CONGRESSWOMAN ELISE STEFANIK
H.R. 1032 is expected to be considered on the House floor on Wednesday, September 29, 2010, under a suspension of the rules, requiring a two-thirds majority vote to pass. Rep. Capps (D-CA) introduced H.R. 1032 on February 12, 2010, and it was referred to the Committee on Energy and Commerce.
H.R. 1032 would require the Comptroller General of the United States to 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.
The Comptroller General would be required to report its findings to various committees of the Congress, and the Secretary of Health and Human Services (HHS) would be required to submit a corrective action plan to various committees of the Congress based on the findings of the Comptroller General's report.
In addition, the Secretary would be required to prepare and submit a report to Congress on the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases.
Lastly, H.R. 1032 would extend the Wisewoman grant program. The bill would authorize the appropriation of $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 Congressional Budget Office estimates that implementing H.R. 1032 would cost $82 million over the 2011-2015 time period.