H.R. 877House111th Congress (2009-2011)In Committee

Patients First Act of 2009

Introduced February 4, 2009

Legislative Activity

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2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Health.

February 9, 2009

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HouseIntro Referral

Introduced in House

February 4, 2009

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

February 4, 2009

HouseCommittee

Referred to the Subcommittee on Health.

February 9, 2009

Floor Debate

10 members

What members said about H.R. 877 on the floor

10 Republicans
Christopher H. Smith
Rep. Christopher H. SmithR-NJ-4 · Mar 4, 2009

Madam Speaker, I yield such time as he might consume to my good friend and colleague, Zach Wamp. I thank my good friend, but especially for his extraordinary work on banning human cloning and for his…

J. Randy Forbes
Rep. J. Randy ForbesR-VA-4 · Mar 4, 2009

Thank you, Congressman Smith. And I also want to thank Congressman Fortenberry for his comments and to begin by saying that many of us come to this debate for different reasons. Some because of…

Virginia Foxx
Rep. Virginia FoxxR-NC-5 · Mar 4, 2009

I want to thank my colleague from New Jersey (Mr. Smith) for sharing this time with me and for taking the lead on this special order on stem cell research. I want to also say that I want to associate…

John Fleming
Rep. John FlemingR-LA-4 · Mar 4, 2009

Thanks to the gentleman for yielding. I have put up a quote here which we'll get to in just a moment, and it is on the subject that we are currently discussing about stem cell research. I apologize…

Zach Wamp
Rep. Zach WampR-TN-3 · Mar 4, 2009

I thank the Speaker, and most of all I thank the gentleman from New Jersey for his extraordinary leadership. He brings us to the floor today to talk about something that doesn't get enough attention.…

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Jim Jordan
Rep. Jim JordanR-OH-4 · Mar 4, 2009

I thank the gentleman for yielding and for the comments from our colleague from Virginia too. I want to just take us a minute to thank the gentleman from New Jersey for his commitment over the years,…

Jeff Fortenberry
Rep. Jeff FortenberryR-NE-1 · Mar 4, 2009

First, let me thank the gentleman from New Jersey for conducting this very, very important discussion. Madam Speaker, over the past several years, I have received scores of letters from my…

Michele Bachmann
Rep. Michele BachmannR-MN-6 · Mar 4, 2009

I thank the gentleman from New Jersey for yielding. It's exciting to see what science has wrought just in the last few days, the discoveries that have come about. But the bottom line in all of it is…

Gus M. Bilirakis
Rep. Gus M. BilirakisR-FL-9 · Mar 4, 2009

Madam Speaker, fellow Members, I'm glad to be on the House floor with you this afternoon discussing this very important topic of adult stem cell therapy. The breakthroughs in technology that have…

Mark E. Souder
Rep. Mark E. SouderR-IN-3 · Mar 4, 2009

I thank my friend, colleague from New Jersey. I think one of the happiest moments in our life, or any grandparent, is to see your first grandchild. And my grandson, Grant, was born about a year and a…

J. Randy Forbes
Rep. J. Randy ForbesR-VA-4 · Apr 15, 2010

Mr. Speaker, I ask unanimous consent to remove Ms. Eshoo of California as a cosponsor of H.R. 877.

Bill Text

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Introduced in HouseIssued February 4, 2009

I

111th CONGRESS

1st Session

H. R. 877

IN THE HOUSE OF REPRESENTATIVES

February 4, 2009

Mr. Forbes (for himself and Mr. Lipinski) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To intensify stem cell research showing evidence of substantial clinical benefit to patients, and for other purposes.

1.

Short title

This Act may be cited as the Patients First Act of 2009.

2.

Purposes

It is the purpose of this Act to—

(1)

intensify research that may result in improved understanding of or treatments for diseases and other adverse health conditions;

(2)

promote research and human clinical trials using stem cells that are ethically obtained and show evidence of providing clinical benefit for human patients; and

(3)

promote the derivation of pluripotent stem cell lines without the creation of human embryos for research purposes and without the destruction or discarding of, or risk of injury to, a human embryo.

3.

Human stem cell research and therapy

(a)

Authorization

Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by inserting after section 409I the following:

409J.

Human stem cell research and therapy

(a)

In general

The Secretary shall conduct and support basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells that may result in improved understanding of or treatments for diseases and other adverse health conditions, including pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not such pluripotent stem cells have an embryonic source), prioritizing research with the greatest potential for near-term clinical benefit in human patients, provided that such isolation, derivation, production, testing, or use will not involve—

(1)

the creation of a human embryo for research purposes;

(2)

the destruction of or discarding of, or risk of injury to, a living human embryo; or

(3)

the use of any stem cell, the derivation or provision of which would be inconsistent with the standards established in paragraph (1) or (2).

(b)

Guidelines

Not later than 90 days after the date of the enactment of this section, the Secretary, after consultation with the Director of NIH, shall issue final guidelines implementing subsection (a) to ensure that any research (including any clinical trial) supported under subsection (a)—

(1)

is clearly consistent with the standards established in subsection (a) if conducted using human cells, as demonstrated by animal trials or other substantial evidence;

(2)

is prioritized in terms of potential for near-term clinical benefit in human patients, as indicated by substantial evidence from basic research or by substantial clinical evidence which may include but is not limited to—

(A)

evidence of improvement in one or more human patients suffering from illness or injury, as documented in reports by professional medical or scientific associations or in peer-reviewed medical or scientific literature; or

(B)

approval for use in human trials by the Food and Drug Administration; and

(3)

consistent with the standards established in subsection (a), may take into account techniques outlined by the President’s Council on Bioethics and any other appropriate techniques and research.

(c)

Definitions

In this section:

(1)

Human embryo

The term human embryo includes any organism, not protected as a human subject under part 46 of title 45, Code of Federal Regulations, as of the date of the enactment of this section, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

(2)

Risk of injury

The term risk of injury means subjecting a human embryo to risk of injury or death greater than that allowed for research on fetuses in utero under section 46.204(b) of title 45, Code of Federal Regulations (or any successor regulation), or section 498(b) of this Act.

.

(b)

Priority setting; reports

Section 492 of the Public Health Service Act (42 U.S.C. 289a) is amended by adding at the end the following:

(d)
(1)

With respect to human stem cell research, the Secretary, acting through the Director of NIH, shall give priority to conducting or supporting research in accordance with section 409J.

(2)

At the end of fiscal year 2010 and each subsequent fiscal year, the Secretary shall submit to the Congress a report outlining the number of research proposals under section 409J that were peer reviewed, a summary and detailed list of all such research proposals that were not funded, and an explanation of why the proposals did not merit funding. The reports under this paragraph shall be in addition to the reporting on stem cell research included in the biennial report required by section 403.

.

(c)

Biennial reports

Section 403(a)(5) of the Public Health Service Act (42 U.S.C. 283(a)(5)) is amended—

(1)

by redesignating subparagraph (L) as subparagraph (M); and

(2)

by inserting after subparagraph (K) the following:

(L)

Stem cells.

.

4.

Study to expand access to therapeutic stem cell products

Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall study and submit recommendations to the Congress on any structural changes to the C.W. Bill Young Cell Transplantation Program established under 379 of the Public Health Service Act (42 U.S.C. 274k) that would help to expand access to new and future stem cell therapeutic products, including stem cells derived from amniotic fluid as well as other sources such as dental pulp, nasal tissue, and fat that may benefit from inclusion in the coordinated distribution of bone marrow and cord blood stem cells.