[Congressional Record Volume 156, Number 132 (Tuesday, September 28, 2010)]
[House]
[Pages H7189-H7190]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
HEART DISEASE EDUCATION, ANALYSIS RESEARCH, AND TREATMENT FOR WOMEN ACT
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (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, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 1032
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''.
[[Page H7190]]
SEC. 2. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.
(a) In General.--The Comptroller General of the United
States shall conduct a study investigating the extent to
which sponsors of clinical studies of investigational drugs,
biologics, and devices and sponsors of applications for
approval or licensure of new drugs, biologics, and devices
comply with Food and Drug Administration requirements and
follow guidance for presentation of clinical study safety and
effectiveness data by sex, age, and racial subgroups.
(b) Report by GAO.--
(1) Submission.--Not later than 12 months after the date of
the enactment of this Act, the Comptroller General shall
complete the study under subsection (a) and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report on the results of
such study.
(2) Contents.--The report required by paragraph (1) shall
include each of the following:
(A) A description of the extent to which the Food and Drug
Administration assists sponsors in complying with the
requirements and following the guidance referred to in
subsection (a).
(B) A description of the effectiveness of the Food and Drug
Administration's enforcement of compliance with such
requirements.
(C) An analysis of the extent to which females, racial and
ethnic minorities, and adults of all ages are adequately
represented in Food and Drug Administration-approved clinical
studies (at all phases) so that product safety and
effectiveness data can be evaluated by gender, age, and
racial subgroup.
(D) An analysis of the extent to which a summary of product
safety and effectiveness data disaggregated by sex, age, and
racial subgroup is readily available to the public in a
timely manner by means of the product label or the Food and
Drug Administration's Website.
(E) Appropriate recommendations for--
(i) modifications to the requirements and guidance referred
to in subsection (a); or
(ii) oversight by the Food and Drug Administration of such
requirements.
(c) Report by HHS.--Not later than 6 months after the
submission by the Comptroller General of the report required
under subsection (b), the Secretary of Health and Human
Services shall submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a response to
that report, including a corrective action plan as needed to
respond to the recommendations in that report.
(d) Definitions.--In this section:
(1) The term ``biologic'' has the meaning given to the term
``biological product'' in section 351(i) of the Public Health
Service Act (42 U.S.C. 262(i)).
(2) The term ``device'' has the meaning given to such term
in section 201(h) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h)).
(3) The term ``drug'' has the meaning given to such term in
section 201(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)).
SEC. 3. REPORTING ON QUALITY OF AND ACCESS TO CARE FOR WOMEN
WITH CARDIOVASCULAR DISEASES.
Part P of title III of the Public Health Service Act (42
U.S.C. 280g et seq.) is amended by adding at the end the
following:
``SEC. 399V-5. REPORTING ON QUALITY OF AND ACCESS TO CARE FOR
WOMEN WITH CARDIOVASCULAR DISEASES.
``Not later than September 30, 2013, and annually
thereafter, the Secretary of Health and Human Services shall
prepare and submit to the Congress a report on 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. 4. 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
$23,000,000 for fiscal year 2012, $25,300,000 for fiscal year
2013, $27,800,000 for fiscal year 2014, $30,800,000 for
fiscal year 2015, and $34,000,000 for fiscal year 2016.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Texas (Mr. Burgess) each
will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material in the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
{time} 2220
Mr. PALLONE. I yield myself such time as I may consume.
I rise today in strong support of H.R. 1032, the HEART for Women Act.
Heart disease is the number one killer of women, and stroke is the
number three killer of women. H.R. 1032 expands the CDC's Wise Women
Program, which serves low-income, uninsured, and underinsured women by
providing cardiovascular disease screenings, referrals, outreach, and
education about healthy behaviors.
I urge my colleagues to support this legislation.
I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
H.R. 1032, the Heart Disease Education, Analysis, Research, and
Treatment for Women Act, would take several important steps in the
fight against heart disease, stroke, and other cardiovascular diseases.
First, the amended bill would require the Government Accountability
Office to conduct a study on the extent to which sponsors of new drugs,
biologics, and devices follow current guidelines with respect to
providing clinical trial data by gender and ethnicity. It would also
require the Secretary to submit a report to Congress by September 30,
2013, and annually thereafter on the quality and access to care for
women with heart disease, stroke, and other cardiovascular disease.
Finally, the bill would reauthorize the Wise Women Program for 5 years.
The program provides preventative benefits to uninsured and
underinsured women who are at high risk of heart disease.
I urge my colleagues to support the bill.
Mrs. CAPPS. Mr. Speaker, I rise in strong support of H.R. 1032, the
HEART for Women Act. As you may know, heart disease is the number one
killer of American women, claiming the lives of over 400,000 women
annually.
The HEART for Women Act seeks to improve our capability to prevent,
diagnose and treat heart disease in women in three ways.
First, it requires a GAO report to carefully look at the FDA's record
of evaluating new drug and device applications in an effort to ensure
we are taking into account how new drugs and devices affect women
differently than men as well as people of different ethnicities or
ages.
This could not be more timely following the recently released
Institute of Medicine report ``Women's Health Research: Progress,
Pitfalls, and Promise'' recommending that ``all medical product
evaluations by the Food and Drug Administration present efficacy and
safety data separately for men and women. . .''
Second, the bill requires the Secretary to report on the quality and
access to care for women with heart disease, stroke and other
cardiovascular disease.
And finally, it expands the CDC's successful WISEWOMAN program which
provides critical cardiovascular screening, treatment, education and
prevention services to low-income women.
I'd like to thank the broad coalition of supporters who have endorsed
this legislation, especially American Heart Association, WomenHeart and
the Society for Women's Health Research.
I urge my colleagues to vote in favor of this legislation and in
favor of improving the health of women living with heart disease.
Mr. BURGESS. I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, I urge passage of the bill, and I yield
back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 1032, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. BURGESS. Mr. Speaker, I object to the vote on the ground that a
quorum is not present and make the point of order that a quorum is not
present.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the
Chair's prior announcement, further proceedings on this motion will be
postponed.
The point of no quorum is considered withdrawn.
____________________