[Congressional Record (Bound Edition), Volume 156 (2010), Part 12]
[House]
[Pages 16948-16949]
[From the U.S. 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''.

     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).

[[Page 16949]]

       (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.

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