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2009 H1N1 "Swine Flu": CRS Experts
This report includes a table which provides access to names and contact information for CRS experts on policy concerns relating to swine influenza A virus (H1N1). Policy areas identified include: Identification, diagnosis, and surveillance of the virus; Treatment and prevention: antiviral drugs (Tamiflu, Relenza) and vaccines; Declarations of emergencies; Official plans and organizational responsibilities; and Restrictions on travel and trade.
The 2009 H1N1 "Swine Flu" Outbreak: An Overview
This report provides an introduction to the situation regarding the potential of a global human influenza pandemic caused by the new H1N1 flu strain. It includes a brief chronology of events; a discussion of key actions taken and authorities invoked by the WHO and the U.S. government; and information about key U.S. government pandemic flu planning documents.
The 2009 Influenza A (H1N1) "Swine Flu" Outbreak: An Overview
This report provides an overview of key actions taken and authorities invoked by WHO and the U.S. government. First, it discusses the WHO process to determine the phase of a threatened or emerging flu pandemic and touches on a number of related issues. The report then examines actions taken by the Departments of Homeland Security and Health and Human Services and provides information about appropriations and funding for pandemic flu activities.
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: An Overview
This report first provides a synopsis of key events, actions taken, and authorities invoked by WHO, the U.S. federal government, and state and local governments. It then discusses the WHO process to determine the phase of a flu pandemic, and selected actions taken by the Departments of Homeland Security and Health and Human Services, and by state and local authorities. Next, it lists congressional hearings held to date, and provides information about appropriations and funding for pandemic flu activities. Finally, it summarizes U.S. government pandemic flu planning documents and lists sources for additional information about the situation as it unfolds.
The 2009 Influenza Pandemic: An Overview
This report provides a synopsis of key events in the H1N1 pandemic response, followed by information about selected federal emergency management authorities and actions taken by the Department of Homeland Security (DHS), Health and Human Services (HHS), and state and local authorities.
The 2009 Influenza Pandemic: An Overview
This report first provides a synopsis of key events, actions taken, and authorities invoked by World Health Organization (WHO), the U.S. federal government, and state and local governments.
The 2009 Influenza Pandemic: An Overview
This report describes the World Health Organization (WHO) process to determine the phase of a threatened or emerging flu pandemic, and touches on several related issues.
The 2009 Influenza Pandemic: An Overview
This report describes the World Health Organization (WHO) process to determine the phase of a threatened or emerging flu pandemic, and touches on several related issues.
The 2009 Influenza Pandemic: Selected Legal Issues
This report provides a brief overview of selected legal issues regarding the H1N1 influenza, including emergency measures, civil rights, liability issues, and employment issues.
The 2009 Influenza Pandemic: Selected Legal Issues
Recent human cases of infection with a novel influenza A(H1N1) virus have been identified both internationally and in the United States. Since there has been human to human transmission and the new virus has the potential to become pandemic, it is timely to examine legal issues surrounding this emerging public health threat. This report will provide a brief overview of selected legal issues.
The 2009 Influenza Pandemic: Selected Legal Issues
This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues.
The 2009 Influenza Pandemic: Selected Legal Issues
Recent human cases of infection with a novel influenza A(H1N1) virus have been identified both internationally and in the United States. Since there has been human to human transmission and the new virus has the potential to become pandemic, it is timely to examine legal issues surrounding this emerging public health threat. This report will provide a brief overview of selected legal issues.
The 2009 Influenza Pandemic: Selected Legal Issues
This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues.
The 2009 Influenza Pandemic: Selected Legal Issues
This report provides a brief overview of selected legal issues regarding the H1N1 influenza, including emergency measures, civil rights, liability issues, and employment issues.
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.
AIDS: Ryan White CARE Act
This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
AIDS: The Ryan White CARE Act
This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
Alert Systems for Missing Adults in Eleven States: Background and Issues for Congress
This report discusses the emerging development of nationwide alert systems to recover missing adults, such as those with mental impairment (such as Alzheimer's disease), developmental disabilities, or suicidal tendencies. This report provides an overview of such alert systems in 11 states: Colorado, Delaware, Florida, Georgia, Kentucky, North Carolina, Ohio, Oklahoma, Rhode Island, Texas, and Virginia. This report also provides a discussion of issues for Congress to consider with respect to the federal role, if any, in developing state alert programs for missing adults.
Americans with Disabilities Act (ADA) Requirements Concerning the Provision of Interpreters by Hospitals and Doctors
This report briefly discusses the Americans with Disabilities Act (ADA), which prohibits discrimination against individuals with disabilities by places of public accommodation. This report specifically discusses a common question of whether or not the ADA requires medical doctors and hospitals to provide an interpreter when they have a patient with a hearing disability.
Animal Identification: Overview and Issues
This report provides information about animal identification and proposed solutions. Livestock industry groups, animal health officials, and the U.S. Department of Agriculture (USDA) have been working to establish a nationwide identification (ID) system capable of quickly tracking animals from birth to slaughter, to deal with animal diseases and/or to satisfy foreign market specifications. Some consumer groups are among those who believe ID also would be useful for food safety or retail labeling purposes.
Background and Legal Issues Related to Stem Cell Research
This report discusses issues regarding stem cell research. With certain restrictions, the President has announced that federal funds may be used to conduct research on human embryonic stem cells. Federal research is limited to "the more than 60" existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds will be used for the derivation or use of stem cell lines derived from newly destroyed embryos; the creation of any human embryos for research purposes; or cloning of human embryos for any purposes.
Biologics and Biosimilars: Background and Key Issues
This report discusses biologic and biosimilar medicines and their production and approval by the FDA. Recent legislation regarding FDA approval regulations and federal research and drug development are also discussed.
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.
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.
Comparison of the Current World Trade Center Medical Monitoring and Treatment Program and the World Trade Center Health Program Proposed by Title I of H.R. 847
This report compares the current federally supported medical screening and treatment program offered to various persons affected by the terrorist attack on New York City on September 11, 2001, with the federal program proposed to be established by Title I of H.R. 847, the James Zadroga 9/11 Health and Compensation Act of 2010, as amended and passed by the House of Representatives. The World Trade Center (WTC) Medical Monitoring and Treatment Program (MMTP) and the World Trade Center Health Program (WTCHP) are the specific programs compared in this report.
Comparison of the Current World Trade Center Medical Monitoring and Treatment Program and the World Trade Center Health Program Proposed by Title I of H.R. 847
This report compares the current federally supported medical screening and treatment program offered to various persons affected by the terrorist attack on New York City on September 11, 2001, with the federal program proposed to be established by Title I of H.R. 847, the James Zadroga 9/11 Health and Compensation Act of 2010, as amended and passed by the House of Representatives. The World Trade Center (WTC) Medical Monitoring and Treatment Program (MMTP) and the World Trade Center Health Program (WTCHP) are the specific programs compared in this report.
Comparison of the Current World Trade Center Medical Monitoring and Treatment Program and the World Trade Center Health Program Proposed by Title I of H.R. 847
This report compares the current federally supported medical screening and treatment program offered to various persons affected by the terrorist attack on New York City on September 11, 2001, with the federal program proposed to be established by Title I of H.R. 847, the James Zadroga 9/11 Health and Compensation Act of 2010, as amended and passed by the House of Representatives.
Comparison of the Current World Trade Center Medical Monitoring and Treatment Program and the World Trade Center Health Program Proposed by Title I of H.R. 847
This report compares the current federally supported medical screening and treatment program offered to various persons affected by the terrorist attack on New York City on September 11, 2001, with the federal program proposed to be established by Title I of H.R. 847, the James Zadroga 9/11 Health and Compensation Act of 2010, as amended and passed by the House of Representatives. The World Trade Center (WTC) Medical Monitoring and Treatment Program (MMTP) and the World Trade Center Health Program (WTCHP) are the specific programs compared in this report.
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.
Direct-to-Consumer Advertising of Prescription Drugs
This report describes the current status of direct-to-consumer (DTC) drug advertising; analyzes issues surrounding it; and discusses potential options for Congress.
DNA Databanking: Selected Fourth Amendment Issues and Analysis
This report looks at how the practice of DNA database programs, which have been looked at favorably by Congress, are in possible violation of the Fourth Amendment's prohibition on unreasonable searches and seizures. It looks at how the databases' legality has currently been holding up in court, as well as how new advances and revelations in the science of forensic analysis and databanking may have potentially significant legal implications.
"Don't Ask, Don't Tell": Military Policy and the Law on Same-Sex Behavior
This report describes the "Don't Ask, Don't Tell" military policy, which holds that the presence in the armed forces of persons who demonstrate a propensity or intent to engage in same-sex acts would create an unacceptable risk to the high standards of morale, good order and discipline, and unit cohesion which are the essence of military capability. Under this policy, but not the law, service members are not to be asked about nor allowed to discuss their "same-sex orientation." This report also describes recent efforts by certain Members of Congress to amending this policy.
"Don't Ask, Don't Tell": The Law and Military Policy on Same-Sex Behavior
This report describes the "Don't Ask, Don't Tell" military policy, which holds that the presence in the armed forces of persons who demonstrate a propensity or intent to engage in same-sex acts would create an unacceptable risk to the high standards of morale, good order and discipline, and unit cohesion which are the essence of military capability. Under this policy, but not the law, service members are not to be asked about nor allowed to discuss their "same-sex orientation." This report also describes recent efforts by certain Members of Congress to amending this policy.
"Don't Ask, Don't Tell:" The Law and Military Policy on Same-Sex Behavior
This report describes the "Don't Ask, Don't Tell" military policy. Under this policy, but not the law, service members are not to be asked about nor allowed to discuss their "same-sex orientation." This report also describes recent efforts by certain Members of Congress to amending this policy.
"Don't Ask, Don't Tell": The Law and Military Policy on Same-Sex Behavior
This report describes the "Don't Ask, Don't Tell" military policy, which holds that the presence in the armed forces of persons who demonstrate a propensity or intent to engage in same-sex acts would create an unacceptable risk to the high standards of morale, good order and discipline, and unit cohesion which are the essence of military capability. This report also describes recent efforts by certain Members of Congress to amending this policy.
Emergency Response: Civil Liability of Volunteer Health Professionals
This report discusses the patchwork of federal and state laws that operate to protect volunteers, which can include volunteer health professionals (VHPs), and those laws that trigger liability protection only for VHPs — with a focus on some of the midwestern states in addition to the Gulf region.
End-of-Life Care: Services, Costs, Ethics, and Quality of Care
This report provides information on various aspects of end-of-life care: (1) demographic and historical changes affecting death and dying in the United States (2) the definitions of end-of-life, palliative, and hospice care (3) costs associated with end-of-life care (4) end-of-life care laws and ethics (5) quality of care at the end of life and (6) policy issues that would modify or expand the federal government's role in addressing end-of-life care.
Family Planning: Title X of the Public Health Service Act
This report discusses Title X of the Public Health Service Act provides support for family planning clinics, research related to family planning and population, training of family planning personnel, and development and dissemination of family planning information.
The FDA Medical Device User Fee Program: MDUFA IV Reauthorization
This report describes current law regarding medical device user fees, the impact of Medical Device User Fee and Modernization Act (MDUFMA) on Federal Drug Administration (FDA) review time of various medical device applications, and the agency's medical device program budget.
FDA Regulation of Follow-On Biologics
This report provides a brief introduction to the relevant law regarding follow-on biologics, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation.
FDA Regulation of Tobacco Products: A Policy and Legal Analysis
This report examines the legislative debate over giving FDA the authority to regulate tobacco products and provides some analysis of S. 2461/H.R. 4433. It begins with an overview of the FDA’s 1996 tobacco rule that includes a summary of the agency’s arguments for asserting jurisdiction over tobacco products. That is followed by an analysis of the U.S. Supreme Court decision in FDA v. Brown & Williamson, which overturned the FDA tobacco rule. The report then reviews the 1997 proposed national tobacco settlement, which would have codified the FDA rule and given the agency explicit authority to regulate tobacco products as medical devices. It includes a discussion of the FDA provisions in the McCain tobacco bill, which was introduced and debated in the 105th Congress in an attempt to implement the proposed settlement. The final section of the report summarizes the provisions in S. 2461/H.R. 4433 and discusses some of the key issues, including preemption and the regulation of reduced-risk products.
FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development
This report provides a brief history of FDA drug regulation, describes FDA's early risk management programs, and focuses on the agency's current risk management authorities, specifically risk evaluation and mitigation strategies (REMS). The report also discusses issues that have arisen as a result of REMS, particularly the impact on generic drug competition. It does not discuss antitrust issues raised by restricted distribution systems.
FDA Tobacco Regulation: The Family Smoking Prevention and Tobacco Control Act of 2009
This report focuses on the Family Smoking Prevention and Tobacco Control Act. It includes a brief discussion of the contrasting views of FDA tobacco regulation held by the public health community and the industry, and provides some analysis of a number of key regulatory issues that the bill raises.
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective
The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
Federal and State Quarantine and Isolation Authority
This report provides an overview of federal and state public health laws as they relate to the quarantine and isolation of individuals, a discussion of constitutional issues that may be raised should individual liberties be restricted in a quarantine situation, and federalism questions that may arise where federal and state authorities overlap. In addition, the possible role of the armed forces in enforcing public health measures is discussed, specifically whether the Posse Comitatus Act would constrain any military role, and other statutory authorities that may be used for the military enforcement of health measures.
Federal Authority to Regulate the Compounding of Human Drugs
This report will examine the FDA's regulation of drug compounding and will discuss relevant legal authorities. The report will conclude by discussing potential limits to the FDA's authority to regulate human drug compounding.
The Federal Food Safety System: A Primer
Report concerning food safety, the resources required to ensure food safety, and whether federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
The Federal Food Safety System: A Primer
The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, many food-related health issues persist. At issue is whether the current U.S. regulatory system has the resources and structural organization to protect consumers from these dangers. Also at issue is whether the federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
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