HEART for Women Act

Bill: 111-hr-1032
Sponsor: Rep. Capps, Lois [D-CA-23]
Introduced: 2009-02-12 in the House
Policy area: Health
Subjects: Cardiovascular and respiratory health
Congressional oversight
Drug safety, medical device, and laboratory regulation
Government information and archives
Health care quality
Health information and medical records
Health programs administration and funding
Health promotion and preventive care
Licensing and registrations
Medical education
Medical research
Prescription drugs
Women's health

Summary:
action_date: 2009-02-12
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 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: (1) 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; and (2) 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 applications for an investigational new drug, a biologics license for a biological product, premarket approval for a class III device, and investigational use of a device.

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 statistics of information reported to 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.

Requires the Director of the Agency for Healthcare Research and Quality to support research and 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.
 
Requires the Secretary to: (1) distribute to females age 65 or older and appropriate health care professionals educational materials relating to the prevention, diagnosis, and treatment of heart disease, stroke, and cardiovascular diseases in women; and (2) conduct an education and awareness campaign for health care professionals relating to such diagnosis and treatment. 

Expands the grant program authorizing the Secretary to award grants for preventive health services to all states. 

action_date: 2010-09-30
text: 
Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - (Sec. 2) Directs to the Comptroller General to study and report to specified congressional committees on 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 (FDA) requirements and follow guidance for presentation of clinical study safety and effectiveness data by sex, age, and racial subgroups. Requires the Secretary of Health and Human Services (HHS) to submit to such committees a response to the the Comptroller General's report, including a corrective action plan as needed to respond to the recommendations in such report.
 
(Sec. 3) Amends the Public Health Service Act to require the Secretary to report to Congress on the quality of, and access to, care for women with heart disease, stroke, and other cardiovascular diseases, including recommendations for eliminating disparities in, and improving the treatment of, heart disease, stroke, and other cardiovascular diseases in women.
 (Sec. 4) Expands and reauthorizes appropriations for FY2012-FY2016 for a program to award grants for preventive heath services and referrals for medical treatment for women through entities that are screening women for breast or cervical cancer.

Legislative actions:
action_date: 2010-11-15
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2010-09-30
text: The title of the measure was amended. Agreed to without objection.
action_date: 2010-09-30
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2010-09-30
text: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR 9/28/2010 H7189-7190)
action_date: 2010-09-30
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR 9/28/2010 H7189-7190)
action_date: 2010-09-30
text: Considered as unfinished business. (consideration: CR H7380)
action_date: 2010-09-28
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: 2010-09-28
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 1032.
action_date: 2010-09-28
text: Considered under suspension of the rules. (consideration: CR H7189-7190)
action_date: 2010-09-28
text: Mr. Pallone moved to suspend the rules and pass the bill, as amended.
action_date: 2010-09-28
text: Placed on the Union Calendar, Calendar No. 379.
action_date: 2010-09-28
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 111-639.
action_date: 2010-09-28
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 111-639.
action_date: 2010-09-23
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2010-09-23
text: Committee Consideration and Mark-up Session Held.
action_date: 2010-09-16
text: Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
action_date: 2010-09-16
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2010-09-15
text: Subcommittee Hearings Held.
action_date: 2009-02-13
text: Referred to the Subcommittee on Health.
action_date: 2009-02-12
text: Referred to the House Committee on Energy and Commerce.
action_date: 2009-02-12
text: Introduced in House
action_date: 2009-02-12
text: Introduced in House