[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1032 Introduced in House (IH)]
111th CONGRESS
1st Session
H. R. 1032
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to improve the prevention, diagnosis, and treatment of
heart disease, stroke, and other cardiovascular diseases in women.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 12, 2009
Mrs. Capps (for herself, Mrs. Bono Mack, Mr. Abercrombie, Mr. Baca, Ms.
Baldwin, Ms. Bean, Ms. Berkley, Mr. Berman, Mrs. Biggert, Mr. Bishop of
New York, Ms. Bordallo, Mr. Boucher, Ms. Corrine Brown of Florida, Ms.
Ginny Brown-Waite of Florida, Mr. Burton of Indiana, Mrs. Capito, Mr.
Carson of Indiana, Ms. Castor of Florida, Mrs. Christensen, Mr.
Cummings, Mrs. Davis of California, Ms. DeGette, Ms. DeLauro, Mr.
Lincoln Diaz-Balart of Florida, Ms. Edwards of Maryland, Mrs. Emerson,
Mr. Engel, Ms. Eshoo, Mr. Fortenberry, Mr. Frank of Massachusetts, Mr.
Gerlach, Ms. Giffords, Mr. Gonzalez, Mr. Gordon of Tennessee, Ms.
Granger, Mr. Graves, Mr. Al Green of Texas, Mr. Gene Green of Texas,
Mr. Grijalva, Ms. Harman, Mr. Hinchey, Ms. Hirono, Mr. Holt, Mr.
Israel, Mr. Issa, Ms. Jackson-Lee of Texas, Ms. Kaptur, Mr. Kildee, Ms.
Kilpatrick of Michigan, Ms. Lee of California, Mr. Levin, Mr. Lipinski,
Mr. LoBiondo, Ms. Zoe Lofgren of California, Mrs. Lowey, Mrs. Maloney,
Mr. Markey of Massachusetts, Mr. Marshall, Ms. Matsui, Ms. McCollum,
Mr. McDermott, Mr. McGovern, Mr. McHugh, Mr. Moore of Kansas, Ms. Moore
of Wisconsin, Mr. Nadler of New York, Mrs. Napolitano, Ms. Norton, Mr.
Oberstar, Mr. Olver, Mr. Pascrell, Ms. Pingree of Maine, Mr. Platts,
Mr. Radanovich, Mr. Reyes, Mr. Rogers of Alabama, Ms. Ros-Lehtinen, Ms.
Roybal-Allard, Ms. Schakowsky, Mrs. Schmidt, Ms. Schwartz, Mr. Serrano,
Mr. Sestak, Ms. Shea-Porter, Mr. Sires, Ms. Slaughter, Mr. Smith of New
Jersey, Mr. Stark, Ms. Sutton, Mrs. Tauscher, Mr. Taylor, Mr. Tierney,
Ms. Tsongas, Mr. Van Hollen, Mr. Walz, Ms. Wasserman Schultz, Mr.
Whitfield, Ms. Woolsey, Mr. Wu, Mr. Michaud, Mr. Price of North
Carolina, and Mrs. Blackburn) introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to improve the prevention, diagnosis, and treatment of
heart disease, stroke, and other cardiovascular diseases in women.
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 ``Heart Disease Education, Analysis
Research, and Treatment for Women Act'' or the ``HEART for Women Act''.
SEC. 2. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, BIOLOGICS, AND
DEVICES.
(a) Drugs.--
(1) New drug applications.--Section 505(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended--
(A) in paragraph (1), in the second sentence--
(i) by striking ``drug, and (G)'' and
inserting ``drug; (G)''; and
(ii) by inserting before the period the
following: ``; and (H) the information required
under paragraph (7)''; and
(B) by adding at the end the following:
``(7)(A) With respect to clinical data in an application under this
subsection, the Secretary may deny such an application if the
application fails to meet the requirements of sections 314.50(d)(5)(v)
and 314.50(d)(5)(vi)(a) of title 21, Code of Federal Regulations.
``(B) The Secretary shall modify the sections referred to in
subparagraph (A) to require that an application under this subsection
include any clinical data possessed by the applicant that relates to
the safety or effectiveness of the drug involved by gender, age, and
racial subgroup.
``(C) Promptly after approving an application under this
subsection, the Secretary shall, through an Internet site of the
Department of Health and Human Services, make available to the public
the information submitted to the Secretary pursuant to subparagraphs
(A) and (B), subject to sections 301(j) and 520(h)(4) of this Act,
subsection (b)(4) of section 552 of title 5, United States Code
(commonly referred to as the `Freedom of Information Act'), and other
provisions of law that relate to trade secrets or confidential
commercial information.
``(D) The Secretary shall develop guidance for staff of the Food
and Drug Administration to ensure that applications under this
subsection are adequately reviewed to determine whether the
applications include the information required pursuant to subparagraphs
(A) and (B).''.
(2) Investigational new drug applications.--Section 505(i)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i))
is amended--
(A) in paragraph (2), by striking ``Subject to
paragraph (3),'' and inserting ``Subject to paragraphs
(3) and (5),''; and
(B) by adding at the end the following:
``(5)(A) The Secretary may place a clinical hold (as described in
paragraph (3)) on an investigation if the sponsor of the investigation
fails to meet the requirements of section 312.33(a) of title 21, Code
of Federal Regulations.
``(B) The Secretary shall modify the section referred to in
subparagraph (A) to require that reports under such section include any
clinical data possessed by the sponsor of the investigation that
relates to the safety or effectiveness of the drug involved by gender,
age, and racial subgroup.''.
(b) Biologics License Applications.--Section 351 of the Public
Health Service Act (42 U.S.C. 262) is amended by adding at the end the
following:
``(k) The provisions of section 505(b)(7) of the Federal Food,
Drug, and Cosmetic Act (relating to clinical data submission) apply
with respect to an application under subsection (a) of this section to
the same extent and in the same manner as such provisions apply with
respect to an application under section 505(b) of such Act.''.
(c) Devices.--
(1) Premarket approval.--Section 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e) is amended--
(A) in subsection (c)(1)--
(i) in subparagraph (G)--
(I) by moving the margin 2 ems to
the left; and
(II) by striking ``and'' after the
semicolon at the end;
(ii) by redesignating subparagraph (H) as
subparagraph (I); and
(iii) by inserting after subparagraph (G)
the following subparagraph:
``(H) the information required under subsection (d)(7);
and''; and
(B) in subsection (d), by adding at the end the
following paragraph:
``(7) To the extent consistent with the regulation of devices, the
provisions of section 505(b)(7) (relating to clinical data submission)
apply with respect to an application for premarket approval of a device
under subsection (c) of this section to the same extent and in the same
manner as such provisions apply with respect to an application for
premarket approval of a drug under section 505(b).''.
(2) Investigational devices.--Section 520(g)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(2)) is
amended by adding at the end the following subparagraph:
``(D) To the extent consistent with the regulation of devices, the
provisions of section 505(i)(5) (relating to individual study
information) apply with respect to an application for an exemption
pursuant to subparagraph (A) of this paragraph to the same extent and
in the same manner as such provisions apply with respect to an
application for an exemption under section 505(i).''.
(d) Rules of Construction.--This Act and the amendments made by
this Act may not be construed--
(1) as establishing new requirements under the Federal
Food, Drug, and Cosmetic Act relating to the design of clinical
investigations that were not otherwise in effect on the day
before the date of the enactment of this Act; or
(2) as having any effect on the authority of the Secretary
of Health and Human Services to enforce regulations under the
Federal Food, Drug, and Cosmetic Act that are not expressly
referenced in this Act or the amendments made by this Act.
(e) Application.--This section and the amendments made by this
section apply only with respect to applications received under section
505 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355,
360e) or section 351 of the Public Health Service Act (42 U.S.C. 262)
on or after the date of the enactment of this Act.
SEC. 3. REPORTING AND ANALYSIS OF PATIENT SAFETY DATA.
(a) Data Standards.--Section 923(b) of the Public Health Service
Act (42 U.S.C. 299b-23(b)) is amended by adding at the end the
following: ``The Secretary shall provide that all nonidentifiable
patient safety work product reported to and among the network of
patient safety databases be stratified by sex.''.
(b) Use of Information.--Section 923(c) of the Public Health
Service Act (42 U.S.C. 299b-23(c)) is amended by adding at the end the
following: ``Such analyses take into account data that specifically
relates to women and any disparities between treatment and the quality
of care between males and females.''.
SEC. 4. QUALITY OF CARE REPORTS BY THE AGENCY FOR HEALTHCARE RESEARCH
AND QUALITY.
Section 903 of the Public Health Service Act (42 U.S.C. 299a-1) is
amended--
(1) in subsection (b)(1)(B), by inserting before the
semicolon the following: ``, and including quality of and
access to care for women with heart disease, stroke, and other
cardiovascular diseases''; and
(2) in subsection (c), by adding at the end the following:
``(4) Annual report on women and heart disease.--Not later
than September 30, 2011, and annually thereafter, the
Secretary, acting through the Director, shall prepare and
submit to Congress a report concerning the findings related to
the quality of and access to care for women with heart disease,
stroke, and other cardiovascular diseases. The report shall
contain recommendations for eliminating disparities in, and
improving the treatment of, heart disease, stroke, and other
cardiovascular diseases in women.''.
SEC. 5. EDUCATIONAL CAMPAIGNS.
(a) Distribution of Educational Material.--The Secretary of Health
and Human Services (referred to in this section as the ``Secretary'')
shall develop and distribute to females who are age 65 or older,
physicians, and other appropriate healthcare professionals, educational
materials relating to the prevention, diagnosis, and treatment of heart
disease, stroke, and cardiovascular diseases in women. The Secretary
may carry out this subsection through contracts with public and private
nonprofit entities.
(b) Healthcare Professional Educational Campaign.--The Secretary,
acting through the Bureau of Health Professions of the Health Resources
and Services Administration, shall conduct an education and awareness
campaign for physicians and other healthcare professionals relating to
the prevention, diagnosis, and treatment of heart disease, stroke, and
other cardiovascular diseases in women. The Bureau of Health
Professions may carry out this subsection through contracts with public
and private nonprofit entities.
SEC. 6. EXTENSION OF WISEWOMAN PROGRAM.
Section 1509 of the Public Health Service Act (42 U.S.C. 300n-4a)
is amended--
(1) in subsection (a)--
(A) by striking the heading and inserting ``In
General.--''; and
(B) in the matter preceding paragraph (1), by
striking ``may make grants'' and all that follows
through ``purpose'' and inserting the following: ``may
make grants to such States for the purpose''; and
(2) in subsection (d)(1), by striking ``there are
authorized'' and all that follows through the period and
inserting ``there are authorized to be appropriated $70,000,000
for fiscal year 2010, $73,500,000 for fiscal year 2011,
$77,000,000 for fiscal year 2012, $81,000,000 for fiscal year
2013, and $85,000,000 for fiscal year 2014.''.
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