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The 2009 Influenza A(H1N1) "Swine Flu" Outbreak: U.S. Responses to Global Human Cases
This report discusses the April 2009 outbreak of the influenza strain known as H1N1, or swine influenza. This report describes the distribution of the virus and the statistics of affected areas, as well as international and U.S. efforts to treat infected persons, respond to outbreaks in various countries, and prepare for a possible influenza pandemic.
The 2009 Influenza Pandemic: U.S. Responses to Global Human Cases
This report discusses the April 2009 outbreak of the influenza strain known as H1N1, or commonly, swine influenza. This report describes the distribution of the virus and the statistics of affected areas, as well as international and U.S. efforts to treat infected persons, respond to outbreaks in various countries (such as Mexico and other Latin American nations), and prepare for a possible influenza pandemic.
The 2014 Ebola Outbreak: International and U.S. Responses
This report discusses the Ebola virus disease (Ebola or EVD), which is a severe, often fatal disease that was first detected near the Ebola River in the Democratic Republic of the Congo (DRC) in 1976.
Centers for Disease Control and Prevention Global Health Programs: FY2001-FY2010
This report explains the role the Centers for Disease Control and Prevention (CDC) plays in U.S. global health assistance, highlights how much the agency has spent on global health efforts from FY2001 to FY2010, and discusses how funding to each of its programs changed during this period.
Centers for Disease Control and Prevention Global Health Programs: FY2001-FY2011
This report explains the role the Centers for Disease Control and Prevention (CDC) plays in U.S. global health assistance, highlights how much the agency has spent on global health efforts from FY2001 to FY2010, and discusses how funding to each of its programs has changed during this period.
The Global Fund to Fight AIDS, Tuberculosis and Malaria: Progress Report and Issues for Congress
The report discusses the progress and issues regarding the global fund to fight AIDS, tuberculosis, and malaria.
The Global Fund to Fight AIDS, Tuberculosis and Malaria: Progress Report and Issues for Congress
The report discusses the progress and issues regarding the global fund to fight AIDS, tuberculosis, and malaria.
Global Health: Appropriations to USAID Programs from FY2001 through FY2008
This report details the funds Congress appropriated from FY2001 through FY2008 to the U.S. Agency for International Development (USAID) for global health programs. The report includes which key programs said appropriations supported and also discusses the role of other U.S. agencies and departments in this context, including the President's Emergency Plan for AIDS Relief (PEPFAR).
HIV/AIDS International Programs: Appropriations, FY2003-FY2006
This report briefly discusses appropriations for international HIV/AIDS programs. FY2006 Appropriations for Foreign Operations (P.L. 109-102), Labor/HHS/Education (H.Rept. 109-300), Defense, and Agriculture (P.L. 109-97) provide more than $3.4 billion for international HIV/AIDS, tuberculosis (TB), and malaria initiatives. The largest portion of the funds is provided through P.L. 109-102, which directs more than $2.8 billion to fighting the three diseases.
Middle East Respiratory Syndrome (MERS-CoV): World Health Organization Responses
This report discusses responses to the recent outbreak of Middle East Respiratory Syndrome coronavirus (MERS-CoV), which has spread to more than a dozen countries.
Neglected Tropical Diseases: Background, Responses, and Issues for Congress
Over the past decade, global health has become a priority in U.S. foreign policy, more than tripling U.S. funding for such efforts. This report discusses neglected tropical diseases (NTDs), a group of 17 diseases that are found primarily among the poorest people in 149 countries and territories. NTDs are an important focus of U.S. global health assistance and may come under scrutiny as the 112th Congress debates spending levels for ongoing global health programs.
The President's Emergency Plan for AIDS Relief (PEPFAR): Funding Issues After a Decade of Implementation, FY2004-FY2013
This report outlines U.S. spending on global HIV/AIDS programs since the inception of the President's Emergency Plan for AIDS Relief (PEPFAR), analyzes global HIV/AIDS funding by other donors, and highlights key issues pertaining to funding that will face the 113th Congress as it considers the future of PEPFAR
Progress in Combating Neglected Tropical Diseases (NTDs): U.S. and Global Efforts from FY2006 to FY2013
This report discusses the prevalence of "neglected tropical diseases" (NTDs), U.S. and global actions to address them, and options the 113th Congress might consider.
U.S. and International Health Responses to the Ebola Outbreak in West Africa
In March 2014, an Ebola Virus Disease (EVD) outbreak was reported in Guinea, West Africa. The outbreak is the first in West Africa and has caused an unprecedented number of cases and deaths. The outbreak is continuing to spread in Guinea, Sierra Leone, and Liberia (the "affected countries"); it has been contained in Nigeria and Senegal, and has been detected in Mali. As of October 22, 2014, more than 10,000 people have contracted EVD, more than half of whom have died. This report focuses on the health impacts of the outbreak and discusses U.S. and international responses to those health challenges.
U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress
No Description Available.
U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress
No Description Available.
U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress
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.
U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress
No Description Available.
U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress
No Description Available.
U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress
No Description Available.
The Global Fund to Fight AIDS, Tuberculosis, and Malaria: Issues for Congress and U.S. Contributions from FY2001 to FY2013
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.
Genetic Ancestry Testing
From Summary: This report describes genetic ancestry testing, outlines the basic scientific limitations of the testing currently, and provides an overview of the policy issues this testing may raise.
Genetic Exceptionalism: Genetic Information and Public Policy
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.
Mental Health Parity and the Patient Protection and Affordable Care Act of 2010
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.
Mental Health Parity and the Patient Protection and Affordable Care Act of 2010
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.
Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests
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.
Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests
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.
CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate
This report discusses the results of a recent experiment on the use of gene modification for decreasing the chance of children having hypertrophic cardiomyopathy which was done through the use of CRISPR to modify the genes of human embryos at a private facility. Restrictions on the use of public funds for such studies, a brief explanation of the science, and ethical concerns are discussed.
Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship
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.
Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship
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.
Patent Reform: Issues in the Biomedical and Software Industries
No Description Available.
Follow-On Biologics: Intellectual Property and Innovation Issues
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.
The Hatch-Waxman Act: A Quarter Century Later
This report provides an overview of the Hatch-Waxman Act a quarter century later.
The Hatch-Waxman Act: Proposed Legislative Changes
No Description Available.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This record provides information about The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents. Congressional interests in the cost of Pharmaceuticals have focused attention on several areas where the federal government has policies and programs.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This record provides information about The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents. Congressional interests in the cost of Pharmaceuticals have focused attention on several areas where the federal government has policies and programs.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This record provides information about The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents. Congressional interests in the cost of Pharmaceuticals have focused attention on several areas where the federal government has policies and programs.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This report describes the Proposed Legislative Changes Affecting Pharmaceutical Patents on the Hatch-Waxman Act. The Hatch-Waxman Act provides the FDA with certain authorities to offer periods of marketing for a pharmaceutical independent of the rights conferred by patents.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This report describes the Proposed Legislative Changes Affecting Pharmaceutical Patents on Hatch-Waxman Act. The Hatch-Waxman Act provides the FDA with certain authorities to offer periods of marketing for a pharmaceutical independent of the rights conferred by patents.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This report describes the Proposed Legislative Changes Affecting Pharmaceutical Patents on Hatch-Waxman Act. The Hatch-Waxman Act provides the FDA with certain authorities to offer periods of marketing for a pharmaceutical independent of the rights conferred by patents.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This report describes the Proposed Legislative Changes Affecting Pharmaceutical Patents on Hatch-Waxman Act. The Hatch-Waxman Act provides the FDA with certain authorities to offer periods of marketing for a pharmaceutical independent of the rights conferred by patents.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This report describes the Proposed Legislative Changes Affecting Pharmaceutical Patents on Hatch-Waxman Act. The Hatch-Waxman Act provides the FDA with certain authorities to offer periods of marketing for a pharmaceutical independent of the rights conferred by patents.
The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents
This report describes the Proposed Legislative Changes Affecting Pharmaceutical Patents on Hatch-Waxman Act. The Hatch-Waxman Act provides the FDA with certain authorities to offer periods of marketing for a pharmaceutical independent of the rights conferred by patents.
The “Hatch-Waxman” Act: Selected Patent- Related Issues
This report explores several of the major patent-related issues that have been raised in relation to the application of the 1984 Act.
Lead-Based Paint Poisoning Prevention: Federal Mandates for Local Government
The federal Lead-Based Paint Poisoning Prevention Act; as amended, established requirements for the detection and control of lead-based paint hazards in public and private housing. Only some local governments have implementation responsibilities, but all local governments are eligible for federal grants to establish poisoning prevention programs.
Endocrine Disruption: An Introduction
Exposure to certain chemicals in the environment could disrupt the hormone systems of animals and humans, according to some scientists who are concerned about potential risks to public health and ecosystems. Congress has mandated chemical screening to assess the potential of pesticides and drinking water contaminants to influence the normal functions of female, male and thyroid hormones. As conflicting scientific evidence accumluates on the hormone disruption hypothesis, legislators may consider proposals to increase or decrease funding for the endocrine disruption screening program, or to expand its requirements to include additional chemicals or hormone functions.
Bisphenol A (BPA) in Plastics and Possible Human Health Effects
This report discusses Bisphenol A (BPA). BPA is used to produce certain types of plastic that are used in thousands of formulations for myriad products. Containers made with these plastics may expose people to small amounts of BPA in food and water. Medical devices and other more ubiquitous products, such as thermal paper coatings, also may contribute significantly to human exposure. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but scientists disagree about the value of the animal studies for predicting harmful effects in people.
Bisphenol A (BPA) in Plastics and Possible Human Health Effects
Bisphenol A (BPA) is used to produce certain types of plastic. Containers made of these plastics may expose people to small amounts of BPA in food and water. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but scientists disagree about the value of the animal studies for predicting harmful effects in people. This report discusses this issue and relevant legislation, as well as inquiries into studies currently underway to determine the true harm inherent in BPA and the degree to which people are regularly exposed to BPA.
Bisphenol A (BPA) in Plastics and Possible Human Health Effects
Bisphenol A (BPA) is used to produce certain types of plastic. Containers made of these plastics may expose people to small amounts of BPA in food and water. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but scientists disagree about the value of the animal studies for predicting harmful effects in people. This report discusses this issue and relevant legislation, as well as inquiries into studies currently underway to determine the true harm inherent in BPA and the degree to which people are regularly exposed to BPA.
Bisphenol A (BPA) in Plastics and Possible Human Health Effects
Bisphenol A (BPA) is used to produce certain types of plastic. Containers made of these plastics may expose people to small amounts of BPA in food and water. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but scientists disagree about the value of the animal studies for predicting harmful effects in people. This report discusses this issue and relevant legislation, as well as inquiries into studies currently underway to determine the true harm inherent in BPA and the degree to which people are regularly exposed to BPA.
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