Congressional Research Service Reports - 198 Matching Results

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Influenza Antiviral Drugs and Patent Law Issues
This report examines the role that intellectual property rights play in affecting the availability of a patented drug such as Tamiflu during public health crises. The report also explains one legal mechanism for increasing a patented drug’s production without the patent holder’s consent: governments may abrogate a pharmaceutical company’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of the drug.
Prescription Drug Coverage Under Medicaid
Medicaid is a joint federal-state entitlement program that pays for medical services on behalf of certain groups of low-income persons. It is the third largest social program in the federal budget, exceeded only by Social Security and Medicare and is typically the second largest spending item for states. This report discusses prescription drug policies under the program.
Frequently Asked Questions About Prescription Drug Pricing and Policy
This report will address frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation, and federal price negotiation. The report provides a broad overview of the issues as well as references to more in-depth CRS products. The appendixes provide references to relevant congressional hearings and documents (see Appendix A) and a directory of CRS prescription drug experts (see Appendix B).
Food Labeling: Allergy Information
Media attention to food allergies is the result of the recent tracking of food allergy sufferers and a clear rise in the number of affected individuals. Several efforts are underway to improve the ability of individuals who have a food allergy to avoid products that cause symptoms that can range from mild to serious. The Food and Drug Administration (FDA) and the Food Allergy Issues Alliance each have released guidelines to address the issues of labeling and cross-contamination. Nine state attorneys general have petitioned FDA for stricter rules, which are also supported by some consumer groups. The FY2002 agriculture appropriations bill directed FDA to address and report on cross-contamination; however, this report had not yet been submitted. Most recently, the Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282) was enacted on August 2, 2004. This report will provide background on food allergies and review efforts to provide improved labeling information for food allergy sufferers; it will be updated to reflect legislative or other activity.
Hospital Cost Containment
This report provides an overview of the dimensions of the problem of rising expenditures for hospital care, the reasons for rising hospital costs, general information on methods of controlling hospital costs and specific programs which have been developed, and some of the issues involved.
TRICARE and VA Health Care: Impact of the Patient Protection and Affordable Care Act (PPACA)
This report addresses key questions concerning how the Patient Protection and Affordable Care Act (PPACA) affects TRICARE and VA health care.
Heroin: Legalization for Medical Use
This report discusses the limited legalization of diacetylmorphine (heroin) for use in the medical treatment of intractable pain. The report attempts to present pros and cons on the issue as well as information on pending legislation. The report also provides a comparison of heroin's analgesic qualities to those of currently available and equivalent pharmaceutical alternatives.
Legal Issues Relating to the Disposal of Dispensed Controlled Substances
This report describes an issue that is the fastest-growing drug problem in the country -- the intentional use of prescription drugs for non-medical purposes. It is the second-most common form of illicit drug abuse among teenagers in the United States behind marijuana use. Several bills have been introduced in the 111th Congress that would create a legal framework governing disposal of controlled substances that have been dispensed to patients.
Health Care for Veterans: Suicide Prevention
This report focuses on suicide prevention activities of the Veterans Health Administration (VHA) within the Department of Veterans Affairs (VA). The VHA's approach to suicide prevention is based on a public health framework, which has three major components: (1) surveillance, (2) risk and protective factors, and (3) interventions.
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.
Veterans Affairs: Presumptive Service Connection and Disability Compensation
This report discusses presumptive service connection, its legislative history, and current challenges in making evidence-based determinations of presumptions. It also discusses the Agent Orange Act (P.L. 102-4) and suggests implications of the process established by the act for future presumptive service-connected determinations.
Veterans Affairs: Presumptive Service Connection and Disability Compensation
The purpose of this report is to examine the very complex and sometimes controversial policy issue of establishing presumptive service connection. The material in it is based in large part on VA's "Analysis of Presumptions of Service Connection," and IOM's "Improving the Presumptive Disability Decision-Making Process for Veterans" reports.
Veterans Medical Care: FY2011 Appropriations
The Department of Veterans Affairs (VA) provides benefits to veterans through three major operating units, one of which is the Veterans Health Administration (VHA), on which this report focuses. This report will track the FY2011 appropriations process for funding VHA, and will be updated as legislative activities warrant.
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 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
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.
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.
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.
Stem Cell Research: Ethical Issues
This report discusses the ethical arguments that surround human embryonic stem cell research (ESR). Human stem cell research is controversial not because of its goals, but rather because of the means of obtaining some of the cells.
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 Number of Veterans That Use VA Health Care Services: A Fact Sheet
This report provides data on the number of veterans and VA health care users, and discusses the allegations of long delays in treatments.
Prescription Drug Monitoring Programs
This report looks at ways that prescription drug monitoring programs (PDMPs), which maintain statewide electronic databases of prescriptions dispensed for controlled substances, can help to deter prescription drug misuse.
Legal Issues Relating to the Disposal of Dispensed Controlled Substances
Prescription drug abuse is the second-most common form of illicit drug abuse among teenagers in the United States, trailing only marijuana use. Prescription drug abuse has become a particular concern amongst federal policymakers. This report discusses this issue, including related pieces of legislation such as the Controlled Substances Act, the Secure and Responsible Drug Disposal Act of 2010, and the proper way to dispose of controlled substances.
International Family Planning Programs: Issues for Congress
This report looks at how the debate over family planning within the U.S. is spilling over to U.S.-funded family planning programs abroad.
Title X (Public Health Service Act) Family Planning Program
This report discusses the Family Planning Program, Title X of the Public Health Service Act (42 U.S.C. §§300 to 300a-6), which is the only domestic federal program devoted solely to family planning and related preventive health services. The report discusses various services related to Title X and also considers current legislation related to the program.
The Public Health and Medical Response to Disasters: Federal Authority and Funding
This report examines (1) the authorities and coordinating mechanisms of the President and the Secretary of Health and Human Services (HHS) in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; (2) mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and (3) existing mechanisms, potential gaps, and proposals for financing the costs of a response to public health and medical emergencies.
The Public Health and Medical Response to Disasters: Federal Authority and Funding
This report examines, first, the authorities and coordinating mechanisms of the President and the Secretary of HHS in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; second, mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and finally, existing mechanisms, potential gaps, and proposals for financing the costs of a response to public health and medical emergencies.
Prevalence of Mental Illness in the United States: Data Sources and Estimates
This report briefly describes the methodology and selected findings of three large federally funded surveys that provide national prevalence estimates of diagnosable mental illness: the National Comorbidity Survey Replication (NCS-R), the National Comorbidity Survey Replication Adolescent Supplement (NCS-A), and the National Survey on Drug Use and Health (NSDUH). This report presents prevalence estimates of any mental illness and serious mental illness based on each survey and ends with a brief discussion of how these prevalence estimates might inform policy discussions.
Veterans Medical Care: FY2011 Appropriations
The Department of Veterans Affairs (VA) provides benefits to veterans through three major operating units, one of which is the Veterans Health Administration (VHA), on which this report focuses. This report will track the FY2011 appropriations process for funding VHA, and will be updated as legislative activities warrant.
Immigration Policies and Issues on Health-Related Grounds for Exclusion
This report discusses the criteria that foreign nationals must meet before admission to the United States including the reasons why a foreign national might be denied admission, most particularly on health-related grounds. It describes this issue in relation to the recent outbreak of the 2009 H1N1 ("swine flu") virus, and how the outbreak has affected various government agencies, such as the Customs and Border Protection (CBP) agency within the Department of Homeland Security (DHS). This report also discusses efforts to confront and address related issues on a legislative front.
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.
Veterans Medical Care: FY2011 Appropriations
This report discusses the FY2011 appropriations process for funding the Veterans Health Administration (VHA). The Department of Veterans Affairs (VA) provides benefits to veterans through three major operating units, including the VHA.
Veterans Affairs: Presumptive Service Connection and Disability Compensation
The purpose of this report is to examine the very complex and sometimes controversial policy issue of establishing presumptive service connection. The material in it is based in large part on VA’s “Analysis of Presumptions of Service Connection,” and IOM’s “Improving the Presumptive Disability Decision-Making Process for Veterans” reports.
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 Public Health and Medical Response to Disasters: Federal Authority and Funding
This report examines (1) the authorities and coordinating mechanisms of the President and the Secretary of HHS in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; (2) mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and (3) existing mechanisms, potential gaps, and proposals for financing the costs of a response to public health and medical emergencies.
Prescription Drug Monitoring Programs
This report looks at ways that prescription drug monitoring programs (PDMPs), which maintain statewide electronic databases of prescriptions dispensed for controlled substances, can help to deter prescription drug misuse.
The Federal Food Safety System: A Primer
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply, which many experts say is among the safest in the world. Nevertheless, critics view this system as lacking the organization and resources to adequately combat foodborne illness, which sickens an estimated 76 million people and kills an estimated 5,000 each year in this country. The 110th Congress may face calls for a review of federal food safety agencies and authorities, and proposals for reorganizing them. Among the issues likely to arise are whether reform can improve oversight, and the cost to industry, consumers, and taxpayers. This report provides a brief introduction to the system and the debate on whether reorganization is needed.
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.
Funding Plant and Animal Health Emergencies: Transfers from the Commodity Credit Corporation
This report examines the Secretary of Agriculture's authority to transfer funds from the Commodity Credit Corporation (CCC) to the Animal and Plant Health Inspection Service (APHIS) for emergency control programs. The Secretary’s use of this authority has increased in recent years, and has become an issue within government concerning the method for funding plant and animal health programs.
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.
The Federal Food Safety System: A Primer
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply, which many experts say is among the safest in the world. This report discusses various food safety proposals in Congress, as well as agencies with food safety related responsibilities.
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.
The Federal Food Safety System: A Primer
This report discusses concerns about 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.
Public Health and Medical Preparedness and Response: Issues in the 111th Congress
This report summarizes key issues in domestic public health and medical preparedness and response, citing other CRS Reports and sources of additional information. Key recent events--the 2001 terrorist attacks, Hurricane Katrina, and concerns about an influenza ("flu") pandemic, among others--sharpened congressional interest in the nation's systems to track and respond to public health threats.
Military Medical Care Services: Questions and Answers
This report attempts to answer basic questions about the Military Health Services System (MHSS), its beneficiary population, the medical services it provides, its costs, and major changes that are underway or have been proposed. Citations are made to more detailed CRS studies where appropriate.
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.
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.