[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.

                          ____________________