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 authorize the Secretary of Health and Human Services to deny a new drug application if the application fails to include required information on clinical investigations.
Also, the bill would direct the Secretary to do the following: (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.
In addition, H.R. 1032 would authorize 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.
H.R. 1032 would apply 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.
Also, the bill would 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 gender.
In addition, the bill would direct 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.
H.R. 1032 would require 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.
Furthermore, the bill would require the Secretary to do the following: (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.
Lastly, H.R. 1032 would expand the Wisewoman grant program. The bill would authorize the appropriation of $70,000,000 for fiscal year 2010, $73,500,000 for fiscal year 2011, $77,000,000 for fiscal year 2012, $81,000,000 for fiscal year 2013, and $85,000,000 for fiscal year 2014.
The Congressional Budget Office estimates that implementing H.R. 1032 would cost $82 million over the 2011-2015 time period.