Congressional Research Service Reports - 97 Matching Results

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Frequently Asked Questions About Prescription Drug Pricing and Policy

Description: 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).
Date: May 2, 2017
Creator: Kirchhoff, Suzanne M.; Johnson, Judith A. & Thaul, Susan
Partner: UNT Libraries Government Documents Department

CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate

Description: 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.
Date: September 12, 2017
Creator: Sargent, John F., Jr.; Sarata, Amanda K. & Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development

Description: 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.
Date: April 11, 2017
Creator: Dabrowska, Agata
Partner: UNT Libraries Government Documents Department

The Federal Food Safety System: A Primer

Description: 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.
Date: December 16, 2016
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department

Orlando Shooting Revives Debate over Restricting Blood Donations by Gay Men

Description: This report discusses new FDA guidance regarding blood donations from sexually-active gay men. Since the 1980s, the Food and Drug Administration (FDA) has recommended that men who have sex with men (MSM) be indefinitely deferred (i.e., permanently banned) from donating blood. This action was taken to help control the spread of the human immunodeficiency virus (HIV) through the blood supply.
Date: August 1, 2016
Creator: Redhead, C. S.
Partner: UNT Libraries Government Documents Department

The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

Description: 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.
Date: June 6, 2016
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

The Veterans Health Administration and Medical Education: A Fact Sheet

Description: This report supplies facts about the Veterans Health Administration and its medical education. It describes the US Department of Veterans Affairs (VA) and its involvement in the medical training of health care professionals. The report also gives details on the VA's academic affiliations, its funding of physician training, and its ongoing graduate medical education (GME) expansion. Figure 1 on page 3 shows the amount the VA spent on education and training from FY2010 to FY2015.
Date: January 19, 2016
Creator: Heisler, Elayne J. & Panangala, Sidath V.
Partner: UNT Libraries Government Documents Department

Health Care for Veterans: Suicide Prevention

Description: 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.
Date: February 23, 2016
Creator: Bagalman, Erin
Partner: UNT Libraries Government Documents Department

Form 1099 Information Reporting Requirements as Modified by the Patient Protection and Affordable Care Act

Description: This report discusses the modifications to IRC § 6041 made by § 9006 of the Patient Protection and Affordable Care Act (PPACA) and briefly discusses the penalties that can be imposed on persons that do not comply with these information reporting requirements.
Date: August 6, 2010
Creator: Pettit, Carol A. & Liu, Edward C.
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

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

Pharmaceutical Supply Chain Security

Description: This report serves as a primer on pharmaceutical supply chain issues. It (1) describes the chain from manufacturer to patient, including where it is vulnerable; (2) summarizes current federal law, regulation, and FDA policies that Congress and the agency designed to protect the integrity of the final drug product, and indicates where those protections may falter; (3) notes state-level and professional association activities; and (4) discusses areas that Congress, FDA, and industry, health care, and patient stakeholders have suggested might be changed to increase the security of the pharmaceutical supply chain.
Date: October 31, 2013
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department

The Ryan White HIV/AIDS Program: Overview and Impact of the Affordable Care Act

Description: This report discusses the impact of the Affordable Care Act on the Ryan White HIV/AIDS Program, which makes federal funds available to metropolitan areas and states to that provide a number of health care services for HIV/AIDS patients.
Date: December 21, 2015
Creator: Johnson, Judith A. & Heisler, Elayne J.
Partner: UNT Libraries Government Documents Department

"Don't Ask, Don't Tell:" The Law and Military Policy on Same-Sex Behavior

Description: 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.
Date: March 25, 2010
Creator: Burrelli, David F.
Partner: UNT Libraries Government Documents Department

Health Care for Veterans: Suicide Prevention

Description: 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.
Date: January 30, 2015
Creator: Bagalman, Erin
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

The Measles: Background and Federal Role in Vaccine Policy

Description: This report presents basic information about measles, its history in the United States, available treatments to prevent individuals from contracting measles, and the federal role in combating measles--from funding, to research, to the authority of the federal government in requiring mandatory childhood vaccinations.
Date: February 9, 2015
Creator: Barry, Matthew B. & Cole, Jared P.
Partner: UNT Libraries Government Documents Department