Congressional Research Service Reports - 537 Matching Results

Search Results

U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress

Description: This report will provide an account of global H5N1-related human infections and deaths, outline U.S. government and international responses to the global spread of H5N1, discuss situations in various countries affected by H5N1, and present some foreign policy issues for Congress.
Date: February 6, 2006
Creator: Salaam-Blyther, Tiaji & Chanlett-Avery, Emma
Partner: UNT Libraries Government Documents Department

The Global Fund to Fight AIDS, Tuberculosis, and Malaria: Issues for Congress and U.S. Contributions from FY2001 to FY2013

Description: The Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund, or the Fund) was established in 2002 as a public-private partnership that could provide significant financial support for global responses to HIV/AIDS, tuberculosis (TB), and malaria. In November 2011, the Global Fund Board announced that due to inadequate resources from donors, it would cancel its 11th round of funding, but would maintain support for existing activities to avoid disruptions in ongoing services. Global health advocates urge Congress to meet the President's FY2013 request for the Fund in order to support the sustainability of its activities and to encourage continued contributions from other donors. Although Congress has traditionally been a strong supporter of the Fund, several issues may affect congressional views about the Fund in the future, which are discussed in this report.
Date: May 15, 2012
Creator: Salaam-Blyther, Tiaji & Kendall, Alexandra E.
Partner: UNT Libraries Government Documents Department

Genetic Exceptionalism: Genetic Information and Public Policy

Description: This report provides an overview of the nature of genetic information and its implications for individuals, family, and society. Individuals utilize genetic information to guide health care and other decisions, when possible, and may experience anxiety as a result of genetic test results. Genetic test results for an individual may often be informative for other close family members and thus influence their care decisions. Society must grapple with the effect genetic information may have on our conception of disease, as well as its impact on issues like privacy and equity. The report ends by summarizing the main policy issues involved with a genetic exceptionalist approach to public policy, including defining genetic information; physically separating genetic information from other medical information; unintended disparities between “genetic” and “nongenetic” disease; and the effect of legislation on participation in genetic research, on uptake of genetic technology and on the delivery of high quality health care.
Date: February 14, 2008
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Mental Health Parity and the Patient Protection and Affordable Care Act of 2010

Description: This report provides a brief background on mental health parity and the policy discussion around parity in health insurance coverage; an overview of federal mental health parity law prior to the enactment of the ACA; and an analysis of the impact of the ACA.
Date: December 28, 2011
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Mental Health Parity and the Patient Protection and Affordable Care Act of 2010

Description: This report provides a brief background on mental health parity and the policy discussion around parity in health insurance coverage; an overview of federal mental health parity law prior to the enactment of the ACA; and an analysis of the impact of the ACA.
Date: January 7, 2011
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

Description: In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or tissue, to provide information in making health care decisions. Examples of IVDs include pregnancy test kits or blood glucose tests for home use; laboratory tests for infectious disease, such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and tests for various genetic diseases or conditions. More recently, a specific type of diagnostic test--called a companion diagnostic--has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine. This report provides an overview of federal regulation of IVDs by FDA, through the Federal Food, Drug, and Cosmetics Act (FFDCA) and the Public Health Service Act (PHSA), and by CMS, through the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
Date: March 27, 2014
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

Description: In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or tissue, to provide information in making health care decisions. Examples of IVDs include pregnancy test kits or blood glucose tests for home use; laboratory tests for infectious disease, such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and tests for various genetic diseases or conditions. More recently, a specific type of diagnostic test--called a companion diagnostic--has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine. This report provides an overview of federal regulation of IVDs by FDA, through the Federal Food, Drug, and Cosmetics Act (FFDCA) and the Public Health Service Act (PHSA), and by CMS, through the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
Date: December 17, 2014
Creator: Sarata, Amanda K. & Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship

Description: This report explores the reasons behind government funding of research and development and subsequent efforts to facilitate private sector commercialization of the results of such work, without addressing issues associated with drug costs or pricing. It particularly looks at the manner in which the National Institutes of Health (NIH) supports research to encourage the development of new pharmaceuticals and therapeutics, particularly through cooperative activities among academia, industry, and government.
Date: February 3, 2009
Creator: Schacht, Wendy H.
Partner: UNT Libraries Government Documents Department

Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship

Description: Interest in methods to provide drugs at lower cost, particularly for the elderly, has rekindled discussion over the role the federal government plays in facilitating the creation of new pharmaceuticals for the marketplace. This report explores the issue of whether or not the substantial federal investment in health-related research and development (R&D) entitles the public to commensurate consideration in prices charged for any resulting drugs. It is intended to provide the reader with an understanding of the rationale for government support of R&D and subsequent efforts to facilitate private sector commercialization of new technologies generated from such work. Concerns surrounding innovation in pharmaceuticals and biotechnology are discussed within the broader context of the federal role in facilitating technological progress.
Date: June 19, 2000
Creator: Schacht, Wendy H.
Partner: UNT Libraries Government Documents Department

Follow-On Biologics: Intellectual Property and Innovation Issues

Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Partner: UNT Libraries Government Documents Department