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S. 1024 (110th): Safer DATA Act

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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

3/29/2007--Introduced. Safer Drug Assessment Technology Advancement Act or the Safer DATA Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.

Directs the Secretary to establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis.

Requires the Secretary to establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to: (1) clean, classify, or aggregate data collected and data that is publicly available or that is provided by the Secretary; (2) perform advanced research on identified drug safety risks; (3) identify safety questions that require further clinical study; and (4) convene an expert advisory committee to oversee the establishment of standards for the ethical and scientific uses for, and communication of, postmarketing data collected.

Requires the Secretary to improve the transparency of pharmaceutical data and allow patients and health care providers better access to pharmaceutical data by developing and maintaining an Internet site that: (1) provides comprehensive drug safety information for prescription drugs; and (2) improves communication of drug safety information to patients and providers.