S. 320Senate114th Congress (2015-2017)In Committee

Medical Innovation Act of 2015

Introduced January 29, 2015

Legislative Activity

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SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S657-658)

January 29, 2015

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SenateIntro Referral

Introduced in Senate

January 29, 2015

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S657-658)

January 29, 2015

Floor Debate

20 members

What members said about S. 320 on the floor

9 Republicans11 Democrats
Lisa Murkowski
Sen. Lisa MurkowskiR-AK · Jan 29, 2015

Mr. President, as we just heard, the House has sent over legislation they have moved through that body that would allow for export of LNG. As we speak, in the Energy and Natural Resources Committee…

John Cornyn
Sen. John CornynR-TX · Jan 29, 2015

The following Senator is necessarily absent: the Senator from Florida (Mr. Rubio). I move to lay that motion on the table. The motion to lay on the table was agreed to. Amendment No. 77 The following…

Benjamin L. Cardin
Sen. Benjamin L. CardinD-MD · Jan 29, 2015

Madam President, I ask unanimous consent that I take a few minutes to debate the next amendment and save a little bit of time at the end by withdrawing the amendment. Madam President, as we consider…

Richard Burr
Sen. Richard BurrR-NC · Jan 29, 2015

Madam President, I will be brief, but I would like my colleagues' attention because we have an opportunity today to take a program that functions well, that this body designed, funded from royalties…

Lamar Alexander
Sen. Lamar AlexanderR-TN · Jan 29, 2015

Mr. President, I ask unanimous consent to speak for up to 15 minutes, and that following me, the Senator from North Carolina be recognized for up to 15 minutes. Mr. President, I am advised by the…

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Susan M. Collins
Sen. Susan M. CollinsR-ME · Jan 29, 2015

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I ask unanimous consent that the Senator from Florida, Mr. Nelson, and I be permitted to proceed…

Elizabeth Warren
Sen. Elizabeth WarrenD-MA · Jan 29, 2015

Mr. President, I come to the floor today to announce the introduction of the Medical Innovation Act, which is a commonsense proposal that could dramatically increase our Nation's investment in…

Elizabeth Warren
Sen. Elizabeth WarrenD-MA · Jan 29, 2015

Mr. President, I come to the floor today to announce the introduction of the Medical Innovation Act, which is a commonsense proposal that could dramatically increase our Nation's investment in…

Maria Cantwell
Sen. Maria CantwellD-WA · Jan 29, 2015

I know originally we pushed the bill back, so I am happy to move it back to reclaim some of that time and help us. I know there are a few things which have been worked out, and we very much…

Dianne Feinstein
Sen. Dianne FeinsteinD-CA · Jan 29, 2015

Mr. President, I wish to speak in opposition to the Keystone XL Pipeline. This bill will not help our economy, it will not create permanent jobs, and it certainly is not a boon to the environment. On…

Christopher Murphy
Sen. Christopher MurphyD-CT · Jan 29, 2015

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I know we are about to bring some final votes on Keystone to the floor, but I want to take a few…

John Thune
Sen. John ThuneR-SD · Jan 29, 2015

Mr. President, last year we saw an all-time record number of motor vehicle recalls, including those by General Motors, Toyota, Honda, and others. The commerce committee held five vehicle safety…

John Hoeven
Sen. John HoevenR-ND · Jan 29, 2015

Madam President, I wish to thank the Senator from Alaska and the Senator from Washington as the bill managers. I think they have done an exceptional job. I know that is not just my opinion, but it is…

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Barbara A. Mikulski
Sen. Barbara A. MikulskiD-MD · Jan 29, 2015

Mr. President, today I am introducing the Accelerating Biomedical Research Act. The bill allows more funding for the National Institutes of Health by allowing NIH funding to grow even while we…

Jack Reed
Sen. Jack ReedD-RI · Jan 29, 2015

Mr. President, today I join with my colleagues Senators Cochran and Whitehouse in introducing the Strengthening Kids' Interest in Learning and Libraries, SKILLS, Act. Fifty years ago, when President…

Bill Nelson
Sen. Bill NelsonD-FL · Jan 29, 2015

Mr. President, this bill is borne out of the work Senator Collins and I did on the Special Committee on Aging. After we had a hearing on the condition of the American senior citizen, it was certainly…

Bill Nelson
Sen. Bill NelsonD-FL · Jan 29, 2015

Mr. President, in light of the late hour, just before our votes, I will submit for the Record a statement which correlates with the chairman of our committee, and I thank the Senator for so much of…

Sherrod Brown
Sen. Sherrod BrownD-OH · Jan 29, 2015

Mr. President, I ask unanimous consent to speak as in morning business for up to 5 minutes. Mr. President, I rise to discuss the Children's Health Insurance Program. This Congress 20 years ago passed…

Debbie Stabenow
Sen. Debbie StabenowD-MI · Jan 29, 2015

Mr. President, I assume there is a little bit of time to make a couple of comments as we are waiting. I would commend the chairwoman of the Energy and Natural Resources Committee, for she and the…

Edward J. Markey
Sen. Edward J. MarkeyD-MA · Jan 29, 2015

Mr. President, throughout my career, I have been proud to stand up for equality for all Americans regardless of their sexual orientation or gender identity. While I have seen much progress with…

Lisa Murkowski
Sen. Lisa MurkowskiR-AK · Jan 29, 2015

Mr. President, I rise today to reintroduce legislation which has been proposed in the past by the Alaska Congressional Delegation to officially restore the traditional name of the nation's highest…

David Vitter
Sen. David VitterR-LA · Jan 29, 2015

Thank you, Mr. President. I want to thank the Senator for her kind words and continuing commitment to work on revenue-sharing measures. As her new role as the Chair of the Energy and Natural…

Edward J. Markey
Sen. Edward J. MarkeyD-MA · Jan 29, 2015

Mr. President, my amendment is very simple. It would require that before the Keystone XL Pipeline is deemed approved, we should determine whether carbon pollution, including the carbon pollution from…

David Perdue
Sen. David PerdueR-GA · Jan 29, 2015

Mr. President, today I wish to speak on S. 1, legislation to approve the Keystone XL pipeline. I am proud to be a cosponsor of this bipartisan bill, which will approve construction of the pipeline…

Bill Text

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Introduced in SenateIssued January 29, 2015

II

114th CONGRESS

1st Session

S. 320

IN THE SENATE OF THE UNITED STATES

January 29, 2015

Ms. Warren (for herself, Mr. Cardin, Mr. Brown, and Ms. Baldwin) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To authorize the collection of supplemental payments to increase congressional investments in medical research, and for other purposes.

1.

Short title

This Act may be cited as the Medical Innovation Act of 2015.

2.

Authority to assess and use supplemental payments to increase congressional investments in medical research

(a)

In general

Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by adding at the end the following:

(f)

Authority To assess and use supplemental payments To increase congressional investments in medical research

(1)

Definitions

For purposes of this subsection:

(A)

Covered blockbuster drug

(i)

In general

The term covered blockbuster drug means any product—

(I)

for which the covered manufacturer reported to the Securities and Exchange Commission on a form, including form 10–K or form 20–F, or is otherwise determined by the Secretary to have received, at least $1,000,000,000 in net sales in the previous calendar year; and

(II)

that was developed, in whole or in part, through Federal Government investments in medical research, as the Secretary determines in accordance with clause (ii).

(ii)

Determination of Federal Government investment

In determining under clause (i)(II) whether a product was developed, in whole or in part, through Federal Government investments in medical research, the Secretary shall consider whether information included in any patent that claims the covered blockbuster drug or that claims a method of using such covered blockbuster drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the covered blockbuster drug, or any element of the covered blockbuster drug—

(I)

relates to, or is based upon, prior science conducted, in whole or in part, by a person that is or was funded by the Federal Government;

(II)

relates to, acts upon, or is based upon knowledge of a signaling pathway, cellular receptor, ion channel, protein, DNA or RNA sequence or mutation, virus, or any other scientific information discovered, in whole or in part, through research funded by the Federal Government; or

(III)

relates to, or is based upon, through the manufacturing process or testing process of the covered blockbuster drug, technology derived, in whole or in part, through research funded by the Federal Government.

(B)

Covered manufacturer

The term covered manufacturer means a person—

(i)

that holds an application approved under section 505 of the Federal Food, Drug, and Cosmetic Act or a license under section 351 of this Act for a covered blockbuster drug; or

(ii)

who is a co-licensed partner of the person described in clause (i) that obtains the covered blockbuster drug directly from a person described in this clause or clause (i).

(C)

Covered settlement agreement

(i)

In general

The term covered settlement agreement means a settlement agreement (including a consent decree), and except as provided under clause (ii), that—

(I)

is between an agency and a covered manufacturer;

(II)

relates to—

(aa)

an alleged violation of, or a penalty under, section 1128A of the Social Security Act (42 U.S.C. 1320a–7a) or section 1128B of the Social Security Act (42 U.S.C. 1320a–7b);

(bb)

an alleged violation under subchapter III of chapter 37 of title 31, United States Code (commonly known as the False Claims Act), or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or

(cc)

an alleged violation of any other Federal civil or criminal law; and

(III)

requires the payment of not less than $1,000,000 by a covered manufacturer.

(ii)

Exception for settlements not affecting taxpayers or public health

The term covered settlement agreement does not include any settlement agreement that the Secretary determines—

(I)

does not involve an alleged criminal violation; and

(II)

does not to relate to—

(aa)

allegations of fraud resulting, or potentially resulting, in a loss of taxpayer dollars; or

(bb)

allegations of conduct having an adverse impact, or a potentially adverse impact, on the health of the public.

(D)

Person

The term person has the meaning given such term in section 201(e) of the Federal Food, Drug, and Cosmetic Act.

(E)

Product

The term product means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351, and subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act.

(2)

Supplemental payments to increase congressional investments in medical research

(A)

Supplemental payment assessment and collection

Beginning with the first fiscal year that begins at least 60 days after the date of enactment of the Medical Innovation Act of 2015, and each subsequent fiscal year, the Secretary shall, in accordance with this paragraph, assess and collect supplemental payments to increase congressional investments in medical research from each covered manufacturer described in subparagraph (B).

(B)

Criteria for assessing payments

A covered manufacturer that meets both of the following criteria for a calendar year (referred to in this subparagraph as the applicable calendar year) shall be assessed a supplemental payment under subparagraph (A) for the fiscal year beginning in the proceeding calendar year:

(i)

A covered manufacturer that, during the 5-year period immediately preceding the date on which the payment is assessed, but not before the date of enactment of the Medical Innovation Act of 2015, entered into a covered settlement agreement.

(ii)

A covered manufacturer that reported net income of at least $1,000,000,000 to the Securities and Exchange Commission on a form, including form 10–K or form 20–F, or that the Secretary otherwise determines to have had net income of at least $1,000,000,000—

(I)

during the applicable calendar year; or

(II)

during the calendar year in which the covered manufacturer entered into a covered settlement agreement, as described in clause (i).

(C)

Payment amount

A covered manufacturer described in subparagraph (B) shall be assessed a supplemental payment to increase congressional investments in medical research for a fiscal year equal to 1 percent of the net income of the covered manufacturer, as reported or determined as described in subparagraph (B)(ii), for the previous calendar year, multiplied by the number of covered blockbuster drugs of the covered manufacturer for that year.

(D)

Publication of payments

Beginning with the first fiscal year that begins at least 60 days after the date of enactment of the Medical Innovation Act of 2015, and not later than 60 days before the start of each fiscal year, the Secretary shall publish in the Federal Register, with respect to the next fiscal year—

(i)

a list of covered manufacturers subject to the payment under this paragraph;

(ii)

a list of the covered blockbuster drugs of each such covered manufacturer;

(iii)

the total payment amount assessed to each such covered manufacturer; and

(iv)

the manner in which payments assessed under this paragraph will be collected.

(E)

Crediting and availability of supplemental payments

(i)

In general

Subject to clause (ii), payments authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such payments are authorized to remain available until expended.

(ii)

Collections and appropriations Acts

(I)

In general

The payments authorized by this paragraph—

(aa)

subject to subclause (II), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year; and

(bb)

shall be available to the Secretary to distribute, as described in paragraph (3).

(II)

Provision for early payments

Payments authorized under clause (iii) for a fiscal year, prior to the due date for such payments, may be accepted by the Secretary.

(iii)

Authorization of appropriations

For the first fiscal year that begins at least 60 days after the date of enactment of the Medical Innovation Act of 2015 and for each subsequent fiscal year, there is authorized to be appropriated for supplemental payments under this paragraph an amount equal to the total amount of supplemental payments assessed for such fiscal year under this paragraph.

(F)

Remitting payments

A covered manufacturer assessed a supplemental payment under subparagraph (A) shall remit the payment no later than the first business day on or after October 1 of each fiscal year, or the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of supplemental payments for such fiscal year.

(G)

Collection of assessed payments that are not remitted

In any case where the Secretary does not receive a supplemental payment assessed under subparagraph (A) within 30 days after it is due, such supplemental payment shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.

(H)

Supplement not supplant

Payments collected under this paragraph shall be used to supplement and not supplant other Federal funds made available to carry out the priorities described in paragraph (4).

(3)

Distribution of payments to agencies to increase congressional investments in medical research

(A)

Distribution to agencies

Subject to subparagraph (C), for the purposes described in paragraph (4), the Secretary shall distribute the amounts appropriated under paragraph (2)(E)(iii) during a fiscal year to—

(i)

the Food and Drug Administration, to be used in accordance with paragraph (4)(A); and

(ii)

the National Institutes of Health organized under title IV, to be used in accordance with paragraph (4)(B).

(B)

Distribution ratio between agencies

The amount that the Secretary distributes to an agency under subparagraph (A) during a fiscal year shall bear the same relation to the total amount appropriated under paragraph (2)(E)(iii) for such fiscal year as the amount of discretionary funds appropriated to such agency for such fiscal year bears to the total amount of discretionary funding appropriated to both agencies listed in subparagraph (A) for such fiscal year.

(C)

Ensuring stable congressional investments in medical research

(i)

In general

Supplemental payments collected in accordance with paragraph (2) shall not be distributed under subparagraph (A) for a fiscal year unless appropriations to both of the agencies listed in such subparagraph for the fiscal year are equal to or greater than appropriations to such agencies for the prior fiscal year.

(ii)

Delayed distribution

If, in accordance with clause (i), the Secretary does not distribute payments collected in accordance with paragraph (2) during any portion of a fiscal year, and, at a later date in such fiscal year, the appropriations to the agencies listed in subparagraph (A) become equal to or greater than the amount of appropriations for the prior fiscal year, the Secretary may distribute such payment at any time in such fiscal year.

(D)

Considerations

In determining amounts appropriated for purposes of subparagraphs (B) and (C)—

(i)

the Secretary shall not consider any amounts appropriated in accordance with paragraph (2)(E)(iii); and

(ii)

with respect to the Food and Drug Administration, the Secretary shall not consider amounts appropriated in accordance with subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (relating to user fees collected by the Secretary).

(4)

Prioritizing urgent needs in medical research

The Secretary shall ensure that the payments distributed under paragraph (3) are used to meet urgent needs in medical research, including priorities as follows:

(A)

FDA

With respect the Food and Drug Administration, the priority use of the distributions shall include carrying out the goals of the strategy and implementation plan for advancing regulatory science for medical products under section 1124 of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 393 note), and other such research activities in order to promote the public health and advance innovation in regulatory decisionmaking, as determined by the Secretary.

(B)

NIH

With respect to the National Institutes of Health, the priority use of the distributions shall include supporting—

(i)

research that fosters radical innovation, including—

(I)

research on diseases or conditions for which treatments exist but are inadequate;

(II)

research on diseases or conditions for which there are unmet medical needs;

(III)

research on diseases for which treatments exist but the side effect profiles of such treatments limit the therapeutic potential of such treatments;

(IV)

research on new approaches to treatment of a disease using a drug, device, or therapy that, at the time of distribution, is not used or is underused; or

(V)

research to identify new biomarkers;

(ii)

research that advances fundamental knowledge even if it does not provide immediate or near-term clinical or therapeutic benefits, including research that advances the understanding of biochemistry, biology, protein science, immunology, genetics, virology, microbiology, or neurology;

(iii)

research related to diseases that disproportionally account for Federal health care spending, including spending under the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of the Social Security Act, the State Children's Health Insurance Program under title XXI of the Social Security Act, the TRICARE program under chapter 55 of title 10, United States Code, and the hospital services and medical care provided through the Veterans Administration under chapters 17 and 18 of title 38, United States Code, and tax credits made available through the amendments to the Internal Revenue Code of 1986 made by the Patient Protection and Affordable Care Act (Public Law 111–148), such as research relating to—

(I)

diseases that disproportionally impact older individuals;

(II)

degenerative diseases, and

(III)

chronic conditions; and

(iv)

early career scientists by—

(I)

awarding research project grants that support discrete, specified, circumscribed projects to be performed by the investigator in an area representing the specific interests and competencies of such investigator, to investigators—

(aa)

who are within 10 years of completing a terminal research degree; or

(bb)

who are within 10 years of completing a medical residency;

(II)

awarding grants that support career development experiences that lead to earlier research independence; and

(III)

awarding grants that support innovative training programs that, in addition to scientific training, provide additional training to enhance employment opportunities, including training in management and business, to—

(aa)

graduate students;

(bb)

post-doctoral fellows;

(cc)

individuals within 10 years of completing a terminal research degree; or

(dd)

individuals within 10 years of completing a medical residency.

(5)

Annual reports

(A)

Secretary of health and human services

Not later than 180 calendar days before the end of a fiscal year in which the Secretary has assessed supplemental payments under paragraph (2), the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, which shall include a description of supplemental payments assessed, collected, and distributed under this subsection for such fiscal year, and a list of the covered manufacturers that were assessed supplemental payments and the amount of such assessments.

(B)

FDA and NIH

For each fiscal year in which amounts are distributed under paragraph (3), the Food and Drug Administration and the National Institutes of Health shall report on the use and impact of such amounts in the annual budget submission of such entity.

.

(b)

Effect of failure To remit payment

Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

(dd)

If it is a drug that is a covered blockbuster drug (as defined in section 301(f)(1) of the Public Health Service Act) for which any payment assessed under section 301(f)(2) of such Act has not been paid in accordance with such section, until such payment is made.

.