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首页> 美国政府科技报告 >Report to Congress: Implementation of Section 3507 of the Patient Protection and Affordable Care Act of 2010 Third Progress Report.
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Report to Congress: Implementation of Section 3507 of the Patient Protection and Affordable Care Act of 2010 Third Progress Report.

机译：向国会报告：2010年第三次进展报告“患者保护和平价医疗法案”第3507条的实施情况。

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In March 2010, President Obama signed into law a comprehensive health reform bill, the Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148, 124 Stat. 119 (codified at note following 42 U.S.C. section 18001), and a package of amendments to the Affordable Care Act, the Health Care and Education Reconciliation Act of 2010 (HCERA; P.L. 111-152). Subsection 3507(a)1 of the Affordable Care Act requires the Secretary of Health and Human Services (the Secretary), acting through the Commissioner of Food and Drugs, to determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in standardized format (similar to Drug Facts on over-the-counter products) to the promotional labeling or print advertising of such drugs would improve health care decision-making by clinicians and patients and consumers. Subsection 3507(b) of the Affordable Care Act requires the Food and Drug Administration (FDA) to consider research in the areas of social and cognitive psychology and to consult drug manufacturers, clinicians, patients and consumers - specifically experts in health literacy, representatives of racial and ethnic minorities, and experts in womens and pediatric health. Finally, subsection 3507(c) of the Affordable Care Act directs the Secretary to submit a report to Congress outlining its determination under subsection (a). If FDA determines that adding these types of standardized risk/benefit summary statements (or tables) to advertising or promotional labeling for prescription drugs would improve health care decision making, subsection 3507(d) of the Affordable Care Act directs the Agency to promulgate proposed regulations setting forth such requirements.

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