H. R. 1740
IN THE HOUSE OF REPRESENTATIVES
April 25, 2013
Mr. Forbes(for himself andMr. Lipinski) introduced the following bill; which was referred to theCommittee on Energy and Commerce
To intensify stem cell research showing evidence of substantial clinical benefit to patients, and for other purposes.
This Act may be cited as the
Patients First Act of
It is the purpose of this Act to—
intensify research that may result in improved understanding of or treatments for diseases and other adverse health conditions;
promote research and human clinical trials using stem cells that are ethically obtained and show evidence of providing clinical benefit for human patients; and
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.
Human stem cell research and therapy
Part B of title IV of the Public Health Service Act( 42 U.S.C. 284 et seq. )is amended by inserting aftersection 409Ithe following:
Human stem cell research and therapy
TheSecretaryshall 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—
the creation of a human embryo for research purposes;
the destruction of or discarding of, or risk of injury to, a living human embryo; or
the use of any stem cell, the derivation or provision of which would be inconsistent with the standards established inparagraph (1)or(2).
Not later than 90 days after the date of the enactment of this section, theSecretary, after consultation with theDirector of NIH, shall issue final guidelines implementingsubsection (a)to ensure that any research (including any clinical trial) supported undersubsection (a)—
is clearly consistent with the standards established insubsection (a)if conducted using human cells, as demonstrated by animal trials or other substantial evidence; and
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—
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
approval for use in human trials by theFood and Drug Administration.
In this section:
The termhuman embryoincludes 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.
Risk of injury
The termrisk of injurymeans subjecting a human embryo to risk of injury or death greater than that allowed for research on fetuses in utero undersection 46.204(b)of title 45, Code of Federal Regulations (or any successor regulation), orsection 498(b) of this Act.
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:
With respect to human stem cell research, theSecretary, acting through theDirector of NIH, shall give priority to conducting or supporting research in accordance withsection 409K.
At the end of fiscal year 2014 and each subsequent fiscal year, theSecretaryshall submit to theCongressa report outlining the number of research proposals undersection 409Kthat 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 bysection 403.
Section 403(a)(5) of the Public Health Service Act(42 U.S.C. 283(a)(5))is amended—
by redesignatingsubparagraph (L)assubparagraph (M); and
by inserting aftersubparagraph (K)the following: