Summary: S.573 — 110th Congress (2007-2008)All Information (Except Text)

There is one summary for S.573. Bill summaries are authored by CRS.

Shown Here:
Introduced in Senate (02/13/2007)

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.