mr. DURBIN. On my side?
The PRESIDING OFFICER. On the Senator's side.
Mr. DURBIN. Any time remaining on the opposite side?
The PRESIDING OFFICER. One minute.
Mr. DURBIN. Mr. President, I respect the Senator from Iowa and the
Senator from Wyoming as well. They are two excellent colleagues, good
people, and this is a tough bill. The underlying bill is a masterpiece
of bipartisan accomplishment they can both be proud of.
What I am saying about dietary supplements is no reflection on
Senators Harkin or Enzi. This is an industry I have been watching for a
long time for a variety of reasons.
I would say the argument Senator Enzi made--that merely disclosing
the label ingredients and name of the product to the FDA doesn't get to
the consumer--argues for a bigger amendment than I am offering. It
argues for a Web site and access and so forth. I understood that going
in, and I agree with Senator Harkin that is an overreach in this time
of budgetary problems. I wish we could do it. I think we should. I
think we have an obligation to. But I didn't put it in here because I
knew the first thing that would be said is we can't afford it.
So we went to the FDA and said: Do you want this information?
They said: Not only do we want it, we have already publicly stated we
want it in reply to the GAO report.
We said: Can you handle it if we send you the basic information of
the products presently being sold?
They said: Yes.
I could go further and say more can be done, but that calls for a
bigger role of government than even this amendment suggests. But when
the Institute of Medicine tells us that each year there are 1,000 new
products--dietary supplements--being placed on shelves all across
America in stores and drugstores, where families and children are
walking in and buying them, how does anyone argue we shouldn't know
they are here; that we don't want that Chinese product that just made
it to the shelf in Springfield, IL, to register with the FDA before
they do business here? How do you make that argument?
Shouldn't we assume, as a consumer, a family member, that when we
walk in the store that somebody somewhere knows this company exists,
that this product exists? Right now, they do not. The only disclosure
to the government is voluntary. As I said, about 1 out of 10 companies
volunteers the information. That, to me, is not the way to protect
consumers.
Why do we need this information? Simply put, when an ingredient turns
out to be dangerous, we want to know if that ingredient is in more than
one product and then go after it to protect American consumers. If we
don't know the product is in the United States, and we don't know what
the ingredients are, how are we going to find that out? Wouldn't we
want that basic information?
God forbid something happens with one of these products and someone
loses their life, like this poor young girl in Hagerstown, MD, who
drank that Monster Energy Drink. She had two of them, and it killed
her, put her in cardiac arrest. God forbid that happens again and we
say: You know, we didn't even know that product was in America because
they don't have to tell anybody anything.
The argument made by Senator Harkin is they have to put a label on
the product. That is a good thing. We also

[[Page S3485]]

found out that sometimes the ingredients listed aren't the actual
ingredients. I will not get into that because that is another whole
issue the FDA is working on. But that isn't enough. My colleagues
should see some of the claims being made on the labels of these dietary
supplements. They are preposterous. Not for all of them, some are basic
and good, but some go way overboard.
Don't we owe it to consumers across America to give them the basic
information, to at least let them know we know the name of the company
and the ingredients in the product sold? Some people say they ought to
be able to sell whatever they want in America and never tell a soul. I
don't believe that. I think we have a responsibility in Congress to
protect these families.
I reserve the remainder of my time.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Just one minor correction I would make, and that is under
the DSHEA law, the FDA must approve any health claims made by any
dietary supplement or vitamin. The only health claims they can make are
structure function claims, but they have to be approved by the FDA. I
just wanted to clear up that point.
I would also say further that I honestly don't know of any vitamin or
supplement that is out there in the market that is dangerous if taken
as directed--if taken as directed. As I said, anybody can abuse things.
But if taken as directed, I, quite frankly, don't know of any
supplement out there that is dangerous. Quite frankly, if taken as
directed, they help maintain people's health and keep them healthy
rather than being injurious to their health.
I yield the floor.
Mr. DURBIN. Mr. President, how much time remains?
The PRESIDING OFFICER. Three minutes.
Mr. DURBIN. I will just close.
I thank the Senator from Iowa. He will acknowledge, I hope, that no
one tests dietary supplements. No one tests them. Companies that make
these products may test them if they wish, but there is no requirement
under the law that they test them. There is certainly no agency of
government that tests the dietary supplements. So to say they are
perfectly safe as they instruct people to take them on the label, how
would we know that? How could we possibly know that? There is no
testing involved.
When it comes to prescription drugs and over-the-counter drugs, there
is testing involved. At least we can point to the test to say whether
it is safe and effective. Dietary supplements is a whole different
world. I will just say that we are conscientious enough on behalf of
consumers to limit the amount of caffeine that can be put in a cola,
but then a company such as this Monster drink company decides to call
theirs a dietary supplement rather than a beverage or a food, and it is
no holds barred. They can put in as much as they want. That is why that
poor girl died. Two Monster Energy Drinks--480 milligrams, I believe,
of caffeine--and she died from cardiac arrest. Is it too much to ask
that we know the ingredients and know the company?
The next time there is another tragedy, I would like to be sure we
can say we at least took this modest, tiny, small step forward to say
to the industry: If you are a good actor, don't be threatened. But when
it comes to bad actors and things coming in from overseas, we are going
to make you show up and identify who you are and what you are selling,
period. That is it.
So at this point, I yield the floor and yield back the remainder of
my time.
I suggest the absence of a quorum.
The PRESIDING OFFICER. 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. Again, Mr. President, I have to ask, how much time
remains on the bill for both sides?
The PRESIDING OFFICER. The majority has 19 minutes and the minority
has 29 minutes.
The PRESIDING OFFICER (Mr. Casey). The Senator from Vermont.

Amendment No. 2109

Mr. SANDERS. Mr. President, I thank the chairman for his hard work on
this legislation and for the opportunity to talk about what I consider
to be a very important amendment.
I ask unanimous consent to call up my amendment No. 2109.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will report.
The assistant legislative clerk read as follows:

The Senator from Vermont [Mr. Sanders] proposes an
amendment numbered 2109.

Mr. SANDERS. I ask unanimous consent that reading of the amendment be
dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To revoke the exclusivity of certain entities that are
responsible for violations of the Federal Food, Drug, and Cosmetic Act,
the False Claims Act, and other certain laws)

At the end of title XI, add the following:

SEC. 11__. CONDITIONS ON AWARD OF DRUG EXCLUSIVITY.

Subchapter E of chapter V (21 U.S.C. 360bbb et seq.) is
amended by inserting after section 569C, as added by this
Act, the following:

``SEC. 569D. CONDITIONS ON AWARD OF DRUG EXCLUSIVITY.

``(a) Termination of Exclusivity.--Notwithstanding any
other provision of this Act, any period of exclusivity
described in subsection (b) granted to a person or assigned
to a person on or after the date of enactment of this section
with respect to a drug shall be terminated if the person to
which such exclusivity was granted or any person to which
such exclusivity is assigned--
``(1) commits a violation described in subsection (c)(1)
with respect to such drug; or
``(2) fails to report such a violation as required by
subsection (e).
``(b) Exclusivities Affected.--The periods of exclusivity
described in this subsection are those periods of exclusivity
granted under any of the following sections:
``(1) Clause (ii), (iii), or (iv) of section 505(c)(3)(E).
``(2) Clause (iv) of section 505(j)(5)(B).
``(3) Clause (ii), (iii), or (iv) of section 505(j)(5)(F).
``(4) Section 505A.
``(5) Section 505E.
``(6) Section 527.
``(7) Section 351(k)(7) of the Public Health Service Act.
``(8) Any other provision of this Act that provides for
market exclusivity (or extension of market exclusivity) with
respect to a drug.
``(c) Violations.--
``(1) In general.--A violation described in this subsection
is a violation of a law described in paragraph (2) that
results in--
``(A) a criminal conviction of a person described in
subsection (a);
``(B) a civil judgment against a person described in
subsection (a); or
``(C) a settlement agreement in which a person described in
subsection (a) admits to fault.
``(2) Laws described.--The laws described in this paragraph
are the following:
``(A) The provisions of this Act that prohibit--
``(i) the adulteration or misbranding of a drug;
``(ii) the making of false statements to the Secretary or
committing fraud; or
``(iii) the illegal marketing of a drug.
``(B) The provisions of subchapter III of chapter 37 of
title 31, United States Code (commonly known as the `False
Claims Act').
``(C) Section 287 of title 18, United States Code.
``(D) The Medicare and Medicaid Patient Protection and
Program Act of 1987 (commonly known as the `Antikickback
Statute').
``(E) Section 1927 of the Social Security Act.
``(F) A State law against fraud comparable to a law
described in subparagraphs (A) through (E).
``(d) Date of Exclusivity Termination.--The date on which
the exclusivity shall be terminated as described in
subsection (a) is the date on which, as applicable--
``(1) a final judgment is entered relating to a violation
described in subparagraph (A) or (B) of subsection (c)(1); or
``(2)(A) a settlement agreement described in subsection
(c)(1)(C) is approved by a court order that is or becomes
final and nonappealable; or
``(B) if there is no court order approving a settlement
agreement described in subsection (c)(1)(C), a court order
dismissing the applicable case, issued after the settlement
agreement, is or becomes final and nonappealable.
``(e) Reporting of Information.--A person described in
subsection (a) that commits a violation described in
subsection (c)(1) shall report such violation to the
Secretary no later than 30 days after the date that--
``(1) a final judgment is entered relating to a violation
described in subparagraph (A) or (B) of subsection (c)(1); or
``(2)(A) a settlement agreement described in subsection
(c)(1)(C) is approved by a court order that is or becomes
final and nonappealable; or

[[Page S3486]]

``(B) if there is no court order approving a settlement
agreement described in subsection (c)(1)(C), a court order
dismissing the applicable case, issued after the settlement
agreement, is or becomes final and nonappealable.''.

Mr. SANDERS. Mr. President, this amendment, to my mind, is an
extremely important amendment and it has the support of some of the
major consumer organizations in our country, including Public Citizen,
U.S. PIRG, the Consumer Federation of America, Consumers Union, the
National Committee to Preserve Social Security and Medicare, and the
National Women's Health Network. These are some of the large consumer
organizations in America representing tens of millions of our people.
When we talk about prescription drugs, it is important to understand
that in our country we pay by far the highest prices in the world for
prescription drugs. That is simply the reality. That causes enormous
problems because millions of our people go to the doctor, the doctor
writes a prescription, and then the person can't afford to fill that
prescription. That is pretty crazy, because doctors are doing the
diagnosis, telling the patients what they need; patients can't afford
to pay for the drugs because they are the highest prices in the world
in this country. This is an issue we have to deal with.
There are a number of reasons why prices in this country are higher
than in Canada, Europe, and Scandinavia. Certainly one of them is that
we are the only major country on Earth that doesn't have a national
health care program so that the government can negotiate prices with
the drug companies. So what happens in this country is the drug
companies simply charge us what the market will bear--any price they
can come up with by which they can make money. The end result is that
in 2009, prices in this country were 85 percent higher than Canada, 150
percent higher than France, Italy, Sweden, Switzerland, and so forth
and so on.
But the reason drug prices are high in this country is not just that
we don't have a national health care program, it is because of the
enormous amount of fraud that takes place within the pharmaceutical
industry. In fact, every single year the major drug companies are
ripping off the American people to the tune of billions of dollars a
year because of fraudulent practices.
While I do not have enough time here today to recite every example of
fraud that has been caught and prosecuted in the last 10 years. But
here is the bottom line--and I am going to list some of the cases of
fraud. Virtually every major pharmaceutical company in this country has
either been convicted of fraud--i.e., ripping off the Federal
Government, State government, or individuals--or else has reached a
settlement. We have got to get a handle on this crisis. I am going to
bore some people because it is a long list. Sadly, it is a long list.
But it is a list that has to get out, and it is an issue we have got to
deal with.
Abbott Labs is one of the top 10 pharmaceutical companies in the
world. It had $38.8 billion in revenues and $4.7 billion in profits in
2011. Last month, Abbott reached an agreement with the U.S. Department
of Justice to pay $1.6 billion for illegally marketing the antiseizure
drug Depakote. According to the New York Times:

As part of the agreement, Abbott said that it would pay
$800 million to resolve civil cases brought by federal and
state authorities, $700 million in criminal penalties and
$100 million to states in connection with consumer protection
matters.

That was just last month, they are going to pay $1.6 billion.
In 2010, 2 years ago, Abbott and two smaller companies collectively
agreed to pay $429 million to settle charges that they deliberately
misreported drug pricing in order to hike reimbursements from Medicare
and Medicaid. That is Abbott in recent years.
Pfizer is the largest pharmaceutical company in the world, $67.9
billion in revenues and $10 billion in profits in 2011. Pfizer in 2012,
this year, allegedly avoided paying hundreds of millions in rebates due
to State Medicaid Programs for Prontonix. Pfizer holds four different
exclusives for Prontonix. Talks are under way with the U.S. Department
of Justice to settle the charges for up to $2 billion for ripping off
Medicaid.
In 2009, Pfizer agreed to plead guilty to a felony of ``misbranding
Bextra with the intent to defraud or mislead'' and to pay $1 billion to
resolve allegations under the civil False Claims Act.
In 2004, a division of Pfizer pled guilty to two felonies and agreed
to pay $430 million to settle charges that it fraudulently promoted the
drug Neurontin for a string of unapproved uses.
Johnson & Johnson is the second largest pharmaceutical company in the
world, which had $65 billion in revenues and almost $10 billion in
profits in 2011.
In 2012, this year, Johnson & Johnson illegally marketed Risperdal,
an antipsychotic medication, to nursing home patients, and paid over $2
billion in fines, which constituted a mere 6.3 percent of sales revenue
from the drugs.
In 2010, two subsidiaries of Johnson & Johnson illegally marketed the
epilepsy drug Topamax for off-label psychiatric uses.
Now we go to Merck. Merck is the third largest pharmaceutical company
in the world. In 2011, last year, Merck pleaded guilty to a criminal
misdemeanor charge for violation of the Food, Drug, and Cosmetic Act,
and paid a $950 million settlement for illegally promoting Vioxx for
rheumatoid arthritis before that use was approved.
In 2011, Merck will pay the State of Massachusetts $24 million to
settle claims that former subsidiary Warrick Pharmaceuticals reported
inflated and false prices for asthma medications, causing the State's
Medicaid Program to overpay.
In 2008, Merck reached a $670 million settlement for fraud on
patients and Medicare/Medicaid, involving a conspiracy with hospitals
to give the elderly cheaper drugs but charging them for the more
expensive product.
Now we go to GlaxoSmithKline. GlaxoSmithKline is, again, one of the
largest pharmaceutical companies in the world. It made profits of
almost $44 billion in 2011.
GlaxoSmithKline in 2011 announced that it had reached an ``agreement
in principle'' with the U.S. government to pay $3 billion to conclude
the company's most significant ongoing Federal Government
investigations, specifically illegal sales and marketing practices in
Colorado and Massachusetts; overcharging the Medicaid rebate program;
and illegal development and marketing of Avandia, a diabetes drug.
In 2006, GlaxoSmithKline agreed to pay $14 million to settle
allegations that it engaged in patient fraud.
In 2005, GlaxoSmithKline paid $150 million to settle claims it
overcharged the government for two antinausea drugs.
In 2003, GlaxoSmithKline signed a corporate integrity agreement and
paid $88 million in a civil fine for overcharging Medicaid.
And on and on and on it goes.
When we talk about the high cost of health care, when we talk about
the fact that the United States has the highest prices in the world for
prescription drugs, it is important for us to address the crisis in
terms of fraud within the pharmaceutical industry and the fact that
virtually every major drug company has been found guilty of fraud or
reached a settlement in terms of fraud charges.
In 2010, the pharmaceutical industry achieved a dubious distinction.
It surpassed the notoriously corrupt defense contracting industry in
defrauding the government. The pharmaceutical industry accounted for
nearly half--$1.8 billion of a total of $4.1 billion--of the penalties
collected in 2011 by the Department of Justice/Health and Human
Services Health Care Fraud and Abuse Control Program.
In 2012--and this is quite amazing--the pharmaceutical industry is
expected to pay out up to four times the amount of last year's penalty,
between $8 billion to $9 billion in penalties due to pending fraud
settlements with the Department of Justice. And those are the penalties
for fraud that has been discovered. Who knows what type of fraud is
taking place on behalf of the drug companies that has not been
discovered.
Let me recapitulate. Virtually every major drug company has either
been found guilty of, or settled charges of, significant fraud over the
last 10 years.
The question arises--and this is an important question--is fraud
within

[[Page S3487]]

the pharmaceutical industry the exception or, is it, simply put, their
business model? Is fraud the business model of the pharmaceutical
industry, which thinks that in most cases they can get away with the
fraud, make huge profits and, in some cases when they get caught, they
will in fact pay a penalty but the penalty will in no way match the
kinds of huge profits they are making from their fraudulent activity?
The question the Senate has got to address is, Do we look away from
this issue, do we ignore this issue, or do we finally address the very
important issue of fraud within the pharmaceutical industry, fraud
being practiced by virtually every drug company in our country?
It is obvious to anyone paying attention to the prevalence of
pharmaceutical industry fraud that our punishments are not enough to
address this problem, because apparently the drug companies are not too
intimidated by the laws on the books. They think it makes business
sense for them to continue going forward on their fraudulent
activities.
The amendment I am offering would send a strong and clear message to
the drug industry: Illegal behavior will not be rewarded with continued
government-granted monopolies. There are some things--patients' safety,
the devotion of scarce public resources to provide health care to needy
patients--that are more important than drug company profits.
This amendment is designed to effectively deter pharmaceutical fraud
by making government-granted monopolies contingent on good corporate
behavior. I think that is the least we can do.
This amendment would penalize any instance of pharmaceutical fraud
resulting in a civil or criminal judgment or a settlement with an
acknowledgement of fault by revoking any applicable data or marketing
exclusivity for the particular drug or product involved in the
fraud. giving pharmaceutical companies another factor to consider, when
weighing whether to violate the law in their sales or billing
practices.

If a company violated Federal or State law by inflating the price of
a drug in Medicare or Medicaid billing or illegally marketing a
medication, under my amendment that company would lose the remainder of
any exclusivity period for that medication. Companies would be required
to self-report qualifying violations to the FDA within 30 days.
Let me conclude by saying this: Our people are paying the highest
prices----
The PRESIDING OFFICER. The time of the Senator has expired.
Mr. SANDERS. I ask unanimous consent for 1 additional minute.
The PRESIDING OFFICER (Mr. Durbin). Without objection, it is so
ordered.
Mr. SANDERS. Our people are paying the highest prices in the world
for prescription drugs. One of the reasons is widespread fraudulent
activity on the part of virtually every major drug company in our
country. It is no longer acceptable to turn a blind eye to that crisis.
The time to act is now. This amendment would go a long way forward to
ending that outrageous fraud. I ask the support of my colleagues for
this amendment.
I yield the floor.
The PRESIDING OFFICER (Mr. Merkley). The Senator from Wyoming.
Mr. ENZI. Mr. President, I appreciate the concern by the Senator from
Vermont, but I have to oppose the amendment, No. 2109, because of some
of the unintended consequences it will have.
This amendment would require drug companies to forfeit exclusivity
for certain violations of the Federal Food, Drug, and Cosmetic Act and
other laws.
``Exclusivity'' means exclusive market rights granted by the Food and
Drug Administration upon approval of a drug. It may or may not run
concurrently with a patent. Exclusivity is a very important type of
intellectual property protection. Without it, innovators cannot
predictably obtain returns on their drug development investments.
The stated purpose of the amendment is to combat healthcare related
fraud. The premise is, if companies know their profits are at risk,
they will be strongly discouraged from engaging in fraudulent activity.
But this amendment is counterproductive: It will make it more costly
for law enforcement to fight fraud and could hurt patients.
Congress is also thinking of ways to improve healthcare antifraud
programs. For example, in a recent open letter to the health care
community, six members of the Senate Finance Committee, led by Chairman
Baucus and Ranking Member Hatch, announced a bipartisan effort to
solicit ideas from the healthcare community on ways to reduce
healthcare waste, fraud and abuse.
Estimates of the amount of fraud and misspending in Medicare and
Medicaid vary widely, from $20 billion to as much as $100 billion. To
address this problem, the six Senators solicited ideas on program
integrity and fraud and abuse enforcement reforms.
This sort of constructive search for real solutions is long overdue.
Healthcare fraud is a serious problem, and I strongly agree that the
Congress should develop substantive solutions to it.
The problem here is, the pending amendment does not really tackle the
problem of fraud.
Instead, the amendment uses a blunt instrument--revocation of
exclusivity--to punish an incredibly broad range of legal violations.
This amendment would discourage settlements in fraud cases. A
settlement agreement concerning a listed violation would trigger
forfeiture.
If a company knows that settlement would trigger a result that could
cost it hundreds of millions of dollars, it will be less likely to
settle. This will make it harder for the government to settle cases,
and increase the backlog of cases waiting for trial. It also creates
the risk that a fraudster could prevail or appeal, and prevent the
prosecutor from pursuing other cases.
Settlement is an important tool in a prosecutor's toolkit. It enables
them to pursue a higher volume of cases, while still obtaining sizable
judgments to deter future fraud.
In fiscal year 2011, the Departments of Justice and Health and Human
Services together recovered nearly $4.1 billion in taxpayer dollars
through healthcare anti-fraud prevention and enforcement efforts. The
ability to settle claims contributed substantially to this achievement
by allowing the government to pursue a higher volume of cases.
Within the Federal Food, Drug, and Cosmetic Act itself, there are
already robust standards and enforcement tools concerning industry
marketing and communications, and interactions with healthcare
providers and professionals.
The False Claims Act and strong anti-kickback laws are also on the
books already.
This amendment will also discourage manufacturers from developing new
cures. It creates tremendous uncertainty about whether investors can
obtain returns on their drug development investments. If a trivial
violation of FDA's detailed, elaborate regulations could put the entire
investment in a drug at risk, it will discourage investment in new
treatments.
This would severely threaten biomedical investment and jobs. More
importantly, it would lead to fewer life-saving therapies for patients.
This amendment could produce absurd results. For example, the
amendment would revoke exclusivity for a civil judgment concerning
adulteration of a drug. A drug is considered adulterated if a
manufacturer violates FDA's current Good Manufacturing Practices, known
as cGMPs. There is no intent requirement, and no minimum number of
inspection requirements to trigger liability. Some examples of cGMP
violations include: Washing and toilet facilities are not easily
accessible to working areas; adequate lighting is not provided in all
areas; laboratory records do not include complete records of the
periodic calibration of laboratory instruments.

It obviously does not make sense to strip drug companies of
exclusivity for violations like this, which do not reflect fraudulent
intent. It is disproportionate and counterproductive.
Again, I strongly agree that healthcare fraud is a significant
problem. The best way to solve it is through robust enforcement of the
many current laws on point, and continuing to work with the health care
community to find effective solutions.

[[Page S3488]]

That would be going through committee hearings as well. The pending
amendment would not reduce fraud. On the contrary, it would frustrate
the government's current anti-fraud efforts, and ultimately harm
patients and taxpayers alike.
I encourage a ``no'' vote on this amendment.
I yield the floor and reserve the remainder of our time.
Mr. COBURN. I ask unanimous consent that the pending amendment be set
aside and that Coburn amendment No. 2131 be called up.
Mr. HARKIN. Mr. President, I object. How much time is left on the
Sanders amendment?
The PRESIDING OFFICER. The Senator from Vermont has no time left. The
Senator from Wyoming controls 10 minutes.
Mr. HARKIN. Will the Senator from Oklahoma withhold? We have some
people who want to speak. Once the time has run, then we automatically
move on to another amendment and could bring up the Senator's amendment
at that point.
Mr. COBURN. It is my understanding that the time is under our
control. At present, there is 10 minutes left.
Mr. HARKIN. There is 10 minutes in opposition to the amendment.
Mr. COBURN. I will be happy to yield to the ranking member. If he has
people who wish to speak in opposition, that is fine.
Mr. HARKIN. Senator Mikulski was here earlier. She wants to speak on
this amendment. If we just wait 5 minutes?
The PRESIDING OFFICER. The Senator from Maryland.
Ms. MIKULSKI. Mr. President, first I thank my colleague from
Oklahoma. I just want to take a few minutes, if I could, to talk about
an important issue.
Mr. HARKIN. I am sorry, I was wrong. I thought the Senator wanted to
speak on the Sanders amendment. She wanted to speak on the underlying
bill itself?
Ms. MIKULSKI. Yes.
Mr. HARKIN. The Senator just seeks 5 minutes?
Ms. MIKULSKI. Or less.
Mr. HARKIN. Since it is my time, I yield the Senator from Maryland 5
minutes on the underlying bill.
Ms. MIKULSKI. I will be very brief.
The PRESIDING OFFICER. The Senator from Maryland.
Ms. MIKULSKI. Mr. President, I say to our colleague from Oklahoma,
himself a physician, that he will be very keenly interested in this
issue of prescription drug shortages. This is a problem that has been
brought to my attention by Marylanders, leaders of great institutions
such as the University of Maryland and Hopkins, as well as family
members who care for someone and find that, although there has been the
right diagnosis and there is even the right drug to care for that
problem--like the dread ``cancer'' word--the drug is not available. So
you can imagine the last thing you want to hear is that your child has
cancer, and then the worst thing you want to hear is that there is a
shortage of that drug to take care of that child. That is not because
it has not been developed, not because there has not been a scientific
breakthrough, but because there has been a manufacturing problem or
because the company stopped making the drug when it was no longer
profitable. That is inexcusable. The bill before us does something
about it.
In 2011 we had more than 250 drug shortages. That is not incidents,
that is 250 drugs that were in shortage. Half of the drugs that
experience a shortage go into shortage multiple times.
This drug shortage threatens public health by preventing patients and
physicians from accessing needed medications. It forces doctors to
often delay medical procedures, use alternative products that may carry
unwanted side effects or to rely on foreign versions of drugs that
might not have been reviewed by FDA or it sends their very able
pharmacists in their institutions to spend endless hours on the phone
to be able to come up with the needed drug.
As I said, this was brought to my attention by letters from some
famous constituents--meaning well-known in our community--with great
health insurance who had a child who had leukemia and then found the
drug was in short supply. We heard from doctors who were forced to
delay or turn to alternative treatments, hospitals scrambling to manage
these shortages, and pharmacists trying to track down needed
treatments. Even then, we heard about gouging and we heard about a gray
market. The gouging was pumping up the price when there was a shortage,
and then there is a gray market where you can go to buy these drugs,
but they might not be the drug you wanted or they might have been on
somebody's shelf a long time and were flawed and even dangerous or they
had not been refrigerated.
I could go through one horror story after another. I wanted to bring
this to the attention of the full Senate because as we work on this
excellent, bipartisan bill on user fees, what we also have is a very
commonsense way of dealing with the drug shortage issue.
It has the support of the private sector and certainly those who care
for patients, as well as patients themselves. I hope we pass this
underlying bill, and I hope we do not tie up this legislation with
amendments that could either derail or deter it.
I yield the floor.
Mr. HARKIN. Mr. President, how much time is remaining on the Sanders
amendment?
The PRESIDING OFFICER. There is 7 minutes in opposition that remains
on the Sanders amendment.
Mr. HARKIN. I will yield myself a couple of minutes.
I join with my colleague Senator Enzi in opposition to the Sanders
amendment. We are all disturbed by a lot of what we are reading and
these big settlements. I know the recent one a couple of weeks ago on
Abbott Labs where part of the prosecution case was actually that this
was part of their business model. Then they had to settle it. So this
is all very disturbing.
However, that cries out more for, perhaps, looking at the criminal
charges and perhaps strengthening some of those things but not taking
away exclusivity. If you do that, a lot of times you could take away
exclusivity from someone who just committed a misdemeanor. A lot of
these settlements were misdemeanor charges where no intent was shown.
A lot of times, if you did this, you might penalize someone who maybe
had done something wrong in the past, and now maybe they have new
leadership, a new company, and reformed themselves, and now they have
to lose their exclusivity? You would not want to do that.
Third, if you do this--I think Senator Enzi pointed this out
correctly--if there is no reason to settle, then people are going to go
to the wall in terms of defending themselves, and DOJ doesn't have all
that kind of personnel and the time to do that. I think we would then
have an even worse situation of people committing fraud because then
they would know they would not have any reason to settle it whatsoever.
Settlement is a good tool to be used by prosecutors to get cases to
justice, to make sure consumers are made whole, and to let people know
they are being watched. That is what they do.
I think the Sanders amendment, while maybe well-intentioned--I know
it is well-intentioned. I know the Senator has all good intentions of
what he wants to do. But I think it goes too far and is not the right
solution to that problem. So I would oppose Senator Sanders amendment
also.

I yield the floor.
The PRESIDING OFFICER. The Senator from Oklahoma.

Amendment No. 2131

Mr. COBURN. I ask unanimous consent that the pending amendment be set
aside, and I call up amendment No. 2131, which is at the desk, and ask
that it be reported.
The PRESIDING OFFICER. Without objection, it is so ordered.
The assistant legislative clerk read as follows:

The Senator from Oklahoma [Mr. Coburn], for himself, and
Mr. Burr, proposes an amendment numbered 2131.

Mr. COBURN. Mr. President, I ask unanimous consent that the reading
of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To require an independent assessment of the Food and Drug
Administration's review of drug applications)

At the end of title VII, add the following:

SEC. 7__. INDEPENDENT ASSESSMENT.

(a) In General.--The Secretary shall contract with a
private, independent consulting

[[Page S3489]]

firm capable of performing the technical analysis, management
assessment, and program evaluation tasks required to conduct
a comprehensive assessment of the process for the review of
drug applications under subsections (b) and (j) of section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(b), (j)) and subsections (a) and (k) of section 351 of
the Public Health Service Act (42 U.S.C. 262(a), (k)). The
assessment shall address the premarket review process of
drugs by the Food and Drug Administration, using an
assessment framework that draws from appropriate quality
system standards, including management responsibility,
documents controls and records management, and corrective and
preventive action.
(b) Participation.--Representatives of the Food and Drug
Administration and manufacturers of drugs subject to user
fees under part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.)
shall participate in a comprehensive assessment of the
process for the review of drug applications under section 505
of the Federal Food, Drug, and Cosmetic Act and section 351
of the Public Health Service Act. The assessment shall be
conducted in phases.
(c) First Contract.--The Secretary shall award the contract
for the first assessment under this section not later than
March 31, 2013. Such contractor shall evaluate the
implementation of recommendations and publish a written
assessment not later than February 1, 2016.
(d) Findings and Recommendations.--
(1) In general.--The Secretary shall publish the findings
and recommendations under this section that are likely to
have a significant impact on review times not later than 6
months after the contract is awarded. Final comprehensive
findings and recommendations shall be published not later
than 1 year after the contract is awarded.
(2) Implementation plan.--The Food and Drug Administration
shall publish an implementation plan not later than 6 months
after the date of receipt of each set of recommendation.
(e) Scope of Assessment.--The assessment under this section
shall include the following:
(1) Identification of process improvements and best
practices for conducting predictable, efficient, and
consistent premarket reviews that meet regulatory review
standards.
(2) Analysis of elements of the review process that consume
or save time to facilitate a more efficient process. Such
analysis shall include--
(A) consideration of root causes for inefficiencies that
may affect review performance and total time to decision;
(B) recommended actions to correct any failures to meet
user fee program goals; and
(C) consideration of the impact of combination products on
the review process.
(3) Assessment of methods and controls of the Food and Drug
Administration for collecting and reporting information on
premarket review process resource use and performance.
(4) Assessment of effectiveness of the reviewer training
program of the Food and Drug Administration.
(5) Recommendations for ongoing periodic assessments and
any additional, more detailed or focused assessments.
(f) Requirements.--The Secretary shall--
(1) analyze the recommendations for improvement
opportunities identified in the assessment, develop and
implement a corrective action plan, and ensure it
effectiveness;
(2) incorporate the findings and recommendations of the
contractors, as appropriate, into the management of the
premarket review program of the Food and Drug Administration;
and
(3) incorporate the results of the assessment in a Good
Review Management Practices guidance document, which shall
include initial and ongoing training of Food and Drug
Administration staff, and periodic audits of compliance with
the guidance.

Mr. COBURN. Mr. President, let me say how proud I am of all of the
members of the HELP Committee on this difficult and complicated issue
they are bringing before us. Having been in business and under the
control of the FDA as a medical device manufacturer, this is a very
complicated area of law that, if done right, will have tremendous
positive effects, and I think the Senators have put out a very good
bill. I congratulate my colleagues and all the members on doing that.
I have two amendments, and I am going to speak for a very short
period of time on both of them. I will work with the ranking member and
the chairman to see if we can't get to where we don't have to vote on
them.
I would like to give just a little history on PDUFA and MDUFA. The
reason they were set up in the first place was to help fund the FDA,
and the reason the manufacturers agreed to do that was to get more
timeliness in terms of response to their applications. That was the
whole basis for it. And what we have before us today is some
improvement in terms of the FDA's response but really not everything we
should have gotten.
I, along with Senator Burr, asked for a GAO study to the FDA in terms
of meeting stated performance goals, and we found out a whole lot about
that, and that is my next amendment, but I say that to preface why I
have this amendment.
In this bill is a wonderful requirement that causes the FDA to
contract with an independent management company to assess the
management of the missions and resources of the device regulation
component of the FDA. What is missing is that same independent review
in terms of drugs. It is one of those situations where we invest in
something that would pay us additional big dividends. I know it will
pay big dividends in the device area. It will also pay big dividends in
the drug area. I don't know what the workings of the committee are and
why they decided not to put this in as far as the drug review process,
but having a second look at a very complicated regulatory and approval
structure could be very beneficial in terms of improving both the
quality of the outcome as well as the timeliness.
So this amendment simply says that what we are going to do for the
device, which is in the bill already, we are also going to do for the
drug side of the FDA. It is about gathering knowledge for both the FDA
and for us as we help this agency perform very needed things.
As a physician, I read a lot about new science on new drugs. The
things that are coming in this country are going to be phenomenal in
terms of new treatments and new drugs and new capabilities. In terms of
our competitiveness worldwide but also in terms of how we address these
diseases, we need to have the most efficient regulatory agency we can.
All I am asking is that we treat all of the FDA the same in terms of
taking a look at how well they are doing, what could they do better,
and how they could do it better. That report comes to us and the FDA,
and so we can see the weaknesses. We have not been through every area
of the FDA as Members of the Senate, and to have an independent
assessment of the drug side as well as the device side will pay huge
benefits to the FDA, but mostly it will pay huge benefits to people of
this country in terms of the timeliness of drug presentation.
I won't speak any more to that. It is a commonsense, good-government
amendment. Part of it is in the bill, and part of it is not in the
bill. It is something that will pay us big dividends not only in terms
of health care and improving the operation of the FDA but also in terms
of improving our competitiveness worldwide.

Amendment No. 2132

Mr. COBURN. Mr. President, I ask that that amendment be set aside,
and I call up amendment No. 2132, which is at the desk, and ask that it
be reported.
The PRESIDING OFFICER. The clerk will report.
The assistant legislative clerk read as follows:

The Senator from Oklahoma [Mr. Coburn], for himself, and
Mr. Burr, proposes an amendment numbered 2132.

Mr. COBURN. Mr. President, I ask unanimous consent that the reading
of the amendment be waived.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To provide that a portion of the performance awards of each
employee of the Center for Drug Evaluation and Research, the Center for
Devices and Radiological Health, and the Center for Biologics
Evaluation and Research be connected to an evaluation of the employee's
contribution to goals under the user fee agreements)

At the end of title XI, add the following:

SEC. 11__. PERFORMANCE AWARDS.

(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall establish a system by which a portion of the
performance awards of each employee described in subsection
(b) shall be connected to the evaluation of the employee's
contribution, in the discretion of the Secretary, to the
goals under the user fee agreements described in section
101(b), 201(b), 301(b), or 401(b), as appropriate.
(b) Employees Described.--
(1) In general.--Subsection (a) shall apply only to
employees who--
(A) are employed by the Center for Drug Evaluation and
Research, the Center for Devices and Radiological Health, or
the Center for Biologics Evaluation and Research; and

[[Page S3490]]

(B) are involved in the review of drugs, devices, or
biological products.
(2) Commissioned corps.--For purposes of this section, the
term ``employee'' includes members of the Public Health
Service Commissioned Corps.
(c) Effect on Award.--The degree to which the performance
award of an employee is affected by the evaluation of the
employee's contribution to the goals under the user fee
agreements, as described in subsection (a), shall be
proportional to the extent to which the employee is involved
in the review of drugs, devices, or biological products.
(d) Report.--The Secretary shall issue an annual report
detailing how many employees were involved in meeting the
goals under the user fee agreements described in section
101(b), 201(b), 301(b), and 401(b), and the manner of the
involvement of such employees.

Mr. COBURN. Mr. President, this is an amendment that comes out of a
study of GAO's findings, and GAO did a wonderful job looking at the
FDA. What we found out--part of it will be covered if, in fact, we do
this other study on the management, but what GAO is telling us is that
there is an irregular pattern of performance review at the FDA. Part of
the evaluation of about 40 percent of the people who are involved in
the drug and device approval process, in terms of their performance
review, has to do with the timeliness of their work product. And it is
only a small component, but it is still a component of it.
What this amendment does is it says: FDA, make this part of your
component on the people who are actually reviewed in the review
process--not to try to push them to do it better but to have a
management tool with which to evaluate individual employees doing this.
The fact that they are already doing this on some--and what GAO
really said is that it is just a lack of management effectiveness that
they have not installed it everywhere else. All this amendment says is
that this should be one component as they evaluate their employees on
their performance reviews and ask: How did you do on timeliness? Was
your work product timely?
The idea behind this is not to push drugs out that should not be
approved. It is not to push out devices that should not be approved.
But remember that the purpose for PDUFA and MDUFA in the first place
was to fund FDA with additional money so they would be more timely.
The opposition I hear to this amendment that we are afraid that if
this is a component of review, they might review a product and let it
go when they shouldn't does not make sense since already 40 percent of
the employees doing this are being evaluated on this performance
standard anyway. So I would raise the question: If we are in opposition
to this amendment, why in the world haven't we eliminated this as a
part of all the review process already if, in fact, there is a concern?
There is not a concern with it. It is a good management tool. It is
used in all sorts of government agencies. And I commend to the
attention of my colleagues the GAO report that backs up exactly what I
am saying and their recommendation. These are not Tom Coburn's
recommendations, these are the GAO recommendations for FDA. They
address the concerns of inappropriate pressure for early approval or
inappropriate approval for drugs or devices.
Again, it is good government and common sense. It is how one would
manage a private organization. You would put every component that the
employee is involved with as a component as part of the review process.
My hope is that we do not have to vote on this. When my colleagues
actually thoroughly study the GAO report, they will embrace what they
are saying. It is common sense with sound judgment that deals with the
FDA.
I yield the floor.
Mr. HARKIN. Would the Senator yield for a question?
Mr. COBURN. I would be happy to.
Mr. HARKIN. I think the Senator is making a lot of common sense. The
only question I would ask is--and I don't know a lot about this. I
haven't read the GAO report. But if, in fact, every employee says, I
know they are going to get me on this timeliness. So it is the balance
of safety and quickness, safety and expediency. In other words, we try
to get a balance. We want devices and drugs approved as quickly as
possible, but we don't want to jeopardize safety. Those are the two
things we always try to balance here, safety being the foremost. We
want things to be safe.
My question is, by enshrining this into law rather than in the
administration, would this somehow put more undue pressure on reviewers
and others to do something quickly and jeopardize the safety aspect?
Mr. COBURN. My answer to the chairman through the Chair is that the
FDA does nothing quickly now, and he knows that because he has been
sitting in oversight over them for years. That is No. 1. The answer to
No. 2 is, if the Senator reads the GAO report, they have no explanation
on why they do it on some employees and not others. The fact is, if
this is a bad thing, why are they doing it on 40 percent of the
employees now? The No. 1 and No. 2 things the FDA is charged with are
safety and efficacy. Safety comes first. They get graded on how well
they do on that. So we have this counterbalance.
Well, what we have is a lack of responsiveness even though billions
of dollars are going to the FDA from the device companies and the drug
companies. Part of the deal was to make them more timely. That means in
no way do you ignore safety and in no way do you ignore efficacy. The
fact is they do deserve answers, and what is happening a lot of times
is they are not.
I fully support the bureaucracy of the FDA in terms of them doing
their job. I think they do an awfully good job. They are just awfully
slow at it, and when you ask why, there is not a good answer.
The point is, if there are a large number of employees who are
already reviewed as a small component, it doesn't have to be a major
one, but it ought to be something you think about. Do I push this off
my desk because I am bored with it? Does the timeframe mean anything?
We are not going after eliminating safety and efficacy, we are going
after smart management, and those two things, safety and efficacy,
reign supreme at the FDA. That is why we spend so much in this country.
That is why most of the drugs are approved outside of this country way
ahead of when they get approved here, because our drugs and devices are
safer and we are slow to approve, and rightly so, but we should not be
like frozen ice slowly slipping down a hill. All this says is, let's
make it one component of many in terms of review. Again, I tell the
chairman, this is not my recommendation, this is the GAO's
recommendation.
So I would appreciate consideration by the chairman and ranking
member for these amendments. I think they are common sense. We could
look at them again. If the Senator thinks there is a problem, we can
put in a caveat. Let's look at it in a year and say: Have there been
problems because we have done this? But it is good management, it does
make sense, and they are already doing it on 40 percent of their
employees who are involved in the approval of both drugs and devices.
I thank the chair for his question.
I yield the floor, and I will be back.
The PRESIDING OFFICER. The Senator from Iowa.

Amendment No. 2129

Mr. GRASSLEY. Mr. President, I rise for the purpose of calling up
amendment No. 2129.
The PRESIDING OFFICER. Without objection, it is so ordered.
The assistant legislative clerk read as follows:

The Senator from Iowa [Mr. Grassley], proposes an amendment
numbered 2129.

Mr. GRASSLEY. Mr. President, I ask unanimous consent that the reading
of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To provide deadlines for the issuance of certain regulations
and to require a GAO report on the implementation of the clinical trial
registration and reporting requirements under the Public Health Service
Act)

At the end of title XI, add the following:

SEC. 11__. REGULATIONS ON CLINICAL TRIAL REGISTRATION; GAO
STUDY OF CLINICAL TRIAL REGISTRATION AND
REPORTING REQUIREMENTS.

(a) Definitions.--In this section--
(1) the term ``applicable clinical trial'' has the meaning
given such term under section 402(j) of the Public Health
Service Act (42 U.S.C. 282(j));
(2) the term ``Director'' means the Director of the
National Institutes of Health;
(3) the term ``responsible party'' has the meaning given
such term under such section 402(j); and

[[Page S3491]]

(4) the term ``Secretary'' means the Secretary of Health
and Human Services.
(b) Required Regulations.--
(1) Proposed rulemaking.--Not later than 180 days after the
date of enactment of this Act, the Secretary, acting through
the Director, shall issue a notice of proposed rulemaking for
a proposed rule on the registration of applicable clinical
trials by responsible parties under section 402(j) of the
Public Health Service Act (42 U.S.C. 282(j)) (as amended by
section 801 of the Food and Drug Administration Amendments
Act of 2007).
(2) Final rule.--Not later than 180 days after the issuance
of the notice of proposed rulemaking under paragraph (1), the
Secretary, acting through the Director, shall issue the final
rule on the registration of applicable clinical trials by
responsible parties under such section 402(j).
(3) Letter to congress.--If the final rule described in
paragraph (2) is not issued by the date required under such
paragraph, the Secretary shall submit to Congress a letter
that describes the reasons why such final rule has not been
issued.
(c) Report by GAO.--
(1) In general.--Not later than 2 years after the issuance
of the final rule under subsection (b), the Comptroller
General of the United States shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report on the implementation of the
registration and reporting requirements for applicable drug
and device clinical trials under section 402(j) the Public
Health Service Act (42 U.S.C. 282(j)) (as amended by section
801 of the Food and Drug Administration Amendments Act of
2007).
(2) Content.--The report under paragraph (1) shall
include--
(A) information on the rate of compliance and non-
compliance (by category of sponsor, category of trial (phase
II, III, or IV), whether the applicable clinical trial is
conducted domestically, in foreign sites, or a combination of
sites, and such other categories as the Comptroller General
determines useful) with the requirements of--
(i) registering applicable clinical trials under such
section 402(j);
(ii) reporting the results of such trials under such
section; and
(iii) the completeness of the reporting of the required
data under such section; and
(B) information on the promulgation of regulations for the
registration of applicable clinical trials by the responsible
parties under such section 402(j).
(3) Recommendations.--If the Comptroller General finds
problems with timely compliance or completeness of the data
being reported under such section 402(j), or finds that the
implementation of registration and reporting requirements
under such section 402(j) for applicable drug and device
clinical trials could be improved, the Comptroller General
shall, after consulting with the Commissioner of Food and
Drugs, applicable stakeholders, and experts in the conduct of
clinical trials, make recommendations for administrative or
legislative actions to increase the compliance with the
requirements of such section 402(j).

Mr. GRASSLEY. Mr. President, first of all, I congratulate my
colleague from Iowa and my colleague from Wyoming for the
bipartisanship of this legislation.
The FDA amendments of 2007 mandated basic public results reporting
for all clinical trials supporting FDA-approved drugs and devices.
Clinical trials results help both patients and doctors understand the
benefits and efficacy of a particular medical product.
Moreover, a July 2011 FDA report stated:

Understanding variable characteristics in clinical trial
sites is becoming increasingly important because of the
international nature of current clinical trials. The sources
of differences in efficacy results between the U.S. and
foreign clinical trials sites have yet to be determined, but
differences rooted in the conduct of the clinical trial
should be evaluated.

It has been 5 years since the passage of the FDA Amendments Act, and
the National Institutes of Health is still in the process of writing
proposed regulations. The clinicaltrials.gov program and title VIII of
the FDA Amendments Act were considered major reforms and helped science
information advances. If they are not being implemented well or
adequately enforced, society will fail to reap the full benefits of the
billions of dollars in good medical science research.
This amendment before the Senate will impose a deadline by which the
NIH will finalize both the proposed and final regulations. Further, 2
years after the regulation has been in place, the Government
Accountability Office will conduct a study on compliance with
regulations and will look at, among other things, whether the
applicable clinical trial is conducted domestically, in foreign sites,
or in a combination of sites. The rapid increase in trials being run
overseas makes it imperative that the Government Accountability Office
investigate this matter.

Currently, ``80 percent of approved marketing applications for drugs
and biologics contained data from foreign clinical trials.'' The ``FDA
inspected 1.9 percent of domestic clinical trial sites and 0.7 percent
of foreign clinical trial sites.'' We need stronger reporting
requirements to ensure we understand what the implications are of this
move to having so many trials conducted overseas. I encourage my
colleagues to support this important amendment.
Before I move on, I wish to talk about another amendment I am a
cosponsor of, which is an amendment offered by Senator Portman that
will make dangerous synthetic drugs such as K2 and bath salts schedule
I narcotics. I have worked for over a year now to get this legislation
passed through the Senate after a constituent of mine named David Rozga
committed suicide shortly after smoking K2 with some friends nearly 2
years ago.
I introduced the David Mitchell Rozga Act in March of 2011, and the
Senate Judiciary Committee unanimously passed it out of committee along
with two other related bills sponsored by Senator Schumer and Senator
Klobuchar last July. Since that time, the use of synthetic drugs has
grown very rapidly, with the number of calls into poison control
centers going from as few as 19 in the year 2009 to over 6,000 in the
year 2011.
The House passed their version of this bill last December on a strong
bipartisan vote, but one Senator has blocked consideration of this
legislation in this Chamber up to now.
So I am grateful we are finally able to have a vote on this issue,
and I urge passage of the Portman amendment as well.
Madam President, I wish to go to another amendment, if that would be
appropriate at this time.
The PRESIDING OFFICER (Ms. Klobuchar). Without objection, it is so
ordered.

Amendment No. 2121

Mr. GRASSLEY. I call up amendment No. 2121.
The PRESIDING OFFICER. The clerk will report.
The bill clerk read as follows:

The Senator from Iowa [Mr. Grassley] proposes an amendment
numbered 2121.

Mr. GRASSLEY. I ask unanimous consent that the reading of the
amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To provide employee protections for the Commissioned Corps of
the Public Health Service Act)

At the end of title XI, add the following:

SEC. 11__. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE
PUBLIC HEALTH SERVICE ACT.

(a) In General.--Section 221(a) of the Public Health
Service Act (42 U.S.C. 213a(a)) is amended by adding at the
end the following:
``(18) Section 1034, Protected Communications; Prohibition
of Retaliatory Personnel Actions.''.
(b) Conforming Amendment.--Section 221(b) of the Public
Health Service Act (42 U.S.C. 213a(b)) is amended by adding
at the end the following: ``For purposes of paragraph (18) of
subsection (a), the term `Inspector General' in section 1034
of such title 10 shall mean the Inspector General of the
Department of Health and Human Services.''.

Mr. GRASSLEY. Madam President, the bill before us, S. 3187, did not
address a top priority of mine, and that is ensuring whistleblowers
have adequate protections.
Four months ago my office learned of a very abusive treatment by the
FDA on certain whistleblowers due to those whistleblowers' protected
communications with Congress and, more specifically, with this
Senator's office. Once the agency learned of the communication, even
though they were on personal e-mail, it began actively monitoring and
observing employees' personal e-mail, as one might expect, and they
observed those e-mail accounts for 2 years--for a whole 2 years--until
the agency was able to have the employee fired.
Whistleblowers shouldn't be fired for doing what is patriotic; that
is, reporting wrongdoing to Congress. Regrettably, I was not shocked to
learn that the FDA was mistreating whistleblowers within its agency, as
it has done on more than one occasion, and as I have pointed out to my
colleagues. I have been reporting those things ever since the Vioxx
situation of 2004, I believe.

[[Page S3492]]

What makes this example different, though--and even worse--is the FDA
intentionally went after an employee because it knew this employee was
not covered by the Whistleblower Protection Act. Now, it might surprise
some of my colleagues that all employees aren't covered by the
Whistleblower Protection Act. This employee in question was a member of
the Public Health Service Commissioned Corps, and because of a decision
from the Court of Federal Claims these employees--meaning the Public
Health Service along with other members of the uniformed services--are
not covered by the Federal employee whistleblower protections.
I think the court case was wrong, but anyway, that is the way the
Court of Federal Claims ruled. That ruling came as a result of the
Verbeck v. United States case, and the Court of Federal Claims held
that an officer in the Public Health Service Commissioned Corps is a
member of the uniformed service and as such is not covered by the
civilian Whistleblower Protection Act, nor even the Military
Whistleblower Protection Act. This same logic extends to the
commissioned corps of the National Oceanic and Atmospheric
Administration as well. So under the precedent of this Verbeck case,
the officers of both the Public Health Service and NOAA currently have
no whistleblower protection under Federal law.
This is particularly problematic when we consider that the Public
Health Service and NOAA officers can be detailed to agencies such as
the FDC or the Centers for Disease Control. There, these officers,
working in another agency, happen to work side-by-side with civilian
employees of that agency doing very critical work to review and approve
drugs, oversee medical devices, and even work on infectious diseases.
However, unlike their civilian colleagues who are employees of that
agency and who are sitting right next to them, if these employees
uncover wrongdoing, waste, fraud, and abuse, they can be retaliated
against by the agency and have no recourse for it. That is exactly what
happened to this Public Health Service employee working in the Food and
Drug Administration when they reported wrongdoing at that agency to
Congress. They did it by personal e-mail, and the FDA got on to it and
then fired the one employee who was reporting to Congress but did not
fire the employees who were protected by the Whistleblower Protection
Act. So that is why I say this is wrong, and it needs to be fixed. This
amendment will fix it.
Whistleblowers point out fraud, waste, and abuse when no one else
will, and they do so while risking their professional careers.
Whistleblowers have played a critical role in exposing government
failures, and retaliation against whistleblowers should never be
tolerated.
For this reason, I offered an amendment that expands whistleblower
protection for uniformed employees of the Public Health Service. It
corrects the anomaly pointed out by the Court of Federal Claims and
ensures that officers in the Public Health Service have some baseline
whistleblower protection. It expressly includes the commissioned corps
of the Public Health Service within the protections of the Military
Whistleblower Protection Act. This is consistent with the structure of
the commissioned corps functioning like a military organization and
matches the fact that these officers receive military-like benefits in
retirement.
Unfortunately, this amendment, which I was able to get into this
legislation, only covers employees of the Public Health Service. It
does not address the commissioned corps of NOAA because of other
Senators' concern that is not related to the underlying bill. So I hope
to be able to address that remaining gap in whistleblower protections
in the near future so that all employees of the Federal Government are
covered.
All Federal employees should feel comfortable expressing their
opinions both inside the agency they work for as well as to Congress.
The inclusion of this language will ensure those opinions receive
appropriate protections.
I wish to take this opportunity, as I did in my opening comments on
these two amendments, to express my appreciation to Senators Harkin and
Enzi and their commitment and efforts over the years to reform and
improve the FDA.
I yield the floor.
The PRESIDING OFFICER. The Senator from North Carolina.
Mr. BURR. What is the pending business on the Senate floor?
The PRESIDING OFFICER. The pending business is Grassley amendment No.
2121.

Amendment No. 2130

Mr. BURR. I ask unanimous consent to set aside the pending amendment
and to call up amendment No. 2130.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will report.
The bill clerk read as follows:

The Senator from North Carolina [Mr. Burr], for himself and
Mr. Coburn, proposes an amendment numbered 2130.

The PRESIDING OFFICER. I ask unanimous consent that the reading of
the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To ensure transparency in Food and Drug Administration user
fee agreement negotiations)

At the end of title XI, add the following:

SEC. 11__. TRANSPARENCY IN FDA USER FEE AGREEMENT
NEGOTIATIONS.

(a) PDUFA.--Section 736B(d) (21 U.S.C. 379h 2(d)), as
amended by section 104, is further amended by adding at the
end the following:
``(7) Inclusion of congressional representatives.--
Notwithstanding any other provision of this section, Members
of Congress or their designated staff may be present at any
negotiation meeting conducted under this subsection between
the Food and Drug Administration and the regulated industry,
if a Member of Congress decides to attend, or have his or her
designated staff attend on his or her behalf. Any staff
designated under the preceding sentence may be required to
comply with applicable confidentiality agreements.''.
(b) MDUFA.--Section 738A(b) (21 U.S.C. 379j 1(b)), as
amended by section 204, is further amended by adding at the
end the following:
``(7) Inclusion of congressional representatives.--
Notwithstanding any other provision of this section, Members
of Congress or their designated staff may be present at any
negotiation meeting conducted under this subsection between
the Food and Drug Administration and the regulated industry,
if a Member of Congress decides to attend, or have his or her
designated staff attend on his or her behalf. Any staff
designated under the preceding sentence may be required to
comply with applicable confidentiality agreements.''.
(c) GDUFA.--Section 744C(d), as added by section 303 of
this Act, is amended by adding at the end the following:
``(7) Inclusion of congressional representatives.--
Notwithstanding any other provision of this section, Members
of Congress or their designated staff may be present at any
negotiation meeting conducted under this subsection between
the Food and Drug Administration and the regulated industry,
if a Member of Congress decides to attend, or have his or her
designated staff attend on his or her behalf. Any staff
designated under the preceding sentence may be required to
comply with applicable confidentiality agreements.''.
(d) BSUFA.--Section 744I(e), as added by section 403 of
this Act, is amended by adding at the end the following:
``(4) Inclusion of congressional representatives.--
Notwithstanding any other provision of this section, Members
of Congress or their designated staff may be present at any
negotiation meeting conducted under this subsection between
the Food and Drug Administration and the regulated industry,
if a Member of Congress decides to attend, or have his or her
designated staff attend on his or her behalf. Any staff
designated under the preceding sentence may be required to
comply with applicable confidentiality agreements.''.

Mr. BURR. Madam President, let me reiterate what my colleague just
said, which is that Chairman Harkin and Ranking Member Enzi have done a
wonderful job with a very complicated bill in navigating what was a
negotiation that Members of Congress never played a part in--
negotiations that happened between the Food and Drug Administration and
the pharmaceutical industry for one piece, the device industry for
another piece, and the generic drug industry for a third piece; and, I
might say, the third piece is the first time Congress will consider
this.
I think it is important that Members of the Senate, Members of
Congress, and the American people understand that, typically, all
legislation is crafted in the Congress of the United States. It is not
negotiated in the back room of the Food and Drug Administration or in
the back rooms of the device, pharmaceutical, and generic drug

[[Page S3493]]

manufacturers--except for this. In fact, my amendment gets at the heart
of that issue. It is called the amendment ``to ensure transparency in
the Food and Drug Administration user fee agreement negotiations.''
The amendment is straightforward. It would ensure transparency in
FDA's drug and device user agreement negotiations by allowing Members
of Congress or their designated staff to attend the negotiations
between the FDA and the industry. What a novel thing to say, that those
who are responsible to actually implement the policy could sit in the
room and listen. I am not talking about playing a role in negotiating.
Why is this amendment necessary? The bottom line is while the FDA may
consult with many of the stakeholders at various points in the process,
the drug and device user fee agreements are not negotiated so Members
of Congress and the general public know exactly what is in them.
Congress is effectively shut out of the process until the negotiated
deal behind closed doors is announced. In other words, we are presented
with what they have negotiated, and we are basically told: Here is what
we want you to pass. At no other point in the legislative process does
it happen like this in the Congress of the United States.
The drug and device user fee agreements have significant implications
for the American people as well as Congress's ability to do oversight.
The No. 1 role of the Congress of the United States is to serve on
behalf of the American people as an oversight tool over Federal
agencies. Congress should not have to read between the lines of the
minutes of a negotiation to try to figure out, in fact, the spirit of
those negotiations. The ability for Congress and the American people to
fully understand and weigh the negotiated agreements and the
implications they present for patients, taxpayers, the FDA, and for
Congress would greatly be improved by ensuring that Congress might
attend the negotiations.

Some of my colleagues will probably come down and suggest this
amendment would put Congress at the negotiating table and potentially
would jeopardize negotiations. It is not true. It is not what I am
attempting to do with this amendment. The amendment merely states if a
Member of Congress wants to attend or if they want to have their
designated to attend in their place, they may. This amendment does not
call for Members of Congress to participate in the negotiation, or
certainly staff. The negotiations would still be between the FDA and
the industry, but it does ensure that Members of Congress or their
staff may be in the room and be informed of the negotiations in real
time. Congressional staff may be required to comply with all applicable
confidentiality agreements. The FDA's negotiations with the industry
would not be jeopardized. Let me say that again to my colleagues: would
not be jeopardized because the Members of Congress or the staff would
be there just for observation purposes.
Let me suggest that if our being in the room jeopardizes the outcome,
then we would not be allowed to attend the Supreme Court when some of
the most important cases are tried across the street. But Members of
Congress and their staff regularly sit in and listen to the arguments
that are made.
The fact is, Congress should not have to wait to be informed of how
FDA's public health mission could be strengthened and improved on
behalf of patients. By having the option to attend the negotiations,
Congress and its staff would gain invaluable insight into how Congress
can work with the FDA to ensure the agency is fulfilling its public
health mission on behalf of patients.
Congress has a critical role to play in the process. When the
negotiated user fee agreements arrive on our doorstep, we are expected
to take them up, and we are expected to pass them quickly without
change. Let me say that again. We are expected to take them up, we are
expected to take them up quickly because we do not want to break the
continuity of the user fee agreements, and we are expected to do it
without change, because to change those agreements would be to break
what was negotiated.
Let me suggest to my colleagues: This is the only time in the
legislative process where Congress is asked to take somebody else's
negotiated product and not to provide the input of two Senators from
every State or every Member of the House of Representatives. It
completely goes around the structure, the legislative structure, of the
Congress of the United States--something that has been tested and
tested for hundreds of years.
So Congress is told to tiptoe around the agreements, and we focus our
efforts on belt-and-suspender policies to complement the agreements.
This does not make for the most deliberative process in considering how
Congress can work with the FDA and industry to strengthen and improve
FDA's drug and device work.
As a matter of fact, I would say to my colleagues, as we talk about
health care policy in this institution, where our goal today is how we
reduce the overall cost of health care, remember, as we sign off on
this user fee agreement, every dime that is transferred from the
industry to an agency means industry is going to have to raise the
price of its products to accommodate what they are paying.
What are we here doing? We are raising the cost of pharmaceutical
products, devices, and for the first time we are raising the cost of
generics because an industry has negotiated something outside of the
walls of the Congress of the United States.
FDA faces unprecedented challenges today--challenges we could not
have envisioned a generation ago. The agreements and many of the
provisions in the Senate bill are intended to help address these real
challenges the agency is facing.
But I ask my colleagues this, in closing: What if they do not? What
if they do not address the challenges? What if now generic drugs become
more expensive than some people can pay because of this agreement? That
is why it is absolutely crucial that Congress play a part in this role
to balance this policy.
Where will we be in 5 years when it is time to renegotiate this
agreement? Well, I hope we are in a much better situation than we are
today, that we actually have the right matrix in place through this
legislation--not something that was negotiated between the FDA and the
industry but something that the Senate of the United States put into
this language that gives people on both sides of the aisle the ability
to have a yardstick of measurement of success. Did the agency live up
to what they promised the industry and, more importantly, does that
compute to a beneficial product for patients across this country? I
hope that is what we will find 5 years from now. It is what we have
tried to construct in a very difficult and challenging piece of
legislation.
I will tell my colleagues, this is not an amendment I will ask for a
vote on. At the end of the day, the reality is this probably upsets the
apple cart a little too much. But I think it is absolutely crucial that
somebody ask the questions of how can Congress legitimately stand here
and allow something this complex and this important to be negotiated
without the input, the full input of the Congress of the United States.
Again, I conclude the same way I started: I think Chairman Harkin and
Ranking Member Enzi have done a magnificent job of navigating a very
difficult issue, and they deserve a tremendous amount of credit for
taking a negotiated product and incorporating what I think are some
very positive changes that make this a better product than was
negotiated by the private sector and the agency.
My only wish is that the next time we do this, we will not have to
try to figure out why certain things happened in the negotiations, we
will be privy to those negotiations, and we will better understand
collectively how we can take an agency and an industry and public
policy and move it in a situation where the American patients are the
beneficiaries of it in a much more effective way than I think we have
today.
I yield the floor.
The PRESIDING OFFICER. The Senator from Wyoming is recognized.
Mr. ENZI. Madam President, I thank the Senator for his comments and
his insight and his idea. I appreciate that we are not going to be
voting on this one right away because I think this needs a little time
to germinate. I

[[Page S3494]]

think it is something that, as people look at it and think about it,
they will recognize the value there would be if we had more insight
into what the negotiations were--not just on this but perhaps on
regulations that are being done as well.
I want to thank the Senator, though, for the way he has dug into the
entire user fee bill and made some very substantial changes in a number
of other places. I do not know of anybody who works as hard on the
medical issues as does Senator Burr, and understands it, and gets into
some of the details. And, of course, he worked all of these when he was
in the House and now works them in the Senate, and is our foremost
expert on any of the pandemic issues and was very successful earlier in
the year in getting that bill through the Senate. He has been very
cooperative on the other amendments which are now a part of the bill
that we will not be voting on because they are already in there. I
appreciate this one more suggestion and suggest that is something we
should take a look at.
I yield the floor and reserve the remainder of the time.
The PRESIDING OFFICER. The Senator from Iowa is recognized.
Mr. HARKIN. Madam President, I join Senator Enzi in thanking Senator
Burr for being not only a very valuable member of our committee but I
would say the Senator's fingerprints are a lot on this bill we have
before us. He has worked very hard on this bill and I think helped to
improve it every step of the way over the last year.
I was looking through the list of different things here. Senator Burr
was one of the leaders in our working group on the supply chain, which
we have in this bill to make sure those things coming from other
countries have good manufacturing practices on them and we can keep
track of them.
The provision of clarifying the ``least burdensome'' standard on
clinical data for device approval was also the result of the Senator's
hard work. The Senator was also in the working group on the GAIN bill
regarding antibiotic incentives for getting more incentives for new
antibiotics. And there was a Burr-Coburn bill regarding enhanced
reporting requirements for FDA, and that basically is also included in
the bill we have in front of us.
So in every respect, the Senator from North Carolina is a great
member of our committee, a very valuable member of our committee. As I
said, we are looking at the amendment he has now brought up, and I am
sure, as Senator Enzi said, we will be talking about this in the next
few hours and going into tomorrow. But I again want to pay my respect
to the Senator from North Carolina and thank him for all the hard work
he has done on this bill.
I yield the floor.
The PRESIDING OFFICER. Who yields time?
The Senator from Minnesota is recognized.
Mr. FRANKEN. Thank you, Madam President.
Madam President, I wish to thank my friends on both sides of----
The PRESIDING OFFICER. Who yields time?
Mr. HARKIN. Madam President, an inquiry: Is the Senator bringing up--
--no, the Senator does not have an amendment pending.
Mr. FRANKEN. I wish to speak on the FDA bill.
Mr. HARKIN. The Senator wishes to speak on which amendment?
Mr. FRANKEN. Not on an amendment, just on the bill overall.
Mr. HARKIN. Madam President, how much time is remaining on the
Grassley amendments, the amendments offered by the Senator from Iowa?
The PRESIDING OFFICER. The Senator from Iowa has 9 minutes and the
time in opposition is 15 minutes.
Mr. HARKIN. How much time does the Senator wish to take?
Mr. FRANKEN. Well, about 10 minutes.
Mr. HARKIN. I would ask that 10 minutes of the time in opposition to
the Grassley amendment be allocated to the Senator from Minnesota.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
Mr. FRANKEN. I object to the Grassley amendment.
I am joking.
The PRESIDING OFFICER. The Senator from Minnesota.
Mr. FRANKEN. Thank you. I thank the Senator from Iowa for the time.
Madam President, I thank my friends on both sides of the aisle for
their work on the legislation we are considering today. The Food and
Drug Administration Safety and Improvement Act is not only among the
most important piece of legislation we will consider this year, it is
also the product of more than a year's hard work and negotiation.
This legislation will help support a culture of innovation in this
country. It will help millions of Americans access the lifesaving
medications and devices they need, when they need them. As a member of
the HELP Committee, I am proud of the bipartisan bill before us today
and look forward to passing it into law.
Let me tell you why. Of course, the Presiding Officer spoke so
eloquently about this bill earlier. The Presiding Officer does not have
to know why, but let me tell you a story about a little girl in
Minnesota--from our State--named Josie.
Josie seemed perfectly healthy when she was born, but at 9 months of
age Josie's parents found out she had a rare congenital heart disorder,
a condition with the scary name of ``atrial septal defect,'' which
means she had a hole in the wall between the upper two chambers of her
heart.
When the doctors tested her, they found Josie had not one, not two,
but three holes in her heart. It became clear that what was originally
a fairly simple surgery to repair the hole was actually a lot more
complicated.
But Josie was lucky. Josie's parents live in Minnesota, and Josie's
doctor, Dr. Daniel Gruenstein, works at the University of Minnesota.
Dr. Gruenstein was able to operate on Josie's heart because he had a
brandnew device the FDA had approved only months before. The device,
which was also developed in Minnesota, saved Josie's life. Because of
this procedure, Josie was acting like her same old silly self the very
night of her operation, and she walked out of the hospital the next
day.
A few years later when Josie's little sister Jenna was born with the
same congenital heart defect, Dr. Gruenstein repaired her heart using
the very same device. But too many children like Josie and Jenna are
not so lucky. Too many children do not have access to the medical
technology they needed to save their lives or to prevent their illness
or to help them recover from their rare condition. That is because too
many medical devices get stuck or delayed in the agency that regulates
our medical technologies. It is because we do not do enough to support
a culture of innovation in this country.
The Food and Drug Administration has a tough job. The technologies
they regulate are moving at the speed of light, and they do not have
the workforce or the expertise to know everything about every new
treatment.
In fact, the number of annual 510(k) submissions--that is the most
common kind of new device application the FDA receives--has quadrupled
since 1976. That is why when the HELP Committee sat down to develop
this legislation, we agreed we had to streamline the FDA's processes
and make them more efficient. We agreed we had to do more to support a
culture of innovation which will help manufacturers get safe
technologies and treatments to patients. That is exactly what the bill
does. I thank both the chairman and the ranking member.
It requires the FDA to stop using ``FDA days'' and start using
regular calendar days like everyone else. It lifts restrictive
constraints on the FDA's consultation with outside experts, something
the Presiding Officer knows well--outside experts such as are at the
University of Minnesota. It creates new incentives for manufacturers
that develop treatments for people with rare diseases and conditions
like Josie's and Jenna's. These provisions will support innovation and
will remove redtape from the process.
The three provisions I championed are included in this legislation in
addition to the base bill which we negotiated as a committee. The first
provision will strengthen the Food and Drug Administration's workforce
by removing overly restrictive requirements that keep the FDA from
consulting with outside experts, again something the Presiding Officer
has been a leader

[[Page S3495]]

on as well. This provision will change the rules that keep the FDA from
talking with many outside experts. It will make these rules consistent
with those of all other agencies, including the National Institutes of
Health, so as the FDA's experienced workforce retires, the FDA will be
able to consult with leading experts when they are reviewing a new
technology or a new treatment for a rare disease.
This provision will give the FDA the flexibility it needs to consult
with experts and keep patients safe, and at the end of the day that
means more patients will get the health care they need.
The second provision will require the FDA to remove new and
burdensome guidance on the industry that could triple the number of
required new submissions for existing devices. This provision, which
Senator Burr from North Carolina also championed, will prevent this
guidance from overburdening both the industry and the FDA, which could
have caused innovation to come to a screeching halt.
My third provision will help companies develop innovative new
products for patients across the country with rare conditions.
According to the National Institutes of Health, 25 million Americans
struggle with a rare disease, and these patients have to jump hurdle
after hurdle to get the care they need. Many of them will go from
doctor to doctor for years before they find a specialist who
understands their condition.
If you live in rural Minnesota, you may have to drive hundreds of
miles to find a doctor who can help you. Even for patients who find the
right doctor, too often the treatment for their condition does not
exist, or has not been approved. So my provision will reward companies
that choose to develop treatments for patients with rare diseases.
We did this in 2007 to help companies develop devices for children
with rare conditions, and we saw the number of devices that companies
developed quadruple in a few years. This provision will help get
treatments to adult patients with rare conditions in Minnesota and
around the country and around the world.
Minnesotans know what it means to foster a culture of innovation. Our
manufacturers have developed new treatments for everything from skin
lacerations to brain aneurysms. This bill will go farther to support
this kind of innovation by streamlining the processes that are
currently impeding investment in new technologies and making the FDA
more efficient and predictable.
This legislation will help patients in Minnesota access the medical
technologies they need, just like Josie and Jenna. And in a time of
economic hardship, it is an investment in one of our country's
strongest industries, one of our State's strongest industries. This
bill is a step toward a healthier future for our country. I look
forward to making sure it becomes part of our law.
I yield the floor.
The PRESIDING OFFICER. The Senator from Alaska is recognized.

Amendment No. 2108

Ms. MURKOWSKI. Madam President, I ask unanimous consent to call up
amendment No. 2108.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will report.
The bill clerk read as follows:

The Senator from Alaska [Ms. Murkowski], for herself, Mr.
Begich, Mr. Merkley, Mr. Sanders, Mr. Leahy, and Ms.
Cantwell, proposes an amendment numbered 2108.

Ms. MURKOWSKI. Madam President, I ask unanimous consent that the
reading of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To prohibit approval by the Food and Drug Administration of
genetically engineered fish unless the National Oceanic and Atmospheric
Administration concurs with such approval)

At the end of title XI, add the following:

SEC. 11__. ANALYSES OF APPLICATION FOR APPROVAL OF
GENETICALLY-ENGINEERED FISH.

Notwithstanding any other provision of law, approval by the
Secretary of Health and Human Services of an application
submitted under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) for approval of any genetically modified
marine or anadromous organism shall not take effect until the
date that the Secretary of Commerce, acting through the Under
Secretary for Oceans and Atmosphere, approves such
application using standards applied by the Under Secretary
under the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.), which shall include a Regulatory Impact
Review required by Executive Order 12866 (58 Fed. Reg. 51735)
and Initial Regulatory Flexibility Analyses required under
chapter 6 of title 5, United States Code (commonly referred
to as the ``Regulatory Flexibility Act'').

Ms. MURKOWSKI. Madam President, I rise today to speak to an amendment
we will have on the floor tomorrow afternoon. This is an amendment that
certainly has generated a fair amount of interest within my State, in
fact, most of our coastal States, anywhere where we have an interest in
seafood and the seafood industry. It has been kind of unceremoniously
dubbed the frankenfish amendment, so my apologies to my colleague who
just yielded the floor to me. Certainly no affront to him.
But what we are speaking about today is genetically engineered
salmon. It has been somewhat affectionately dubbed frankenfish because
of the images this genetically engineered fish conjures up, a fish that
would literally be growing in size, doubling in size, unlike the fish
we see in our streams and in our waters.
What is happening today is the FDA is on a path to approve an
application for this genetically engineered fish. I want to discuss the
amendment I have filed which would require NOAA to conduct a full
environmental assessment and analysis of economic impact to affected
fisheries before the FDA approves any of these genetically engineered
fish.
I start my comments by saying I am not looking to pull the plug on
the FDA. I am not looking to insert Congress's judgment into the FDA
process. I am asking that when we are talking about basically a new
fishery for a modified salmon, I am asking the agency that is tasked
with our fisheries have some role in what is moving forward. So let me
give you a little background in terms of what we are talking about with
this genetically engineered fish, this frankenfish. This would be a
fish, an Atlantic salmon, that has DNA spliced from a Chinook salmon
with that of what they call an ocean pout, which is some kind of an eel
type of a fish that apparently is in colder waters. But the technology
the FDA is looking at that would allow for this genetic engineering
would essentially provide for a fish that would grow to market size in
about half the time of a conventional salmon. In other words, a salmon
out in the wild takes about 30 months to gain full maturity. With this
frankenfish, this genetically modified salmon, they could be of good
market size, basically good eating size, within about 15 to 18 months.
You are thinking, okay, well, how can this be bad? We get a salmon
that looks like a salmon, and it comes to us in half the time. So how
can this be a bad thing? I wish to share with you why I feel this is a
bad thing. When I am talking, you will hear me talking about salmon,
because that is what the FDA process is engaged with right now. But I
will tell you we understand that similar efforts are underway to
develop a genetically modified trout, as well as a genetically modified
tilapia, again, designed to grow faster than occurs in nature and out
in the wild.
The pending application for the salmon would be the very first food
from a transgenic animal that has been approved by the FDA, so this is
precedent setting. People have suggested that, well, we see this in
other forms of agriculture. But the fact is this would be the first
food from a transgenic animal application that has been approved by the
FDA, so this is quite precedent setting.
What is happening is this approval process for the genetically
engineered fish continues to move forward as a new animal drug, rather
than what it is, what I mentioned before, which is a new fishery for
this modified salmon, this salmon that has been tinkered with,
basically a test-tube salmon.
Here are the reasons why I think this is a bad thing, to be messing
with Mother Nature, to encourage this unnatural growth. We heard on the
floor this morning--the Senator from New Jersey and the Senator from
New York both stood and talked about a measure

[[Page S3496]]

that is out there, the march that was out on the Capitol yesterday,
mothers concerned about toxins in the food supply, toxins in the world
around us, and knowing what is out there, knowing what we are exposed
to.
Well, I, along with many consumers out there, am concerned about
genetically engineered animal products that are intended for human
consumption, including those that are in our marine resources. I am not
the best cook in the family; my husband is. But I want to know, he
wants to know, our kids want to know, that what we are eating is good
and safe and sound.
At home, we eat a lot of salmon. I can stand there and tell my kids:
Eat this. This is brain food. This is good for you. It is loaded with
omega-3 fatty acids. It is as good as you can possibly get. I can say
that with certainty.
We cannot say that, we will not be able to say that with this
genetically engineered fish. As a mom, I am not going to say to my
kids: Eat this frankenfish. Not quite sure what an eel pout is or an
ocean pout; not quite sure how they splice this DNA together; not quite
sure whether they have made it sterile.
We are not quite sure what it is, but it came to market quickly, and
we are going to be able to get a cheaper price on it. I think we want
to know.
The scary thing with the FDA right now is that they are reluctant to
label genetically engineered products, even though it allows the public
to know what they are eating. The data out there is pretty clear that
there are higher human allergen effects with genetically engineered
fish. If you are a mom and your kids have allergies, are you going to
look at this fish and say: I wonder if this is going to set allergies
off. No. You are going to stay away from it. You will not serve that to
your kids or your family even though you know the wild stuff is good
and healthy. But how do you know which is which if the FDA isn't moving
forward to label and you are not quite sure that what you are buying in
the grocery store is as advertised? How are we helping the consumer
here?
The first problem I have is that this is, again, a product that is
intended for human consumption, and we have some real concerns about
the safety of the food in the first place. Second--and this is one
that, as an Alaskan, where we have very strong fisheries, very healthy
fisheries, I worry about what will happen if, in fact, there was
escapement into the wild by these genetically engineered fish. You have
a frankenfish that gets loose. They will tell you: They are going to be
in pens, and we will make sure there is no escape. How can they make
sure we are not going to see escapement? We have seen that, clearly,
from the farm fish that mingle with the wild stock. We see the disease
that can be transmitted. How is any of this good? Even though the
genetically engineered fish supposedly is going to be kept in onshore
pens, the possibility of escape is recognized, it is out there, and it
exists.
Then you are going to have these genetically engineered fish that
will breed year-round. They are also going to be eating year-round.
They are going to be feeding year-round. What you can very possibly see
is this competition with the wild stock. They will compete with one
another for the food the species feeds on, and they will wreak havoc
with the ecosystem. So you can introduce--granted, not intentionally--
into the ecosystem that fish that just doesn't work with our wild
stock. Unlike hatchery produced fish, genetically produced fish would
reportedly be sterilized and their hormones altered. But many
scientists believe that the FDA testing to confirm the agricultural
safety and sterilization of these fish is deficient. We see this in the
CRS report that has looked specifically to this issue.
Unlike other agricultural products, if you have an escape of
frankenfish, it would be to an uncontrolled marine environment,
exposing valued ecosystems to associated risks. If you have a cow that
has been genetically modified and that cow is on land and gets out of
the pen, you have more ability to control that. You don't have the
ability to control in a marine environment. It is just not possible. So
what is happening is that we are putting at risk the health and safety
of our wild stock. Unacceptable.
Third, many find the FDA process for approving an animal product
intended for human consumption as it would a veterinary drug to be
insufficient. It lacks the robustness and transparency one would expect
for a product that would be treated as a substitute for fish that is
currently on our dinner plates in this country today.
The CRS report which I just mentioned will be introduced for the
Record. It is a report by CRS, dated June 7 of last year, titled
``Genetically Engineered Fish and Seafood: Environmental Concerns.''
One of the concerns raised in this report is this:

A National Research Council report stated that transgenic
fish pose the ``greatest science-based concerns associated
with animal biotechnology, in large part due to the
uncertainty inherent in identifying environmental problems
early on and the difficulty of remediation once a problem has
been identified.

Our fishermen are very highly regulated, and any change to a Federal
fishery, including a new GE fishery, should be analyzed for
environmental effects and economic impacts to affected businesses and
fishing communities. We are bringing NOAA in to be part of this process
in this amendment.
The last point I will make on this is that there could be very
significant economic consequences of approving genetically engineered
fish. Historically, the entrance and growth of farmed salmon in the
marketplace has had negative impacts on our salmon industry. We have an
incredible abundance in the wild stocks, and we are very proud of it.
The seafood industry in Alaska is our second largest employer, valued
at $500 million with salmon alone. But the concern is that, although we
have very strong wild stocks, we could see the market respond with
unreasonable fear and confusion to the introduction and growth of
engineered fish, particularly if it is not labeled. This, in my
opinion, could have a devastating economic impact on our fish industry
and the jobs it supports, clearly at a time that our Nation can't
afford it.
Some will come back and say: Hey, this is a new industry, it is going
to create new jobs.
I will take you back to that CRS report. One of the things I find
interesting is that it says:

To address these concerns, AquaBounty has proposed
producing salmon eggs in Canada, shipping these eggs to
Panama, growing and processing fish in Panama, and shipping
table-ready, processed fish to the United States for retail
sale.

They would ship these frankenfish to the United States for resale. So
basically we get all the harm, but we don't get any jobs. But what we
are doing is putting at risk the existing jobs within the seafood
industry in this country--priority No. 1.
I see that my time has expired.
I commend to my colleagues this CRS Report dated June 7, 2011.
I ask unanimous consent that two letters of support for my amendment
be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Consumers Union,

Washington, DC, May 23, 2012.
Hon. Lisa A. Murkowski,
U.S. Senate,
Washington, DC.
Dear Senator Murkowski: Consumers Union, (CU) the advocacy
and public policy arm of Consumer Reports^', urges
you to support Senator Murkowski's amendment to the Food and
Drug Administration Safety and Innovation Act (S. 3187),
which would require additional approval by the Secretary of
Commerce of GE fish applications using standards applied by
the Under Secretary under the National Environmental Policy
Act of 1969 (42 U.S.C. 4321 et seq.).
Consumers Union has frequently spoken out on the issues and
concerns surrounding the approval of genetically-engineered
salmon for human consumption. Among our many concerns is that
not enough research has been carried out to determine the
increased potential of Aquabounty GE salmon to cause allergic
reactions in humans. CU's Dr. Michael Hansen, a Ph.D.
biologist, testified at the FDA hearing on this matter that
Aquabounty's assessment of the potential for allergic
reactions was based on just six (6) engineered fish. We
believe that a much larger assessment involving hundreds to
thousands of fish should be conducted. FDA has also indicated
that once GE salmon are approved for human consumption, it
does not intend to require labeling--a position CU strongly
opposes.
We are also concerned about the potential environmental
impacts of genetically-engineered fish, and particularly in
regards to the impact that GE salmon would have on

[[Page S3497]]

the wild Alaska salmon population. Alaska wild salmon is a
tasty, healthful, low-cost, and low mercury canned fish
alternative. Consumers Union recommends it for pregnant women
and young children who should limit mercury intake. However,
some studies have shown that if GE salmon were to escape into
the wild, they could potentially have serious effects upon
the wild salmon population.
Consumers Union urges you to support the Murkowski
amendment, in order to ensure that GE fish applications
undergo an additional environmental impact review. Should you
have any questions, please do not hesitate to contact me at
(202) 462 6262.
Sincerely,
Ioana Rusu,
Regulatory Counsel.
____

Trout Unlimited,

Arlington, VA, May 22, 2012.
Re Support for Murkowski genetically engineered fish
amendment to S. 3187

To: U.S. Senate
On behalf of Trout Unlimited and its 140,000 members
nationwide I write to urge you to support the Murkowski
amendment to ensure adequate study of genetically engineered
fish prior to FDA approval. The amendment to S. 3187
prohibits approval by the FDA of genetically engineered fish
unless NOAA concurs with such approval.
The acute need for this amendment is illustrated by the
flawed process currently being used to review an application
for commercial production of genetically modified salmon.
AquaBounty Technologies has requested FDA approval for the
production and marketing of genetically modified Atlantic
salmon as a new animal drug. Asking the FDA to consider
impacts to wild salmon is like going to a chiropractor to get
your eyes checked. The FDA's pending decision has
extraordinary implications for wild salmon, yet the agency
with a mission to conserve and manage wild salmon--NOAA--has
not been asked to analyze potential impacts, and does not
have a say in the final decision. The Murkowski amendment
simply states that the agency with expertise in the affected
resource, NOAA, must be involved in a decision that could
profoundly impact anadromous fish.
Trout Unlimited's mission is to conserve, protect and
restore North America's trout and salmon fisheries and their
watersheds. We work to protect healthy runs of wild salmon in
places like Alaska's Bristol Bay, and restore depleted runs
through habitat restoration projects on the Atlantic and
Pacific coasts. Wild salmon and other anadromous fish are too
important commercially, recreationally, and culturally to be
put at risk by decisions that failed to adequately consider
the potential impacts.
Trout Unlimited strongly supports the Murkowski amendment,
and encourages you to vote Yes when the amendment is offered.
Sincerely,
Keith Curley,
Director of Government Affairs.

The PRESIDING OFFICER. The Senator from Maryland.

Amendment No. 2125

Mr. CARDIN. Madam President, I ask unanimous consent that the pending
amended be set aside so that I may call up amendment No. 2125.
The PRESIDING OFFICER. Without objection, it is so ordered. The clerk
will report.
The legislative clerk read as follows:

The Senator from Maryland [Mr. Cardin] proposes an
amendment numbered 2125.

The amendment is as follows:

(Purpose: To ensure that adequate information is disseminated to health
care providers and payors about the potential benefits and risks of
medical products on all patient populations, particularly
underrepresented subpopulateds, including racial subgroups)

At the end of title XI, add the following:

SEC. 11__. ENSURING ADEQUATE INFORMATION REGARDING
PHARMACEUTICALS FOR ALL POPULATIONS,
PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS,
INCLUDING RACIAL SUBGROUPS.

(a) Communication Plan.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary''),
acting through the Commissioner of Food and Drugs, shall
review and modify, as necessary, the Food and Drug
Administration's communication plan to inform and educate
health care providers, patients, and payors on the benefits
and risks of medical products, with particular focus on
underrepresented subpopulations, including racial subgroups.
(b) Content.--The communication plan described under
subsection (a)--
(1) shall take into account--
(A) the goals and principles set forth in the Strategic
Action Plan to Reduce Racial and Ethnic Health Disparities
issued by the Department of Health and Human Services;
(B) the nature of the medical product; and
(C) health and disease information available from other
agencies within such Department, as well as any new means of
communicating health and safety benefits and risks related to
medical products;
(2) taking into account the nature of the medical product,
shall address the best strategy for communicating safety
alerts, labeled indications for the medical products, changes
to the label or labeling of medical products (including black
box warnings, health advisories, health and safety benefits
and risks), particular actions to be taken by healthcare
professionals and patients, any information identifying
particular subpopulations, and any other relevant information
as determined appropriate to enhance communication, including
varied means of electronic communication; and
(3) shall include a process for implementation of any
improvements or other modifications determined to be
necessary.
(c) Issuance and Posting of Communication Plan.--
(1) Communication plan.--Not later than 1 year after the
date of enactment of this Act, the Secretary, acting through
the Commissioner of Food and Drugs, shall issue the
communication plan described under this section.
(2) Posting of communication plan on the office of minority
health website.--The Secretary, acting through the
Commissioner of Food and Drugs, shall publicly post the
communication plan on the Internet website of the Office of
Minority Health of the Food and Drug Administration, and
provide links to any other appropriate webpage, and seek
public comment on the communication plan.

Amendment No. 2141

Mr. CARDIN. Madam President, I ask unanimous consent that that
amendment be set aside so I may call up my amendment No. 2141.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will report.
The legislative clerk read as follows:

The Senator from Maryland [Mr. Cardin] for himself, and Ms.
Landrieu, proposes an amendment numbered 2141.

The amendment is as follows:

(Purpose: To require the Commissioner of Food and Drugs to report to
Congress on issues with respect to small businesses)

At the end of title XI, add the following:

SEC. 11__. REPORT ON SMALL BUSINESSES.

Not later than 1 year after the date of enactment of this
Act, the Commissioner of Food and Drugs shall submit a report
to Congress that includes--
(1) a listing of and staffing levels of all small business
offices at the Food and Drug Administration, including the
small business liaison program;
(2) the status of partnership efforts between the Food and
Drug Administration and the Small Business Administration;
(3) a summary of outreach efforts to small businesses and
small business associations, including availability of toll-
free telephone help lines;
(4) with respect to the program under the Orphan Drug Act
(Public Law 97 414), the number of applications made by small
businesses and number of applications approved for research
grants, the amount of tax credits issued for clinical
research, and the number of companies receiving protocol
assistance for the development of drugs for rare diseases and
disorders;
(5) with respect to waivers and reductions for small
business under the Prescription Drug User Fee Act, the number
of small businesses applying for and receiving waivers and
reductions from drug user fees under subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379f et seq.);
(6) the number of small businesses submitting applications
and receiving approval for unsolicited grant applications
from the Food and Drug Administration;
(7) the number of small businesses submitting applications
and receiving approval for solicited grant applications from
the Food and Drug Administration;
(8) barriers small businesses encounter in the drug and
medical device approval process; and
(9) recommendations for changes in the user fee structure
to help alleviate generic drug shortages.

Mr. CARDIN. Madam President, I rise to discuss the FDA Safety and
Innovation Act, the bill now under consideration here in the Senate.
I applaud Chairman Harkin and Ranking Member Enzi for their
leadership in moving this critical legislation through the HELP
committee, and now to the Senate floor.
As an agency of the Department of Health and Human Services, the FDA
has as part of its broad mission to protect Americans' health by
assuring the safety of drugs, biologics, medical devices, our Nation's
food supply, vaccines, tobacco, cosmetics, and animal food and drugs.
Every single day, every single American depends on the vital work of
FDA's employees.
There is a second key element to the FDA's work--helping to speed
innovations to the marketplace through the drug, biologic, and medical
device approval process. It's that component of the FDA's mission that
we are addressing this week--reauthorizing the user fees that help fund
the approval process.
I'm proud of the FDA's workers--the majority of the agency's more
than 11,000 employees are based at its headquarters in Silver Spring,
MD. It's

[[Page S3498]]

there that the process of medical innovation, which begins at NIH with
basic research, is completed as lifesaving drugs and medical devices
are approved for use.
A recent report from the IMS Institute for Healthcare Informatics
found that in 2011 ``medicines with new mechanisms of action were
launched in greater numbers than in prior years, with many representing
significant breakthroughs and first-time therapies became available to
treat several types of cancer, multiple sclerosis, hepatitis C, and
cardiovascular conditions.''
At the same time, we know that greater resources are needed for the
agency to be able to fulfill its mission in a timely and effective
manner. For all of our Nation's investment in health care research,
additional new medicines will not reach patients promptly unless the
FDA has the necessary funds to perform its regulatory duties.
That's why the user fee amendments are so important. This 5-year
reauthorization bill is Congress' opportunity to improve and update the
regulatory process, and augment appropriations so that the agency can
achieve its goals.
The purpose of the user fee program is to reduce the time in which
FDA can review and make decisions on marketing applications. Lengthy
review times affect drug and medical device manufacturers, who face
delays in bringing their products to market, and more importantly they
affect patients, who face delays in receiving needed treatments and
cures.
The bill reported out of committee will move us forward. It will
reauthorize the prescription drug user fee program, PDUFA, through
October 1, 2017.
This is necessary so that the Federal Goverment can continue to
collect application, establishment, and product fees from drug
companies to support the review process for the next five years.
It will also reauthorize the medical device user fee program, MDUFA,
through 2017 as well, and in an effort to ensure that the FDA's
personnel needs are met, it would authorize a streamlined hiring of
employees. Additionally, the Critical Path Public-Private partnerships,
which are so important in encouraging medical product innovation, are
reauthorized through 2017.
Two new user fee programs are established in the bill for generics
and one for biosimilars. It's estimated that the monies generated from
the generic user fee program will enable the FDA approval time for
generics to be shortened from the current time frame of 30 months to
10, speeding savings to patients and to all taxpayers, as Medicare,
Medicaid, and CHIP programs will reap considerable cost savings.
The base bill takes key first steps toward resolving the vexing issue
of drug shortages. I want to acknowledge Senator Klobuchar's work in
this area.
All of us have heard from our community hospitals and physicians
about the anguish they feel when they cannot secure medicines necessary
to treat the patients in their care. I certainly have, and I have also
heard from patients themselves who cannot fathom how such shortages
could occur.
Carey Fitzmaurice of Bethesda, who is undergoing treatment for
ovarian cancer, wrote to me:

My doctor put me on Doxil and carboplatin to try to get rid
of some tumors. Doxil was chosen because of recent research
showing that it works especially well in those patients with
the BRCA gene, like me.
I had four treatments with both drugs and was responding
very, very well. I have now missed three doses of Doxil due
to the shortage. I am ``treading water'' with the Carbo but
am frustrated that I am no longer making progress towards
remission. Then there is all of the stress involved with the
shortage--not knowing if there is anything I can do, or what
will happen next or how long I will be in treatment.
I am trying to continue to be a wife and mother and to hold
down a job. This shortage is adding insult to injury. I
wonder why we are being asked to raise money to find cures
when we can't even get access to the cures that exist now.

Carey is one reason why I am a cosponsor of Senator Klobuchar's
bipartisan bill, the Preserving Access to Life Saving Medications Act,
and I am pleased that the bill's early notification requirement
provisions are included in the PDUFA bill we are considering today. It
also requires the Secretary to establish a task force and create a
strategic plan to address shortages.
This is also an urgent matter because shortages affect the ability to
conduct clinical trials. Senator Rockefeller and I worked together some
years ago to get Medicare beneficiaries coverage for the routine costs
associated with clinical trials.
As a result of Senator Brown's work on the Affordable Care Act,
insurance companies now must also cover the routine costs of trials.
Access to trials often means the difference between life and death for
cancer patients, and the availability of trials has enormous
implications for the effectiveness of treatments for all patients going
forward. There are more than 150 cancer clinical trials being conducted
now at the NIH Clinical Center in Bethesda.
But the impact of shortages on clinical trials has not received a
great deal of attention outside the research world. It is an extremely
important issue for Medicare beneficiaries, who have the highest rates
of cancer incidence. Cancer trials do not usually use placebos.
Rather, they compare standard of care drugs, versus, or in
combination with, the experimental drug.
Doctors face difficult choices when the standard of care drug is in
short supply. They must decide whether to use the limited supply of an
existing drug to treat new patients, or use it in clinical trials to
help find a cure for those who are seeking new therapies. Cancer trials
have been delayed, limited the number of patients enrolled in the trial
or stopped the trial entirely because there is simply not enough of the
standard of care drug.
So I am pleased that the bill contains language requiring the
Secretary's strategic plan to considering the impact of drug shortages
on research and clinical trials.
The Finance Committee held hearings on drug shortages earlier this
year as well, and we learned that the majority of shortages are found
in the generic drug market. Some are due to a lack of raw materials,
while others occur because the drugs yield lower profits than newer
generics, and the interest in continuing to market those drugs is no
longer there.
The notification language in this bill is a good start, but I believe
it should be strengthened to better ensure compliance, and so I have
cosponsored Senator Blumenthal's amendment establishing civil monetary
penalties for manufacturers who knowingly fail to notify the FDA of
shortages for essential medicines.
I express my appreciation to Senator Pryor for his leadership on
nanotechnology. I am pleased to join him in this effort and am hopeful
that the language we have sponsored can be included in this bill.
Nanotechnology has become increasingly indispensible in our daily
lives--everything from cellphones and MP3 players, to packaging of our
snack foods, to cancer treatments in development employ the use of
nanotechnology.
As this burgeoning technology continues to power more of our consumer
products and drive job creation in America, it is essential that we
fully assess, understand, and address any risks that it may pose to
safety, public health and our environment.
By soundly assessing the safety of nanotechnology and developing best
practices, the Nanotechnology Regulatory Science Act of 2011 will
further job creation, public safety and growth in the industry.
Our bill would establish a program within the FDA to assess the
health and safety implications of using nanotechnology in everyday
products, and develop best practices for companies using
nanotechnology. This new program would bring more highly-skilled
research jobs to Maryland.
FDA's laboratories and research facilities at its consolidated
headquarters are ideally suited to conduct the scientific studies
required under the bill.
The USDA's Beltsville Agricultural Research Center, BARC, is
similarly equipped to provide innovative scientific technology,
training, methods development, and technical expertise to improve
public health.
Lastly, I urge my colleagues to support language addressing the lack
of available information on the benefits and adverse effects of drugs
and medical devices for minority populations.
Today, warnings and safety precautions are included as part of the
initial approval by the FDA. The Agency

[[Page S3499]]

may also require them post approval--after the drug has been approved
and sold for months or years. We know that additional side effects or
risks may become known once a product is in the market and a much
larger, diverse patient population is using it.
Ideally, a detailed conversation between physician and patient about
the risks versus the potential benefit of taking a drug would always
take place in a timely and informed manner. However, this is not always
the case and is especially true if the warning is added after drug is
initially prescribed and been on the market for an appreciable time
period.
The randomized controlled trials used by the FDA when reviewing new
drug applications, while the gold standard for examining efficacy, do
not necessarily reflect the overall population for a variety of
reasons.
For example, members of minority groups are generally
underrepresented in clinical drug trials even though they are
disproportionately affected by diseases such as diabetes, hypertension,
colorectal, prostate and cervical cancer, stroke, congestive heart
failure, acute coronary disease, and asthma.
We know that there are racial and ethnic differences in responses to
pharmaceuticals, and they may not become known until the drug is in
wide use, certainly beyond the constraints of a controlled clinical
trial.
In today's world, post-approval surveys and studies are becoming more
prevalent, and our ability to discern the effect of a drug over time on
a variety of patient types is significantly improving. This information
should be made available in a variety of ways to ensure that it reaches
physicians, payors and patients, and I have filed an amendment that
would greatly improve access to this information.
It would build on the current HHS ``Strategic Action Plan to Reduce
Racial and Ethnic Health Disparities'' by directing the Secretary to
develop a communications plan to ``address the best strategy for
communicating safety alerts, changes to the label or labeling of drugs,
including black box warnings, biological products or devices, health
advisories, any information identifying particular subpopulations, and
any other relevant information as determined appropriate to enhance
communication, including varied means of electronic communication.''
This amendment has the support of the chairman and the ranking
member, as well as the FDA and BIO, and I urge the Senate to adopt it.
Mr. President, PDUFA reauthorization is essential to furthering the
Nation's health, bringing the medical innovations conceived by
researchers and entrepreneurs into practice, and creating jobs. I look
forward to working through the process to improve this bipartisan
legislation.
Again, I thank and congratulate Senator Harkin and Senator Enzi for
their incredible work in bringing forward this bill that is so
important to the public health of our Nation. We are dealing with the
safety of drugs, biologics, medical devices, our Nation's food supply,
vaccines, cosmetics, and the list goes on and on. It is critically
important that we have the proper authorization so that the FDA has the
resources it needs to advance innovation into the marketplace, products
that fall within the jurisdiction of the FDA.
We know that the basic research has gone on at NIH. To get products
to market, it is important that the FDA have the resources in order to
move the process forward. I am proud of the 11,000-member workforce
headquartered in Silver Spring, MD, for the FDA. They work very hard.
This reauthorization legislation of the user fees will give them the
tools in order to get the job done. I am particularly impressed that
this is a 5-year reauthorization bill that will give them
predictability, which is needed in order to get the job done.
I applaud Senator Harkin and Senator Enzi. We don't see enough of
these bills moving forward with the type of process our leaders have
brought forward. They have resolved a lot of the issues, and we thank
them for that. They have brought us a bill that enjoys broad bipartisan
support and is in the best interest of our Nation. I am proud to
support this legislation, and I thank them for the manner in which they
have proceeded in committee and now on the floor.
Also, I point out that this bill deals with the drug shortage issues.
I applaud the occupant of the chair, Senator Klobuchar, and her efforts
in dealing with those issues. We need more effective notification of
potential shortages so that we can take appropriate action to make sure
the people of this Nation have an adequate supply of medicines.
Let me share with my colleagues a letter I received from Carey
Fitzmaurice of Bethesda, MD, who is undergoing treatment for ovarian
cancer. She wrote:

My doctor put me on Doxil and carboplatin to try to get rid
of some tumors. Doxil was chosen because of recent research
showing that it works especially well in those patients with
the BRCA gene, like me.
I had four treatments with both drugs and was responding
very, very well. I have now missed three doses of Doxil due
to the shortage. I am ``treading water'' with the Carbo but
am frustrated that I am no longer making progress towards
remission. Then there is all of the stress involved with the
shortage--not knowing if there is anything I can do, or what
will happen next, or how long I will be in treatment.
I am trying to continue to be a wife and mother and to hold
down a job. This shortage is adding insult to injury. I
wonder why we are being asked to raise money to find cures
when we can't even get access to the cures that exist now.

That is a frustration that is out there on drug shortages. I am very
pleased that this legislation will move us in the right direction in
answering that question.
It doesn't only affect those under active treatment, it also affects
a number of clinical trials. There are currently about 150 clinical
trials at NIH involving cancer and trying to find answers and cures for
cancer. The problem is that on these clinical trials they don't use
placebos, they use the current drug therapy that is known for the
treatment against an experimental process. If there are not enough
drugs available to treat people for the current protocols, how can
those drugs be used in a clinical trial. As a result, we are finding it
very challenging to move forward with the clinical trials that are
needed. This legislation recognizes that concern and specifically deals
with it. I congratulate the committee leadership for addressing that
issue.
I also will mention one other issue: nanotechnology. I congratulate
Senator Pryor for his leadership in this area. Programs at FDA to
access health safety facts and using nanotechnology in everyday
products is something we need to do. This legislation advances that. I
point out that I am proud that the lab facilities at the FDA are fully
capable of dealing with the challenges presented by nanotechnology.
This legislation acknowledges that.
We also, in Maryland, are proud of the Beltsville Agricultural
Research Center, which will advance nanotechnology and the impact it
has on everyday products and safety. Those issues will be addressed
also by the underlying bill. We very much appreciate the leadership of
the committee.
Let me talk for a moment about the two amendments I have brought
forward. Amendment No. 2125 deals with safety warnings, particularly as
they affect the minority community. Clinical trials don't always
represent the diversity of our community. We know there is
underrepresentation of minorities within clinical trials. Quite
frankly, when the FDA gives approval, they give approval to the known
risks, as I am sure you are all aware, but it doesn't always represent
the impact on all communities. We also know there are racial and ethnic
differences in response to pharmaceuticals, and they may not become
known until the drug is in wide use, certainly beyond the constraints
of a controlled clinical trial. So we do have the initial approval of
FDA that includes the known risks, but we also have the capacity under
FDA to do postapproval warnings. My amendment deals with that aspect.

Health and Human Services has a strategy to deal with minority health
and health disparities. It is called the Strategic Action Plan to
Reduce Racial and Ethnic Health Disparities. We also now have an
institute at the National Institutes of Health that deals solely with
minority health and health disparities. We have a commitment to do a
better job as a nation in dealing with minority health disparities.
This amendment would help us move forward in that regard.

[[Page S3500]]

One particular drug that is used to treat an inflammatory disorder
has been determined by several studies to have a mortality risk that is
three times higher for African-Americans than the general public.
However, it is still widely prescribed, and ads for the product on the
Internet and on television prominently feature African-American actors.
This is an area in which the National Medical Association and many
other groups concerned about the quality of minority health have
focused on for years. Beyond the black box warning, which is the most
serious warning that can be issued about the side effects of approved
drugs, there are other concerns about products that are marketed for
the overall population that may have side effects, but the specific
data has not been developed yet to warrant a black box warning.
The amendment I have offered directs the FDA to develop communication
plans to address the best strategy for communicating benefits and
risks, safety alerts, changes to the label or labeling of drugs,
including black box warnings, biological products or devices, health
advisories, any information identifying particular subpopulations, and
any other relevant information as determined appropriate to enhance
communication, including a variety of means of electronic
communication.
I might point out this amendment has the support of the FDA and BIO,
and it is budget neutral. So I would urge my colleagues to support this
amendment to advance the commitment we all have made to deal with
reducing and hopefully one day eliminating minority health disparities
in our health care system. It is totally consistent with the Strategic
Action Plan to Reduce Racial and Ethnic Health Disparities at the
Department of Health and Human Services.
The second amendment I have brought forward, amendment No. 2141,
deals with small businesses. This is a very appropriate amendment, as
it is being considered during Small Business Week. We all acknowledge
the importance of small business in the growth of our economy. Two out
of every three new jobs are created through small business. We get more
innovation through our small businesses on a per-employee basis than we
do through larger companies. It is critically important small
businesses be energized if our economy is going to rebound, as we know
it needs to.
This is particularly true as we deal with innovation in drug
development or medical devices. My amendment deals with the issues of
coordinating the work between the FDA and small business. It provides a
listing of the staffing levels at the small business offices of the FDA
so that we know the capacity we have and we can evaluate that. It is
our responsibility to do that. It provides an overview of the status of
partnership efforts between the FDA and the SBA. We want the two
agencies, the Food and Drug Administration and the Small Business
Administration, to be working in concert to advance the cause for small
businesses as well as the mission of the FDA.
My amendment provides a summary of all outreach efforts to small
businesses and small business associations. It details the number of
small businesses receiving protocol assistance. It shows the number of
unsolicited and solicited grant applications to small businesses,
again, so we can evaluate that. Most importantly, it calls for the
examination of existing barriers, particularly as it relates to the
generic drug shortages.
It is interesting that with regard to the fee schedule, the FDA has
the authority to do waivers as it relates to brand names. We know a lot
of the generics are where we have our shortages because of the
economics of the circumstances. But the SBA has limited ability to
waive the fee structure as it relates to the general development of
generic drugs. My amendment would ask the SBA to report back to
Congress on what impact that has on small businesses being innovative
in developing generic drugs to help us generally with less costly drugs
that are available for treatment, but also to make sure we deal with
the drug shortage issue, which I alluded to earlier.
This amendment is also supported by Senator Landrieu, the chairman of
the Small Business Committee, on which I have the pleasure of serving.
I urge my colleagues to support both amendments I have brought forward.
I believe they only enhance the strength of the bill before us and are
totally consistent with the work of the chairman and the ranking member
of the committee.
With that, Madam President, I would again urge my colleagues to
support both amendments and to support the underlying bill.
I yield the floor, and I suggest the absence of a quorum.
The PRESIDING OFFICER (Mr. Whitehouse). The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. HARKIN. 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, how much time remains on the two
amendments offered by the Senator from Maryland?
The PRESIDING OFFICER. Six minutes for the majority on amendment No.
2125, and 15 minutes in opposition. For amendment No. 2141, 11 minutes
in favor and 15 minutes in opposition.
Mr. HARKIN. Mr. President, I will speak on the time available for the
amendments.

Amendment No. 2125

First of all, amendment No. 2125 will help ensure that health care
providers, patients, and payers better understand the benefits and
risks associated with drugs, especially with respect to those drugs by
underrepresented subpopulations.
I believe this is an important and noncontroversial amendment. I hope
we can support this amendment.

Amendment No. 2141

On the other amendment, No. 2141, which is the small business report,
I think it is important FDA give small businesses a helping hand. I
understand each FDA center has a small business office and that each of
FDA's five regional offices has a small business representative. This
report the FDA would have to submit on the basis of the amendment
offered by Senator Cardin would provide Congress with more information
about how FDA uses its resources for small businesses to help encourage
small companies.

Again, I think this is another valuable addition to our bill and,
hopefully, we can support that amendment also. So I thank the Senator
from Maryland for his offering these two amendments and for what I
consider to be improvements to the underlying bill.
I thank him very much for that.
Mr. President, again, I would say to the Members who may be in their
offices that we still have some extra time before we will be adjourning
this evening. Again, I would advise Senators that by at least 2 p.m.
tomorrow, when the bell rings, we will be moving to voting, if not
before then. So any Senator who has an amendment to bring up and who
wishes to talk about it, I wish they would come to the floor and do
that now.
Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Wyoming.
Mr. ENZI. Mr. President, I would echo the comments of the chairman,
and I, too, thank the Senator from Maryland for his amendments. I think
everybody appreciates both those amendments and, hopefully, they will
become a part of this bill.
I also appreciate all those who have come to speak this afternoon. I
know there are still probably a couple of controversial amendments on
which Senators should come and speak, and then we might have the
possibility of moving some things up a little bit tomorrow so we can
get this bill finished expediently.
So I hope if anyone has an amendment, they will come and use their
time. I think we have a few minutes in opposition perhaps to two of the
amendments that have been debated so far. But that is it, and then I
think there are three controversial ones that are left to be debated.
One of those has a significant amount of time allocated to it, but the
others are limited to 30 minutes equally divided.
So I hope we can take care of some more of those this evening and get
started on votes as soon as possible.
I yield the floor, and I suggest the absence of a quorum.

[[Page S3501]]

Mr. HARKIN. Mr. President, I ask unanimous consent that the time
during the quorum call be divided equally.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. PAUL. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.

Amendment No. 2143

(Purpose: To amend the Federal Food, Drug, and Cosmetic Act
concerning claims about the effects of foods and dietary
supplements on health-related conditions and disease, to
prohibit employees of the Food and Drug Administration from
carrying firearms and making arrests without warrants, and to
adjust the mens rea of certain prohibited acts under the
Federal Food, Drug, and Cosmetic Act to knowing and willful)

Mr. PAUL. Mr. President, I ask unanimous consent to call up my
amendment No. 2143.
The PRESIDING OFFICER. The clerk will report.
The assistant legislative clerk read as follows:

The Senator from Kentucky [Mr. Paul] proposes an amendment
numbered 2143.

Mr. PAUL. Mr. President, I ask that the reading of the amendment be
waived.
The PRESIDING OFFICER. Without objection, it is so ordered.
(The amendment is printed in the Record of Tuesday, May 22, 2012,
under ``Text of Amendments.'')
Mr. PAUL. Mr. President, today I am offering an amendment to the FDA.
I am troubled by images of armed FDA agents raiding Amish farms and
preventing them from selling milk directly from the cow. I think we
have bigger problems in our country without sending armed FDA agents
onto peaceful farmers' land and telling them they can't sell milk
directly from the cow.
My amendment has three parts.
First, it attempts to stop the FDA's overzealous regulation of
vitamins, food, and supplements by codifying the first amendment
prohibition on prior restraint.
What do I mean by that? The first amendment says we can't prevent
speech--even commercial speech--in advance of the speech. We can't tell
Cheerios they can't say that there is a health benefit to their
Cheerios.
Under our current FDA laws, the FDA says that if someone wants to
market prune juice, they can't say it cures constipation. They can't
make a health claim about a food supplement or about a vitamin. They
can do it about a pharmaceutical, but they are not allowed to do it
about a health supplement. I think this should change. There have been
several court cases that show this goes against not only the spirit but
the letter of the law of the first amendment. So this amendment would
change that.
This amendment would stop the FDA from censoring claims about
curative, mitigative, or preventive effects of dietary supplements. It
would also stop the FDA from prohibiting distribution of scientific
articles and publications regarding the role of nutrients in protecting
against disease.
Despite four court orders condemning the practice as a violation of
the first amendment, the FDA continues to suppress consumers' rights to
be informed and to make informed choices by denying them this
particular information. It is time for Congress to put an end to FDA
censorship.
Second, my amendment would disarm the FDA. Now, some of you might be
surprised the FDA is armed. Well, you shouldn't be. We have nearly 40
Federal agencies that are armed.
I am not against having police. I am not against the Army, the
military, or the FBI. But I think bureaucrats don't need to be carrying
weapons, and I think what we ought to do is if there is a need for an
armed policeman to be there, the FBI--who are trained to do this--
should do it. But I don't think it is a good idea to be arming
bureaucrats to go on the farms, with arms, to stop people from selling
milk from a cow.
I think we have too many armed Federal agencies and that we need to
put an end to this. Criminal law is increasingly used as a tool of our
government bureaucracy to punish and control honest businessmen who are
simply attempting to make a living. Historically, the criminal law was
intended to punish only the most horrible offenses that everyone agreed
were inherently wrong or evil--offenses like murder, rape, theft,
arson. But now we have basically federalized thousands of activities
and called them crimes.
If bureaucrats need to involve the police, let's have them use the
FBI. But I see no reason to have the FDA carrying weapons.
Today, the criminal law is used to punish behavior such as even
fishing without a permit, packaging a product incorrectly, or shipping
something with an improper label. Simply said, the Federal Government
has gone too far.
The plain language of our Constitution specifies a very few Federal
crimes. In fact, the Constitution originally only had four Federal
crimes, and now we have thousands of Federal crimes. We have moved
beyond the original intent of the Constitution. We don't even know or
have a complete list of all the Federal crimes. It is estimated there
are over 4,000, but no one has an exact number.
Finally, my amendment will require adequate mens rea protection. In
other words, when there is a crime, we are supposed to prove the
intent. People have to have intended to harm someone. It can't be an
honest mistake, where a business man or woman has broken a regulation
and didn't intend to harm anyone. If we want to convict someone of a
crime and put them in a jail, it should have a mens rea requirement.
This is something we have had for hundreds of years that comes out of
our common law tradition.
This amendment would fix this problem by strengthening the mens rea
component of each of the prohibited acts in the FDA Act by including
the words ``knowing'' and ``willful'' before we address and accuse
someone of a crime. I think this would give protection to folks who are
guilty of inadvertently breaking a regulation and would keep from
overflowing our jails. We have plenty of violent criminals without
putting people in for honest breaches of regulations.
If Congress is going to criminalize conduct at the Federal level, as
it does with the FDA Act, then the least it can do is have an adequate
mens rea requirement. My amendment will attempt to do this. It is not
that we will not have rules at the Federal level, but the rules ought
to be reasonable. We ought to allow people to market vitamins. There is
no earthly reason why someone who markets prune juice can't advertise
that it helps with constipation. We have gone too far. We have
abrogated the first amendment. What we need to do is tell the FDA the
courts have ruled that the first amendment does apply to commercial
speech, and the FDA has been overstepping their bounds.
I hope this amendment will pass. I will ask for the yeas and nays at
the appropriate time.
I suggest the absence of a quorum.
The PRESIDING OFFICER. 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, I rise in opposition to the amendment
offered by the Senator from Kentucky, and I oppose it for several
reasons.
I believe I am in the court of equity now: I come with clean hands
because I am one of the authors of the Dietary Supplement and Health
Education Act, along with Senator Hatch, in 1994. We worked in tandem
over a period of a couple of years to get the legislation through. A
lot of compromises were made at that time, not only here in the Senate
but also with the House when we went to conference. I believe the right
balance was struck, and I think it has proven its worth over the years.
We have done some minor modifications to it over the years. As I have
often said, when we write laws around here they are not chiseled in
stone for all eternity. These aren't the Ten Commandments, they are
laws, and sometimes they need to be modified and changed a little bit,
usually tweaking. But this amendment basically turns the whole law that
we had since 1994 on its head.
We have a process now where the FDA regulates the supplements as
foods. These are foods, not drugs. So as

[[Page S3502]]

we hammered out this agreement, supplements can make nutrient,
structure, function claims without any FDA preapproval. If they want to
make a health claim, then it has to be approved by FDA, and FDA has to
find that it is supported by appropriate scientific evidence. Under
this amendment, substances that today are considered drugs and used to
treat diseases as serious as cancer or HIV could be marketed without
any rigorous FDA review that we have heard from many speakers here
today is the gold standard of drug regulation throughout the world. It
would turn our current system of drug regulation on its head. It would
be a huge setback for health. It would foster a system rife with
potential for health fraud. The big losers would be patients.

Frankly, as someone who is a strong supporter of the Dietary
Supplement Health and Education Act, and I would say along with Senator
Hatch one of its protectors for all these years, I daresay the
amendment offered by the Senator from Kentucky would destroy DSHEA. It
would destroy it and I don't want to see it destroyed because I think
it is doing a lot of good for a lot of people in this country. It is
working well. Consumers have access to a wide range of safe products.
There is no reason to upset its success, because this amendment would
do that.
To think that somehow you could go out and make any health claim you
want? Back to the days of snake oil salesmen: ``This elixir will do
everything, it will cure every ailment you have and turn the clock back
20 years on your age.'' People would buy it, and what was it? It was
80-percent alcohol and 20-percent water or something like that. They
made all these crazy claims. We are going to move to that kind of
system now? And the only recourse would be to take them to Federal
court and then have a trial and go through all that and then, OK, then
they appeal it and finally you find out, OK, the court says no, there
is not enough scientific evidence to warrant it so you have to take
that product off the market.
We are going to do that for every one of the thousands and thousands
of different products that are out there? What a mess this would be.
First of all, the Federal courts would not have the wherewithal to do
every one of those. Second, who has the money to take all that to
court? And it would literally destroy--bring down an industry that has
done well in this country. The dietary supplement industry, the
vitamins and minerals industry in this country, has done a great job
and I do not want to see it ruined. This would ruin it.
Last, the Senator from Kentucky talked about increasing the mens rea,
the mind; you know, in law school, what your mental condition, what
your thought processes were--what was your intent. It would increase
it. It would need to be shown to enjoin or prosecute serious violations
of the Food, Drug, and Cosmetic Act. I find this amazing. This idea
that we need to make it harder to enforce a public health protection
statute, not easier, is deeply troubling. I see no legitimate reason to
do this.
The goal of this amendment is clearly to render the FDA virtually
incapable of addressing industry abuses. I think this amendment would
have deleterious effects on the Dietary and Supplement Education Act,
and the industry, and also on the FDA's ability to regulate
prescription drugs. You can say just about anything about what your
health claims would be on any kind of product and the only recourse, as
I said, would be to go to Federal court.
Again, this is a consensus measure. We have built a very broad
bipartisan support for this FDA user fee bill. It is must-pass
legislation. We cannot jeopardize that consensus.
For those reasons, I oppose the amendment offered by the Senator from
Kentucky.
Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. HARKIN. Mr. President, I ask unanimous consent the order for the
quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. HARKIN. Mr. President, how much time remains on the amendments
offered by the Senator from Maryland, Senator Cardin?
The PRESIDING OFFICER. On amendment No. 2141, there is 11 minutes
remaining in support and 15 minutes in opposition.
Mr. HARKIN. Mr. President, I ask the Senator from Colorado, how much
time does the Senator seek?
Mr. BENNET. I would like to try for 10 minutes but if I can do it
shorter----
Mr. HARKIN. I ask 10 minutes of the time from amendment No. 2141 be
yielded to the Senator from Colorado.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. BENNET. I thank the Senator from Iowa, the chairman of the HELP
Committee, for his indulgence.
Yesterday I spoke about some of the process on the important issues
of drug safety and making sure there is a good system for safer drugs,
both in preparation and distribution. I know we seem to get close to
reaching a resolution, which is tremendous. I have heard many of my
colleagues praise different parts of the bill, which I will do as well
in a minute. But I want to take 1 more minute again, while the chairman
and the ranking member are on the floor, to recognize what an enormous
accomplishment their leadership has resulted in, getting this bill to a
close.
As I said yesterday, I think the work of the HELP Committee, both
Democrats and Republicans, with the leadership of the chairman and the
ranking member, is a model for this Congress. It is the reason why the
quality of this bill is so high. We still have a few votes to go
tomorrow, but people forget that it is rare to be working on a full
extension of anything here. This has become the land of flickering
lights, where we keep things on for 1 more month or 2 more months. Here
we actually have a 5-year extension of this legislation. It is
wonderful to be working in such a bipartisan and businesslike fashion.
It is not lost on me how much work has been put into the bill by my
colleagues on the HELP Committee, including the Presiding Officer, or
the HELP Committee staff. I want to reiterate my thanks and gratitude
for the work on the bill that will truly help patients and American
families get the medical products they need when they need them.
That brings me to the subject of medical devices. Colorado is the
sixth largest medical device sector in the country, with over 600
bioscience companies overall. We obviously need to strike a balance, as
we think about this legislation, because as we speed the FDA approvals,
we have to ensure that devices are safe. This year has represented a
good-faith bipartisan effort among members on and off the HELP
Committee to find policies that will empower the FDA to ensure safer
devices and also ensure that our companies on the ground have more
regulatory certainty and predictability.
The FDA has been upfront about the challenges the device center
faces--reviewer turnover, young, less experienced reviewers, and
management challenges. At the same time we have heard from venture
capital investors who say that regulatory uncertainty at the FDA is a
reason they have been hesitant about continued investments in the
United States and thought about the future investment in Asia and
Europe. The new medical device user fee will go a long way toward
ensuring the FDA has the resources to provide safer, more effective
medical devices in less time and with more predictability.
Over the course of a year we were also able to craft a balance of
policies on both the innovation and safety side. This includes
reinforcing regulations in place since 1997 that require the FDA to
take the least burdensome approach to approving medical devices by not
asking companies for unnecessary or unrelated information.
I see the Senator from Minnesota on the floor, and I thank her for
her leadership on this piece of legislation. It also includes important
safety provisions such as ensuring the medical devices have a tracking
number so if there is any problem, doctors and patients can quickly
know if their product is one that works.
I would like to say a word about drug shortage, which is a discussion
issue every Member is hearing about in their States. In just the last
year, the FDA was notified of about 220 drug shortages. We know that
the amount of patients this affects is monumental. For

[[Page S3503]]

cancer alone, over 550,000 patients have been currently affected by our
national drug shortage crisis.
In Colorado, our patients and providers are extremely frustrated. A
pharmacist at St. Mary's Hospital in Grand Junction said that he keeps
a 2-page list of 50 drugs that he cannot get or can barely get a hold
of, including 12 chemotherapy drugs.
I want to share a couple of constituent stories from my home State.
Dawn Gibbs from Long Mount, CO, wrote:

Dear Senator Bennet: I am contacting you to inform you of
my grave concern of the national shortage of the preservative
free cancer drug Methotrexate. My 2-year-old cousin receives
this drug for her newly diagnosed leukemia of October 2011.
Her doctors told her that they only have a 2 week supply left
at their clinic. This drug keeps her leukemia from traveling
to her brain. This shortage is life threatening to her and
3,000+ like her with this cancer.
I thank you for your assistance in this matter. I know that
my little 2-year-old cousin cannot speak out on her own
behalf, so I am honored to be her voice. I feel my voice will
not be enough alone to make a difference, and I hope that you
will be our voice.

Dawn Gibbs' voice is being heard on behalf of her cousin, just as
patients all across the country are lending their voices to this
important debate.
Carol Gill from Morrison, CO, wrote:

Dear Senator Bennet: I have stage 4 cancer. My current
treatment regimen is doing a fine job of keeping the disease
stable. This regimen includes a biweekly infusion of two
generic drugs--5FU and leucovorin--and two other drugs still
on patent. I receive treatment at the University of Colorado
Hospital. My oncologist just called me to say that the
University of Colorado Hospital is out of 5FU.
Today oncologists at the University of Colorado Hospital
are calling their patients to tell them some or all of their
cancer treatment must be suspended.
Thank you for taking this seriously and taking immediate
steps to correct it.
Carol Gill.

My hope is that this Senate bill can give some reprieve to these
Coloradans in desperate need of their lifesaving drugs.
The Senate bill would give the Food and Drug Administration the much
needed authority to require drug manufacturers to report any
discontinuance or interruption or other adjustment that would likely
result in a shortage, especially those drugs needed to provide
emergency care. It would also immediately create a task force that
would create a strategic plan to address drug shortages and submit
recommendations to Congress as well as study the effect on drug pricing
as it relates to shortages.
The people in my home State and every one of our home States need us
to provide solutions to this problem yesterday. They cannot wait any
longer, nor should they.
I will say again that it is because of the leadership of the two
people sitting here, the ranking member of our committee and the
chairman of our committee, that we have been able to get this bill to
the floor for a vote. I think we should take that vote tomorrow and
move forward on behalf of patients all across this country and the
bioscience community.
I thank the Chair.
I yield the floor.
Mr. ENZI. I thank the Senator from Colorado, Mr. Bennet, for his
comments, but he sold himself pretty short on the influence on this
bill. He has worked dramatically on every portion of this bill and made
some significant contributions that are now a part of the bill. He
didn't have to do amendments at this point because he got them all in.
That was very important across-the-aisle work that the Senator did by
working with a number of people on both sides of the aisle and being
faithful and helping committee and staff members, not to mention all
the committee meetings held on Fridays throughout the year. This bill
wouldn't have been possible without the Senator's efforts.
Mr. BENNET. I thank the ranking member.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Mr. President, I join Senator Enzi in thanking Senator
Bennet for being a very valuable member of our committee and for all of
the great work the Senator did on this bill. His fingerprints are all
over this bill, and, as he pointed out, it is a great bill. There was
great bipartisan support.
I thank the Senator for all of his work in our working groups,
especially the drug supply chain. This is a key part of this bill. The
FDA will have the authority and the wherewithal to go back up the chain
to where these drugs come from. The Senator was the first one to point
out to me at the committee hearing that I think about 80 percent of all
of the ingredients that go into our drugs in this country come from
outside this country, but we had no real idea on where and how, and now
we can insist on good manufacturing practices. So I would say this
singular addition to this bill can be traced right back to the Senator
from Colorado, and I thank him very much for his leadership on this
issue and in helping us to get this bill to where we are today. I thank
the Senator.
I would like to yield 10 minutes off of the opposition of the
Grassley amendment 2121 to the Senator from Minnesota.
The PRESIDING OFFICER. The Senator from Minnesota.
Ms. KLOBUCHAR. Mr. President, this bill means so much to my State. I
spoke earlier today about the need to improve the approval process at
the FDA, and this bill will speed that up with the agreement reached
between industry and the FDA on the fees. I thank the Senator for his
leadership on that issue.
We have literally tens of thousands of employees in our State who
have incredibly good jobs in the high-tech industry. This is a huge
potential export. It is already an export, but even more could come if
we do this right as we look at the growing middle class in countries
such as China and India who are going to the hospital and using medical
devices. So this bill is speeding up that process but still keeping the
very important safety standards in place, which couldn't be more
important--as well as for patients who have been waiting for lifesaving
treatment. So I thank the Senator for that.
I also thank the Senator for including, as Senator Bennet referenced,
my drug shortage provision. We worked on that for 2 years. We gathered
support as the years went on.
I thank Senator Harkin for the hearing we had on that bill and for
the work of his staff in bringing people together. We got Senator
Casey's and Senator Collins' provisions in this bill.
We all know what has been going on. As several Senators have
mentioned, we are talking about 4-year-old boys with leukemia whose
parents find out they have no cancer treatment drug and literally are
put into a panic, so they book flights to Canada so this little child
can complete his treatment, or the woman with breast cancer who has to
call around for Prudoxin and is then faced with the ethical dilemma
that she explained to us that she knew she was taking it away from
another patient. That should not happen in the United States of
America, and this early notification of the FDA, as we have seen, has
been very positive.
Over 200 drug shortages have been averted because of the early
notification with orphan drugs in the last few years, so this provision
will truly make a difference. I thank the Senator for including that.
I am here to talk about another matter the two Senators have been
involved in negotiating. These are bills that Senator Schumer, Senator
Grassley, and I have been working on. We each had one of the three
bills that covered different synthetic drugs.
My drug bill covered 2C-E, which is a synthetic hallucinogen, which,
sadly, is something a young man died from taking in Minnesota. There
was actually a murder prosecution because of it, and, again, we have
seen it go like wildfire through our State with these synthetic drugs.
Senator Portman and myself and Senator Grassley will be offering this
amendment, and I thank the Senator for his work on it. I also encourage
my colleagues to support this amendment, and I hope it will pass
overwhelmingly.
As members of the Judiciary Committee, Senator Grassley, Senator
Schumer, and I have been working on this, as I mentioned, for years.
There have been reports from every State in the country of people
acting violently while under the influence of these drugs, which leads
to death or injuries to themselves and others. While taking these
drugs, people can experience elevated heart rates and blood pressure,

[[Page S3504]]

hallucinations, seizures, and extreme agitation, which is dangerous,
but they are also dangerous to themselves.
Up in Moorhead, MN, with the Fargo sheriff, we did a forum. A group
of people were sitting in the front row. I actually thought they were
there to object to our provisions. They were there to support them
because they had lost a loved one who thought he was taking what he
considered to be synthetic marijuana, and it turned out to be very
different from any marijuana. It turned out to be much stronger, and he
ended up hitting a tree and killing himself. They were sobbing while
telling their story.
Until 2006, I was a Hennepin County attorney. During my time there we
just didn't have this as an issue. We can see how quickly it has
changed. Listen to these numbers. In 2011 poison control centers across
America received more than 13,000 calls about synthetic drugs. How many
calls did they get in 2010? They only got 3,200. Look at that--3,200 to
13,000 in just 1 year. In Minnesota there were a total of 392 calls to
poison control relating to synthetic drugs in 2011 compared to 107 in
2010--a tripling of calls about this problem in just 1 year.
This all hit home, as I mentioned in my State, with the tragic death
of a 19-year-old man, Trevor Robinson, in Blaine, MN, when he overdosed
on 2C-E. It is a synthetic hallucinogen. Another young man was thought
to have shot himself in Minnesota while under the influence of
synthetic drugs. We can imagine the pain of these families, and that is
why I introduced a bill to add 2C-E and similar drugs to the substance
list so they will be treated in the same manner as other banned drugs
they claim to represent.
I am also a cosponsor of the two bills authored by Senators Grassley
and Schumer. All three of these bills are contained in the amendment we
are offering with Senator Portman. These drugs can kill, and if we
don't take action, they are going to become more and more prevalent.
They are available on the Internet. The Federal Government has to make
clear that they are illegal. That is what is going on today because
people literally buy these drugs that have numbers like 2C-E. They
don't really know what they are. They get them, and they turn out to be
deadly. That is what happened in Blaine, MN.
I am hopeful that we vote to ban these drugs as part of the debate on
this bill. We have seen what happened in Minnesota. We know the DEA has
been taking action on its own, and they temporarily banned some of
these drugs, but most of the substances covered in our three bills have
not been banned, including all of the substances in my bill. That is
why, in fact, we are offering this amendment.
On the State level, roughly 40 States have banned some synthetic
drugs, including my State, where a major law regarding synthetic drugs
took effect in July. We need a Federal law. This crosses State lines. A
lot of it is done on the Internet. We cannot simply have this State by
State, and passing a Federal law will help create the partnership we
need to send a strong message that we need to eradicate these
substances.
I am pleased this amendment is being offered. We need to get it done
now, ban these drugs, and make a clear statement that these drugs are
illegal.
I again thank Senator Harkin and Senator Enzi for working it out so
we can offer this amendment, and also my colleagues, Senators Portman,
Schumer, and Grassley, for their hard work. I know we are committed to
getting this done.
I yield the floor.
The PRESIDING OFFICER. The Senator from Washington.
Mrs. MURRAY. Mr. President, I ask unanimous consent to speak for 15
minutes in morning business and not to take time away from the debate
on the bill.
The PRESIDING OFFICER. Is there objection?
Mr. ENZI. Mr. President, it was my understanding that because of the
special event tonight, we were going to be out of here at 6 pm. I am
not sure what leadership has in mind at this point.
Mrs. MURRAY. Mr. President, I have had a conversation with them----
The PRESIDING OFFICER. Is there objection to the Senator's request?
Without objection, it is so ordered.

Veterans Employment

Mrs. MURRAY. Mr. President, next week Americans are going to spend
time honoring and commemorating the men and women who died fighting for
our great country. Memorial Day is a day to reflect on and give thanks
to the sacrifices made by those who made the ultimate sacrifice. It is
also a day to look forward and to think about what we all can do to
help our veterans who sacrificed so much and who deserve our support
when they come home.
So I come to the floor today to discuss an issue that, quite frankly,
defies common sense. The high rate of unemployment among recently
separated veterans is an issue that continues to make the transition
home for veterans harder than ever. Despite the fact that our veterans
have the leadership ability and the discipline and technical skills to
not only find work but to excel in the workforce of the 21st century,
our veterans continue to struggle.
Despite the skill and talent and training of our veterans, statistics
continue to paint a grim picture.
According to the Department of Labor, young veterans between the ages
of 18 and 24 have an unemployment rate that is nearly 20 percent. One
in five of our Nation's heroes can't find a job to support their
family, doesn't have an income that provides stability, and doesn't
have work that provides them with the self-esteem and pride that is so
critical to their transition home.

We know this should not be the case. We shouldn't let the skills and
training our Nation's veterans have attained go to waste. That is why
all of us joined together to overwhelmingly pass my VOW to Hire Heroes
Act here in the Senate late last year. Among many other things, that
law would provide tax incentives to encourage businesses to hire
veterans; it makes participation in the transition assistance program
mandatory for most separating servicemembers, and expands the education
and training we provide to transitioning servicemembers.
Thanks to that legislation, we have been able to take real concrete
steps toward putting our veterans to work. The tax credit is working,
and VA is set to begin accepting applications for a retraining program
that will benefit unemployed veterans ages 35 to 60 and help them get
back to work.
But that bill is only that, a first step. Today I am here to talk
about the next step, and that step is to build partnerships with
private businesses, large and small, all across our country, to hire
our Nation's heroes. Recently I was up in New York where I participated
in a lively roundtable discussion hosted by the Robin Hood Foundation.
This discussion on veterans employment was moderated by Tom Brokaw on
the USS Intrepid and brought together people of various backgrounds,
including former Chairman of the Joint Chiefs ADM Mike Mullen, and
Housing and Urban Development Secretary Shaun Donovan, to talk about
this important issue.
What is very apparent is that there is momentum to build public-
private partnerships. What is also apparent is there is a lot of room
for improvement in this area.
I want to first make clear that a lot of companies across the country
are far ahead of the curve. In fact, many private sector companies have
already joined our efforts in addressing this critical issue. J.C.
Penney, one of America's largest retailers, and Joseph Abboud, a men's
clothing company, partnered with Iraq and Afghanistan Veterans of
America to launch the Welcome Home Joe--Thanks A Million Program.
To prepare veterans for job interviews, this program has provided
5,000 veterans with certificates to purchase business attire. For the
last decade, we have expected our brave men and women in uniform to
prepare for the battlefield. In the process, they have become
accustomed to wearing combat boots and battle dress uniforms. Now they
are expected to wear a suit and tie for job interviews--something that
sometimes seems pretty foreign to them. But thanks to this program,
thousands of transitioning veterans can now hang up their battle dress
uniforms and dress for their next challenge.
Other companies such as Schneider National, one of America's largest

[[Page S3505]]

trucking companies, are realizing the skills our veterans have gained
over the last decade of work are directly applicable to their business.
Schneider National recognizes that a veteran who has driven a 7-ton
truck across Afghanistan's dangerous and rugged terrain is more than
qualified to drive a freight truck across our Nation's roads. In
addition to providing many veterans with new jobs, Schneider National
also provides newly separated veterans with on-the-job training through
their military apprenticeship program. As part of that program, veteran
employees are eligible to earn a monthly educational benefit check from
the VA in addition to a paycheck. Schneider National serves as a great
example of how companies can hire veterans who have proven they can
perform on the job but lack proper certifications for civilian
employment.
The U.S. Chamber of Commerce also should be commended for launching
its Hiring Our Heroes initiative which has sponsored 150 hiring fairs
in 48 of our States. At one of these recent hiring fairs, General
Electric, the employer of 10,000 veterans, launched its veterans
network transition assistance program. As part of that program, General
Electric has vowed to hire 1,000 additional veterans every year for the
next 5 years and provides job-seeking veterans with one-on-one
mentoring sessions. Those sessions help transitioning veterans improve
resume writing and interviewing techniques so they can capitalize on
the skills they have developed during their military service.
That is just a fraction of the work being done by our Nation's
employers. There are many success stories at big companies such as Home
Depot and small companies such as General Plastics in my home State
which has created a pipeline to hire veterans at its aerospace
composite factory. All of these companies are not only examples of
success stories but they have also created a roadmap about how best to
find, hire, and train veterans. It is our job to make sure those
lessons are being heard.
Today I am here on the floor to lay out a few things that all
businesses, large and small, can do to bring our Nation's heroes into
their companies. First, get the word out to companies to educate their
human resources teams about the benefits of hiring veterans and how
skills they learned in the military translate to the work a company
does. I can't tell my colleagues how often I hear from veterans who
tell me the terms they use in interviews and on resumes fail to get
through to the interviewer.
Second, help our companies provide job training and resources for
transitioning servicemembers. This is something I have seen done at
large organizations such as Amazon and Microsoft, but also at smaller
companies in conjunction with local colleges. In fact, the most
successful of these programs capitalizes on skills developed during
military service but also utilizes on-the-job training.
Third, let business leaders know how important it is to publicize job
openings with our Veterans Service Organizations at local military
bases so we can help connect veterans with jobs, and to work with local
one-stop career centers.
Fourth, develop an internal veterans group within our companies to
mentor recently discharged veterans.
Finally, if possible, please reach out to local community colleges
and universities to help develop a pipeline of the many veterans who
are using GI bill benefits to gain employment in a particular area.
If we can spread the message on just a few of these steps, I am
confident we will be able to continue to build on the success we have
had in hiring veterans.
There is one other even more important step we have to take to ensure
that businesses are taking, and it has to do with the difficult issue
that some potential employees face. I have heard repeatedly from
veterans that they do not put their military service on their resume
because they fear it stigmatizes them. They fear that those who have
not served see them all as damaged or unstable. We have to understand
what mental health challenges are and what they are not.

As we seek to employ more veterans, we need future bosses and
coworkers to understand that issues such as posttraumatic stress or
depression are natural responses to some of the most stressful events a
person can experience. We need them to understand that these illnesses
do not afflict every veteran and, most importantly, we need to
understand that for those who are affected by these illnesses, they can
get help, they can get better, and they can get back to their lives. We
need to let businesses know if they have a veteran who is facing some
challenges, we should do the right thing and encourage him or her to
get help. They need to know it is OK to reach out. Help them take
advantage of the excellent mental health care the VA is capable of
providing. The veteran will be better and they will be an even stronger
member of a company's team.
Those are some steps our employers can take, but we also need to make
sure our veterans are taking steps to stand out as candidates.
Unfortunately, too often our veterans don't see how the skills they
learned in the military translate from the battlefield to the working
world. One of the biggest reasons for that is often our veterans don't
understand the vernacular of the working world.
A few weeks ago I was home in Washington State talking about this
issue when I met a woman named Anne Spurte. Anne is a veteran. She
helps other local veterans find work through an organization called The
Unfinished Mission. Anne told me how often she has heard from veterans
who told her they were not qualified for the jobs they had seen on line
or in the paper. Repeatedly they told her they didn't see how their
experiences mattered to employers in the area. So one day in front of a
whole group of veterans, Anne pulled out this job advertisement from
Boeing for a position as a fabrication specialist. Anne could once
again sense that the veterans who sat there and read this ad thought
they weren't qualified for this manufacturing job that is listed in
Boeing's space exploration division. But then Anne concentrated all the
attention of the veterans in the room on the competency and
qualifications section that was listed on that job advertisement and
she asked all of them: Did you spend time in the service working
together to remove obstacles to help a team accomplish its goals? Did
you work to fully involve others on the team in decisions and actions?
Were you held responsible? Did you demonstrate your commitment to the
team? Around the room, all of these veterans' heads were nodding as she
read verbatim from the Boeing job announcement. Every veteran
understood they had the core skills employers at Boeing were looking
for, but they just didn't realize it.
What Anne made those veterans come to understand was that their
skills were being lost in translation, and what many of them needed to
do was simply articulate their experiences in a way that employers
could understand.
So today I want to reiterate to all of our veterans that no matter
what branch you served in or when you served or how long you served,
the skills you learned are valuable and it is up to you to make sure
employers see that.
Our veterans don't ask for a lot. Oftentimes they come home and don't
even acknowledge their own sacrifice. My own father never talked about
his time fighting in World War II. In fact, I never saw his Purple
Heart or knew that he had a wallet with shrapnel in it from when he was
hit or a diary that detailed his time in combat, until after he died
and my family gathered to start sorting through his belongings. But our
veterans shouldn't have to ask. We should know to provide for them.
When my father's generation came home from the war, they came home to
opportunity. My father came home to a community that supported him. He
came home to college and a job--a job that gave him pride and helped
him start a family and one that ultimately led to me starting my own.
That is the legacy of opportunity we have to live up to for today's
veterans. Together, working with the private sector, we can ensure that
the brave men and women who have worn our uniform have that real
opportunity. We can make sure they get a fair shot from America's
employers, that they are not measured by fear or stigma but by what
they can do, what they have done, and what they will do.

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I thank those companies that are leading the way as our veterans
transition from military service to the civilian workforce. The
Veterans Affairs' Committee, which I chair, has a Web site with a list
of some of those companies that are contributing to this effort. I
would encourage all of our colleagues to visit that Web site and
suggest companies that can be added to our list. I look forward to
working with all of them, and many more of our Nation's businesses, on
this important next step in bringing our veterans home to opportunity.
As we celebrate our fallen heroes on Memorial Day next week, let's
all keep thinking about how we can make sure our veterans are getting
everything they need after they have given so much.
Before I yield the floor, I wish to take a moment to acknowledge a
young Marine reservist, an Afghanistan combat veteran, who has been
working part time on my Veterans' Affairs Committee staff for the last
year. Carlos Fuentes is a hard-working, well-liked young man who
graduated from American University earlier this month. He has helped
our committee get a better understanding of what our veterans are
facing when they are looking for work, and I want to thank him for his
continued service to our Nation. I need my colleagues to know that
Carlos is going to be getting married this weekend and I wish him and
his bride many happy years to come.
Thank you, Mr. President. I yield the floor and I suggest the absence
of a quorum.
The PRESIDING OFFICER (Mr. Bennet). The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. MANCHIN. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.

Amendment No. 2151, as Modified

Mr. MANCHIN. Mr. President, I ask unanimous consent to set aside the
pending amendments, so I may call up my amendment No. 2151, as
modified, with the changes at the desk.
The PRESIDING OFFICER. Without objection, the clerk will report.
The legislative clerk read as follows:

The Senator from West Virginia [Mr. Manchin], for himself,
Mr. Kirk, Mrs. Gillibrand, Mr. Schumer, and Mr. Rockefeller,
proposes an amendment numbered 2151, as modified.

The amendment, as modified, is as follows:

(Purpose: To amend the Controlled Substances Act to make any substance
containing hydrocodone a schedule II drug)

At the end of subtitle C of title XI, add the following:

SEC. 1133. HYDROCODONE AMENDMENT.

The Controlled Substances Act is amended--
(1) in schedule III(d) in section 202(c) (21 U.S.C.
812(c)), by--
(A) striking paragraphs (3) and (4); and
(B) redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (3), (4), (5), and (6), respectively; and
(2) in section 401(b)(1) (21 U.S.C. 841(b)(1)), by adding
at the end the following:
``(F) In the case of any material, compound, mixture, or
preparation containing--
``(i) not more than 300 milligrams of dihydrocodeinone per
100 milliliters or not more than 15 milligrams per dosage
unit, with a fourfold or greater quantity of an isoquinoline
alkaloid of opium; or
``(ii) not more than 300 milligrams of dihydrocodeinone per
100 milliliters or not more than 15 milligrams per dosage
unit, with one or more active, nonnarcotic ingredients in
recognized therapeutic amounts,
subparagraph (C) shall not apply and such case shall be
subject to subparagraph (E).''.

Mr. MANCHIN. Mr. President, I wish to give a brief explanation of the
amendment and hope it will be accepted. Basically, what we are doing is
changing the hydrocodone combination drugs to be schedule II drugs
rather than schedule III drugs. That makes it much harder for people to
have access to this drug that has been wreaking havoc throughout our
States and throughout the country.
I would appreciate adoption of this amendment.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Mr. President, as the Senator said, his amendment would
amend the Controlled Substances Act to make any substance containing
hydrocodone--Vicodin--a schedule II drug. As he said, this is presently
a schedule III drug. The most significant difference is, for patients,
schedule II drugs are not allowed to be refilled. That is the key to
the amendment.
I applaud the Senator. I have great concerns regarding the increased
abuse of prescription drugs. According to the Centers for Disease
Control and Prevention:

Overdoses involving prescription painkillers are at
epidemic levels--

Epidemic levels--

and now kill more Americans than heroin and cocaine combined.

That is a quote from the Centers for Disease Control and Prevention.
According to CDC, more than 40 people die in America every day from
overdoses involving narcotic pain relievers such as hydrocodone.
For this reason, I applaud Senator Manchin for his amendment and the
efforts he has undertaken to reschedule this drug. It is the most
frequently abused narcotic and that is a strong reason to reschedule it
into section II.
Again, I thank the Senator for this amendment. At the appropriate
time I will ask for its adoption. Again, I thank the Senator from West
Virginia. This is a great amendment. It improves the bill. It is widely
accepted, and the Senator has been on the right track on this issue for
a long time. I applaud him for doing this and, believe me, a lot of
people in America are going to thank the Senator for getting this drug
rescheduled to cut down on the terrible overuse of this drug in
America. I thank the Senator very much.
The PRESIDING OFFICER. The Senator from West Virginia.
Mr. MANCHIN. Mr. President, if I may say this: Senator Kirk, as you
know, has worked very closely with me on this matter, and we have many
other Senators--Gillibrand, Schumer, Rockefeller--so many people who
are having this problem in their States. This is one way for us to
fight this abuse.
I have said this: If we do nothing else--if we go to some of these
communities that have been ravaged, and we speak to these young
children, they will come up to us and say: Please help me to help my
daddy or my mommy get off of this addiction. It will tear your heart
out.
This gives us a chance--one more tool with which we can fight the
drug abuse that is going on with prescription drugs. I appreciate its
consideration and would ask unanimous consent that it be adopted, if we
can do that.
I thank the Senator.
Mr. HARKIN. If the Senator would withhold the unanimous consent
request.
Mr. MANCHIN. OK.
Mr. HARKIN. We have a number of amendments we are putting together,
and at the appropriate time I will make sure that happens.
Mr. MANCHIN. Absolutely.
Mr. HARKIN. I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The 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.

Amendment No. 2126

Mr. HARKIN. Mr. President, I ask unanimous consent to set aside all
pending amendments in order to call up Reed amendment No. 2126, and I
ask that the clerk report the amendment by number.
The PRESIDING OFFICER. Without objection, it is so ordered. The clerk
will report.
The legislative clerk read as follows:

The Senator from Iowa [Mr. Harkin], for Mr. Reed, proposes
an amendment numbered 2126.

The amendment is as follows:

(Purpose: To make effective the proposed rule of the Food and Drug
Administration relating to sunscreen drug products)

At the end of title XI, add the following:

SEC. 11__. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.

In accordance with the final rule issued by the
Commissioner of Food and Drug entitled ``Labeling and
Effectiveness Testing; Sunscreen Drug Products for Over-the-
Counter Human Use; Delay of Compliance Dates'' (77 Fed. Reg.
27591 (May 11, 2012)), a product subject to the final rule
issued by the Commissioner entitled ``Labeling and
Effectiveness Testing; Sunscreen Drug Products for Over-

[[Page S3507]]

the-Counter Human Use'' (76 Fed. Reg. 35620 (June 17, 2011)),
shall comply with such rule not later than--
(1) December 17, 2013, for products subject to such rule
with annual sales of less than $25,000 and
(2) December 17, 2012, for all other products subject to
such rule.

Mr. HARKIN. Mr. President, I further ask unanimous consent that the
following amendments be agreed to en bloc: Cardin No. 2125; Cardin No.
2141; Grassley No. 2121; Grassley No. 2129; Manchin No. 2151, as
modified; and Reed No. 2126.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
The amendments (Nos. 2125; 2141; 2121; 2129; 2151, as modified; and
2126) were agreed to.
Mr. LEAHY. Mr. President, I thank Chairman Harkin and ranking member
Enzi for including the Counterfeit Drug Penalty Enhancement Act in
their substitute amendment to S. 3187. I introduced the Counterfeit
Drug Penalty Act, S. 1886, last year along with Senator Grassley and
others, and the Senate passed it by unanimous consent in March.
Unfortunately, the House of Representatives has yet to take action on
it.
The Counterfeit Drug Penalty Enhancement Act has the support of
industry and consumer groups and bipartisan backing in the House of
Representatives. It will strengthen the provisions already included in
S. 3187 that are intended to improve the safety of our supply chain and
increase penalties for adulterated drugs.
This provision increases penalties for trafficking counterfeit drugs
to a level commensurate with counterfeit cases in which the offender
knowingly or recklessly causes or attempts to cause serious bodily
injury. By strengthening the penalties appropriately, it will deter the
sale of dangerous counterfeit drugs.
Few things are more important to consumer well-being than ensuring
the safety of our pharmaceutical supply chain. Law enforcement is
finding counterfeit versions of drugs that patients rely on to treat
blood clots, cholesterol, prostate cancer, influenza, Alzheimer's, and
other serious conditions. Counterfeit drugs reportedly result in
100,000 deaths globally each year and account for an estimated $75
billion in annual revenue for criminal enterprises. We must do more to
prevent and deter this conduct.
In addition to protecting consumers, deterring the manufacture and
sale of counterfeit drugs also protects American intellectual property,
helping American workers and manufacturers. That is why this
legislation has the broad support of not only the pharmaceutical
industry and consumer groups such as the Alliance for Safe Online
Pharmacies and Easter Seals but also the U.S. Chamber of Commerce.
I appreciate the work of Chairman Harkin and Ranking Member Enzi to
protect American consumers from adulterated and counterfeit drugs, and
I thank them for including the Counterfeit Drug Penalty Enhancement Act
as part of that effort in this legislation.
Mr. WHITEHOUSE. Mr. President, I rise today to speak in support of
the Food and Drug Safety and Innovation Act. This measure includes a
number of important reforms to promote the development of new
treatments for patients in need and to ensure that drugs and other
medical products are safe and effective for American families. I
commend Chairman Harkin and Ranking Member Enzi for their hard work and
leadership on this bill.
As a participant in the drug supply chain integrity working group,
along with the chairman and ranking member and Senators Bennet, Burr,
and Grassley, I am especially proud of the strong, bipartisan measures
to protect patients that have been included in this bill. The not-too-
distant incidents concerning adulterated Heparin and counterfeit
Avastin demonstrate the critical importance of protecting Americans
from unsafe medical products manufactured overseas. The new tools and
authorities in this law should help safeguard Rhode Island families
from dangerous drugs, while leveling the playing field for U.S.
manufacturers and providing more transparency and accountability across
our drug supply chain.
I particularly want to thank the chairman and ranking member for
working with me to include the Expanding and Promoting Expertise in
Rare Treatments Act of 2012, or EXPERT Act, which I introduced earlier
this year, in the bill on the floor.
During my time in office, I have been moved by the personal stories
of dozens of Rhode Islanders with rare conditions. In the last year, I
have met with Rhode Island advocates who have or whose family member
has a rare disease, like Fragile X, spinal muscular atrophy, and CLOVES
syndrome, among many others. Treatments for these rare conditions often
do not exist or are so early in the development pipeline that it will
take years for patients to benefit. Rather than simply waiting for the
products to come to market, these families want to play a role in
educating others about the rare disease that affects their loved one
and working toward a successful treatment.
The EXPERT Act is intended to give patients and experts a role in
strengthening and expediting the FDA's review of new treatments for
rare diseases. The measure encourages the agency to take advantage of
the wisdom and insights of rare disease experts in order to speed the
development of therapies for patients suffering from rare diseases. The
bill also gives rare disease patients and their advocates a role in
consulting with the FDA on topics like the severity of the disease,
unmet medical needs, and the benefits and risks of therapies to treat
the disease.
We have seen that when the FDA gets the technical and scientific
assistance it needs from rare disease experts, incredible progress can
be made. The Cystic Fibrosis Foundation's recent work with Vertex
Pharmaceuticals on a treatment named Kalydeco, which specifically
targets the underlying causes of the disease in some patients, is a
good example. As a result of close consultation with the CF Foundation
and renowned experts, FDA approval for this treatment was one of the
fastest in the agency's history.
Rhode Islanders are already benefiting from Kalydeco. Sheri, a former
resident of Narragansett, was diagnosed with cystic fibrosis when she
was 16 years old. This past year, Sheri was surprised with the news
that she is one of the 4 percent of cystic fibrosis patients who can be
treated by the newly approved Kalydeco. For the past months Sheri has
been on Kalydeco and says that she already feels the difference in her
health, and, most importantly, it has given her hope to start thinking
about her future. Recently engaged in February, Sheri shared, ``I can
think about having children and seeing them grow up . . . even living
to see my grandchildren!''
I hope the EXPERT Act will lead to more good stories for other Rhode
Island patients and families afflicted with rare diseases. I have great
admiration for the determination and optimism of the Rhode Islanders
with rare disease I have met over the years, and I wanted to share a
few more of those stories here today.
I heard from Susan, a Providence resident and mother of 3\1/2\-year-
old Phoebe. Susan describes her daughter as a ``bright, happy, and
beautiful'' child. When Phoebe was 5 months old, Susan and her husband
noticed that their daughter did not reach for or look at objects placed
on the left side of her body. After numerous tests and doctor's visits,
Phoebe was finally diagnosed with developmental dyspraxia, a motor-
processing disorder. Because of the rarity of their daughter's
condition, Susan and her husband found that specialists ``looked at us
like we had two heads when we told them what her diagnosis was.''
Phoebe is reaching milestones in her development and is continuing to
improve, but because so little is known about dyspraxia, Susan and her
husband have encountered several hurdles to getting Phoebe the
treatment and therapy she needs. Susan said, ``It breaks our hearts to
think that Phoebe is being held back from reaching her full potential
because of lack of awareness and education about her disease.''
Dorrie, from Warwick, wrote to share her family's story with me. Her
youngest son was diagnosed with an extremely rare disorder called
atypical non-ketotic hyperglycinemia, or NKH, when he was 4 years old.
He is the only child living in Rhode Island with this disorder, which
has no known cure or treatment. However, doctors have

[[Page S3508]]

found several products can be used off label to improve their son's
speech and alertness. Dorrie notes that ``he has progressed farther
than we could ever have hoped possible. He is not only walking, but
riding a two-wheel bicycle and playing kickball with his peers.''
Because they are using products off label, their private insurance will
not cover their costs, and so they are forced to shoulder the burden of
paying for their son's treatments out-of-pocket. This has caused
anxiety and extreme stress on their family. As her son grows older,
Dorrie is faced with more uncertainty about his future and says they
are ``living on eggshells'' as he experiences increased and more severe
symptoms.
For these Rhode Islanders and others like them, the challenge of
having a rare disease or having a family member with a rare disease
comes not just from the symptoms of the disease but the loneliness of
having something that so few people understand, let alone have. The
EXPERT Act is one step toward empowering patients and their families
with an opportunity to participate in a process that is critically
important for their future. I am pleased that the act is supported by
64 national organizations, including the Rhode Island Rare Disease
Foundation. I again thank the chairman and ranking member for including
this measure in this legislation so that more families in Rhode Island
and around the country can receive the same kind of good news that
Sheri and many other cystic fibrosis patients received earlier this
year.
Mr. WARNER. Mr. President, I rise today to add my voice to the
bipartisan support for the Food and Drug Administration Safety and
Innovation Act, S. 3187.
In addition to continuing the fee-based funding system for timely FDA
reviews, S. 3187 also calls for strengthening early scientific dialogue
and transparency, promotion of innovation through enhanced
communications, and modernization of regulatory science.
These provisions, including enhancing dialog between the FDA and
medical device, pharmaceutical, generic and biotechnology companies
early in their new product development cycle, will facilitate a clearer
understanding of the specific criteria the FDA will require in its
review process and provide a succinct roadmap for successful product
approval.
The ultimate goal is to reduce misunderstandings and expensive
superfluous testing, with the hope of reducing the time and costs to
bring new medical technologies safely to patients in need.
I want to commend the chairman of the HELP committee, my friend
Senator Harkin, and the ranking member, Senator Enzi, who worked to
find bipartisan consensus on these provisions.
By creating a more user friendly and accessible FDA, innovative U.S.
companies built on the principle of American ingenuity, will be
attracted and encouraged to develop new medical devices, technologies
and pharmaceuticals.
With this new cooperation, together we will extend the quality of
life for our citizens, reduce healthcare complexities and costs, create
new U.S.-based jobs, and move this current national crisis to a
financially manageable level for individuals, employers and tax payers.
For example, in my State of Virginia, medical and bioscience research
and development is vibrant in our academic institutions and among our
companies, both large and small. The biopharmaceutical companies employ
nearly 77,000 workers in Virginia, both directly and indirectly. In the
bioscience field alone employment has grown by 23 percent, compared to
6 percent total growth statewide and 3.5 percent across all sectors in
the U.S.
We have a number of companies rushing to develop and market new
products and technologies that are focused on improving healthcare
delivery at a lower cost premium--companies like Engineered
BioPharmaceuticals in Danville, VA, who is focused on repositioning
current and future pharmaceutical therapeutics to be more effective at
lower doses, with longer shelf-lives and better consumer compliance.
To help these companies, and encourage more innovation, I am glad to
see that the FDA has committed to being more open with applicants about
using more appropriate data, but also communicating why certain data is
not able to be used. I look forward to working with stakeholders and
the FDA in monitoring this issue.
One of the most exciting innovations in health care is related to
mobile and health IT markets. Estimates indicate that the number of
smartphone consumers using medical apps will grow to 500 million by
2015.
How these innovations are regulated matters a great deal. It is
important to balance market creativity, with patient safety issues and
the intended use of the medical software.
A number of agencies have jurisdiction over pieces of mobile medical
applications, including FDA, Office of National Coordinator, ONC, and
the Federal Communications Commission, FCC,--to properly regulate
health information technology as well as address proper regulations of
mobile medical applications.
I am pleased that language has been included in this bill which asks
for the Secretary to work across the different agencies--the FDA, ONC,
and FCC--to come up with guidance that makes sense. It also encourages
an outside stakeholder group to be consulted.
I would like to thank my colleagues Senator Bennet, Senator Burr,
Hatch and Coburn for their leadership on this as well.
I would also like to briefly acknowledge language in the FDA bill
regarding the use of data from clinical trials conducted outside the
United States. As many in industry will tell you, there are a number of
countries around the world that have comparable safety standards as the
U.S.
I have been interested in learning more about the application of
appropriate clinical data across borders. I believe that if the FDA can
do more to establish comparability between its guidelines for clinical
trials and those set by countries in the European Union, for instance,
we may be able to reduce the need for duplicative work and we may be
able to get safe products to market sooner.
The FDA has committed to being more open with applicants about using
this type of data. They have agreed to provide applicants with more
information about why certain data is not appropriate for use in the
U.S. The FDA will also report on regulatory science, which will
specifically indicate which specific metrics can be used to determine
comparability.
I am hopeful that there will soon be measurable improvement on this
issue, and I look forward to working with interested stakeholders and
the FDA to do more in this area in the future.
One final point I would like to make is about something that is not
directly included in this bill, a new innovation--biomarkers.
Preeclampsia is a disorder that affects hundreds of thousands of
pregnant women every year which undiagnosed can put a woman at risk for
death and the fetus at risk of still-birth.
Doctors currently use a mix of imprecise signs and symptoms to
diagnose it but oftentimes such signs and symptoms are wrong. However,
researchers have found a biomarker--a particular biological process or
sign--that can accurately identify women with preeclampsia that are at
risk for pregnancy complications.
Unfortunately, tests for novel biomarkers are taking 5 or more years
to get approved by the FDA, delaying patients from receiving the
benefits of more accurate diagnoses and treatments.
I was pleased that a recent commitment letter between FDA and
industry specifically mentions the FDA's commitment to work together
with industry to create a transitional IVD, or ``T IVD'' process for
the development of tests for novel biomarkers.
I look forward to seeing how this T IVD process develops in
discussions between FDA and industry and am interested in progress
towards its implementation which supports advances in the sciences and
promotes access to these emerging diagnostics.
If reducing healthcare costs is a national priority, we need to act
today. I encourage my colleagues to pass S. 3187 and allow the FDA to
work more closely with the medical industry to safely bring new
technologies to the marketplace.
Let's increase the quality of life of our citizens, structurally
reduce

[[Page S3509]]

healthcare costs without increasing risks to patients and stimulate the
growth of American ingenuity and U.S.-based jobs.
Mr. HARKIN. Mr. President, we are finished with business for today.
We do have some more amendments to be called up and voted on tomorrow.
I understand we are coming in--I do not know exactly what time has been
set for the morning, but after the leaders' time has been used, we will
be back on this bill.
Again, I remind Senators and their staffs that we have until 2 p.m.
for their amendments to be brought up and to be debated. The sooner we
get to those in the morning, the better off we will be.
So as soon as the leader time is exhausted tomorrow morning, we will
be back on our bill.
So, Mr. President, I suggest the absence of a quorum and ask
unanimous consent that the time in the quorum call not be taken off our
bill.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. REID. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.

____________________