[Congressional Record Volume 154, Number 151 (Tuesday, September 23, 2008)]
[House]
[Pages H8688-H8691]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                          HEART FOR WOMEN ACT

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill

[[Page H8689]]

(H.R. 1014) 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. 1014

       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: ``, 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, 2009, 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 
     $37,000,000 for fiscal year 2009, $38,850,000 for fiscal year 
     2010, $40,792,500 for fiscal year 2011, $42,832,000 for 
     fiscal year 2012, and $44,974,000 for fiscal year 2013.''.

  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 to revise and extend their remarks and 
include extraneous material on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in strong support of H.R. 1014, the Heart Disease 
Education, Analysis Research, and Treatment (HEART) for Women Act. This

[[Page H8690]]

legislation will go a long way in improving the prevention, diagnosis, 
and treatment of heart disease, stroke, and other cardiovascular 
diseases in women.
  Heart disease and other forms of cardiovascular disease are the 
leading cause of death in the United States and a major cause of 
disability. More than 850,000 people die of cardiovascular disease in 
the U.S. annually, representing nearly 36 percent of all U.S. deaths.
  Although heart disease is sometimes thought of as ``man's disease,'' 
one in three American women die of heart disease and other 
cardiovascular diseases, making it the leading cause of death for both 
women and men in the United States. Heart disease is the leading cause 
of death among women aged 65 years and older and is the second and 
third leading cause of death among women aged 45 to 64 years, and women 
aged 25 to 44 years respectively.
  H.R. 1014 proposes to reduce the cardiovascular disease death rate 
for women through improved health education, gender-specific analysis 
and research, and increased access to screening for women. H.R. 1014 
authorizes the Department of Health and Human Services to educate 
health care professionals and older women about unique aspects of care 
in the prevention, diagnosis, and treatment of women with heart disease 
and stroke.
  H.R. 1014 requires clinical data that is already being reported to 
the Federal Government by drug and advice manufacturers to be gender-
specific. Additionally, the bill before us authorizes the expansion of 
the CDC's Well-Integrated Screening and Evaluation for Women Across the 
Nation (WISEWOMAN) program. This program, currently available in only 
20 States, provides free cardiovascular screenings to low-income 
uninsured women.
  H.R. 1014 is the result of the leadership of Representative Lois 
Capps and Barbara Cubin and the hard work and cooperation of the 
Democratic and Republican members of the Energy and Commerce Committee. 
The bill enjoys the support of a majority of the House of 
Representatives and numerous public health organizations, including the 
American Heart Association and the American Stroke Association, the 
Society for Women's Health Research, and WomenHeart: The National 
Coalition for Women with Heart Disease.
  I strongly urge all of my colleagues to vote to improve the health of 
women by passing this bill.
  I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, in deference to the primary sponsor of the 
bill, I will reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield once again to the gentlewoman from 
California, the sponsor of the bill, the vice-chair of the Health 
Subcommittee and obviously someone who's worked very hard on so many 
health care initiatives, 3 minutes.
  Mrs. CAPPS. Mr. Speaker, I rise in strong support of H.R. 1014, the 
HEART for Women Act. I thank my colleague for yielding to me, and I 
thank the lead co-sponsor of this bill, Congresswoman Barbara Cubin of 
Wyoming.
  I was proud to first introduce the HEART for Women Act in 2006 with 
the help of organizations such as the American Heart Association, 
WomenHeart, and the Society for Women's Health Research. Since then, 
the list of supporters has grown to over 50 organizations, 237 
cosponsors in the House, and 47 cosponsors of the Senate companion 
legislation.
  This legislation was borne out of the realization that despite heart 
disease being the number one killer of women, too few people are aware 
of it. In 2006, only 21 percent of women identified heart disease as 
women's greatest health problem, and too few people were aware that 
heart disease manifests itself differently in women than in men.
  The HEART for Women Act would improve the diagnosis and treatment of 
cardiovascular disease in women in three important ways.
  First, it would authorize educational campaigns aimed at health 
providers and older women to make them more aware of the risks for 
cardiovascular disease among women.
  Secondly, it will authorize the expansion of CDC's highly successful 
WISEWOMAN program, to which our chairman alluded. Since 2000, WISEWOMAN 
has been providing screenings for low-income uninsured women. The CDC 
has touted the success of WISEWOMAN in that they have screened over 
79,000 women in need, identified over 7,600 new cases of high blood 
pressure, over 7,900 new cases of high cholesterol, and over 1,000 
cases of diabetes.
  I am proud that this legislation will play a part in reaching 
hundreds of thousands of new women in the years to come.
  Finally, H.R. 1014 will improve the way we collect and analyze 
research data. By directing the FDA to collect data about safety and 
the efficacy of new and investigational drugs and devices according to 
gender, age, and racial subgroups.
  We will help women and their health care providers better understand 
which course of treatment may yield the best outcome.
  Once again, I thank our colleague Congresswoman Cubin, the coalition 
of supporters, and the Energy and Commerce Committee majority and 
minority staff.
  I urge my colleagues to vote ``yes'' on H.R. 1014.

                              {time}  2130

  Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 1014. This legislation 
encourages manufacturers of drugs and devices to report to the Food and 
Drug Administration gender and race-specific information on their 
products. The legislation also authorizes the Secretary to develop a 
public awareness campaign relating to the prevention, diagnosis, and 
treatment of heart disease, stroke, and cardiovascular diseases in 
women.
  Lastly, the bill authorizes the WISEWOMAN program at the Centers for 
Disease Control which provides heart disease and stroke prevention 
screening, such as tests for high blood pressure and high cholesterol, 
to low-come uninsured and underinsured women.
  I urge Members to support the bill.
  Mr. Speaker, I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I urge support of this important 
legislation relative to heart disease.
  Mr. RADANOVICH. Mr. Speaker, I would like to thank my colleagues Mrs. 
Capps and Mrs. Cubin for sponsoring H.R. 1014, the Heart Disease 
Education, Analysis Research and Treatment, or HEART, for Women Act. I 
lend my strong support for its swift passage both here and on the House 
floor Heart for Women Act will be a vital step forward in addressing 
the disparities in the diagnosis and treatment of heart disease and 
stroke between men and women.
  Heart disease, stroke, and other cardiovascular diseases are the 
number one killer of women, both nationally and in my home state of 
California. They account for over 30 percent of all female deaths in 
California, and there are currently approximately 43 million adult 
women living with one or more forms of heart disease.
  These numbers are very telling about the need for this reporting and 
authorization. But to really understand the importance of this 
legislation, you must look at how this can affect the lives of any one 
of those 43 million women living with heart disease today. I personally 
have seen the effects it can have--the struggles for the individual and 
the difficulties it can place on a family--through the experiences of a 
longtime and valued member of my staff But also through her, I have 
seen the courage displayed by women living with heart disease. They are 
dedicated to this cause, so that others may have it a little easier 
than they have. For her and all women living with this disease, this 
legislation today is a triumph and a testament to their strength.
  Thank you again to the bill's sponsors, and I encourage all my 
colleagues to fully support this extremely important legislation.
  Mr. PALLONE. Mr. Speaker, 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. 1014, 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

[[Page H8691]]

Chair's prior announcement, further proceedings on this motion will be 
postponed.
  The point of no quorum is considered withdrawn.

                          ____________________