HEART for Women Act

Bill: 110-hr-1014
Sponsor: Rep. Capps, Lois [D-CA-23]
Introduced: 2007-02-13 in the House
Policy area: Health
Subjects: Access to health care
Administrative procedure
Cardiovascular diseases
Clinical trials
Commerce
Communication in medicine
Communication in science
Congress
Congressional investigations
Congressional reporting requirements
Data banks
Department of Health and Human Services
Drug approvals
Drug industry
Drugs
Education
Food and Drug Administration (FDA)
Government Operations and Politics
Government paperwork
Government publicity
Governmental investigations
Health education
Health information systems
Health surveys
Higher education
Hospital care
Indian medical care
Indian women
Law
Licenses
Medical education
Medical malpractice
Medical records
Medical screening
Medical statistics
Medical supplies
Medical tests
Medically uninsured
Medicare
Minorities
Minority health
Native Americans
Peer review organizations (Medicine)
Pharmaceutical research
Physicians
Poverty
Preventive medicine
Quality of care
Science, Technology, Communications
Social Welfare
Standards
Stroke
Women
Women's health

Summary:
action_date: 2007-02-13
text: 
Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by sex, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.

Requires the Comptroller General to study the drug approval process to ensure compliance with this Act.

Requires the Secretary to require that all nonidentifiable patient safety work product reported to a patient safety database be stratified by sex. 

Requires the Secretary, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), to report to Congress concerning the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases.

Provides for an educational campaign relating to heart disease, stroke, and cardiovascular diseases in women.

Authorizes appropriations to enable the Director of the Centers for Disease Control and Prevention to implement Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program projects in all states and territories.

action_date: 2008-09-25
text: 
Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services to deny a new drug application if the application fails to include required information on clinical investigations.

Directs the Secretary to require that a new drug application include any clinical data possessed by the applicant that relates to the safety and effectiveness of the drug involved by gender, age, and racial subgroup. (Currently, this is required by regulation.)

Requires the Secretary to develop guidance for the staff of the Food and Drug Administration (FDA) to ensure that new drug applications are adequately reviewed to determine whether they include the required clinical data.

Authorizes the Secretary to place a clinical hold on an investigation under an investigational new drug application if the sponsor of the investigation fails to meet the requirements of an annual report on the status of each study in progress. 

Applies provisions relating to clinical data submission for new drug applications to an investigational new drug application, an application for a biologics license for a biological product, an application for premarket approval for a class III device, and an application for investigational use of a device.

(Sec. 3) Amends the Public Health Service Act to require the Secretary to provide that all nonidentifiable patient safety work product reported to and among the network of patient safety databases be identified by sex.

Directs that analyses of national and regional statistics of information reported to and among the network of patient safety databases 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) Requires the Director of the Agency for Healthcare Research and Quality to conduct and support research and support demonstrations to identify and evaluate clinical and organizational strategies to improve the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases.

(Sec. 5) Requires the Secretary to develop and distribute to females who are age 65 or older, physicians, and other appropriate health care professionals educational materials relating to the prevention diagnosis and treatment of heart disease, stroke, and cardiovascular diseases in women. 

Requires the Secretary, acting through the Bureau of Health Professions of the Health Resources and Services Administration, to conduct an education and awareness campaign for physicians and other health care professionals relating to the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 

(Sec. 6) Expands the grant program authorizing the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to award grants for preventive health services to all states. (Currently, only three grants may be awarded). Authorizes appropriations for FY2009-FY2013.


Legislative actions:
action_date: 2008-09-26
text: Received in the Senate.
action_date: 2008-09-25
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2008-09-25
text: On motion to suspend the rules and pass the bill, as amended Agreed to by recorded vote (2/3 required): 418 - 4 (Roll no. 642). (text: CR 9/23/2008 H8689)
action_date: 2008-09-25
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by recorded vote (2/3 required): 418 - 4 (Roll no. 642).(text: CR 9/23/2008 H8689)
action_date: 2008-09-25
text: Considered as unfinished business. (consideration: CR H9927)
action_date: 2008-09-23
text: At the conclusion of debate, the chair put the question on the motion to suspend the rules. Mr. Burgess objected to the vote on the grounds that a quorum was not present. Further proceedings on the motion were postponed. The point of no quorum was withdrawn.
action_date: 2008-09-23
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 1014.
action_date: 2008-09-23
text: Considered under suspension of the rules. (consideration: CR H8688-8691)
action_date: 2008-09-23
text: Mr. Pallone moved to suspend the rules and pass the bill, as amended.
action_date: 2008-09-23
text: Placed on the Union Calendar, Calendar No. 570.
action_date: 2008-09-23
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-874.
action_date: 2008-09-23
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-874.
action_date: 2008-09-17
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2008-09-17
text: Committee Consideration and Mark-up Session Held.
action_date: 2007-05-01
text: Subcommittee Hearings Held.
action_date: 2007-02-14
text: Referred to the Subcommittee on Health.
action_date: 2007-02-13
text: Referred to the House Committee on Energy and Commerce.
action_date: 2007-02-13
text: Introduced in House
action_date: 2007-02-13
text: Introduced in House