[Congressional Record Volume 157, Number 175 (Wednesday, November 16, 2011)]
[Senate]
[Pages S7614-S7617]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. BARRASSO (for himself, Mr. Hatch, and Ms. Snowe):
S. 1880. A bill repeal the health care law's job-killing health
insurance tax; to the Committee on Finance.
Mr. HATCH. Mr. President, I want to thank my good friend from
Wyoming, Senator Barrasso, for his work on this and other issues
related to the President's health law. He is a leading orthopedist, and
I have nothing but respect for him. As a former medical liability
defense lawyer defending doctors, nurses, hospitals, and other health
care providers, I appreciate good doctors, and this is one good doctor.
He and Dr. Coburn are two of the best people I have known and are a
credit to their profession.
I thank him for his work on this and other issues related to the
President's health care law. He has been tireless in his careful
analysis and fair criticism of the health spending law, and I believe
we are in agreement on that bill's fundamental flaw.
The President and his allies repeatedly promised that the health law
would decrease costs. That is not going to happen. The so-called
Affordable Care Act is going to, in fact, drive up the cost of
coverage.
Among the biggest reasons for this inflationary impact are the taxes
that will be imposed on the American people to pay for the lost $2.6
trillion in new spending. At the top of the list of senseless cost-
increasing taxes is the law's tax on health insurance. It is not clear
to me how the cost of health insurance will decrease by taxing it.
Many people probably don't even know this tax exists. Like most of
the taxes in ObamaCare, its implementation was conveniently delayed
until after the 2012 Presidential election. But this tax is coming. It
is going to hurt employers and employees. It is going to be a drag on
our economy, and it is going to depress wages.
I am glad to be standing here with Senator Barrasso as we introduce
the Jobs and Premium Protection Act, a bill that repeals this onerous
and counterproductive tax on American workers and job creators. The
President speaks about the need for Congress to do something about
jobs. Well, we would go a long way toward creating the conditions for
job growth by passing this legislation.
Unemployment in this country remains a full-blown crisis. Millions
are out of work, and the 9-percent unemployment rate doesn't begin to
capture the full extent of our jobs deficit. We need policies that will
encourage businesses to invest and expand. Yet the health law's
insurance tax does just the opposite. According to a recent analysis,
in just the first 10 years, the insurance tax would impose $87 billion
in costs on businesses and their employees. Revenue that could be spent
on higher wages, new hires, and capital investment--increasing jobs and
growing the economy--will instead go to pay this tax. And that is just
the start. In the second decade, this tax will cost businesses and
their employees $208 billion.
[[Page S7615]]
It is important to understand how this insurance tax will work.
Starting in 2014, the health insurance companies will have to pay a tax
based on their net premiums written in the fully insured market. This
is the market where 87 percent of small businesses purchase their
health insurance. It is the market where the self-employed and
uninsured go to purchase insurance.
So who will pay this tax? Someone has to pay it. Contrary to the
talking points that all too often come out of this administration, all
of these new mandates and regulations are not free. Someone has to foot
the bill. Ultimately, it will be those least able to afford it who are
paying it. Primarily small businesses--and their employees--will be
responsible for paying this tax. When the cost of coverage goes up due
to this tax, employees will pay for it in lower wages or higher health
care costs.
According to a recent study, the average employee with a family plan
will see his or her take-home pay reduced by $5,000 over the next
decade because of this tax. The American people should remember that
statistic the next time they hear their liberal supporters of the
health care law talk about wage stagnation or income inequality.
The costs of this tax will be felt by citizens even beyond those
small businesses. The factories that lose orders because their
customers' health care costs are going up will pay for this tax. Those
searching for work will feel it too, because money that could go to new
wages for new employees will instead go to pay for this tax and
increased health care costs for existing employees.
This tax will hit wide swaths of the American economy, with millions
of businesses and individuals impacted. A study by the National
Federation of Independent Business shows this tax alone will lead to a
loss of 125,000 to 249,000 jobs between now and 2021.
The legislation we are introducing today will help to reverse this
trend. Ultimately, all of Obamacare must be repealed. I am fully
committed to uprooting it in its entirety. It undermines our
Constitution and it undermines personal liberty. It exacerbates the
Nation's debt crisis by creating and expanding entitlement spending,
and it also undermines our economy, destroying existing jobs and
preventing the creation of new ones.
The people of Utah and people all over the United States need a jobs
agenda. Repeal of the health insurance tax through the Jobs and Premium
Protection Act we are introducing today would do much to address the
scourge of unemployment and get our economy moving again.
Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Wyoming.
Mr. BARRASSO. Mr. President, first, I wish to congratulate and thank
my colleague, the senior Senator from Utah, Mr. Hatch, for his
continued leadership on the issue of health care. As the ranking member
of the Finance Committee, he has been a stalwart and strong supporter
in efforts to get for the American people the health care they need,
from the doctor they want, at a price they can afford, and amazing in
his fight against what this body, what the House of Representatives,
and what the President have forced onto people all across this country,
which, to me, has been bad for patients, bad for the providers of those
patients--the nurses and doctors who take care of them--and terrible
for taxpayers.
That is why week after week I come to the floor to give a doctor's
second opinion about the health care law, and why I am so pleased to be
here with my colleague today to join in the introduction of this piece
of legislation.
As people all around the country know--those who listened to the many
speeches given during the debate on health care--the President and
Democrats in Washington promised the American people this trillion
dollar health care spending law would lower health insurance premiums.
That is what the President promised, that health insurance premium
costs would go down. Well, the American people have now had 19 months
to review what is in the health care law, and they are finding that the
President and the Washington Democrats sold them a bill of goods.
On September 27 of this year, the Kaiser Family Foundation issued its
annual survey of employer-sponsored health insurance premiums. The
report showed that employer-provided health insurance premiums rose--
went up, not down--$1,303 for an average family last year alone.
Remember--and we do--that the President repeatedly promised his health
care law would reduce the average annual family premium by $2,500. Yet
the exact opposite of what the President promised has occurred. The
Kaiser Family Foundation report shows significant premium increases,
not savings as the President promised.
Not only are premiums continuing to climb, but the President and
Washington Democrats paid for their health care spending law by
imposing billions of dollars in new taxes on American business and
American consumers. Independent experts agree these taxes only serve to
increase an individual, a family, or a small business's cost to buy
medical coverage. Specifically, section 9010 of the health care law
creates a new $60-plus billion tax on health insurance plans starting
in 2014.
The health care law slaps this tax on all health insurance companies
based on net premiums in what is called the fully insured market. This
means the tax an insurance company must pay is equal to the percent of
their market share. The larger the insurance company's market share,
the higher their annual health insurance tax becomes. The aggregate tax
in 2014 is $8 billion and climbs to $11.3 billion in 2015 and 2016,
eventually reaching over $14 billion in 2018. After that, the law
mandates the health insurance tax grow by premium inflation. More
inflation, higher taxes.
Former Congressional Budget Office Director Douglas Holtz-Eakin
released a study in March of this year estimating the health insurance
tax could exceed $87 billion between 2014 and 2020. Some on the other
side of the aisle want to message this tax as a ``health insurance
fee.'' I would say to my friends all across this country, Do not be
fooled. This new tax directly hits small business.
The Joint Committee on Taxation makes it clear the insurance tax will
be borne by consumers in the form of higher prices, by owners of firms
in the form of lower profits, by employees of those firms in the form
of lower wages, or by other suppliers to the firms in the form of lower
payments.
Remember, this tax only hits health insurance companies that sell
their products in the fully insured market. As we have learned, and
heard earlier on the Senate floor, 87 percent of small businesses buy
their health insurance in this fully insured market.
The fully insured market is also the place that uninsured individuals
and the self-employed go when they need to purchase medical insurance.
Insurance companies selling plans to individuals and small businesses
are the ones that are hit with the tax. The new tax doesn't hit large,
self-insured businesses. Ultimately, uninsured individuals, small
businesses, and their employees are the ones who are going to end up
paying this unfair tax. This new punitive tax will add hundreds of
dollars to family and small business insurance premiums every year.
The Wyoming Blue Cross Blue Shield Association tells me that a
Wyoming family of four will see a premium increase because of this tax
of over $300 in 2014. In 2018, that same Wyoming family of four will
see over a $500 premium increase as a result of the tax. These premium
increases will have been passed through to consumers as a direct result
of this health care law's tax component--what the President and the
Democrats in this body have foisted on the American public.
Additionally, the Holtz-Eakin March 2011 study proves the health
insurance tax will raise premiums by as much as 3 percent or nearly
$5,000 for a family of four over the next decade. What American family,
I ask you, can afford to see their take-home pay reduced by $5,000 over
the next decade thanks to the President's new tax. The Nation's
unemployment rate stands at 9 percent. There are 14 million Americans,
people across our country, unemployed and looking for work. Struggling
American families cannot bear the brunt of President's Obama's new tax.
A recent study by the National Federation of Independent Business
found this health insurance tax will force the
[[Page S7616]]
private sector to shed somewhere between 125,000 and 249,000 jobs
between now and 2021. More than half of those losses will fall on the
backs of small businesses.
Two million small businesses across this country cannot afford
President Obama's new tax. Twenty-six million workers, who get their
insurance through their employer, cannot afford President Obama's new
tax. And the 12 million people who buy health insurance plans on their
own in the individual market cannot afford President Obama's new tax.
That is why today we introduce legislation called the Jobs and Premium
Protection Act.
I introduced this bill along with my friend, the ranking member of
the Senate Finance Committee, Senator Hatch. Our legislation is simple
and straightforward. It eliminates the health care law's punitive tax
on every individual, family, and small business that chooses to do the
right thing and buy health insurance. Unbelievably, the health care law
punishes individuals and punishes small businesses, the very two groups
who find buying health insurance at an affordable price extremely
challenging. Why would the Federal Government implement policies that
make it harder by imposing a tax on the products these individuals buy?
Some must believe that insurers will simply be able to absorb the
tax. Well, experts tell us that assumption is false. Here is what the
nonpartisan Joint Committee on Taxation said in a letter to Senator
John Kyl in June of this year:
We expect a very large portion of the insurance industry
fee to be passed forward to purchasers of insurance in the
form of higher premiums.
A very large portion, they say. Then they go on to say:
Eliminating this fee would decrease the average family
premium in 2016 by $300 to $400.
Isn't that what we want, to lower the cost of insurance for
individuals? This is the way to do it.
Finally, the Joint Committee on Taxation letter confirms the
following:
Repealing the health insurance industry fee would reduce
the premium prices of plans offered by covered entities by 2
to 2\1/2\ percent.
This ill-conceived discriminatory tax must be eliminated. It must be
stopped well before it starts to impact individuals, families, and
small businesses. Our bill is a critical piece of pro-business
legislation. It has the support of organizations such as the National
Federation of Independent Business, the U.S. Chamber of Commerce, Blue
Cross Blue Shield Association, and America's health insurance plans.
I urge colleagues on both sides of the aisle who are concerned about
the cost of insurance for families of America, who are shocked and
surprised, some in disbelief, that what the President promised the
American people--of a reduction in premiums--isn't true, and who want
to try to in a little way right that wrong to do so by cosponsoring and
supporting the Jobs and Premium Protection Act.
I thank the Chair and the ranking member of the Senate Finance
Committee, Senator Hatch--especially Senator Hatch--for his leadership
and for joining me in introducing this legislation today. The time has
come to eliminate a bad policy that not only increases health insurance
costs but also negatively impacts America's job creators.
______
By Mr. BINGAMAN (for himself, Mr. Vitter, Mr. Merkley, and Mr.
Brown of Ohio.
S. 1882. A bill to amend the Federal Food, Drug, and Cosmetic Act to
ensure that valid generic drugs may enter the market; to the Committee
on Health, Education, Labor, and Pensions.
Mr. BINGAMAN. Mr. President, I rise today with Senators Vitter,
Merkley, and Brown of Ohio to introduce the Fair and Immediate Release
of Generic Drugs Act of 2011. The FAIR GENERxICS Act is an important
step in addressing the root cause of the growing cost of healthcare--
the delay of generic drugs entering the market. This legislation has
broad support from consumer advocates, the generics industry, and
experts including: AARP, Apotex generics manufacturer, Families USA,
U.S. PIRG, Consumers Union, Consumer Federation of America, Center for
Medicare Advocacy, the National Legislative Association on Prescription
Drug Prices, Alliance for Retired Americans, and Community Catalyst.
According to the Kaiser Family Foundation, prices for brand-name
prescription drugs have continued to outpace inflation. Overall
spending on prescription drugs also has increased sharply. In 2008
spending in the U.S. for prescription drugs was $234.1 billion, nearly
6 times the $40.3 billion spent in 1990. Generic drugs can be an
important source of affordable prescription drugs for many Americans.
On average, generic drugs are four times less expensive than name brand
drugs.
Pay-for-delay patent settlements brand and generic pharmaceutical
manufacturers, however, are delaying timely public access to generic
drugs, which costs consumers and taxpayers billions of dollars
annually. In 2010 the Federal Trade Commission reported 31 such
settlements, a 60 percent increase since 2009, and in 2011 FTC reported
28 such settlements. Many experts and consumer advocates have called
for legislation to address this problem and ensure access to affordable
medicines for all Americans.
The FAIR GENERxICS Act of 2011 addresses the root cause of anti-
competitive pay-for-delay settlements between brand and generic
pharmaceutical manufacturers--the unintended, structural flaw in the
Hatch-Waxman Act that allows ``parked'' exclusivities to block generic
competition. By doing so, the legislation ensures consumers will
benefit from full and fair generic competition at the earliest, most
appropriate time.
The legislation would prevent ``parked exclusivities'' from delaying
full, fair, and early generic competition by modifying three key
elements of existing law. First, the legislation would grant the right
to share exclusivity to any generic filer who wins a patent challenge
in the district court or is not sued for patent infringement by the
brand company. The legislation also maximizes the incentive for all
generic challengers to fight to bring products to market at the
earliest possible time by holding generic settlers to the deferred
entry date agreed to in their settlements. Finally, in order to create
more clarity regarding litigation risk for pioneer drug companies and
generic companies, the legislation requires pioneer companies to make a
litigation decision within the 45 day window provided for in the Hatch-
Waxman Act.
As a result of these changes, companies who prevail in their patent
challenges and immediately come to market may be the sole beneficiary
of the 180 day exclusivity period. In addition, companies will
understand litigation risk before launching generic products.
Taken in concert these changes will ensure that generic markets are
opened as they were originally envisioned under the Hatch-Waxman
exclusivity periods; and will generate significant savings for the U.S.
consumers, the Federal Government, and the American health care system.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 1882
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Fair And Immediate Release
of Generic Drugs Act'' or the ``FAIR Generics Act''.
SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING FIRST
APPLICANT STATUS.
(a) Amendments to Federal Food, Drug, and Cosmetic Act.--
(1) In general.--Section 505(j)(5)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) is amended--
(A) in clause (iv)(II)--
(i) by striking item (bb); and
(ii) by redesignating items (cc) and (dd) as items (bb) and
(cc), respectively; and
(B) by adding at the end the following:
``(v) First Applicant Defined.--As used in this subsection,
the term `first applicant' means an applicant--
``(I)(aa) that, on the first day on which a substantially
complete application containing a certification described in
paragraph (2)(A)(vii)(IV) is submitted for approval of a
drug, submits a substantially complete application that
contains and lawfully maintains a certification described in
paragraph (2)(A)(vii)(IV) for the drug; and
``(bb) that has not entered into a disqualifying agreement
described under clause (vii)(II); or
[[Page S7617]]
``(II)(aa) for the drug that is not described in subclause
(I) and that, with respect to the applicant and drug, each
requirement described in clause (vi) is satisfied; and
``(bb) that has not entered into a disqualifying agreement
described under clause (vii)(II).
``(vi) Requirement.--The requirements described in this
clause are the following:
``(I) The applicant described in clause (v)(II) submitted
and lawfully maintains a certification described in paragraph
(2)(A)(vii)(IV) or a statement described in paragraph
(2)(A)(viii) for each unexpired patent for which a first
applicant described in clause (v)(I) had submitted a
certification described in paragraph (2)(A)(vii)(IV) on the
first day on which a substantially complete application
containing such a certification was submitted.
``(II) With regard to each such unexpired patent for which
the applicant described in clause (v)(II) submitted a
certification described in paragraph (2)(A)(vii)(IV), no
action for patent infringement was brought against such
applicant within the 45 day period specified in paragraph
(5)(B)(iii); or if an action was brought within such time
period, such an action was withdrawn or dismissed by a court
(including a district court) without a decision that the
patent was valid and infringed; or if an action was brought
within such time period and was not withdrawn or so
dismissed, such applicant has obtained the decision of a
court (including a district court) that the patent is invalid
or not infringed (including any substantive determination
that there is no cause of action for patent infringement or
invalidity, and including a settlement order or consent
decree signed and entered by the court stating that the
patent is invalid or not infringed).
``(III) If an applicant described in clause (v)(I) has
begun commercial marketing of such drug, the applicant
described in clause (v)(II) does not begin commercial
marketing of such drug until the date that is 30 days after
the date on which the applicant described in clause (v)(I)
began such commercial marketing.''.
(2) Conforming amendment.--Section 505(j)(5)(D)(i)(IV) of
such Act (21 U.S.C. 355(j)(5)(D)(i)(IV)) is amended by
striking ``The first applicant'' and inserting ``The first
applicant, as defined in subparagraph (B)(v)(I),''.
(b) Applicability.--The amendments made by subsection (a)
shall apply only with respect to an application filed under
section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)) to which the amendments made by section
1102(a) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Public Law 108-173) apply.
SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING
AGREEMENTS TO DEFER COMMERCIAL MARKETING.
(a) Amendments to Federal Food, Drug, and Cosmetic Act.--
(1) Limitations on agreements to defer commercial marketing
date.--Section 505(j)(5)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(B)), as amended by section
2, is further amended by adding at the end the following:
``(vii) Agreement by first applicant to defer commercial
marketing; limitation on acceleration of deferred commercial
marketing date.--
``(I) Agreement to defer approval or commercial marketing
date.--An agreement described in this subclause is an
agreement between a first applicant and the holder of the
application for the listed drug or an owner of one or more of
the patents as to which any applicant submitted a
certification qualifying such applicant for the 180-day
exclusivity period whereby that applicant agrees, directly or
indirectly, (aa) not to seek an approval of its application
that is made effective on the earliest possible date under
this subparagraph, subparagraph (F) of this paragraph,
section 505A, or section 527, (bb) not to begin the
commercial marketing of its drug on the earliest possible
date after receiving an approval of its application that is
made effective under this subparagraph, subparagraph (F) of
this paragraph, section 505A, or section 527, or (cc) to both
items (aa) and (bb).
``(II) Agreement that disqualifies applicant from first
applicant status.--An agreement described in this subclause
is an agreement between an applicant and the holder of the
application for the listed drug or an owner of one or more of
the patents as to which any applicant submitted a
certification qualifying such applicant for the 180-day
exclusivity period whereby that applicant agrees, directly or
indirectly, not to seek an approval of its application or not
to begin the commercial marketing of its drug until a date
that is after the expiration of the 180-day exclusivity
period awarded to another applicant with respect to such drug
(without regard to whether such 180-day exclusivity period is
awarded before or after the date of the agreement).
``(viii) Limitation on acceleration.--If an agreement
described in clause (vii)(I) includes more than 1 possible
date when an applicant may seek an approval of its
application or begin the commercial marketing of its drug--
``(I) the applicant may seek an approval of its application
or begin such commercial marketing on the date that is the
earlier of--
``(aa) the latest date set forth in the agreement on which
that applicant can receive an approval that is made effective
under this subparagraph, subparagraph (F) of this paragraph,
section 505A, or section 527, or begin the commercial
marketing of such drug, without regard to any other provision
of such agreement pursuant to which the commercial marketing
could begin on an earlier date; or
``(bb) 180 days after another first applicant begins
commercial marketing of such drug; and
``(II) the latest date set forth in the agreement on which
that applicant can receive an approval that is made effective
under this subparagraph, subparagraph (F) of this paragraph,
section 505A, or section 527, or begin the commercial
marketing of such drug, without regard to any other provision
of such agreement pursuant to which commercial marketing
could begin on an earlier date, shall be the date used to
determine whether an applicant is disqualified from first
applicant status pursuant to clause (vii)(II).''.
(2) Notification of fda.--Section 505(j) of such Act (21
U.S.C. 355(j)) is amended by adding at the end the following:
``(11)(A) The holder of an abbreviated application under
this subsection shall submit to the Secretary a notification
that includes--
``(i)(I) the text of any agreement entered into by such
holder described under paragraph (5)(B)(vii)(I); or
``(II) if such an agreement has not been reduced to text, a
written detailed description of such agreement that is
sufficient to disclose all the terms and conditions of the
agreement; and
``(ii) the text, or a written detailed description in the
event of an agreement that has not been reduced to text, of
any other agreements that are contingent upon, provide a
contingent condition for, or are otherwise related to an
agreement described in clause (i).
``(B) The notification described under subparagraph (A)
shall be submitted not later than 10 business days after
execution of the agreement described in subparagraph (A)(i).
Such notification is in addition to any notification required
under section 1112 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003.
``(C) Any information or documentary material filed with
the Secretary pursuant to this paragraph shall be exempt from
disclosure under section 552 of title 5, United States Code,
and no such information or documentary material may be made
public, except as may be relevant to any administrative or
judicial action or proceeding. Nothing in this paragraph is
intended to prevent disclosure to either body of the Congress
or to any duly authorized committee or subcommittee of the
Congress.''.
(3) Prohibited acts.--Section 301(e) of such Act (21 U.S.C.
331(e)) is amended by striking ``505 (i) or (k)'' and
inserting ``505 (i), (j)(11), or (k)''.
(b) Infringement of Patent.--Section 271(e) of title 35,
United States Code, is amended by adding at the end the
following:
``(7) The exclusive remedy under this section for an
infringement of a patent for which the Secretary of Health
and Human Services has published information pursuant to
subsection (b)(1) or (c)(2) of section 505 of the Federal
Food, Drug, and Cosmetic Act shall be an action brought under
this subsection within the 45-day period described in
subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the
Federal Food, Drug, and Cosmetic Act.''.
(c) Applicability.--
(1) Limitations on acceleration of deferred commercial
marketing date.--The amendment made by subsection (a)(1)
shall apply only with respect to--
(A) an application filed under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) to
which the amendments made by section 1102(a) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003
(Public Law 108-173) apply; and
(B) an agreement described under section
505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)(1)) executed after the date
of enactment of this Act.
(2) Notification of fda.--The amendments made by paragraphs
(2) and (3) of subsection (a) shall apply only with respect
to an agreement described under section 505(j)(5)(B)(vii)(I)
of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)(1)) executed after the date of enactment of
this Act.
____________________